Commission Implementing Regulation (EU) 2025/2221of 31 October 2025amending Implementing Regulation (EU) 2023/364 as regards administrative changes to the Union authorisation of the biocidal product family IPA Family 1(Text with EEA relevance)

Commission Implementing Regulation (EU) 2025/2221 of 31 October 2025 amending Implementing Regulation (EU) 2023/364 as regards administrative changes to the Union authorisation of the biocidal product family IPA Family 1 (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 50(2) thereof, Whereas: (1) On 16 February 2023, Commission Implementing Regulation (EU) 2023/364 Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family IPA Family 1 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 50, 17.2.2023, p. 28, ELI: http://data.europa.eu/eli/reg_impl/2023/364/oj). granted a Union authorisation, under number EU-0028425-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family IPA Family 1. Annex II to that Implementing Regulation provides the summary of product characteristics for that biocidal product family. (2) On 30 November 2023 and 17 December 2024, Ecolab Deutschland GmbH submitted notifications to the European Chemicals Agency (the Agency), in accordance with Article 11(1) of 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, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj). , of administrative changes to the Union authorisation for the biocidal product family IPA Family 1, as referred to in Title 1 of the Annex to that Regulation. The notifications were recorded in the Register for Biocidal Products (the Register) under case numbers BC-KE090454-43 and BC-JF101949-39. The notified proposed changes to that authorisation concern a clarification of the instructions for use for all products in the family, the addition of new trade names, the removal and addition of the biocidal product formulators and the addition of active substance manufacturers. (3) On 24 January 2024 and 16 January 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions ECHA Opinions Nos UAD-C-1706275-25-00/F of 24 January 2024 and UAD-C-1790252-35-00/F of 16 January 2025 on the administrative change of the Union authorisation of the biocidal product family IPA Family 1, https://echa.europa.eu/opinions-on-union-authorisation. on the notified administrative changes to the Union authorisation for the biocidal product family IPA Family 1, together with a revised summary of the biocidal product characteristics. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(4) On 23 January 2025, the Agency transmitted to the Commission a revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family IPA Family 1 in all the official languages of the Union, covering all the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013. (5) The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family IPA Family 1 to introduce the administrative changes requested by Ecolab Deutschland GmbH. (6) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of IPA Family 1 as set out in Annex II to Implementing Regulation (EU) 2023/364 remains unchanged. (7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, Annex II to Implementing Regulation (EU) 2023/364 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the Register in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes. (8) Implementing Regulation (EU) No 2023/364 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Implementing Regulation (EU) No 2023/364 is replaced by the text in the Annex to this Regulation.

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, 31 October 2025. For the Commission The President Ursula von der Leyen

Annex

ANNEX Summary of product characteristics for a biocidal product family IPA Family 1 Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number EU-0028425-0000 R4BP asset number EU-0028425-0000 PART I FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION 1.1. Family name NameIPA Family 1 1.2. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 1.3. Authorisation holder Name and address of the authorisation holderNameEcolab Deutschland GmbHAddressEcolab Allee 1 40789 Monheim am Rhein GermanyAuthorisation numberEU-0028425-0000R4BP asset numberEU-0028425-0000Date of the authorisation9.3.2023Expiry date of the authorisation28.2.2033 1.4. Manufacturer(s) of the product Name of manufacturerEcolab Europe GmbHAddress of manufacturerRichtistrasse, 7 8304 Walliselen SwitzerlandLocation of manufacturing sitesEcolab Europe GmbH site 1 Richtistrasse, 7 8304 Walliselen SwitzerlandName of manufacturerEcolab Limited

