LegalizeCommission Implementing Regulation (EU) 2019/2029 of 29 November 2019 granting a Union authorisation for the single biocidal product CVAS Disinfectant product based on Propan-2-ol (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0020461-0000 is granted to CVAS Development GmbH for the making available on the market and use of the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’, in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 24 December 2019 until 30 November 2029.
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
Summary of product characteristics for a biocidal product
CVAS Disinfectant product based on Propan-2-ol
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Authorisation number: EU-0020461-0000
R4BP asset number: EU-0020461-0000
1. ADMINISTRATIVE INFORMATION
| Trade name(s) | CVAS Disinfectant product based on Propan-2-ol calgonit DS 622 R 3000 SCHNELLDESINFEKTION IPADES 70 Alpha Septin Blu-Sept Disinfect home Schnell Des Disinfect Rapid Bakt-Ex Pur Bakt-Ex Rapid ROTIE-DES quick Bactazol I Dezynfektator EOSSAN-Desinfektionsspray-Fluid FS-7-Spray Gartengeräte Hygiene Spray NeudoClean Hygiene Spray |
|---|---|
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Am Hafen 16 68526 Ladenburg Germany |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| Name of manufacturer | Brenntag GmbH |
| --- | --- |
| Address of manufacturer | Messeallee 11 45131 Essen Germany |
| Location of manufacturing sites | Brenntag GmbH Am Nordseekai 22 73207 Plochingen Germany |
| Name of manufacturer | ACT GmbH |
| --- | --- |
| Address of manufacturer | Weidenweg 12 73087 Bad Boll Germany |
| Location of manufacturing sites | ACT GmbH Weidenweg 12 73087 Bad Boll Germany |
| Name of manufacturer | Meyer Chemie GmbH & Co. KG |
| --- | --- |
| Address of manufacturer | Werkstr 25 32130 Enger Germany |
| Location of manufacturing sites | Meyer Chemie GmbH & Co. KG Werkstr 25 32130 Enger Germany |
| Name of manufacturer | Calvatis GmbH |
| --- | --- |
| Address of manufacturer | Am Hafen 16 68526 Ladenburg Germany |
| Location of manufacturing sites | Calvatis GmbH Am Hafen 16 68526 Ladenburg Germany |
| Name of manufacturer | Arthur Schopf Hygiene GmbH & Co. KG |
| --- | --- |
| Address of manufacturer | Pfaffensteinstr. 1 83115 Neubeuern Germany |
| Location of manufacturing sites | Arthur Schopf Hygiene GmbH & Co. KG Pfaffensteinstr. 1 83115 Neubeuern Germany |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Shell Nederland Raffinaderij B.V. |
| Address of manufacturer | Vondelingenweg 601 3196 KK, Vodelingenenplaat Rotterdam Netherlands (the) |
| Location of manufacturing sites | Shell Nederland Raffinaderij B.V. site 1 Vondelingenweg 601 3196 KK, Vodelingenenplaat Rotterdam Netherlands (the) |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | ExxonMobil |
| Address of manufacturer | 4999 Scenic Highway LA 70897 Baton Rouge, Louisana United States (the) |
| Location of manufacturing sites | ExxonMobil site 1 4999 Scenic Highway LA 70897 Baton Rouge, Louisana United States (the) |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | INEOS Solvents Germany GmbH |
| Address of manufacturer | Römerstraße 733 47443 Moers Germany |
| Location of manufacturing sites | INEOS Solvents Germany GmbH site 1 Römerstraße 733 47443 Moers Germany |
2. PRODUCT COMPOSITION AND FORMULATION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 61,25 % (w/w) |
Any other liquid (ready-to-use)
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 | P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents /container in accordance with local regulations. P264: Wash hands thoroughly after handling. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P370+P378: In case of fire: Use alcohol-resistant foam to extinguish. |
4. AUTHORISED USE(S)
| 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: Bacteria Common name: Bacteria Development stage: All Scientific name: Yeasts Common name: Yeasts Development stage: All |
| Field(s) of use | indoor use Disinfection of non-porous surfaces in domestic areas. |
| Application method(s) | Method: Spraying Detailed description: Spraying (with trigger sprayer or pump spray) Method: Spraying and wiping Detailed description: Spraying (with trigger sprayer or pump spray) and wiping Method: Pouring and wiping Detailed description: - |
| Application rate(s) and frequency | Application Rate: 40-50 mL/m2 - Number and timing of application: - |
| Category(ies) of users | general public (non-professional) |
| Pack sizes and packaging material | 1. Bottle: High-density polyethylene (HDPE, 250 - 1000 mL 2. Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL |
The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:
— Trigger spray: Apply 20 spray strokes per 0,5 m2.
— Pump spray: Apply 3 jets per 100 cm2.
