LegalizeCommission 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
A Union authorisation with authorisation number EU-0022128-0000 is granted 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’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 24 August 2020 until 31 July 2030.
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.
ANNEX
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
| 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. |
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.
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.
See general directions for use.
See general directions for use.
See general directions for use.
4.2. Use description
| 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) |
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.
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.
See general directions for use.
See general directions for use.
See general directions for use.
4.3. Use description
| 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 |
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.
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.
See general directions for use.
See general directions for use.
See general directions for use.
4.4. Use description
| 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 |
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.
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.
See general directions for use.
See general directions for use.
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.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.