Commission Implementing Regulation (EU) 2023/2087 of 28 September 2023 granting a Union authorisation for the biocidal product family Lysoform IPA Surface in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the CouncilText with EEA relevance.
European Union
Commission Implementing Regulation (EU) 2023/2087 of 28 September 2023 granting a Union authorisation for the biocidal product family Lysoform IPA Surface 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. , and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 25 November 2022, Lysoform Dr Hans Rosemann GmbH submitted to the European Chemicals Agency (the Agency) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4). for authorisation of a same biocidal product family, as referred to in Article 1 of that Regulation, named Lysoform IPA Surface, for product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-DP082158-26 in the Register for Biocidal Products (the Register). The application also indicated the application number of the related reference biocidal product family Lyso IPA Surface Disinfection, recorded in the Register under case number BC-GX025200-35. (2) The same biocidal product family Lysoform IPA Surface 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-types 2 and 4. (3) On 31 March 2023, the Agency submitted to the Commission its opinion ECHA opinion for Lysoform IPA Surface, 31 March 2023, https://echa.europa.eu/opinions-on-union-authorisation. and the draft summary of the biocidal product characteristics (SPC) of Lysoform IPA Surface in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. (4) The opinion concludes that the proposed differences between the same biocidal product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4). , and that based on the assessment of the related reference biocidal product family Lyso IPA Surface Disinfection and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.
(5) On 31 March 2023, 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. (6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family Lysoform IPA Surface. (7) The expiry date of this authorisation is aligned to the expiry date of the reference biocidal product family Lyso IPA Surface Disinfection. (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-0030790-0000 is hereby granted to Lysoform Dr Hans Rosemann GmbH for the making available on the market and use of the same biocidal product family Lysoform IPA Surface in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 19 October 2023 until 30 November 2030.
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, 28 September 2023. For the Commission The President Ursula von der Leyen
Annex
ANNEX Summary of product characteristics for a biocidal product family Lysoform IPA Surface Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Product type 4 – Food and feed area (Disinfectants) Authorisation number: EU-0030790-0000 R4BP asset number: EU-0030790-0000 PART I FIRST INFORMATION LEVEL
- ADMINISTRATIVE INFORMATION 1.1. Family name NameLysoform IPA Surface 1.2. Product type(s) Product type(s) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants) 1.3. Authorisation holder Name and address of the authorisation holderNameLysoform Dr Hans Rosemann GmbHAddressKaiser-Wilhelm-Str. 133, 12247 Berlin GermanyAuthorisation numberEU-0030790-0000R4BP asset numberEU-0030790-0000Date of the authorisation19 October 2023Expiry date of the authorisation30 November 2030 1.4. Manufacturer(s) of the biocidal products Name of manufacturerLysoform Dr Hans Rosemann GmbHAddress of manufacturerKaiser-Wilhelm-Straße 133, 12247 Berlin GermanyLocation of manufacturing sitesKaiser-Wilhelm-Straße 133, 12247 Berlin GermanyName of manufacturerImecoAddress of manufacturerBoschstr. 5, 63768 Hösbach Germany Location of manufacturing sites Boschstr. 5, 63768 Hösbach Germany Neue Straße 2-4, 09471 Köningswalde Germany Name of manufacturerA.F.P. GmbHAddress of manufacturerOtto Brenner Straße 16, 21337 Lüneburg GermanyLocation of manufacturing sitesOtto Brenner Straße 16, 21337 Lüneburg GermanyName of manufacturerSterisol ABAddress of manufacturerKronoängsgatan 3, 592 23 Vadstena SwedenLocation of manufacturing sitesKronoängsgatan 3, 592 23 Vadstena SwedenName of manufacturerWHR GmbHAddress of manufacturerAm Galgenturm 2, 97638 Mellrichstadt GermanyLocation of manufacturing sitesAm Galgenturm 2, 97638 Mellrichstadt GermanyName of manufacturerHygan GmbH | SrlAddress of manufacturerMeucci-Str. 5, 39055 Leifers | Laives (BZ) ItalyLocation of manufacturing sitesMeucci-Str. 5, 39055 Leifers | Laives (BZ) ItalyName of manufacturerLaboratoire Sarbec SAAddress of manufacturer10 rue du Vertuquet, 59960 Neuville-en-Ferrain FranceLocation of manufacturing sites10 rue du Vertuquet, 59960 Neuville-en-Ferrain FranceName of manufacturerDr Schumacher GmbHAddress of manufacturerAm Roggenfeld 3, 34323 Malsfeld GermanyLocation of manufacturing sites
Am Roggenfeld 3, 34323 Malsfeld Germany Jeleniogórska 12, 59-800 Lubań Poland 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 Römerstraße 733, 47443 Moers Germany Shamrockstr. 88, 44643 Herne Germany Active substancePropan-2-olName of manufacturerShell Chemicals Europe B.V.Address of manufacturerPostbus 2334, 3000 CH Rotterdam NetherlandsLocation of manufacturing sitesShell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxPropan-2-olActive Substance67-63-0200-661-763,163,1 2.2. Type(s) of formulation Formulation(s) Any other liquid (AL), ready-to-use Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation PART II SECOND INFORMATION LEVEL – META SPC(S) META SPC 1
