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

ANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT
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 holder
Name
Diversey Europe Operations B.V.
Address
Regulatory team Maarssenbroeksedijk 2 3542 DN Utrecht NL
Authorisation number
EU-0032009-0000
R4BP asset number
EU-0032009-0000
Date of the authorisation
22 January 2025
Expiry date of the authorisation
31 December 2034
1.3.    Manufacturer(s) of the product
Name of manufacturer
Diversey Europe Operations B.V.
Address of manufacturer
Maarssenbroeksedijk 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 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
Name of manufacturer
Pluswipes Ltd
Address of manufacturer
Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Pluswipes Ltd site 1 Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
ITW Contamination Control BV
Address of manufacturer
Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the)
Location of manufacturing sites
ITW Contamination Control BV site 1 Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the)
Name of manufacturer
ITW Texwipe
Address of manufacturer
1210 South Park Drive 27284 North Carolina Kernersville United States (the)
Location of manufacturing sites
ITW Texwipe site 1 1210 South Park Drive 27284 North Carolina Kernersville United States (the)
Name of manufacturer
ITW Contamination Control (Wujiang) Co., LTD
Address of manufacturer
No 4660 Pangjin Road Wujiang Economic &amp; Technological Development Zone Suzhou, Jiangsu province 215021 Suzhou China
Location of manufacturing sites
ITW 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 substance
Propan-2-ol
Name of manufacturer
INEOS Solvents Germany GmbH
Address of manufacturer
Anckelmannplatz D-20537 Hamburg Germany
Location 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 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
Exxon Mobil Chemicals
Address of manufacturer
Hermeslaan 2 1831 Machelen Belgium
Location 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 substance
Propan-2-ol
Name of manufacturer
Novapex
Address of manufacturer
21 Chemin de la Sauvegarde 21 Écully Park CS 33167 69134 Écully France
Location of manufacturing sites
Novapex 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 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
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 type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
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
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 m 2 . 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 users
Industrial; professional
Pack 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 1 000 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 type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
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
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 m 2 . 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 users
Industrial; professional
Pack 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 1 000 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 type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
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
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 m 2 . 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 users
Industrial; professional
Pack 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 1 000 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   ( 1 )
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  ( 2 ) 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.
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
( 2 )   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 ).
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

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