Commission Implementing Regulation (EU) 2025/1905of 11 September 2025granting a Union authorisation for the biocidal product family desmanol pure in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council(Text with EEA relevance)

Den Europæiske UnionForordning2025

European Union

Commission Implementing Regulation (EU) 2025/1905 of 11 September 2025 granting a Union authorisation for the biocidal product family desmanol pure in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 19 April 2016, Schülke & Mayr GmbH submitted an application to the European Chemicals Agency (the Agency) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named desmanol pure of product-type 1, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Austria had agreed to evaluate the application. The application was recorded under case number BC-GA023097-64 in the Register for Biocidal Products. (2) desmanol pure contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1. (3) On 13 June 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. (4) On 13 December 2024, the Agency submitted to the Commission its opinion Opinion of 28 November 2024 on the Union authorisation of the biocidal product family desmanol pure (ECHA/BPC/455/2024), https://echa.europa.eu/opinions-on-union-authorisation. , the draft summary of the biocidal product characteristics (SPC) of desmanol pure and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012. (5) The opinion concludes that desmanol pure is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation. (6) On 8 January 2025, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. (7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family desmanol pure. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0033833-0000 is granted to Schülke & Mayr GmbH for the making available on the market and use of the biocidal product family desmanol pure in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 23 October 2025 until 30 September 2035.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 September 2025. For the Commission The President Ursula von der Leyen

Annex

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Desmanol pure Product type(s) PT01: Human hygiene Authorisation number: EU-0033833-0000 R4BP asset number: EU-0033833-0000 PART I FIRST INFORMATION LEVEL

ADMINISTRATIVE INFORMATION 1.1. Family name Namedesmanol pure 1.2. Product type(s) Product type(s)PT01: Human hygiene 1.3. Authorisation holder Name and address of the authorisation holderNameSchuelke & Mayr GmbHAddressRobert-Koch-Str. 2 22851 Norderstedt DEAuthorisation numberEU-0033833-0000R4BP asset numberEU-0033833-0000Date of the authorisation23 October 2025Expiry date of the authorisation30 September 2035 1.4. Manufacturer(s) of the product Name of manufacturerSchülke & Mayr GmbHAddress of manufacturerRobert-Koch-Str. 2 22851 Norderstedt GermanyLocation of manufacturing sitesSchülke & Mayr GmbH site 1 Robert-Koch-Str. 2 22851 Norderstedt GermanyName of manufacturerBOCHEMIE a.s.Address of manufacturerLidická 326 735 95 Bohumín CzechiaLocation of manufacturing sitesBOCHEMIE a.s. site 1 Lidická 326 735 95 Bohumín Czechia Name of manufacturerPrisman Chemie GmbHAddress of manufacturerOtto-Hahn-Ring 6-18 64653 Lorsch GermanyLocation of manufacturing sitesPrisman Chemie GmbH site 1 Otto-Hahn-Ring 6-18 64653 Lorsch GermanyName of manufacturerA.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbHAddress of manufacturerOtto-Brenner-Straße 16 21337 Lüneburg GermanyLocation of manufacturing sitesA.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH site 1 Otto-Brenner-Straße 16 21337 Lüneburg GermanyName of manufacturerLysoform Dr. Hans Rosemann GmbHAddress of manufacturerKaiser-Wilhelm-Straße 133 12247 Berlin GermanyLocation of manufacturing sitesLysoform Dr. Hans Rosemann GmbH site 1 Kaiser-Wilhelm-Straße 133 12247 Berlin GermanyName of manufacturerSterisol ABAddress of manufacturerKronoängsgatan 3 592 23 Vadstena SwedenLocation of manufacturing sitesSterisol AB site 1 Kronoängsgatan 3 592 23 Vadstena SwedenName of manufacturerRudolf Dankwardt GmbHAddress of manufacturerGutenbergring 50-52 22848 Norderstedt GermanyLocation of manufacturing sitesRudolf Dankwardt GmbH site 1 Gutenbergring 50-52 22848 Norderstedt GermanyName of manufacturerRudolf Dankwardt GmbH - JessenitzAddress of manufacturerLagerstr. 15 19249 Jessenitz - Werk / Lübtheen GermanyLocation of manufacturing sitesRudolf Dankwardt GmbH - Jessenitz site 1 Lagerstr. 15 19249 Jessenitz - Werk / Lübtheen Germany 1.5. Manufacturer(s) of the active substance(s) Active substancePropan-2-olName of manufacturerIneos Solvents Germany GmbH (formerly Sasol)Address of manufacturerRömerstraße 733 47443 Moers GermanyLocation of manufacturing sites

