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
Date: 2025-12-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, pharmaceutical product








L_202502553EN.000101.fmx.xml












Official Journal of the European Union


EN
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.












(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
            





(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.




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




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

















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 substance


67-63-0


200-661-7


63,1  % (w/w)




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.
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 authorised use


Not relevant




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 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/m2 surface. 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.
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 authorised use


Not relevant




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 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/m2 surface. 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










—


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 authorised use


Not relevant




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 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/m2 surface. 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 / m2 surface;










—


Sterile trigger (bag in bottle): apply 16 sprays / m2 surface;










—


Trigger spray bottle: apply 14 sprays / m2 surface;










—


Airless trigger spray bottle: apply 21 sprays / m2 surface.




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.
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 authorised use


Not relevant




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 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








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.
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/m3 for the professional user was agreed and used for the risk assessment of the product.


(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
ISSN 1977-0677 (electronic edition)