- META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier IdentifierSuperficid® 1.2. Suffix to the authorisation number Number1-1 1.3. Product type(s) Product type(s) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants)
- META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxPropan-2-olActive Substance67-63-0200-661-763,163,1 2.2. Type(s) of formulation of the meta SPC 1 Formulation(s)Any other liquid (AL), ready-to-use
- HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to/container to an approved waste disposal plant.
- AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1
Use # 1 disinfection of surfaces – spraying Product typePT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)Where relevant, an exact description of the authorised use- Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Field(s) of use Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B) Application method(s) Method: Spraying Detailed description: Product will be sprayed directly on the surface. Application rate(s) and frequency Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application:
Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 125-1000 ml packaging material: HDPE Clack cap material: PP; Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil) 4.1.1. Use-specific instructions for use Spray ready-to-use product onto the surfaces and allow to take effect for at least 1 minute at room temperature (20 ± 2 °C). 4.1.2. Use-specific risk mitigation measures The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product. 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 See general directions for use. 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 See general directions for use. 4.2. Use description Table 2 Use # 2 – disinfection of surfaces – wiping Product typePT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)Where relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Field(s) of use Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B) Application method(s) Method: Wiping Detailed description: Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping). Application rate(s) and frequency Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application:
Category(ies) of users Industrial Professional Pack sizes and packaging material
Bottle: 125-1000 ml packaging material: HDPE Clack cap material: PP Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil) Canister: 5-30 L packaging material: HDPE closure material: HDPE 4.2.1. Use-specific instructions for use Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C). 4.2.2. Use-specific risk mitigation measures The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product. 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 See general directions for use. 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 See general directions for use. 4.3. Use description Table 3 Use # 3 – disinfection of surfaces with food and feed contact – spraying Product typePT04 – Food and feed area (Disinfectants)Where relevant, an exact description of the authorised use- Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - Field(s) of use Indoor Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) Application method(s) Method: Spraying Detailed description: Product will be sprayed directly on the surface. Application rate(s) and frequency Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application:
Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 125-1000 ml packaging material: HDPE Clack cap material: PP Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil) 4.3.1. Use-specific instructions for use Spray ready-to-use product onto the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity). 4.3.2. Use-specific risk mitigation measures The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product. 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
See general directions for use. 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 See general directions for use. 4.4. Use description Table 4 Use # 4 – disinfection of surfaces with food and feed contact – wiping Product typePT04 – Food and feed area (Disinfectants)Where relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - Field(s) of use Indoor Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) Application method(s) Method: Wiping Detailed description: Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping). Application rate(s) and frequency Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application:
Category(ies) of users Industrial Professional Pack sizes and packaging material Bottle: 125-1000 ml packaging material: HDPE Clack cap material: PP Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil) Canister: 5-30 L packaging material: HDPE closure material: HDPE 4.4.1. Use-specific instructions for use Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C). 4.4.2. Use-specific risk mitigation measures The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product. 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 See general directions for use. 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 See general directions for use. 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. OF THE META SPC 1 5.1. Instructions for use Clean the surface carefully before use. Remove excess water from the surface before disinfection, if appropriate. Do not apply more than 25 ml/m2. Make sure to wet surfaces completely. Used wipes must be disposed in a closed container.
