Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2025/2553 18.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2553 of 17 December 2025 amending Implementing Regulation (EU) 2020/1147 as regards administrative changes to the Union authorisation for the single biocidal product ‘ClearKlens product based on IPA’ (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on...
Official Journal EN of the European Union L series 2025/2553 18.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2553 of 17 December 2025 amending Implementing Regulation (EU) 2020/1147 as regards administrative changes to the Union authorisation for the single biocidal product ‘ClearKlens product based on IPA’ (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(1), and in particular Article 50(2) thereof,
Whereas:
(1) On 31 July 2020, Commission Implementing Regulation (EU) 2020/1147(2)granted a Union authorisation, under number EU-0022128-0000, to Diversey Europe Operations B.V. for the making available on the market and use of the single biocidal product ‘ClearKlens product based on IPA’. Annex to that Implementing Regulation provides the summary of product characteristics for that single biocidal product.
(2) On 21 October 2021, Diversey Europe Operations B.V. submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013(3), a notification of administrative change to the Union authorisation for the single biocidal product ‘ClearKlens product based on IPA’, recorded in the register for biocidal products under case number BC-DN070816-28. The notified proposed change concern the addition of a manufacturer of the active substance.
(3) On 10 November 2021, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinion(4)on the notified administrative change to the Union authorisation for the single biocidal product ‘ClearKlens product based on IPA’. In the opinion, the Agency concludes that the proposed change is an administrative change as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the change, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.
(4) On 3 January 2022, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product ‘ClearKlens product based on IPA’ in all official languages of the Union, covering the administrative change applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.
(5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation for the single biocidal product ‘ClearKlens product based on IPA’ to introduce the administrative change requested by Diversey Europe Operations B.V.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2020/1147 of 31 July 2020 granting a Union authorisation for the single biocidal product ‘ClearKlens product based on IPA’ (OJ L 252, 4.8.2020, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2020/1147/oj).
(3) 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).
(4) ECHA opinion UAD-C-1543546-33-00/F of 10 November 2021 on administrative changes of the Union authorisation of the single biocidal product ‘ClearKlens product based on IPA’, https://echa.europa.eu/opinions-on-union-authorisation.
ELI: http://data.europa.eu/eli/reg_impl/2025/2553/oj 1/12EN OJ L, 18.12.2025
(6) Except for the amendments regarding the administrative change, all other information included in the summary of the biocidal product characteristics of ‘ClearKlens product based on IPA’ as set out in Annex to Implementing Regulation (EU) 2020/1147 remain 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, the Annex to Implementing Regulation (EU) 2020/1147 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 for biocidal products 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 2020/1147 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1 The Annex to Implementing Regulation (EU) 2020/1147 is replaced by the text set out 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, 17 December 2025.
For the Commission The President Ursula VON DER LEYEN 2/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2553/ojEN OJ L, 18.12.2025 ANNEX Summary of product characteristics for a biocidal product ClearKlens product based on IPA Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Authorisation number:EU-0022128-0000 R4BP asset number:EU-0022128-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product Trade name(s) ClearKlens IPA ClearKlens IPA 70% ClearKlens IPA 70% v/v ClearKlens IPA VH1 ClearKlens IPA Airless ClearKlens IPA Pouch ClearKlens IPA Non Sterile ClearKlens IPA Non Sterile VH1 ClearKlens IPA SS ClearKlens IPA SS VH1 ClearKlens IPA RTU ClearKlens IPA RTU VH1 Texwipe® Sterile 70% Isopropanol VH01 ClearKlens IPA
1.2. Authorisation holder Name and address of the authorisation holder Name Diversey Europe Operations B.V.
Address De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL Authorisation number EU-0022128-0000 R4BP asset number EU-0022128-0000 Date of the authorisation 24.8.2020 Expiry date of the authorisation 31.7.2030