Address of manufacturerBrunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesEcolab Limited site 1 Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerEcolab LeedsAddress of manufacturerLotherton Way, Garforth, LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesEcolab Leeds site 1 Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerEsoform S.p.A.Address of manufacturerViale del Lavoro 10, 45100 Rovigo ItalyLocation of manufacturing sitesEsoform S.p.A. site 1 Viale del Lavoro 10, 45100 Rovigo ItalyName of manufacturerNalco Deutschland Manufacturing GmbH und Co.KGAddress of manufacturerJustus-von-Liebig-Str. 11 D-64584 Biebesheim GermanyLocation of manufacturing sitesNalco Deutschland Manufacturing GmbH und Co.KG site 1 Justus-von-Liebig-Str. 11 D-64584 Biebesheim GermanyName of manufacturerEcolab NETHERLANDS BVAddress of manufacturerBrugwal 11, 3432NZ Nieuwegein Netherlands (the)Location of manufacturing sitesEcolab NETHERLANDS BV site 1 Brugwal 11, 3432NZ Nieuwegein Netherlands (the)Name of manufacturerEcolab WeavergateAddress of manufacturerWinnington Avenue CW8 3AA Northwich Cheshire United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesEcolab Weavergate site 1 Winnington Avenue CW8 3AA Northwich Cheshire United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerEcolab Mullingar, Ireland Address of manufacturerForest Park, Zone C Mullingar Ind. Estate, - Mullingar, Co. Westmeath, IrelandLocation of manufacturing sitesEcolab Mullingar, Ireland site 1 Forest Park, Zone C Mullingar Ind. Estate, - Mullingar, Co. Westmeath, IrelandName of manufacturerEcolab d.o.o.Address of manufacturerVajngerlova 4 2000 Maribor SloveniaLocation of manufacturing sitesEcolab d.o.o. site 1 Vajngerlova 4 2000 Maribor SloveniaName of manufacturerEcolab Rozzano, ItalyAddress of manufacturerVia A. Grandi 9/11, 20089 Rozzano (MI) ItalyLocation of manufacturing sitesEcolab Rozzano, Italy site 1 Via A. Grandi 9/11, 20089 Rozzano (MI) ItalyName of manufacturerEcolab B.V.B.AAddress of manufacturerHavenlaan 4 3980 Tessenderlo BelgiumLocation of manufacturing sitesEcolab B.V.B.A site 1 Havenlaan 4 3980 Tessenderlo BelgiumName of manufacturerNalco Española Manufacturing, SLUAddress of manufacturerC/Tramuntana s/n Polígono Industrial de Celrà 17460 Celrà SpainLocation of manufacturing sitesNalco Española Manufacturing, SLU site 1 C/Tramuntana s/n Polígono Industrial de Celrà 17460 Celrà SpainName of manufacturerEcolab production France SASAddress of manufacturerBP509, Avenue de Général Patton 51006 Châlons-en-Champagne FranceLocation of manufacturing sitesEcolab production France SAS site 1 BP509, Avenue de Général Patton 51006 Châlons-en-Champagne FranceName of manufacturerEcolab Mandra, GreeceAddress of manufacturer25km Old National Road Athens- Theve, - Mandra Attica GreeceLocation of manufacturing sitesEcolab Mandra, Greece site 1 25km Old National Road Athens- Theve, - Mandra Attica Greece

Name of manufacturerNALCO FINLAND MANUFACTURING OYAddress of manufacturerKivikummuntie 1, FIN-07955 Tesjoki FinlandLocation of manufacturing sitesNALCO FINLAND MANUFACTURING OY site 1 Kivikummuntie 1, FIN-07955 Tesjoki FinlandName of manufacturerManufacturing Plant Cisterna NalcoAddress of manufacturerVia Ninfina II 4012 Cisterna Di Latina, ItalyLocation of manufacturing sitesManufacturing Plant Cisterna Nalco site 1 Via Ninfina II 4012 Cisterna Di Latina ItalyName of manufacturerManufacturing Plant Fawley NalcoAddress of manufacturerOne buisness center 1180 SO45 3NP Hardley Hants United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesManufacturing Plant Fawley Nalco site 1 One buisness center 1180 SO45 3NP Hardley Hants United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerNalco Champion Plant, Tooling Plant, Aberdeen NalcoAddress of manufacturerMinto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesNalco Champion Plant, Tooling Plant, Aberdeen Nalco site 1 Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerMicrotek Medical B.V.Address of manufacturerHekkehorst, 24 7207 BN Zutphen Netherlands (the)Location of manufacturing sitesMicrotek Medical B.V. site 1 Hekkehorst, 24 7207 BN Zutphen Netherlands (the)Name of manufacturerMicrotek Medical Malta Ltd.Address of manufacturerSorbonne Centre F20 Mosta Technopark MST 3000 Mosta MaltaLocation of manufacturing sitesMicrotek Medical Malta Ltd. site 1 Sorbonne Centre F20 Mosta Technopark MST 3000 Mosta Malta Name of manufacturerInnovate GmbHAddress of manufacturerAm Hohen Stein, 11 06618 Naumburg GermanyLocation of manufacturing sitesInnovate GmbH site 1 Am Hohen Stein, 11 06618 Naumburg GermanyName of manufacturerCHRISTEYNS FRANCE S.A.Address of manufacturer31 rue de la Maladrie 44120 Vertou FranceLocation of manufacturing sitesCHRISTEYNS FRANCE S.A. site 1 54 avenue de la Plaine - ZI 13106 Rousset FranceName of manufacturerTechtexAddress of manufacturerUnits 7 & 8, Rhodes Business Park, Silbum Way M24 4NE Middelton, Manchester United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesTechtex site 1 Units 7 & 8, Rhodes Business Park, Silbum Way M24 4NE Middelton, Manchester United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerTechnical Textile Services LtdAddress of manufacturerUnit 4, Rhodes Business Park, Silburn Way M24 4NE Middleton, Manchester United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesTechnical Textile Services Ltd Unit 4, Rhodes Business Park, Silburn Way M24 4NE Middleton, Manchester United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerPal International LimitedAddress of manufacturerUnit 3 Mountpark, Victoria Road LE67 1FA Ellistown, Coalville United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesPal International Limited Unit 3 Mountpark, Victoria Road LE67 1FA Ellistown, Coalville United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerCID LINES NVAddress of manufacturerWaterpoortstraat 2 8900 Ieper BelgiumLocation of manufacturing sitesCID LINES NV Waterpoortstraat 2 8900 Ieper Belgium

