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

ANNEXSummary of product characteristics for a biocidal product
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/m 2 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/m 2 .
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/m 2 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/m 2 .
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/m 2 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 / m 2 surface:
—
Trigger spray pouch: apply 19 sprays / m 2 surface;
—
Sterile trigger (bag in bottle): apply 16 sprays / m 2 surface;
—
Trigger spray bottle: apply 14 sprays / m 2 surface;
—
Airless trigger spray bottle: apply 21 sprays / m 2 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/m 2 .
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/m 3  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.
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

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