Ineos Solvents Germany GmbH (formerly Sasol) site 1 Römerstraße 733 47443 Moers Germany Ineos Solvents Germany GmbH (formerly Sasol) site 2 Shamrockstr. 88 44643 Herne Germany Active substancePropan-2-olName of manufacturerShell Chemicals Europe B.V.Address of manufacturerPostbus 2334 3000 CH Rotterdam Netherlands (the)Location of manufacturing sitesShell Chemicals Europe B.V. site 1 BV/Shell Nederland Raffinaderij B.V. Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the) 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,1 - 75 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30 - 0,5 % (w/w) 2.2. Type(s) of formulation Formulation type(s)AL Any other liquid PART II SECOND INFORMATION LEVEL META SPC(S)

META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifierdesmanol pure meta SPC1 1.2. Suffix to the authorisation number Number1-1 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 - 75 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30,25 - 0,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.
AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #1 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #2 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #3 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #4 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #5 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #6 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. Product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #7.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #7.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #7.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #7.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #7.1.: as required (typically 25 applications per day) Use #7.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm. Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #8 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #8.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry. Use #8.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #8.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec. Use #8.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #8.1.: as required (typically 25 applications per day) Use #8.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #9 Surgical hand rub - professional user – bacteria, yeasts – pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.10. Use description Table 10 Use #10 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #10.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use # 10.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #10.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #10.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #10.1.: as required (typically 25 applications per day) Use #10.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging

Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)desmanol® pureMarket area: EUSeptoderm® liquidMarket area: EUWrights alcohol hand rubMarket area: EURely alcohol hand rubMarket area: EUHS Handisinfection liquidMarket area: EUProfect Hand disinfection liquidMarket area: EUdesmanol® hand disinfectionMarket area: EUsensiva® hand disinfection liquidMarket area: EUdesmanol® N hand disinfectionMarket area: EUunodent hand disinfectionMarket area: EUeurosept hand disinfectionMarket area: EUInnocid HändedesinfektionMarket area: EUdesmanol® pure proMarket area: EUdesmanol® pure expertMarket area: EUdesmanol® pure cleverMarket area: EU desmanol® pure universalMarket area: EUdesmanol® pure pocketMarket area: EUdesmanol® pure clientMarket area: EUmicroshield® hand rubMarket area: EUmicroshield® pureMarket area: EUHalasept 792Market area: EUAuthorisation numberEU-0033833-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30,5 % (w/w)
META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifierdesmanol pure meta SPC2 1.2. Suffix to the authorisation number Number1-2 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 - 75 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30,25 - 0,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects.

EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #11 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #12 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #13 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersIndustrialPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #15 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #16 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #17 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Field of use description: Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Contact time: 90 sec. (in total) Number and timing of application: Frequency: Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #18 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #18.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.

Use #18.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #18.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #18.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #19 Surgical hand rub - professional user – bacteria, yeasts – pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use

The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.10. Use description Table 10 Use #20 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #20.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #20.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #20.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #20.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #20.1.: as required (typically 25 applications per day) Use #20.2.: as required (typically 4 applications per day)

Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.11. Use description Table 11 Use #21 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (in case of special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.12. Use description Table 12 Use #22 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.12.2. Use-specific risk mitigation measures

4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.13. Use description Table 13 Use #23 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.13.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.14. Use description Table 14 Use #24 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.14.2. Use-specific risk mitigation measures

4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)desmanol® pure gelMarket area: EUSeptoderm® IPA gelMarket area: EUWrights alcohol hand gelMarket area: EURely alcohol hand gelMarket area: EUHS Hand disinfection gelMarket area: EUProfect Hand disinfection gelMarket area: EUsensiva® hand gelMarket area: EUdesmanol® N gelMarket area: EU unodent hand gelMarket area: EUeurosept gelMarket area: EUInnocid Händedesinfektions-GelMarket area: EUdesmanol® pure gel proMarket area: EUdesmanol® pure gel expertMarket area: EUdesmanol® pure gel cleverMarket area: EUdesmanol® pure gel universalMarket area: EUdesmanol® pure gel pocketMarket area: EUdesmanol® pure gel clientMarket area: EUmicroshield® gelMarket area: EUmicroshield® pure gelMarket area: EUAuthorisation numberEU-0033833-0002 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30,5 % (w/w)

META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifierdesmanol pure meta SPC3 1.2. Suffix to the authorisation number Number1-3 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 - 75 % (w/w) 2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.
AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #25 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #26 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s)

Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #28 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersIndustrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #29 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #30 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #31 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #31.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #31.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency

Application Rate: Use #31.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #31.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #31.1.: as required (typically 25 applications per day) Use #31.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP.