Name of manufacturerLABORATOIRES ANIOSAddress of manufacturer3330 Rue de Lille 59262 Sainghin-en-Mélantois FranceLocation of manufacturing sitesLABORATOIRES ANIOS 3330 Rue de Lille 59262 Sainghin-en-Mélantois France 1.5. Manufacturer(s) of the active substance(s) Active substancePropan-2-olName of manufacturerIneos Solvents Germany GmbHAddress of manufacturerRömerstrasse 733, D-47443 Moers GermanyLocation of manufacturing sites Ineos Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany Ineos Solvents Germany GmbH site 2 Romestrasse, 733, D-47443 Moers 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 Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis, Netherlands (the)Active substancePropan-2-olName of manufacturerExxonMobil Chemical EuropeAddress of manufacturerHermeslaan 2 1831 Machelen BelgiumLocation of manufacturing sites ExxonMobil Chemical Europe site 1 Fawley Refinery and Petrochemical Plant, Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the) ExxonMobil Chemical Europe site 2 Baton Rouge Chemical Plant 4999 Scenic Highway 70805-3359 LA United States (the) Active substancePropan-2-olName of manufacturerBrenntag N.V.Address of manufacturerNijverheidslaan, 38 8540 Deerlijk BelgiumLocation of manufacturing sites Shell Energy and Chemicals Park Rotterdam Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the) ExxonMobil Baton Rouge Refinery 4045 Scenic Highway Baton Rouge 70805 LA United States (the) Active substancePropan-2-olName of manufacturerUNIVARAddress of manufacturerSteuber Drive M44 5AL Manchester United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesExxonMobil Chemicals Fawley Refinery and Petrochemical Plant, Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (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-olActive substance67-63-0200-661-730,3 - 65,66 % (w/w) 2.2. Type(s) of formulation Formulation type(s) AE Aerosol dispenser AL Any other liquid XX – Ready to use wipe impregnated with water based liquid PART II SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier IdentifierMeta SPC: Meta-SPC 1.1 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
2. 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-olActive substance67-63-0200-661-760,61 - 65,66 % (w/w)

2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s)AL Any other liquid 3. 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. 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. P280: Wear eye protection. P280: Wear face protection. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use # 1.1 – Disinfection of surfaces in cleanrooms by spraying or mopping. Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Enveloped viruses Development stage: no data Field(s) of use indoor use Disinfection of cleanroom hard non-porous surfaces in life sciences industry. Application method(s) Method: Trigger spraying or mopping Detailed description: Direct application onto surfaces by trigger spraying followed by wiping with a dry wipe for distribution or mopping. Application rate(s) and frequency Application Rate: c.a. 18 ml/m2 ready to use product Number and timing of application: As required Category(ies) of usersprofessionalPack sizes and packaging material0,5 liter - 10 liters Polyvinylpyrrolidone (PVP) or (High density polyetheylene (HDPE) bottle / container (with and without trigger spray) 4.1.1. Use-specific instructions for use Clean and dry surfaces prior to disinfection. Application by trigger spraying directly onto the surface: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m2, corresponding to 20 strokes/m2) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Always close the nozzle after use. Do not transfer the product to a trigger sprayer, but apply from a package delivered with trigger sprayer. Application on surfaces by Mopping: Impregnate the clean mop with the liquid using a mop bucket and apply to the surface to be disinfected. Ensure complete wetting of the surface (18 mL/m2). Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. No additional wiping necessary. Do not mix product with other products. Do not pour any unused product back into the original container. 4.1.2. Use-specific risk mitigation measures Avoid contact with eyes. Gloves, eye protection and respiratory protection equipment (RPE) of protection factor of 10 should be worn during mopping. Unprotected personnel should not be present in the room during disinfection by mopping.

