LegalizeCommission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family ‘IPA Family 1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0028425-0000 is hereby granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘IPA Family 1’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.
The Union authorisation is valid from 9 March 2023 to 28 February 2033.
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 I
Terms and conditions (EU-0028425-0000)
The authorisation holder shall conduct a long-term ambient storage stability test of ‘Klercide 70/30 IPA Aerosol’ of meta-SPC 1.3 in the commercial packaging in which the product will be made available on the market. The long-term ambient storage stability test shall address the relevant physical, chemical and technical properties of that product both prior to and after storage in accordance with section 2.6.4 of the Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment (ECHA, March 2022) (1), in order to confirm a shelf life of 24 months. The authorisation holder shall include in the study report information about the packaging stability, the spray characteristics and internal pressure before and after storage.
By 9 January 2024 the authorisation holder shall submit the results of the study to the Agency.
ANNEX II
Summary of product characteristics for a biocidal product family
IPA Family 1
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Authorisation number EU-0028425-0000
R4BP asset number EU-0028425-0000
PART I
FIRST INFORMATION LEVEL
| Name | IPA Family 1 |
|---|---|
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Ecolab Allee 1 40789 Monheim am Rhein Germany |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| Name of manufacturer | Ecolab Europe GmbH |
| --- | --- |
| Address of manufacturer | Richtistrasse, 7 8304 Walliselen Switzerland |
| Location of manufacturing sites | Ecolab Europe GmbH site 1 Richtistrasse, 7 8304 Walliselen Switzerland |
| Name of manufacturer | Ecolab Limited |
| --- | --- |
| Address of manufacturer | Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Ecolab Limited site 1 Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | Ecolab Leeds |
| --- | --- |
| Address of manufacturer | Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Ecolab Leeds site 1 Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | Esoform S.p.A. |
| --- | --- |
| Address of manufacturer | Viale del Lavoro 10, 45100 Rovigo Italy |
| Location of manufacturing sites | Esoform S.p.A. site 1 Viale del Lavoro 10, 45100 Rovigo Italy |
| Name of manufacturer | Nalco Deutschland Manufacturing GmbH und Co.KG |
| --- | --- |
| Address of manufacturer | Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany |
| Location of manufacturing sites | Nalco Deutschland Manufacturing GmbH und Co.KG site 1 Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany |
| Name of manufacturer | Ecolab NETHERLANDS BV |
| --- | --- |
| Address of manufacturer | Brugwal 11, 3432NZ Nieuwegein Netherlands (the) |
| Location of manufacturing sites | Ecolab NETHERLANDS BV site 1 Brugwal 11, 3432NZ Nieuwegein Netherlands (the) |
| Name of manufacturer | Ecolab Weavergate |
| --- | --- |
| Address of manufacturer | Winnington Avenue CW8 3AA Northwich Cheshire United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Ecolab Weavergate site 1 Winnington Avenue CW8 3AA Northwich Cheshire United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | Ecolab Mullingar, Ireland |
| --- | --- |
| Address of manufacturer | Forest Park, Zone C Mullingar Ind. Estate, - Mullingar, Co. Westmeath, Ireland |
| Location of manufacturing sites | Ecolab Mullingar, Ireland site 1 Forest Park, Zone C Mullingar Ind. Estate, - Mullingar, Co. Westmeath, Ireland |
| Name of manufacturer | Ecolab d.o.o. |
| --- | --- |
| Address of manufacturer | Vajngerlova 4 2000 Maribor Slovenia |
| Location of manufacturing sites | Ecolab d.o.o. site 1 Vajngerlova 4 2000 Maribor Slovenia |
| Name of manufacturer | Ecolab Rozzano, Italy |
| --- | --- |
| Address of manufacturer | Via A. Grandi 9/11, 20089 Rozzano (MI) Italy |