4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #32 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #32.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry. Use #32.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas, e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #32.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #32.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #32.1: as required (typically 25 applications per day) Use #32.2: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.10. Use description Table 10 Use #34 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #34.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). Use #34.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #34.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #34.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #34.1.: as required (typically 25 applications per day) Use #34.2.: as required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)desmanol® pure lightMarket area: EUAuthorisation numberEU-0033833-0003 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 % (w/w)

META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifierdesmanol pure meta SPC4 1.2. Suffix to the authorisation number Number1-4 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 4 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 - 75 % (w/w) 2.2. Type(s) of formulation of the meta SPC 4 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.
AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #35 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria

Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #36 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #37 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #38 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #39 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria

Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #41 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #41.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #41.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #41.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #41.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #42 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #42.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #42.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #42.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #42.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #42.1.: as required (typically 25 applications per day) Use #42.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #43 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.10. Use description Table 10 Use #44 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #44.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #44.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #44.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #44.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #44.1.: as required (typically 25 applications per day) Use #44.2.: as required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml

Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts, and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.12.

Use description Table 12 Use #46 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.12.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.13. Use description Table 13 Use #47 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor

Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersProfessional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.13.2. Use-specific risk mitigation measures

4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.14. Use description Table 14 Use #48 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.14.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only. 4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)desmanol® pure light gelMarket area: EUAuthorisation numberEU-0033833-0004 1-4Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 % (w/w)
META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifierdesmanol pure meta SPC5 1.2. Suffix to the authorisation number Number1-5 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 5 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 5 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,1 - 63,1 % (w/w) 2.2. Type(s) of formulation of the meta SPC 5 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #49 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #50 Hygienic hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #51 Surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: 2 x 5 mL per disinfection, corresponding to 2 x 2.76 g a.s. Contact time 180 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #52 Hygienic hand rub - industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses,: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersIndustrialPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #53 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi

Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #54 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #55 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #55.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry. Use #55.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #55.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Use #55.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #55.1.: as required (typically 25 applications per day) Use #55.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8. Use description Table 8 Use #56 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #56.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry. Use #56.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #56.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Use #56.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #56.1.: as required (typically 25 applications per day) Use #56.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #57 Surgical hand rub - professional user – bacteria, yeasts, fungi – pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency

Application Rate: Bactericide, yeasticide, fungicide: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #58.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #58.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #58.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Use #58.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #58.1.: as required (typically 25 applications per day) Use #58.2.: as required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

Surgical hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Septoderm® softMarket area: EUseptosoftMarket area: EUpluradent hand disinfectionMarket area: EUDezoseptMarket area: EUAuthorisation numberEU-0033833-0005 1-5Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,1 % (w/w)

META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier Identifierdesmanol pure meta SPC6 1.2. Suffix to the authorisation number Number1-6 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 6 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 6 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,14 - 63,14 % (w/w) 2.2. Type(s) of formulation of the meta SPC 6 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. EUH208: Contains Isoeugenol. May produce an allergic reaction. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.
AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #59 Hygienic hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.

Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 125, 500 1000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.1.2. Use-specific risk mitigation measures

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.2. Use description Table 2 Use #60 Surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 125, 500 1000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.3. Use description Table 3 Use #61 Hygienic/surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use

Indoor use Use #61.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #61.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #61.1.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s. Contact time: 30 sec. Use #61.2.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: Use #61.1.: as required (typically 25 applications per day) Use #61.2.: as required (typically 4 applications per day) Category(ies) of usersProfessional Pack sizes and packaging material Bottle: 125, 500 1000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds. Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.4. Use description Table 4 Use #62 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 125, 500 1000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)AntiLy1Market area: EUAuthorisation numberEU-0033833-0006 1-6Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,14 % (w/w)
META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier Identifierdesmanol pure meta SPC7 1.2. Suffix to the authorisation number Number1-7 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 7 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 7 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,14 - 63,14 % (w/w) 2.2. Type(s) of formulation of the meta SPC 7 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #63 Hygienic hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 125, 500 1000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.1.2. Use-specific risk mitigation measures

