LegalizeCommission Implementing Regulation (EU) 2023/1200 of 21 June 2023 granting a Union authorisation for the biocidal product family ‘Airedale PAA product family’ 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-0028970-0000 is hereby granted to Rigest Trading (Ireland) Limited for the making available on the market and use of the biocidal product family ‘Airedale PAA product family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 12 July 2023 to 30 June 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
Airedale PAA product family
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
PT03: Veterinary hygiene
Authorisation number: EU-0028970-0000
R4BP asset number: EU-0028970-0000
PART I.
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | Airedale PAA product family |
|---|---|
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary hygiene |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Floor 3, Block 3 Miesian Plaza D02 Y754 Dublin 2 IE |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| Name of manufacturer | Airedale Chemical Company Ltd |
| --- | --- |
| Address of manufacturer | Airedale Mills, Skipton Road, Cross Hills BD20 7BX Keighley United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Airedale Chemical Company Ltd site 1 Airedale Mills, Skipton Road, Cross Hills BD20 7BX Keighley United Kingdom of Great Britain and Northern Ireland (the) |
| Active substance | Peracetic acid |
| --- | --- |
| Name of manufacturer | Airedale Chemical Company Ltd |
| Address of manufacturer | Airedale Mills, Skipton Road, Cross Hills BD20 7BX Keighley United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Airedale Chemical Company Ltd site 1 Airedale Mills, Skipton Road, Cross Hills BD20 7BX Keighley United Kingdom of Great Britain and Northern Ireland (the) |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Peracetic acid | Active substance | 79-21-0 | 201-186-8 | 1,74 - 15,9 % (w/w) | |
| Hydrogen peroxide | Hydrogen Peroxide | Non-active substance | 7722-84-1 | 231-765-0 | 8,1 - 25,97 % (w/w) |
| Acetic Acid | Acetic Acid | Non-active substance | 64-19-7 | 200-580-7 | 7,7 - 15,9 % (w/w) |
| HEDP | etidronic acid | Non-active substance | 2809-21-4 | 220-552-8 | 0,99 - 1,2 % (w/w) |
| Formulation type(s) | SL Soluble concentrate | ||||
| --- | --- |
PART II.
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: Peracetic Acid 2% Foamy |
|---|---|
| Number | 1-4 |
| --- | --- |
| Product type(s) | PT04: Food and feed area PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| --- | --- |
2. META SPC 1 COMPOSITION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Peracetic acid | Active substance | 79-21-0 | 201-186-8 | 1,74 - 2,36 % (w/w) | |
| Hydrogen peroxide | Hydrogen Peroxide | Non-active substance | 7722-84-1 | 231-765-0 | 8,1 - 9,9 % (w/w) |
| Acetic Acid | Acetic Acid | Non-active substance | 64-19-7 | 200-580-7 | 14,1 - 15,9 % (w/w) |
| HEDP | etidronic acid | Non-active substance | 2809-21-4 | 220-552-8 | 0,99 - 0,99 % (w/w) |
| Formulation type(s) | SL Soluble concentrate | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | H272: May intensify fire; oxidiser. H290: May be corrosive to metals. H314: Causes severe skin burns and eye damage. H302: Harmful if swallowed. H411: Toxic to aquatic life with long lasting effects. EUH071: Corrosive to the respiratory tract. |
|---|---|
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P234: Keep only in original packaging. P260: Do not breathe vapours. P260: Do not breathe spray. P264: Wash exposed skin thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER. P310: Immediately call a doctor. P363: Wash contaminated clothing before reuse. P391: Collect spillage. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P501: Dispose of contents to a licensed hazardous-waste collection point. P501: Dispose of container to a licensed hazardous-waste collection point. |
4. AUTHORISED USE(S) OF THE META SPC
| Product type | PT04: Food and feed area |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: - Common name: Bacteria Development stage: - Scientific name: - Common name: Yeasts Development stage: - Scientific name: - Common name: fungi Development stage: - Scientific name: - Common name: Viruses Development stage: - |
| Field(s) of use | indoor use In food/feed industry including dairies, breweries, beverage and soft drinks industry, food processing and meat industries (except in slaughterhouses and other processes with blood) Disinfection of hard and non-porous surfaces by spraying or pouring |