| Location of manufacturing sites | Ecolab Rozzano, Italy site 1 Via A. Grandi 9/11, 20089 Rozzano (MI) Italy |
| Name of manufacturer | Ecolab B.V.B.A |
| --- | --- |
| Address of manufacturer | Havenlaan 4 3980 Tessenderlo Belgium |
| Location of manufacturing sites | Ecolab B.V.B.A site 1 Havenlaan 4 3980 Tessenderlo Belgium |
| Name of manufacturer | Nalco Española Manufacturing, SLU |
| --- | --- |
| Address of manufacturer | C/Tramuntana s/n Polígono Industrial de Celrà 17460 Celrà Spain |
| Location of manufacturing sites | Nalco Española Manufacturing, SLU site 1 C/Tramuntana s/n Polígono Industrial de Celrà 17460 Celrà Spain |
| Name of manufacturer | Ecolab production France SAS |
| --- | --- |
| Address of manufacturer | BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France |
| Location of manufacturing sites | Ecolab production France SAS site 1 BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France |
| Name of manufacturer | Ecolab Mandra, Greece |
| --- | --- |
| Address of manufacturer | 25km Old National Road Athens- Theve, - Mandra Attica Greece |
| Location of manufacturing sites | Ecolab Mandra, Greece site 1 25km Old National Road Athens- Theve, - Mandra Attica Greece |
| Name of manufacturer | NALCO FINLAND MANUFACTURING OY |
| --- | --- |
| Address of manufacturer | Kivikummuntie 1, FIN-07955 Tesjoki Finland |
| Location of manufacturing sites | NALCO FINLAND MANUFACTURING OY site 1 Kivikummuntie 1, FIN-07955 Tesjoki Finland |
| Name of manufacturer | Manufacturing Plant Cisterna Nalco |
| --- | --- |
| Address of manufacturer | Via Ninfina II 4012 Cisterna Di Latina, Italy |
| Location of manufacturing sites | Manufacturing Plant Cisterna Nalco site 1 Via Ninfina II 4012 Cisterna Di Latina Italy |
| Name of manufacturer | Manufacturing Plant Fawley Nalco |
| --- | --- |
| Address of manufacturer | One buisness center 1180 SO45 3NP Hardley Hants United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Manufacturing Plant Fawley Nalco site 1 One buisness center 1180 SO45 3NP Hardley Hants United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | Nalco Champion Plant, Tooling Plant, Aberdeen Nalco |
| --- | --- |
| Address of manufacturer | Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Nalco Champion Plant, Tooling Plant, Aberdeen Nalco site 1 Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | Microtek Medical B.V. |
| --- | --- |
| Address of manufacturer | Hekkehorst, 24 7207 BN Zutphen Netherlands (the) |
| Location of manufacturing sites | Microtek Medical B.V. site 1 Hekkehorst, 24 7207 BN Zutphen Netherlands (the) |
| Name of manufacturer | Microtek Medical Malta Ltd. |
| --- | --- |
| Address of manufacturer | Sorbonne Centre F20 Mosta Technopark MST 3000 Mosta Malta |
| Location of manufacturing sites | Microtek Medical Malta Ltd. site 1 Sorbonne Centre F20 Mosta Technopark MST 3000 Mosta Malta |
| Name of manufacturer | Innovate GmbH |
| --- | --- |
| Address of manufacturer | Am Hohen Stein, 11 06618 Naumburg Germany |
| Location of manufacturing sites | Innovate GmbH site 1 Am Hohen Stein, 11 06618 Naumburg Germany |
| Name of manufacturer | CHRISTEYNS FRANCE S.A. |
| --- | --- |
| Address of manufacturer | 31 rue de la Maladrie 44120 Vertou France |
| Location of manufacturing sites | CHRISTEYNS FRANCE S.A. site 1 54 avenue de la Plaine - ZI 13106 Rousset France |
| Name of manufacturer | Techtex |
| --- | --- |
| Address of manufacturer | Units 7 & 8, Rhodes Business Park, Silbum Way M24 4NE Middelton, Manchester United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Techtex site 1 Units 7 & 8, Rhodes Business Park, Silbum Way M24 4NE Middelton, Manchester United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | Technical Textile Services Ltd |
| --- | --- |
| Address of manufacturer | Unit 4, Rhodes Business Park, Silburn Way M24 4NE Middleton, Manchester United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Technical Textile Services Ltd Unit 4, Rhodes Business Park, Silburn Way M24 4NE Middleton, Manchester United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | Pal International Limited |