— Bottle: Apply one measuring cup per m2
See section 5.2.
See section 5.3.
See section 5.4.
See section 5.5.
| 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: Bacteria Common name: Bacteria Development stage: All Scientific name: Yeasts Common name: Yeasts Development stage: All |
| Field(s) of use | indoor use Disinfection of non-porous surfaces in industry, small enterprises, institutions and domestic areas. |
| Application method(s) | Method: Spraying Detailed description: Spraying (with trigger sprayer or pump spray) Method: Spraying and wiping Detailed description: Spraying (with trigger sprayer or pump spray) and wiping Method: Pouring and wiping Detailed description: - |
| Application rate(s) and frequency | Application Rate: 40-50 mL/m2 - Number and timing of application: - |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 1. Bottle: HDPE, 250 - 1000 mL 2. Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL 3. Intermediate bulk containers (IBC): HDPE, 720 L 4. Drum: Steel, zinc coated and painted, 200 - 220 L 5. Canister: HDPE, 5 - 50 L |
See section 5.1.
The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and / or organisational measures: The use of eye protection during handling of the product is recommended.
The product must only be applied for disinfection of small surfaces.
See section 5.3.
See section 5.4.
See section 5.5.
| Product type | PT04: Food and feed area |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: All Scientific name: Yeasts Common name: Yeasts Development stage: All |
| Field(s) of use | indoor use Disinfection of non-porous surfaces in kitchens. Disinfection of gardening equipment for human hygiene purpose only. |
| Application method(s) | Method: Spraying Detailed description: Spraying (with trigger sprayer or pump spray) Method: Spraying and wiping Detailed description: Spraying (with trigger sprayer or pump spray) and wiping Method: Pouring and wiping Detailed description: - |
| Application rate(s) and frequency | Application Rate: 40-50 mL/m2 - Number and timing of application: - |
| Category(ies) of users | general public (non-professional) |
| Pack sizes and packaging material | 1. Bottle: HDPE, 250 - 1000 mL 2. Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL |
For use at room temperature (20±2°C).
The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:
— Trigger spray: Apply 20 spray strokes per 0,5 m2. — Pump spray: Apply 3 jets per 100 cm2. — Bottle: Apply one measuring cup per m2
Disinfection of gardening equipment for human hygiene purpose only.
Disinfect gardening equipment only indoors.
See section 5.2.
See section 5.3.
See section 5.4.
See section 5.5.
| Product type | PT04: Food and feed area |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: All Scientific name: Yeasts Common name: Yeasts Development stage: All |
| Field(s) of use | indoor use Disinfection of non-porous surfaces in canteens or kitchens, food processing industry (including breweries). Disinfection of gardening equipment for human hygiene purpose only. |
| Application method(s) | Method: Spraying Detailed description: Spraying (with trigger sprayer or pump spray) Method: Spraying and wiping Detailed description: Spraying (with trigger sprayer or pump spray) and wiping Method: Pouring and wiping Detailed description: - |
| Application rate(s) and frequency | Application Rate: 40-50 mL/m2 - Number and timing of application: - |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 1. Bottle: HDPE, 250 - 1000 mL 2. Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL 3. IBC: HDPE, 720 L 4. Drum: Steel, zinc coated and painted, 200 - 220 L 5. Canister: HDPE, 5 - 50 L |
For use at room temperature (20±2°C).
Disinfection of gardening equipment for human hygiene purpose only.
Disinfect gardening equipment only indoors.
Provide adequate ventilation (industrial ventilation or keeping windows and doors open).
The product must only be applied for disinfection of small surfaces.
The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and / or organisational measures: The use of eye protection during handling of the product is recommended.
See section 5.3.
See section 5.4.
See section 5.5.
5. GENERAL DIRECTIONS FOR USE (1)
Clean surfaces before use.
Apply the product to the surface undiluted by spraying. Make sure to wet surfaces completely. Allow to take effect for at least 15 minutes.
Apply the product to the surface undiluted by spraying / pouring the product and wiping of the surface afterwards. Make sure to wet surfaces completely. Allow to take effect for at least 5 minutes.
Do not apply more than 50 mL/m2.
Used wipes must be disposed in a closed container.
For non-professional users only: Do not use more than 4 applications per day.
Keep out of reach of children and pets.
Avoid contact with eyes.
Do not apply in the presence of small children.
Keep children and pets away from rooms, where disinfection is taking place. Provide adequate ventilation before children enter treated rooms.
For refilling a funnel must be applied.
First aid:
IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
Call a POISON CENTER or doctor/physician if you feel unwell.
If eye irritation persists, get medical advice/attention.
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Store cool (not above 30°C) and protect from frost.
Shelf-life: 24 month.
6. OTHER INFORMATION
Please be aware of the European reference value of 129,28 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the product.
Information on hazard and precautionary statements:
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.