Commission Implementing Regulation (EU) 2025/86of 20 January 2025correcting Implementing Regulation (EU) 2024/2189 as regards the summary of the biocidal product characteristics(Text with EEA relevance)

Commission Implementing Regulation (EU) 2025/86 of 20 January 2025 correcting Implementing Regulation (EU) 2024/2189 as regards the summary of the biocidal product characteristics (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 22 April 2024, the Standing Committee on Biocidal Products (the Committee) expressed a positive opinion on a draft act granting a Union authorisation for the single biocidal product ClearKlens wipes based on IPA including the Annex thereto providing the summary of the biocidal product characteristics (the SPC). (2) On 3 September 2024, Commission Implementing Regulation (EU) 2024/2189 Commission Implementing Regulation (EU) 2024/2189 of 3 September 2024 granted a Union authorisation for the single biocidal product ClearKlens wipes based on IPA in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2024/2189, 4.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2189/oj). granting the authorisation was adopted and subsequently published, however without the SPC. (3) Implementing Regulation (EU) 2024/2189 should therefore be corrected to include the SPC. (4) In the interests of clarity and legal certainty, that correction should be made without delay and this Regulation should apply retroactively as the terms and conditions relating to the making available on the market and use of the single biocidal product ClearKlens wipes based on IPA are defined in the SPC. (5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products delivered prior to the adoption of Implementing Regulation (EU) 2024/2189, HAS ADOPTED THIS REGULATION:

Article 1

In Implementing Regulation (EU) 2024/2189, the text set out in the Annex to this Regulation is added as the Annex.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 24 September 2024. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 January 2025. For the Commission The President Ursula von der Leyen

Annex

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT ClearKlens wipes based on IPA Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals Authorisation number: EU-0032009-0000 R4BP asset number: EU-0032009-0000

1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) ClearKlens IPA 70 % non sterile WW ClearKlens IPA 70 % v/v wipes

ClearKlens IPA 70 % wipes ClearKlens IPA 70 % wipes non sterile ClearKlens IPA 70 % wipes non sterile VH1 ClearKlens IPA 70 % wipes VH1 ClearKlens IPA 70 % WW ClearKlens IPA 70 % WW VH1 ClearKlens IPA 70 % non sterile wipes ClearKlens IPA 70 % non sterile wipes VH1 ClearKlens IPA wipe ClearKlens IPA Wipes ClearKlens IPA WW Divodes IPA WW IPA 70 % v/v WW IPA 70 % wipes IPA 70 % WW IPA 70 % WW VH1 IPA wipes IPA WW Divodes IPA Wipes Soft Care IPA Desinfection Wipes TASKI Sprint IPA Wipes TASKI Sani IPA Wipes TASKI Jontec IPA Wipes TechniSat® DES TexVantage™ DES PolySat® DES AlphaSat™ DES ThermaSat DES TechniScrub™ DES HoneyComb® DES AlphaSat™ 10 DES ClearKlens IPA 70 % v/v WW Suma IPA Wipes Vectra Honeycomb 10 TechniSat DCO TechniSat MDC TexVantage DCO TexVantage MDC PolySat DCO PolySat MDC AlphaSat DCO AlphaSat MDC ThermaSat DCO ThermaSat MDC TechniScrub DCO TechniScrub MDC HoneyComb DCO HoneyComb MDC AlphaSat 10 DCO AlphaSat 10 MDC 1.2. Authorisation holder Name and address of the authorisation holderNameDiversey Europe Operations B.V.AddressRegulatory team Maarssenbroeksedijk 2 3542 DN Utrecht NLAuthorisation numberEU-0032009-0000R4BP asset numberEU-0032009-0000Date of the authorisation22 January 2025Expiry date of the authorisation31 December 2034 1.3. Manufacturer(s) of the product Name of manufacturerDiversey Europe Operations B.V.Address of manufacturerMaarssenbroeksedijk 2 3542DN Utrecht Netherlands (the)Location of manufacturing sites Diversey Europe Operations B.V. site 1 Avenida Conde Duque 5, 7 y 9; Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain Diversey Europe Operations B.V. site 2 Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy Diversey Europe Operations B.V. site 3 Cotes Park Industrial Estate DE55 4PA Somercotes Alfreton United Kingdom of Great Britain and Northern Ireland (the) Diversey Europe Operations B.V. site 4 Rembrandtlaan 414 7545 ZW Enschede Netherlands (the) Diversey Europe Operations B.V. site 5 Morschheimer Strasse 12 D-67292 Kirchheimbolanden Germany Name of manufacturerFlexible Medical Packaging LtdAddress of manufacturerUnit 8, Hightown, White Cross Industrial Estate LA1 4XS Lancaster, Lancashire United Kingdom of Great Britain and Northern Ireland (the) Location of manufacturing sitesFlexible Medical Packaging Ltd site 1 Unit 8, Hightown, White Cross Industrial Estate LA1 4XS Lancaster, Lancashire United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerArdepharmAddress of manufacturerLes Iles Ferays 07300 Tournon-sur-Rhône FranceLocation of manufacturing sitesArdepharm site 1 Les Iles Ferays 07300 Tournon-sur-Rhône FranceName of manufacturerEntegris Cleaning Process (ECP) S.A.SAddress of manufacturer395 rue Louis Lépine 34000 Montpellier FranceLocation of manufacturing sitesEntegris Cleaning Process (ECP) S.A.S site 1 395 rue Louis Lépine 34000 Montpellier FranceName of manufacturerPluswipes LtdAddress of manufacturerPywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesPluswipes Ltd site 1 Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerITW Contamination Control BVAddress of manufacturerSaffierlaan 5 2132 VZ Hoofddorp Netherlands (the)Location of manufacturing sitesITW Contamination Control BV site 1 Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the)Name of manufacturerITW TexwipeAddress of manufacturer1210 South Park Drive 27284 North Carolina Kernersville United States (the)Location of manufacturing sitesITW Texwipe site 1 1210 South Park Drive 27284 North Carolina Kernersville United States (the)Name of manufacturerITW Contamination Control (Wujiang) Co., LTD