1.3. Manufacturer(s) of the product Name of manufacturer Diversey Europe Operations B.V.
Address of manufacturer Maarssenbroeksedijk 2 3542 DN 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
ELI: http://data.europa.eu/eli/reg_impl/2025/2553/oj 3/12EN OJ L, 18.12.2025 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 67292 Kirchheimbolanden Germany Name of manufacturer Multifill BV Address of manufacturer Constructieweg 25a 3640 AJ Mijdrecht Netherlands
(the) Location of manufacturing sites Multifill BV site 1 Constructieweg 25a 3640 AJ Mijdrecht Netherlands (the) Name of manufacturer Flexible Medical Packaging Ltd Address of manufacturer Unit 8, Hightown, White Cross Industrial Estate LA1 4XS Lancaster, Lancashire United Kingdom of Great Britain and Northern Ireland (the) Location of manufacturing sites Flexible 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 manufacturer Ardepharm Address of manufacturer Les Iles Ferays 07300 Tournon-sur-Rhône France Location of manufacturing sites Ardepharm site 1 Les Iles Ferays 07300 Tournon-sur- Rhône France Name of manufacturer Entegris Cleaning Process (ECP) S.A.S Address of manufacturer 395 rue Louis Lépine 34000 Montpellier France Location of manufacturing sites Entegris Cleaning Process (ECP) S.A.S site 1 395 rue Louis Lépine 34000 Montpellier France
1.4. Manufacturer(s) of the active substance(s) Active substance Propan-2-ol Name of manufacturer INEOS Solvents GmbH Address of manufacturer Anckelmannsplatz D-20537 Hamburg Germany Location of manufacturing sites INEOS Solvents GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany INEOS Solvents GmbH site 2 Römerstrasse 733 D-47443 Moers Germany 4/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2553/ojEN OJ L, 18.12.2025 Active substance Propan-2-ol Name of manufacturer Shell Chemicals Europe B.V.
Address of manufacturer Postbus 2334 3000 CH Rotterdam Netherlands (the) Location of manufacturing sites Shell Chemicals Europe B.V. site 1 Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the) Active substance Propan-2-ol Name of manufacturer Novapex Address of manufacturer 21 Chemin de la Sauvegarde - 21 Ecully Parc - CS 33167 69134 Écully Cedex France Location of manufacturing sites Novapex site 1 Novapex SAS Usine de Rousillon, Rue Gaston Monmousseau 38556 Saint Maurice l’Exil, Cédex France Active substance Propan-2-ol Name of manufacturer Exxon Mobil Chemicals Address of manufacturer Hermeslaan 2 1831 Machelen Belgium Location of manufacturing sites Exxon Mobil Chemicals site 1 4045 Scenic Highway LA 70805 Baton Rouge United States (the) Exxon Mobil Chemicals Southampton SO45 1TX Hampshire United Kingdom of Great Britain and Northern Ireland (the)
2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63,1 % (w/w) substance
2.2. Type(s) of formulation AL Any other liquid
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 spray.
P264: Wash hands thoroughly after handling.
P403+P235: Store in a well-ventilated place. Keep cool.
P501: Dispose of contents, in accordance with local regulations.
P501: Dispose of container, in accordance with local regulations.
ELI: http://data.europa.eu/eli/reg_impl/2025/2553/oj 5/12EN OJ L, 18.12.2025 P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P370+P378: In case of fire: Use alcohol-resistant foam to extinguish.
4. AUTHORISED USE(S)
4.1. Use description Table 1 PT02: Non-porous hard surface disinfectant – professionals – mopping Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: no data stage) 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 product for the disinfection of cleaned non-porous hard surfaces in pharmaceutical and cosmetics manufacturing facilities with air change rate of 60 per hour or more and in clean rooms with air change rate of 150 per hour or more.
Application method(s) Method: Disinfection using a mop
Detailed description: - Application rate(s) and frequency Application Rate: Apply 18,4 mL product/m2surface. 0
Number and timing of application: - Category(ies) of users professional Pack sizes and packaging material Containers (High Density Polyethylene (HDPE), Polypropylene (PP), Polyethylene (PE)): 1 - 20 L.