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 Potential Health Effects Eyes – Causes serious eye irritation. Skin – Health injuries are not known or expected under normal use. Ingestion – Health injuries are not known or expected under normal use. Inhalation – Inhalation may cause central nervous system effects. Chronic Exposure - Health injuries are not known or expected under normal use. First Aid 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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use (5.4). 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 (5.5). 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use Please refer to specific instructions for use for meta-SPC 1 5.2. Risk mitigation measures Please refer to specific Risk mitigation measures for meta-SPC 1 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Please refer to specific information for meta-SPC 1 5.4. Instructions for safe disposal of the product and its packaging Product Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility. Contaminated packaging Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national, and/or international regulations. Product residues Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store away from direct sunlight and at temperature between 0°C to 25°C Shelf life: 24 months 6. OTHER INFORMATION Safety data sheet and technical sheet available for professional users on request. AEL acute/medium-term/long-term 17,9 mg/kg body weight (bw)/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report on Propan-2-ol in PT2 – Germany – (January 2015).

1. 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)Klercide 70/30 IPAMarket area: EUKlercide non-sterile 70/30 IPAMarket area: EUKlercide 70/30 IPA non-sterileMarket area: EUAuthorisation numberEU-0028425-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,27 % (w/w)
2. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier IdentifierMeta SPC: Meta-SPC 1.2 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
3. 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-olActive substance67-63-0200-661-760,61 - 65,66 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s)XX – Ready to use wipe impregnated with water based liquid
4. 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. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statementsP210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
5. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use # 2.1 – Disinfection of surfaces in cleanroom by wiping Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Enveloped viruses Development stage: no data Field(s) of use indoor use Disinfection of cleanroom hard non-porous surfaces in life sciences industry by wiping. Application method(s) Method: Wiping Detailed description: Direct application onto surfaces by wiping with pre-wetted wipes. Application rate(s) and frequency Application Rate: c.a. 10 ml/m2 ready to use product Number and timing of application: Tub (200 wipes/pack, 230×200, Synthetic/cellulose blend): c.a. 0,13 m2 can be disinfected with 1 wipe Tub (100 wipes/pack, 200×230, Synthetic/cellulose blend): c.a. 0,23 m2 can be disinfected with 1 wipe Mop (10 wipes/pack, 420×250, Polyester/cellulose): c.a. 1,1 m2 can be disinfected with 1 wipe Pouch (15 wipes/pack, 200×200, Polyester/cellulose): c.a. 0,33 m2 can be disinfected with 1 wipe Pouch (10 wipes/pack, 200×200, 100% polyester): c.a. 0,51 m2 can be disinfected with 1 wipe Pouch (15 wipes/pack, 300×300, Polyester/cellulose): c.a. 0,47 m2 can be disinfected with 1 wipe

Pouch (10 wipes/pack, 300×300, 100% polyester): c.a. 0,73 m2 can be disinfected with 1 wipe Category(ies) of usersprofessionalPack sizes and packaging material Tub (HDPE) (100-200 wipes/pack, 200×230, Synthetic/cellulose blend) Pouch (10-30 wipes/pack, 200×200, Polyester/cellulose, 100% polyester) Pouch (10-30 wipes/pack, 300×300, Polyester/cellulose, 100% polyester) Mop wipe (10-30 wipes/pack, 420×250, Polyester/cellulose) 4.1.1. Use-specific instructions for use Clean and dry surfaces prior to disinfection. Wiping: Wipe surface to be disinfected. Use wipe once. Ensure complete wetting of the surface (10 ml/m2). About 0,13-1,1 m2 can be disinfected with 1 wipe depending on the wipe. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Dispose of the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary. For multipack wipes, close the package after opening. Do not mix with other products. 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 Potential Health Effects Eyes – Causes serious eye irritation. Skin – Health injuries are not known or expected under normal use. Ingestion – Health injuries are not known or expected under normal use. Inhalation – Inhalation may cause central nervous system effects. Chronic Exposure – Health injuries are not known or expected under normal use. First Aid 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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use (5.4). 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 (5.5). 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use Please refer to specific instructions for use for meta-SPC 2 5.2. Risk mitigation measures Please refer to specific risk mitigation measures for meta-SPC 2 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Please refer to specific information for meta-SPC 2 5.4. Instructions for safe disposal of the product and its packaging Product Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.