5.2. Risk mitigation measures The product must only be applied for disinfection of small surfaces. Ensure adequate ventilation to prevent the formation of explosive atmospheres. Avoid contact with eyes. Apply a funnel for refilling. Keep out of reach of children and pets. Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid: In case of accident: Call a poison centre or a doctor. IF INHALED: Remove person to fresh air and keep comfortable for breathing. If on skin: Wash with water. If skin irritation occurs: Get medical advice. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. 5.4. Instructions for safe disposal of the product and its packaging
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months Keep container tightly closed. Store in a well-ventilated place. Protect from sunlight. Store at room temperature in the original container. 6. OTHER INFORMATION The product contains propan-2-ol (CAS No: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product. 7. 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)Superficid®Market area: EUDesocid rapidMarket area: EUNeoseptin rapidMarket area: EUNovosept rapidMarket area: EUNovoseptin rapidMarket area: EU Lyorthol rapidMarket area: EUCosmo rapidMarket area: EUFordesin rapidMarket area: EUSaltero rapidMarket area: EUProp70 rapidMarket area: EUAldovet rapidMarket area: EUVetfarm rapidMarket area: EUMDI rapidMarket area: EUAntiseptica rapidMarket area: EUSterisol SurfaceMarket area: EUMENNO® I-QUICK plusMarket area: EUAuthorisation numberEU-0030790-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,1 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Superficid® pureMarket area: EUDesocid rapid pureMarket area: EUNeoseptin rapid pureMarket area: EUNovosept rapid pureMarket area: EUNovoseptin rapid pureMarket area: EULyorthol rapid pureMarket area: EUCosmo rapid pureMarket area: EUFordesin rapid pureMarket area: EUSaltero rapid pureMarket area: EUProp70 rapid pureMarket area: EUAldovet rapid pureMarket area: EUVetfarm rapid pureMarket area: EUMDI rapid pureMarket area: EUAntiseptica rapid pureMarket area: EUSterisol Surface pureMarket area: EUBTS 6000Market area: EUMENNO® I-QUICKMarket area: EUEWA® DES readyMarket area: EUKiehl-RapinolMarket area: EUDes AMarket area: EU
Authorisation numberEU-0030790-0002 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,1 META SPC 2
- META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier IdentifierDescorapid® 1.2. Suffix to the authorisation number Number1-2 1.3. Product type(s) Product type(s) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants)
- META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxPropan-2-olActive Substance67-63-0200-661-763,163,1 2.2. Type(s) of formulation of the meta SPC 2 Formulation(s)Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
- HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to/container to an approved waste disposal plant.
- AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 5 Use # 1 – disinfection of surfaces – wiping Product typePT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)Where relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Field(s) of use Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B) Application method(s) Method: Wiping Detailed description: Product will be wiped directly on the surface. Application rate(s) and frequency Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application:
Category(ies) of users Industrial Professional Pack sizes and packaging material Can: 100-150 wipes Packaging: HDPE
Closure material: HDPE Pack: 100-150 wipes Packaging: PET/PE 4.1.1. Use-specific instructions for use Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C). 4.1.2. Use-specific risk mitigation measures See general directions for use. 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 See general directions for use. 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 See general directions for use. 4.2. Use description Table 6 Use # 2 – disinfection of surfaces with food and feed contact – wiping Product typePT04 – Food and feed area (Disinfectants)Where relevant, an exact description of the authorised use- Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - Field(s) of use Indoor Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) Application method(s) Method: Wiping Detailed description: Product will be wiped directly on the surface. Application rate(s) and frequency Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application:
Category(ies) of users Industrial Professional Pack sizes and packaging material Can: 100-150 wipes Packaging: HDPE Closure material: HDPE Pack: 100-150 wipes Packaging: PET/PE 4.2.1. Use-specific instructions for use Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C). 4.2.2. Use-specific risk mitigation measures See general directions for use. 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 See general directions for use. 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 See general directions for use. 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. OF THE META SPC 2 5.1. Instructions for use Clean the surface carefully before use. Remove excess water from the surface before disinfection, if appropriate. Make sure to wet surfaces completely. Used wipes must be disposed in a closed container. 5.2. Risk mitigation measures The product must only be applied for disinfection of small surfaces. Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes. Keep out of reach of children and pets. Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid: In case of accident: Call a poison centre or a doctor. IF INHALED: Remove person to fresh air and keep comfortable for breathing. If on skin: Wash with water. If skin irritation occurs: Get medical advice. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. 5.4. Instructions for safe disposal of the product and its packaging
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 24 months Keep container tightly closed. Store in a well-ventilated place. Protect from sunlight. Store at room temperature in the original container. 6. OTHER INFORMATION The product contains propan-2-ol (CAS No: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product. 7. 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)Descorapid® TücherMarket area: EUDesocid TücherMarket area: EUNeoseptin TücherMarket area: EUNovosept TücherMarket area: EUNovoseptin TücherMarket area: EULyorthol TücherMarket area: EUCosmo TücherMarket area: EUFordesin TücherMarket area: EUSaltero TücherMarket area: EUProp70 TücherMarket area: EUManosafe TücherMarket area: EUDermoguard TücherMarket area: EUDermosafe TücherMarket area: EUAldovet TücherMarket area: EUVetfarm TücherMarket area: EUMDI TücherMarket area: EUAntiseptica TücherMarket area: EUAntiseptica wipesMarket area: EUMENNO®WIPMarket area: EUDescorapid® wipesMarket area: EUDesocid wipesMarket area: EUNeoseptin wipesMarket area: EUNovosept wipesMarket area: EUNovoseptin wipesMarket area: EULyorthol wipesMarket area: EUCosmo wipesMarket area: EUFordesin wipesMarket area: EUSaltero wipesMarket area: EUProp70 wipesMarket area: EUManosafe wipesMarket area: EUDermoguard wipesMarket area: EUDermosafe wipesMarket area: EUAldovet wipesMarket area: EU Vetfarm wipesMarket area: EUMDI wipesMarket area: EUAntiseptica wipesMarket area: EUAuthorisation numberEU-0030790-0003 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,1 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Superficid® pure wipesMarket area: EUDesocid rapid pure wipesMarket area: EUNeoseptin rapid pure wipesMarket area: EUNovosept rapid pure wipesMarket area: EUNovoseptin rapid pure wipesMarket area: EULyorthol rapid pure wipesMarket area: EUCosmo rapid pure wipesMarket area: EUFordesin rapid pure wipesMarket area: EUSaltero rapid pure wipesMarket area: EUProp70 rapid pure wipesMarket area: EUAldovet rapid pure wipesMarket area: EUVetfarm rapid pure wipesMarket area: EUMDI rapid pure wipesMarket area: EUAntiseptica rapid pure wipesMarket area: EUAuthorisation numberEU-0030790-0004 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,1
Metadata
- Type
- Forordning
- År
- 2023
- Ikrafttrædelsesdato
- 1. januar 1970