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.2. Use description Table 2 Use #64 Surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 125, 500 1000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.3. Use description Table 3 Use #65 Hygienic/surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #65.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #65.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #65.1.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s. Contact time: 30 sec. Use #65.2.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: Use #65.1.: as required (typically 25 applications per day) Use #65.2.: as required (typically 4 applications per day) Category(ies) of usersProfessional Pack sizes and packaging material

Bottle: 125, 500 1000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds. Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:

The authorisation number;

The trade name of the biocidal product;

The identity and content of each active ingredient;

The instructions for use, including the incorporation time required for the biocidal action;

The information according to CLP. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 125, 500 1000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)AntiLy2Market area: EUAuthorisation numberEU-0033833-0007 1-7Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,14 % (w/w)
META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier Identifierdesmanol pure meta SPC8 1.2. Suffix to the authorisation number Number1-8 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 8 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 8 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 - 75 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30,25 - 0,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 8 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.
AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #67 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor

Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #68 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #69 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #70 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersIndustrialPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #71 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.6. Use description Table 6 Use #72 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: as required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #73.1 .: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #73.2 .: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #73.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #73.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Frequency: Use #73.1.: as required (typically 25 applications per day) Use #73.2.: as required (typically 4 applications per day) Number and timing of application: Frequency: Use #73.1.: as required (typically 25 applications per day) Use #73.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm. Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #74 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #74.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry. Use #74.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #74.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec. Use #74.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #74.1.: as required (typically 25 applications per day) Use #74.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Table 9 Use #75 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.10. Use description Table 10 Use #76 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #76.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #76.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #76.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #76.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #76.1.: as required (typically 25 applications per day) Use #76.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)desmanol® pureMarket area: EUSeptoderm® liquidMarket area: EUWrights alcohol hand rubMarket area: EURely alcohol hand rubMarket area: EUHS Handisinfection liquidMarket area: EUProfect Hand disinfection liquidMarket area: EUdesmanol® hand disinfectionMarket area: EUsensiva® hand disinfection liquidMarket area: EUdesmanol® N hand disinfectionMarket area: EUunodent hand disinfectionMarket area: EU eurosept hand disinfectionMarket area: EUInnocid HändedesinfektionMarket area: EUdesmanol® pure proMarket area: EUdesmanol® pure expertMarket area: EUdesmanol® pure cleverMarket area: EUdesmanol® pure universalMarket area: EUdesmanol® pure pocketMarket area: EUdesmanol® pure clientMarket area: EUmicroshield® hand rubMarket area: EUmicroshield® pureMarket area: EUHalasept 792Market area: EUAuthorisation numberEU-0033833-0008 1-8Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30,5 % (w/w)
META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier Identifierdesmanol pure meta SPC9 1.2. Suffix to the authorisation number Number1-9 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 9 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 9 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 - 75 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30,25 - 0,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 9 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #77 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #78 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #79 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #80 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersIndustrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #81 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: as required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.7. Use description Table 7 Use #83 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Contact time: 90 sec. (in total) Number and timing of application: Frequency: Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #84 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #84.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry. Use #84.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #84.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #84.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml

Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #85 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #86.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #86.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #86.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #86.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #86.1.: as required (typically 25 applications per day) Use #86.2.: as required (typically 4 applications per day) Category(ies) of usersProfessional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.11. Use description Table 11 Use #87 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (in case of special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.12. Use description Table 12 Use #88 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 4.12.2. Use-specific risk mitigation measures

4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.13. Use description Table 13 Use #89 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.13.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.14. Use description Table 14 Use #90 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 4.14.2. Use-specific risk mitigation measures

4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 9 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)desmanol® pure gelMarket area: EUSeptoderm® IPA gelMarket area: EUWrights alcohol hand gelMarket area: EU

Rely alcohol hand gelMarket area: EUHS Hand disinfection gelMarket area: EUProfect Hand disinfection gelMarket area: EUsensiva® hand gelMarket area: EUdesmanol® N gelMarket area: EUunodent hand gelMarket area: EUeurosept gelMarket area: EUInnocid Händedesinfektions-GelMarket area: EUdesmanol® pure gel proMarket area: EUdesmanol® pure gel expertMarket area: EUdesmanol® pure gel cleverMarket area: EUdesmanol® pure gel universalMarket area: EUdesmanol® pure gel pocketMarket area: EUdesmanol® pure gel clientMarket area: EUmicroshield® gelMarket area: EUmicroshield® pure gelMarket area: EUAuthorisation numberEU-0033833-0009 1-9 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 % (w/w)1-TetradecanolTetradecan-1-olNon-active substance112-72-1204-000-30,5 % (w/w)