| Application method(s) | Method: Spraying or pouring (followed by wiping for a homogenous distribution) Detailed description: The diluted product shall be placed in and sprayed with a trigger spray bottle or poured onto the equipment or surface to be disinfected (followed by wiping for a homogenous distribution). For uses in dairy industries, cleaning prior to the disinfection procedure is mandatory. |
| Application rate(s) and frequency | Application Rate: At room temperature, in 5 minutes contact time • Active against bacteria and yeasts : 0,02% PAA (e.g. 1% product with 2% PAA i.e. 10 ml product/litre) At room temperature, in 15 minutes contact time • Active against bacteria, yeasts, fungi and viruses : 0,15% PAA (e.g. 7,5% product with 2% PAA i.e. 75 ml product/litre) The dilution instructions in brackets must be adapted when using a product with a different concentration of PAA. 1-7,5% Number and timing of application: 1-2 applications per day |
| Category(ies) of users | industrial professional |
| Pack sizes and packaging material | HDPE bottle/pail with HDPE screw cap: 5 litres, 25 litres, 30 litres HDPE drum with PP bung: 200 litres HDPE IBC with HDPE screw cap: 1 000 litres |
See general directions for use
See general directions for use
See general directions for use
See general directions for use
See section 5.5 for meta-SPC 1 in this document
| Product type | PT04: Food and feed area |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: - Common name: Bacteria Development stage: - Scientific name: - Common name: Yeasts Development stage: - Scientific name: - Common name: fungi Development stage: - Scientific name: - Common name: Viruses Development stage: - |
| Field(s) of use | indoor use In food/feed industry including dairies, breweries, beverage and soft drinks industry, food processing and meat industries (except in slaughterhouses and other processes with blood) Disinfection of equipment (hard and non-porous surfaces) by dipping |
| Application method(s) | Method: Dipping Detailed description: The equipment to be disinfected shall be placed in a dipping bath.For uses in dairy industries, cleaning prior to the disinfection procedure is mandatory. |
| Application rate(s) and frequency | Application Rate: At room temperature, in 5 minutes CT • Active against bacteria and yeasts : 0,02% PAA (e.g. 1% product with 2% PAA i.e. 10 ml product/litre) At room temperature, in 15 minutes CT • Active against bacteria, yeasts, fungi and viruses : 0,15% PAA (e.g. 7,5% product with 2% PAA i.e. 75 ml product/litre) The dilution instructions in brackets must be adapted when using a product with a different concentration of PAA. 1-7,5% Number and timing of application: 1-2 applications per day |
| Category(ies) of users | industrial professional |
| Pack sizes and packaging material | HDPE bottle/pail with HDPE screw cap: 5 litres, 25 litres, 30 litres HDPE drum with PP bung: 200 litres HDPE IBC with HDPE screw cap: 1 000 litres |
See general directions for use
See general directions for use
See general directions for use
See general directions for use
See general directions for use
| Product type | PT04: Food and feed area |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: - Common name: Bacteria Development stage: - Scientific name: - Common name: Yeasts Development stage: - Scientific name: - Common name: fungi Development stage: - Scientific name: - Common name: Viruses Development stage: - |
| Field(s) of use | indoor use In food/feed industry including dairies, breweries, beverage and soft drinks industry, food processing and meat industries (except in slaughterhouses and other processes with blood). Disinfection of hard and non-porous surfaces by CIP procedures (with circulation). |
| Application method(s) | Method: Manual or automated dosing Detailed description: The diluted product shall be transferred to equipment to be disinfected by manual or automated dosing. For uses in dairy industries, cleaning prior to the disinfection procedure is mandatory. For all industries, final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces must be rinsed with water and the water must be drained into the sewer system. |
| Application rate(s) and frequency | Application Rate: At room temperature, for 5 minutes contact time • Active against bacteria and yeasts: 0,02% PAA (e.g. 1% product with 2% PAA, that is 10 ml product/litre) • Active against bacteria, yeasts and fungi: 0,1% PAA (e.g. 5% product with 2% PAA, that is 50 ml product/litre) At room temperature, for 15 minutes contact time • Active against bacteria, yeasts, fungi and viruses: 0,15% PAA (e.g. 7,5% product with 2% PAA, that is 75 ml product/litre) The dilution instructions in brackets must be adapted when using a product with a different concentration of PAA. 1-7,5% Number and timing of application: 1-2 applications per day |
| Category(ies) of users | industrial professional |