Contaminated packaging Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations. Product residues Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store away from direct sunlight and at temperature between 0°C to 25°C Shelf life: 24 months 6. OTHER INFORMATION Safety data sheet and technical sheet available for professional users on request. AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 Germany – (January 2015). 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)Klerwipe 70/30 IPAMarket area: EUKlerwipe non-sterile 70/30 IPAMarket area: EUKlerwipe 70/30 IPA non-sterileMarket area: EUAuthorisation numberEU-0028425-0002 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,27 % (w/w)

1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier IdentifierMeta SPC: Meta-SPC 1.3 1.2. Suffix to the authorisation number Number1-3 1.3. Product type(s) Product type(s)PT02: Disinfectants and algaecides not intended for direct application to humans or animals
2. 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-olActive substance67-63-0200-661-760,61 - 65,66 % (w/w) 2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s)AE Aerosol dispenser
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements H222 : Extremely flammable aerosol. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H229: Pressurised container: May burst if heated 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. P280: Wear eye protection. P280: Wear face protection. P211: Do not spray on an open flame or other ignition source. P251: Do not pierce or burn, even after use. P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F.
4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use # 3.1 – Disinfection of surfaces in cleanroom by aerosols Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage)

Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Enveloped viruses Development stage: no data Field(s) of use indoor use Disinfection of cleanroom hard non-porous surfaces in life sciences industry. Application method(s) Method: Aerosol spraying Detailed description: Direct application onto surfaces by aerosol spraying followed by wiping with a dry wipe for distribution. Application rate(s) and frequency Application Rate: c.a. 18 ml/m2 ready to use product Number and timing of application: As required Category(ies) of usersprofessionalPack sizes and packaging material0,2 liter – 0,5 liter aluminium can 4.1.1. Use-specific instructions for use Clean and dry surfaces prior to disinfection. Application by aerosol spraying: For optimum results hold can upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m2, corresponding to 7,2 seconds/m2 spraying) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Do not mix product with other products. 4.1.2. Use-specific risk mitigation measures Avoid contact with eyes. 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 Potential Health Effects Eyes – Causes serious eye irritation. Skin – Health injuries are not known or expected under normal use. Ingestion – Health injuries are not known or expected under normal use. Inhalation – Inhalation may cause central nervous system effects. Intentional misuse by deliberate inhalation may be harmful or fatal. Chronic Exposure – Health injuries are not known or expected under normal use. First Aid 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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use (5.4). 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 (5.5). 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use Please refer to specific instructions of use for meta-SPC 3 5.2. Risk mitigation measures Please refer to specific risk mitigation measures for meta-SPC 3

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Please refer to specific information for meta-SPC 3 5.4. Instructions for safe disposal of the product and its packaging Product Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility. Contaminated packaging Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations. Product residues Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store away from direct sunlight and at temperature between 0°C to 25°C Shelf life: 24 months 6. OTHER INFORMATION Safety data sheet and technical sheet available for professional users on request. AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015). 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)Klercide 70/30 IPA AerosolMarket area: EUAuthorisation numberEU-0028425-0003 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,269 % (w/w)

1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier IdentifierMeta SPC: Meta-SPC 1.4 1.2. Suffix to the authorisation number Number1-4 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area
2. 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-olActive substance67-63-0200-661-730,3 - 30,3 % (w/w) 2.2. Type(s) of formulation of the meta SPC 4 Formulation type(s)XX - Ready to use wipe impregnated with water based liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements H226: 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 statementsP210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use # 4.1 – Disinfection of non-food and food contact surfaces by pre-wetted wipes

Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Where relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Field(s) of use indoor use Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices. Application method(s) Method: Wiping Detailed description: Direct application onto hard non-porous surfaces by wiping. Application rate(s) and frequency Application Rate: c.a. 10 ml/m2 at room temperature ready to use product Number and timing of application: Wiping with two superposed wipes. About 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used. Category(ies) of usersprofessionalPack sizes and packaging material Container (PP) (100 wipes 130×210) Container (HDPE) (150 wipes 180×300) Bucket (PP) (1500 wipes 150×210) Pouch (PET/PE) (200 wipes 130×210) Wipe material (all packagings): blend of Pulp, Polyester, Binder 4.1.1. Use-specific instructions for use Wiping: Clean and dry surfaces prior to disinfection. Wipe surface to be disinfected with two superposed wipes. Use the wipes once. For optimum results ensure complete wetting of the surface (10 ml/m2 ), about 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used. Allow to take effect for 15 minutes for bacteria and yeast. Dispose the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary. For multipack wipes, close the package after opening. Do not mix product with other products. 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 Potential Health Effects Eyes – Causes serious eye irritation. Skin – Health injuries are not known or expected under normal use. Ingestion – Health injuries are not known or expected under normal use. Inhalation – Inhalation may cause central nervous system effects. Chronic Exposure – Health injuries are not known or expected under normal use. First Aid 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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person isable to swallow. Do NOT induce vomiting. 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.

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use (5.4). 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 (5.5). 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4 5.1. Instructions for use Please refer to specific instructions of use for meta-SPC 4 5.2. Risk mitigation measures Please refer to specific risk mitigation measures for meta-SPC 4 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Please refer to specific information for meta-SPC 4 5.4. Instructions for safe disposal of the product and its packaging Product Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility. Contaminated packaging Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations. Product residues Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store away from direct sunlight and at temperature between 0°C to 25°C Shelf life: 24 months 6. OTHER INFORMATION Safety data sheet and technical sheet available for professional users on request. AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015). 7. 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)Eco-Bac WipesMarket area: EUSirafan Bac WipesMarket area: EUAuthorisation numberEU-0028425-0004 1-4Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-730,3 % (w/w)

1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier IdentifierMeta SPC: Meta-SPC 1.5 1.2. Suffix to the authorisation number Number1-5 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area
2. 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-olActive substance67-63-0200-661-730,3 - 30,3 % (w/w) 2.2. Type(s) of formulation of the meta SPC 5 Formulation type(s)AL Any other liquid

1. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements H226: 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. P280: Wear eye protection. P280: Wear face protection.
2. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use # 5.1 – Disinfection of non-food and food contact surfaces by trigger spray Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Where relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Field(s) of use indoor use Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices. Application method(s) Method: Trigger spraying Detailed description: Direct application onto hard non-porous surfaces by trigger spraying. Application rate(s) and frequency Application Rate: c.a. 18 ml/m2 at room temperature ready to use product Number and timing of application: As required Category(ies) of usersprofessionalPack sizes and packaging material0,5 liter – 10 liter HDPE container (with trigger spray) 4.1.1. Use-specific instructions for use Application by trigger spraying: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m2, corresponding to 29 strokes/m2). Allow to take effect for 30 seconds for bacteria and yeast. Always close the nozzle after use. Do not mix product with other products. Do not pour any unused product back into the original container. 4.1.2. Use-specific risk mitigation measures Avoid contact with eyes. 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 Potential Health Effects Eyes – Causes serious eye irritation. Skin – Health injuries are not known or expected under normal use. Ingestion – Health injuries are not known or expected under normal use. Inhalation – Inhalation may cause central nervous system effects. Chronic Exposure – Health injuries are not known or expected under normal use. First Aid 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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use (5.4). 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 (5.5). 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5 5.1. Instructions for use Please refer to specific instructions of use for meta-SPC 5 5.2. Risk mitigation measures Please refer to specific risk mitigation measures for meta-SPC 5 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Please refer to specific information for meta-SPC 5 5.4. Instructions for safe disposal of the product and its packaging Product Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility. Contaminated packaging Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations. Product residues Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store away from direct sunlight and at temperature between 0°C to 25°C Shelf life: 24 months 6. OTHER INFORMATION Safety data sheet and technical sheet available for professional users on request. AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015). 7. 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)Sirafan Speed-FRMarket area: EUAuthorisation numberEU-0028425-0005 1-5Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-730,3 % (w/w)