| --- | --- |
| Address of manufacturer | Unit 3 Mountpark, Victoria Road LE67 1FA Ellistown, Coalville United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Pal International Limited Unit 3 Mountpark, Victoria Road LE67 1FA Ellistown, Coalville United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | CID LINES NV |
| --- | --- |
| Address of manufacturer | Waterpoortstraat 2 8900 Ieper Belgium |
| Location of manufacturing sites | CID LINES NV Waterpoortstraat 2 8900 Ieper Belgium |
| Name of manufacturer | LABORATOIRES ANIOS |
| --- | --- |
| Address of manufacturer | 3330 Rue de Lille 59262 Sainghin-en-Mélantois France |
| Location of manufacturing sites | LABORATOIRES ANIOS 3330 Rue de Lille 59262 Sainghin-en-Mélantois France |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Ineos Solvents Germany GmbH |
| Address of manufacturer | Römerstrasse 733, D-47443 Moers Germany |
| Location of manufacturing sites | Ineos Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany Ineos Solvents Germany GmbH site 2 Romestrasse, 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 Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis, Netherlands (the) |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | ExxonMobil Chemical Europe |
| Address of manufacturer | Hermeslaan 2 1831 Machelen Belgium |
| Location of manufacturing sites | ExxonMobil Chemical Europe site 1 Fawley Refinery and Petrochemical Plant, Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the) ExxonMobil Chemical Europe site 2 Baton Rouge Chemical Plant 4999 Scenic Highway 70805-3359 LA United States (the) |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Brenntag N.V. |
| Address of manufacturer | Nijverheidslaan, 38 8540 Deerlijk Belgium |
| Location of manufacturing sites | Shell Energy and Chemicals Park Rotterdam Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the) ExxonMobil Baton Rouge Refinery 4045 Scenic Highway Baton Rouge 70805 LA United States (the) |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | UNIVAR |
| Address of manufacturer | Steuber Drive M44 5AL Manchester United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | ExxonMobil Chemicals Fawley Refinery and Petrochemical Plant, Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the) |
| Common name | IUPAC name |
| --- | --- |
| Propan-2-ol | |
| Formulation type(s) | AE Aerosol dispenser AL Any other liquid XX – Ready to use wipe impregnated with water based liquid |
| --- | --- |
PART II
SECOND INFORMATION LEVEL META SPC(S)
| Identifier | Meta SPC: Meta-SPC 1.1 |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| --- | --- |
| Common name | IUPAC name |
| --- | --- |
| Propan-2-ol | |
| Formulation type(s) | AL Any other liquid |
| --- | --- |
| 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. P280: Wear eye protection. P280: Wear face protection. |
| 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 Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Enveloped viruses Development stage: no data |
| Field(s) of use | indoor use Disinfection of cleanroom hard non-porous surfaces in life sciences industry. |
| Application method(s) | Method: Trigger spraying or mopping Detailed description: Direct application onto surfaces by trigger spraying followed by wiping with a dry wipe for distribution or mopping. |
| Application rate(s) and frequency | Application Rate: c.a. 18 ml/m2 ready to use product Number and timing of application: As required |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 0,5 liter - 10 liters Polyvinylpyrrolidone (PVP) or (High density polyetheylene (HDPE) bottle / container (with and without trigger spray) |
Clean and dry surfaces prior to disinfection.
Application by trigger spraying directly onto the surface: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m2, corresponding to 20 strokes/m2) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Always close the nozzle after use. Do not transfer the product to a trigger sprayer, but apply from a package delivered with trigger sprayer.
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.