| Pack sizes and packaging material | HDPE bottle/pail with HDPE screw cap: 5 litres, 25 litres, 30 litres HDPE drum with PP bung: 200 litres HDPE IBC with HDPE screw cap: 1 000 litres |
See general directions for use
See general directions for use
See general directions for use
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 |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: - Common name: Bacteria Development stage: - Scientific name: - Common name: Yeasts Development stage: - Scientific name: - Common name: fungi Development stage: - Scientific name: - Common name: Viruses Development stage: - |
| Field(s) of use | indoor use General (including pharmaceutical and cosmetic industry) Disinfection of hard and non-porous surfaces by spraying or pouring |
| Application method(s) | Method: Spraying or pouring (followed by wiping for a homogenous distribution) Detailed description: The diluted product must be placed in and sprayed with trigger spray bottle or poured onto the equipment or surface to be disinfected (followed by wiping for a homogeneous distribution). |
| Application rate(s) and frequency | Application Rate: At room temperature, in 5 minutes contact time • Active against bacteria and yeasts : 0,02% PAA (e.g. 1% product with 2% PAA i.e. 10 ml product/litre) At room temperature, in 15 minutes contact time • Active against bacteria, yeasts, fungi and viruses : 0,15% PAA (e.g. 7,5% product with 2% PAA i.e. 75 ml product/litre) The dilution instructions in brackets must be adapted when using a product with a different concentration of PAA. 1-7,5% Number and timing of application: 1-2 applications per day |
| Category(ies) of users | industrial professional |
| Pack sizes and packaging material | HDPE bottle/pail with HDPE screw cap: 5 litres, 25 litres, 30 litres HDPE drum with PP bung: 200 litres HDPE IBC with HDPE screw cap: 1 000 litres |
See general directions for use
See general directions for use
See general directions for use
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 |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: - Common name: Bacteria Development stage: - Scientific name: - Common name: Yeasts Development stage: - Scientific name: - Common name: fungi Development stage: - Scientific name: - Common name: Viruses Development stage: - |
| Field(s) of use | indoor use General (including pharmaceutical and cosmetic industry) Disinfection of hard, non-porous surfaces by CIP procedures (with circulation of the product solution in the production system) |
| Application method(s) | Method: CIP - Manual or automated dosing Detailed description: The diluted product shall be transferred to equipment to be disinfected by manual dosing or automated dosing. Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces must be rinsed with water and the water must be drained into the sewer system. |
| Application rate(s) and frequency | Application Rate: At room temperature, for 5 minutes contact time: • Active against bacteria and yeasts: 0,02% PAA (e.g. 1% product with 2% PAA, that is 10 ml product/litre) • Active against bacteria, yeasts and fungi: 0,1% PAA (e.g. 5% product with 2% PAA, that is 50 ml product/litre) At room temperature, for 15 minutes contact time: • Active against bacteria, yeasts, fungi and viruses: 0,15% PAA (e.g. 7,5% product with 2% PAA, that is 75 ml product/litre) The dilution instructions in brackets must be adapted when using a product with a different concentration of peracetic acid (PAA). 1-7,5% Number and timing of application: 1-2 applications per day |
| Category(ies) of users | industrial professional |
| Pack sizes and packaging material | High-density polyethylene (HDPE) bottle/pail with HDPE screw cap: 5 litres, 25 litres, 30 litres HDPE drum with polypropylene (PP) bung: 200 litres HDPE intermediate bulk container (IBC) with HDPE screw cap: 1 000 litres |
See general directions for use
See general directions for use
See general directions for use
See general directions for use
See general directions for use
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
Disinfection cycle (for surface disinfection ONLY):
— the surfaces to be disinfected must be cleaned before the disinfection procedure, and the user must thoroughly clean, rinse and drain the cleaning liquids from the surfaces to be disinfected;
— products must be diluted in potable water before use.
Dilution rate and contact time depends on the use considered. Please refer to the description of application method related to each use.
— Disinfection procedures by CIP: — final rinsing step (with potable water).
After the disinfection procedure, CIP vessels (pipework and tanks) are drained and rinsed with water under closed system conditions
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.