4.1.1. Use-specific instructions for use Ready to use product for the disinfection of non-porous hard surfaces.
6/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2553/ojEN OJ L, 18.12.2025 Clean and dry the surface before disinfection. Wet the mop with the disinfectant and mop the surface. Wet the surface completely. Allow to take effect for at least 30 seconds.
Used mops must be stored in a closed container.
4.1.2. Use-specific risk mitigation measures Apply the product only in a sufficiently ventilated room. The minimum air change rates required are: — 60/h in pharmaceutical and cosmetics manufacturing facilities;
— 150/h in cleanrooms.
Do not use more than 18,4 mL product/m2.
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 PT02: Non-porous hard surface disinfectant – professionals – cloth Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: no data stage) 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 product for the disinfection of cleaned non-porous hard surfaces in laboratories with air change rate of 8 per hour or more, in pharmaceutical and cosmetics manufacturing facilities with air change rate of 60 per hour or more and in clean rooms with air change rate of 150 per hour or more.
Application method(s) Method: Disinfection using a cloth
Detailed description: - Application rate(s) and frequency Application Rate: Apply 18,4 mL product/m2surface. 0
Number and timing of application: -
ELI: http://data.europa.eu/eli/reg_impl/2025/2553/oj 7/12EN OJ L, 18.12.2025 Category(ies) of users professional Pack sizes and packaging material — Containers (High Density PolyEthylene (HDPE), Polypropylene
(PP), Polyethylene (PE)): 1 - 20 L — Containers (HDPE, PP, PE) with a pump: 200 L (cleanroom only) — Intermediate bulk containers (IBCs) with a pump (HDPE, PP, PE):
950 and 1 000 L (cleanroom only)
4.2.1. Use-specific instructions for use Ready to use product for the disinfection of non-porous hard surfaces.
Clean and dry the surface before disinfection. Wet the cloth with the disinfectant and wipe the surface. Wet the surface completely. Allow to take effect for at least 30 seconds. In cleanrooms, the exact amount of required product can also be dispensed either using a low flow-rate spray lance or into a bucket via a system of pipes. Used cloths must be disposed of in a closed container.
4.2.2. Use-specific risk mitigation measures Apply the product 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;
— 150/h in cleanrooms.
Do not use more than 18,4 mL product/m2.
The following personal risk mitigation measure can be applied for wiping disinfection 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 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 PT02: Non-porous hard surface disinfectant – professionals – spraying Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the Not relevant authorised use 8/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2553/ojEN OJ L, 18.12.2025 Target organism(s) (including development Scientific name: no data stage) 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 product for the disinfection of cleaned non-porous hard surfaces in laboratories with air change rate of 8 per hour or more, in pharmaceutical and cosmetics manufacturing facilities with air change rate of 60 per hour or more and in clean rooms with air change rate of 150 per hour or more.
Application method(s) Method: Disinfection using a trigger spray
Detailed description:
Wiping optional to spread the product.
Application rate(s) and frequency Application Rate: Apply 18,4 mL product/m2surface. 0
Number and timing of application: - Category(ies) of users professional Pack sizes and packaging material — Trigger spray pouch (PE): 0,9 – 20 L — Bag in bottle (multilayer coextruded five-layer Ethylene vinyl acetate (EVA)/EVA/Polyvinylidene dichloride (PVDC)/EVA/EVA bag in a HDPE, PP or PE bottle: 0,9 – 2 L — Trigger Spray bottle (HDPE, PP, PE): 0,5 – 1,5 L — Airless trigger spray bottle (Low-density polyethylene (LDPE)):
0,25 – 1 L
4.3.1. Use-specific instructions for use Ready to use product for the disinfection of non-porous hard surfaces.
Clean and dry the surface before disinfection. Spray the surface, wipe if necessary to spread the product. Wet the surface completely. Allow to take effect for at least 30 seconds. Used cloths must be disposed in a closed container.