Address of manufacturerNo 4660 Pangjin Road Wujiang Economic & Technological Development Zone Suzhou, Jiangsu province 215021 Suzhou ChinaLocation of manufacturing sitesITW Contamination Control (Wujiang) Co., LTD site 1 No 4660 Pangjin Road Wujiang Economic & Technological Development Zone Suzhou, Jiangsu province 215021 Suzhou China 1.4. Manufacturer(s) of the active substance(s) Active substancePropan-2-olName of manufacturerINEOS Solvents Germany GmbHAddress of manufacturerAnckelmannplatz D-20537 Hamburg GermanyLocation of manufacturing sites INEOS Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany INEOS Solvents Germany GmbH site 2 Römerstrasse 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 Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)Active substancePropan-2-olName of manufacturerExxon Mobil ChemicalsAddress of manufacturerHermeslaan 2 1831 Machelen BelgiumLocation of manufacturing sites Exxon Mobil Chemicals site 1 4045 Scenic Hailway LA 70805 Baton Rouge United States (the) Exxon Mobil Chemicals site 2 Southampton SO45 1TX Hampshire United States (the) Active substancePropan-2-olName of manufacturerNovapexAddress of manufacturer21 Chemin de la Sauvegarde 21 Écully Park CS 33167 69134 Écully FranceLocation of manufacturing sitesNovapex site 1 Rue Gaston Monmousseau 38556 Saint Maurice l’Exil France 2. PRODUCT COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the product Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olactive substance67-63-0200-661-763,1 % (w/w) 2.2. Type(s) of formulation XX: presaturated wipes 3. HAZARD AND PRECAUTIONARY STATEMENTS 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. P271: Use only outdoors or in a well-ventilated area. P280: Wear protective eye protection/face protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTRE if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P370+P378: In case of fire: Use water to extinguish. P264: Wash hands thoroughly after handling. P501: Dispose of contents to hazardous waste collection point in accordance with local regulations. P405: Store locked up. 4. AUTHORISED USE(S) 4.1. Use description Table 1

Use #1 PT02: Hard surface disinfectant – professionals – 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 Field(s) of use Indoor use Ready-to-use (RTU) pre-saturated wipes for the disinfection of pre-cleaned non-porous hard surfaces in laboratories, cleanrooms and pharmaceutical and cosmetics manufacturing facilities. Application method(s) Method: Wiping using RTU pre-saturated wipes Detailed description: — Application rate(s) and frequency Application rate: Use X per 0,5 m2. Where X is 1 wipe; for wipes with the size 20-46 cm × 38-68 cm 2 wipes; for wipes with the size 15-31 cm × 20-31 cm 3 wipes; for wipes with the size 15 cm × 15 cm 4 wipes; for wipes with the size 10 cm × 10 cm Dilution (%): Ready-to-use Number and timing of application: Apply according to disinfection protocols up to 20 times a day Contact time: allow to take effect for at least 5 minutes. Category(ies) of usersIndustrial; professionalPack sizes and packaging material Packaging: Slider bag Polyethylene terephthalate (PET) / Low-density polyethylene (LDPE) / High-density polyethylene (HDPE) with co-extruded (COEX) barrier layer Flexpack bag PET/LDPE/HDPE with COEX barrier layer Bucket – HDPE Tub – HDPE Each package can contain between 5 to 500 wipes, the bucket (HDPE) can contain up to 1000 wipes. Wipes: 100 % Polyester 100 % Polypropylene 50/50 % Polyester/Cellulose or 45/55 % Polyester/Cellulose 4.1.1. Use-specific instructions Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Fold wipe in mid-air into quarter folds. Wipe in one direction with overlapping strokes. Wet the surface completely. Allow to take effect for at least 5 minutes. Only use wet wipes. Close the package after use. Dispose used wipes immediately after application into a closed container. 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 See general directions for use. 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 PT02: Hard surface disinfectant – professionals – 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 Field(s) of use Indoor use Ready to use (RTU) pre-saturated wipes for the disinfection of pre-cleaned non-porous hard surfaces in cleanrooms and pharmaceutical and cosmetics manufacturing facilities. Application method(s) Method: mopping using RTU pre-satured wipes Detailed description: — Application rate(s) and frequency Application rate: Use X per 1 m2. Where X is 1 wipe for wipes with the size 25-38 cm × 38-68 cm; 2 wipes for wipes with the size 20-46 cm × 31-46 cm; 3 wipes for wipes with the size 15-23 cm × 20-28 cm; Dilution (%): Ready-to-use Number and timing of application: Apply according to disinfection protocols up to 2 times a day Contact time: allow to take effect for at least 5 minutes. Category(ies) of usersIndustrial; professionalPack sizes and packaging material Packaging: Slider bag Polyethylene terephthalate (PET) / Low-density polyethylene (LDPE) / High-density polyethylene (HDPE) with co-extruded (COEX) barrier layer Flexpack bag PET/LDPE/HDPE with COEX barrier layer Bucket – HDPE Tub – HDPE Each package can contain between 5 to 500 wipes, the bucket (HDPE) can contain up to 1000 wipes. Wipes: 100 % Polyester 100 % Polypropylene 50/50 % Polyester/Cellulose or 45/55 % Polyester/Cellulose 4.2.1. Use-specific instructions Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Attach wipe onto the mopping tool. Wipe systematically with overlapping strokes. Wet the surface completely. Allow to take effect for at least 5 minutes. Only use wet wipes. Close the package after use. Dispose used wipes immediately after application into a closed container. 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 See general directions for use. 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 PT02: Hard surface disinfectant – professionals – wiping (equipment and small surfaces) 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 Field(s) of use Indoor use Ready-to-use (RTU) pre-saturated wipes for the disinfection of equipment and small non-porous hard surfaces in facilities (including hospitals, nursing homes and medical practices)

