LegalizeCommission Implementing Regulation (EU) 2020/1991 of 27 November 2020 granting a Union authorisation for the biocidal product family ‘perform-IPA’ (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0023656-0000 is granted to Schuelke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘perform-IPA’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 27 December 2020 until 30 November 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
perform-IPA
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Authorisation number: EU-0023656-0000
R4BP asset number: EU-0023656-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | perform-IPA |
|---|---|
| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Robert-Koch-Str. 2, 22851 Norderstedt Germany |
| Authorisation number | EU-0023656-0000 |
| R4BP asset number | EU-0023656-0000 |
| Date of the authorisation | 27 December 2020 |
| Expiry date of the authorisation | 30 November 2030 |
| Name of manufacturer | Schülke & Mayr GmbH |
| --- | --- |
| Address of manufacturer | Robert-Koch-Str. 2, 22851 Norderstedt Germany |
| Location of manufacturing sites | Robert-Koch-Str. 2, 22851 Norderstedt Germany |
| Name of manufacturer | BOCHEMIE a.s. |
| --- | --- |
| Address of manufacturer | Lidická 326, 735 95 Bohumín Czech Republic |
| Location of manufacturing sites | Lidická 326, 735 95 Bohumín Czech Republic |
| Name of manufacturer | Imeco |
| --- | --- |
| Address of manufacturer | Am Sägewerk 10, 63773 Goldbach Germany |
| Location of manufacturing sites | Boschstr. 5, 63768 Hösbach Germany Neue Straße 2-4, 09471 Köningswalde Germany Am Gansberg 9, 09481 Elterlein Germany ul.Wlo'kiennicza 10, 59-800 Luban Poland |
| Name of manufacturer | Tristel Solutions Limited |
| --- | --- |
| Address of manufacturer | Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom |
| Location of manufacturing sites | Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom |
| Name of manufacturer | Techtex |
| --- | --- |
| Address of manufacturer | Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom |
| Location of manufacturing sites | Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom |
| Name of manufacturer | A.F.P. GmbH |
| --- | --- |
| Address of manufacturer | Otto Brenner Straße 16, 21337 Lüneburg Germany |
| Location of manufacturing sites | Otto Brenner Straße 16, 21337 Lüneburg Germany |
| Name of manufacturer | Innovate GmbH |
| --- | --- |
| Address of manufacturer | Gewerbegebietsstraße 30, 06618 Schönburg Germany |
| Location of manufacturing sites | Gewerbegebietsstraße 30, 06618 Schönburg Germany Keizersveld 99, 5803 AP Venray Netherlands |
| Name of manufacturer | Lysoform Dr. Hans Rosemann GmbH |
| --- | --- |
| Address of manufacturer | Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany |
| Location of manufacturing sites | Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany |
| Name of manufacturer | Sterisol AB |
| --- | --- |
| Address of manufacturer | Kronoängsgatan 3, 592 23 Vadstena Sweden |
| Location of manufacturing sites | Kronoängsgatan 3, 592 23 Vadstena Sweden |
| Name of manufacturer | Rudolf Dankwardt GmbH |
| --- | --- |
| Address of manufacturer | Gutenbergring 50-52, 22848 Norderstedt Germany |
| Location of manufacturing sites | Gutenbergring 50-52, 22848 Norderstedt Germany Lagerstr. 15, 19249 Jessenitz - Werk / Lübtheen Germany |
| Name of manufacturer | BIOXAL SA |
| --- | --- |
| Address of manufacturer | ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France |
| Location of manufacturing sites | ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France |
| Name of manufacturer | Lichtenheldt GmbH |
| --- | --- |
| Address of manufacturer | Industriestrasse 7-9, 23812 Wahlstedt Germany |
| Location of manufacturing sites | Industriestrasse 7-9, 23812 Wahlstedt Germany Justus-Liebig-Weg 1, 23812 Wahlstedt Germany |
| Name of manufacturer | NATURELLE CONSUMER PRODUCTS LTD |
| --- | --- |
| Address of manufacturer | Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom |
| Location of manufacturing sites | Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom |
| Name of manufacturer | Halag Chemie AG |
| --- | --- |
| Address of manufacturer | Weiernstrasse 30, 8355 Aadorf Switzerland |
| Location of manufacturing sites | Weiernstrasse 30, 8355 Aadorf Switzerland |
| Name of manufacturer | PDI (EMEA) Ltd |
| --- | --- |
| Address of manufacturer | Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom |
| Location of manufacturing sites | Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Ineos Solvents Germany GmbH (formerly Sasol) |
| Address of manufacturer | Römerstraße 733, 47443 Moers Germany |
| Location of manufacturing sites | Römerstraße 733, 47443 Moers Germany Shamrockstr. 88, 44643 Herne 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 | Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | |
|---|---|---|---|---|---|---|
| Min | Max | |||||
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 | |
| Formulation(s) | Any other liquid (AL), ready-to-use Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation | |||||
| --- | --- |
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
| Identifier | meta SPC 1 perform IPA liquid |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Common name | IUPAC name |
| --- | --- |
| Min | Max |
| Propan-2-ol | |
| Formulation(s) | Any other liquid (AL), ready-to-use |
| --- | --- |
| 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. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. 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 if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant. |
| 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 | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas |
| Application method(s) | Method: Spraying Detailed description: Product will be sprayed directly on the surface |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP) |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP) closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA drum: 200 - 220 litre packaging material: HDPE closure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
Spray ready-to-use product on the surface and allow to take effect at 20± 2°C for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (limited spectrum virucidal activity).
The following personal risk mitigation measure can be applied for refilling procedure 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.
| 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 | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas |
| Application method(s) | Method: Wiping Detailed description: Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA. drum: 200 - 220 litre packaging material: HDPEclosure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frameclosure material is either: PP, HDPE |
Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
The following personal risk mitigation measure can be applied for refilling procedure 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.
| Product type | PT04 - Food and feed area (Disinfectants) |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces in kitchens and food industry |
| Application method(s) | Method: Spraying Detailed description: Product will be sprayed directly on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA. drum: 200 - 220 litre packaging material: HDPEclosure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure 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.
| Product type | PT04 - Food and feed area (Disinfectants) |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces in kitchens and food industry |
| Application method(s) | Method: Wiping Detailed description: Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA. drum: 200 - 220 litre packaging material: HDPE closure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
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