Number of applications per type of packaging, necessary to obtain an application rate of 18,4 mL product / m2
surface: — Trigger spray pouch: apply 19 sprays / m2surface; — Sterile trigger (bag in bottle): apply 16 sprays / m2surface; — Trigger spray bottle: apply 14 sprays / m2surface; — Airless trigger spray bottle: apply 21 sprays / m2surface.
4.3.2. Use-specific risk mitigation measures Apply the product 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;
— 150/h in cleanrooms Do not use more than 18,4 mL product/m2.
ELI: http://data.europa.eu/eli/reg_impl/2025/2553/oj 9/12EN OJ L, 18.12.2025
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.
4.4. Use description Table 4 PT02: Non-porous glove disinfectant – professionals – non-porous glove disinfection Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: no data stage) 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 product for the disinfection of clean non-porous gloves in laboratories with air change rate of 8 per hour or more, in pharmaceutical and cosmetics manufacturing facilities with air change rate of 60 per hour or more and in clean rooms with air change rate of 150 per hour or more.
Application method(s) Method: Disinfection of non-porous gloves
Detailed description: - Application rate(s) and frequency Application Rate: Apply 3 mL of the product to gloved hands. 0
Number and timing of application: - Category(ies) of users professional Pack sizes and packaging material Automatic dosing — Containers (HDPE, PP, PE): 1 - 20 L — Containers (HDPE, PP, PE) with a pump: 200 L (cleanrooms only) — IBCs with a pump (HDPE, PP, PE): 950 and 1 000 L (cleanrooms only) Manual dosing — Trigger spray pouch (PE): 0,9 - 20 L — Bag in bottle (multilayer coextruded five-layer EVA/EVA/PVDC/EVA/EVA bag in a HDPE, PP or PE bottle): 0,9 - 2 L — Trigger Spray bottle (HDPE, PP, PE): 0,5 – 1,5 L — Airless trigger spray bottle (LDPE): 0,25 - 1 L 10/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2553/ojEN OJ L, 18.12.2025
4.4.1. Use-specific instructions for use Ready to use product for the disinfection of non-porous gloves.
Automatic dosing:
Apply 3 mL of the product directly onto clean gloved hands, distribute evenly and make sure to wet the surface completely. Allow to take effect for at least 30 seconds.
Manual dosing:
Spray 3 mL of the product directly onto clean gloved hands, distribute evenly and make sure to wet the surface completely. Allow to take effect for at least 30 seconds.
Number of applications per type of packaging, necessary to apply 3 mL of product onto clean gloved hands: — Trigger spray pouch: apply 3 sprays of the product on two hands; — Sterile trigger (bag in bottle): apply 3 sprays of the product on two hands;
— Trigger spray bottle: apply 3 sprays of the product on two hands; — Airless trigger spray bottle: apply 4 sprays of the product on two hands.
4.4.2. Use-specific risk mitigation measures Apply the product 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;
— 150/h in cleanrooms.
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 See general directions for use.
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(1)
5.1. Instructions for use See use specific instructions.
5.2. Risk mitigation measures Wear new protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).
Avoid contact with eyes.
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
ELI: http://data.europa.eu/eli/reg_impl/2025/2553/oj 11/12EN OJ L, 18.12.2025
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: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTRE, doctor or physician if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing. If irritation occurs and persists, get medical attention.
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Get medical attention or advice if you feel unwell.
Environmental precautions:
The product should not reach sewage water or drainage ditch undiluted or unneutralised.
Do not allow the product to enter drainage system, surface or ground water. Dilute with plenty of water.
Methods and material for containment and cleaning up. Absorb the product 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. Dispose of or incinerate in accordance with the local regulations.
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 30 °C.
Store in a closed 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/m3for the professional user was agreed and used for the risk assessment of the product.
12/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2553/oj