COMMISSION IMPLEMENTING REGULATION (EU) 2020/1147
of 31 July 2020
granting a Union authorisation for the single biocidal product ‘ClearKlens product based on IPA’
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product
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 |
Maarssenbroeksedijk 2, 3542 DN, Utrecht, Netherlands |
|
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 |
Location of manufacturing sites |
Avenida Conde Duque 5, 7 y 9; Poligono Industrial La Postura, 28343 Valdemoro (Madrid) Spain Strada Statale 235, 26010 Bagnolo Cremasco (CR) Italy Cotes Park Industrial Estate, DE55 4PA Somercotes Alfreton United Kingdom Rembrandtlaan 414, 7545 ZW Enschede Netherlands Morschheimer Strasse 12, 67292 Kirchheimbolanden Germany |
Name of manufacturer |
Multifill BV |
Address of manufacturer |
Constructieweg 25a, 3640 AJ Mijdrecht Netherlands |
Location of manufacturing sites |
Constructieweg 25a, 3640 AJ Mijdrecht Netherlands |
Name of manufacturer |
Flexible Medical Packaging Ltd |
Address of manufacturer |
Unit 8, Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom |
Location of manufacturing sites |
Unit 8, Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom |
Name of manufacturer |
Ardepharm |
Address of manufacturer |
Les Iles Ferays, 07300 Tournon-sur-Rhône France |
Location of manufacturing sites |
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 |
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 |
Shamrockstrasse 88, D-44623 Herne Germany 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 |
Location of manufacturing sites |
Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands |
Active substance |
Propan-2-ol |
Name of manufacturer |
Exxon Mobil Chemicals |
Address of manufacturer |
Hermeslaan 2, 1831 Machelen Belgium |
Location of manufacturing sites |
4045 Scenic Highway, LA 70805 Baton Rouge United States Southampton, SO45 1TX Hampshire United Kingdom |
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 |
2.2.
Type of formulation
3.
HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements |
Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
Precautionary statements |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Avoid breathing spray. Wash hands thoroughly after handling. Store in a well-ventilated place. Keep cool. Dispose of contents in accordance with local regulations. Dispose of container in accordance with local regulations. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. In case of fire: Use alcohol-resistant foam to extinguish. |
4.
AUTHORISED USE(S)
4.1.
Use description
Product type |
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Bacteria Yeasts |
Field(s) of use |
Indoor 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) |
Disinfection using a mop — |
Application rate(s) and frequency |
Apply 18,4 mL product/m2 surface. |
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
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
Product type |
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||
Target organism(s) (including development stage) |
Bacteria Yeasts |
||||||
Field(s) of use |
Indoor 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) |
Disinfection using a cloth |
||||||
Application rate(s) and frequency |
Apply 18,4 mL product/m2 surface. |
||||||
Category(ies) of users |
Professional |
||||||
Pack sizes and packaging material |
|
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
Product type |
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
||||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||||
Target organism(s) (including development stage) |
Bacteria Yeasts |
||||||||
Field(s) of use |
Indoor 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 8, 60 or 150 per hour or more. |
||||||||
Application method(s) |
Disinfection using a trigger spray Wiping optional to spread the product. |
||||||||
Application rate(s) and frequency |
Apply 18,4 mL product/m2 surface. |
||||||||
Category(ies) of users |
Professional |
||||||||
Pack sizes and packaging material |
|
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
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
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
Product type |
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
||||||||||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||||||||||
Target organism(s) (including development stage) |
Bacteria Yeasts |
||||||||||||||
Field(s) of use |
Indoor 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) |
Disinfection of non-porous gloves |
||||||||||||||
Application rate(s) and frequency |
Apply 3 mL of product to gloved hands. |
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Category(ies) of users |
Professional |
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Pack sizes and packaging material |
Automatic dosing:
Manual dosing:
|