META SPC 10 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 10 identifier Identifierdesmanol pure meta SPC10 1.2. Suffix to the authorisation number Number1-10 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 10 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 10 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 - 75 % (w/w) 2.2. Type(s) of formulation of the meta SPC 10 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.
AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #91 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage)

Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #92 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #93 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and limited spectrum virucidal activity: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #94 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of useReady-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industryApplication method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #95 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.6. Use description Table 6 Use #96 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #97.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #97.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #97.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #97.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #97.1.: as required (typically 25 applications per day) Use #97.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #98 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #98.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry. Use #98.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas, e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #98.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #98.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #98.1: as required (typically 25 applications per day) Use #98.2: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #99 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s)

Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #100.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). Use #100.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #100.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #100.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #100.1.: as required (typically 25 applications per day) Use #100.2.: as required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 10 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)desmanol ® pure lightMarket area: EUAuthorisation numberEU-0033833-0010 1-10Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 % (w/w)
META SPC 11 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 11 identifier Identifierdesmanol pure meta SPC11 1.2. Suffix to the authorisation number Number1-11 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 11 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 11

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 - 75 % (w/w) 2.2. Type(s) of formulation of the meta SPC 11 Formulation type(s)AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #101 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #102 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #104 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersIndustrialPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #105 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.6. Use description Table 6 Use #106 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.7. Use description Table 7 Use #107 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #107.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #107.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #107.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #107.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #108 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #108.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #108.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #108.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #108.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #108.1.: as required (typically 25 applications per day) Use #108.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #109 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.10. Use description Table 10 Use #110 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Indoor use Use #110.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #110.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #110.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #110.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #110.1.: as required (typically 25 applications per day) Use #110.2.: as required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts, and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.11. Use description Table 11 Use #111 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years.

In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.12. Use description Table 12 Use #112 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only. 4.12.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.13. Use description Table 13 Use #113 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 4.13.2. Use-specific risk mitigation measures

4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.14. Use description Table 14 Use #114 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas. (e.g. in case of diseases/special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.14.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 11 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)desmanol ® pure light gelMarket area: EUAuthorisation numberEU-0033833-0011 1-11Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-775 % (w/w)

META SPC 12 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 12 identifier Identifierdesmanol pure meta SPC12 1.2. Suffix to the authorisation number Number1-12 1.3. Product type(s) Product type(s)PT01: Human hygiene
META SPC 12 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 12 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,1 - 63,1 % (w/w) 2.2. Type(s) of formulation of the meta SPC 12 Formulation type(s)AL Any other liquid
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.
AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #115 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #116 Hygienic hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activit)y - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersProfessional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use

The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. 4.2.2. Use-specific risk mitigation measures

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #117 Surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time 180 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #118 Hygienic hand rub - industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of usersIndustrialPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. 4.4.2. Use-specific risk mitigation measures

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

4.6. Use description Table 6 Use #120 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.7. Use description Table 7 Use #121 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #121.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.

Use #121.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #121.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Use #121.2.: : 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #121.1.: as required (typically 25 applications per day) Use #121.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #122 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #122.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry. Use #122.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #122.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Use #122.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #122.1.: as required (typically 25 applications per day) Use #122.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml

Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #123 Surgical hand rub - professional user - bacteria, yeasts, fungi - pouring or pumping - indoor Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells

Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Bactericide, yeasticide, fungicide: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

Product typePT01: Human hygieneWhere relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use Indoor use Use #124.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #124.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description:

Application rate(s) and frequency Application Rate: Use #124.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1.65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s. Contact time: 60 sec. (in total) Use #124.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #124.1.: as required (typically 25 applications per day) Use #124.2.: as required (typically 4 applications per day) Category(ies) of usersProfessionalPack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 12 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures

If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Septoderm® softMarket area: EUseptosoftMarket area: EUpluradent hand disinfectionMarket area: EUDezoseptMarket area: EUAuthorisation numberEU-0033833-0012 1-12Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olPropan-2-olActive substance67-63-0200-661-763,1 % (w/w)

Metadata

Type: Forordning
År: 2025
Ikrafttrædelsesdato: 1. januar 1970