Application method(s) Method: Wiping using RTU pre-saturated wipes Detailed description: — Application rate(s) and frequency Application rate: Use X per 0,5 m2. Where X is 1 wipe; for wipes with the size 20-46 cm × 38-68 cm 2 wipes; for wipes with the size 15-31 cm × 20-31 cm 3 wipes; for wipes with the size 15 cm × 15 cm 4 wipes; for wipes with the size 10 cm × 10 cm Dilution (%): Ready-to-use Number and timing of application: Apply according to disinfection protocols up to 20 times a day Contact time: allow to take effect for at least 5 minutes. Category(ies) of usersIndustrial; professionalPack sizes and packaging material Packaging: Slider bag Polyethylene terephthalate (PET) / Low-density polyethylene (LDPE) / High-density polyethylene (HDPE) with co-extruded (COEX) barrier layer Flexpack bag PET/LDPE/HDPE with COEX barrier layer Bucket – HDPE Tub – HDPE Each package can contain between 5 to 500 wipes, the bucket (HDPE) can contain up to 1000 wipes. Wipes: 100 % Polyester 100 % Polypropylene 50/50 % Polyester/Cellulose or 45/55 % Polyester/Cellulose 4.3.1. Use-specific instructions Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Fold wipe in mid-air into quarter folds and wipe in one direction with overlapping strokes. Wet the surface completely. Allow to take effect for at least 5 minutes. Only use wet wipes. Close the package after use. Dispose used wipes immediately after application into a closed container 4.3.2. Use-specific risk mitigation measures See general directions for use. Keep children away from treated surfaces until dried. 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 See general directions for use. 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. 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. 5.1. Instructions for use See use-specific instructions for use. 5.2. Risk mitigation measures The product must be applied only in a sufficiently ventilated room. The minimum air change rates required are: 8/h in laboratories 60/h in pharmaceutical and cosmetics manufacturing facilities 20/h in cleanrooms 1,5/h in other areas (including hospitals, nursing homes and medical practices) Wear chemical resistant gloves consistent with European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). This is without prejudice to the application of Council Directive 98/24/EC Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11, ELI: http://data.europa.eu/eli/dir/1998/24/oj).

and other Union legislation in the area of health and safety at work. See section 6 for the full references. Avoid contact with eyes. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Inhalation: May cause drowsiness or dizziness. Eye contact: Causes severe irritation. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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 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. Environmental precautions: Shall not be released to the ground, watercourses, pipes and sewers. Do not allow to enter the drainage system. Methods and material for containment and cleaning up. Absorb with liquid-binding material (sand, diatomite, universal binders, sawdust). 5.4. Instructions for safe disposal of the product and its packaging The product and its container must be disposed of in a safe way, in compliance with any relevant legislation on the disposal of hazardous waste. Perform disposal or incineration in accordance with the local legislation and requirements. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage 2 years shelf life. Keep only in original packaging. Store away from direct sunlight and below 40 °C. Store in a closed container. 6. OTHER INFORMATION The active substance concentration expressed as percent volume is 70 % v/v. The full titles of the references in section 5.2 Risk mitigation measures are: EN 374 – Protective gloves against dangerous chemicals and micro-organisms. Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work.