LegalizeCommission Implementing Regulation (EU) 2024/2587 of 2 October 2024 granting a Union authorisation for the biocidal product family Divosan PAA products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Article 1
A Union authorisation with authorisation number EU-0032463-0000 is hereby granted to Diversey Europe Operations B.V. for the making available on the market and use of the same biocidal product family ‘Divosan PAA products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 23 October 2024 until 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
Divosan PAA products
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT03: Veterinary hygiene
PT04: Food and feed area
Authorisation number: EU-0032463-0000
R4BP asset number: EU-0032463-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | Divosan PAA products |
|---|---|
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL |
| 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) |
| Name of manufacturer | Diversey Europe Operations B.V. |
| --- | --- |
| Address of manufacturer | De Corridor 4 (Regulatory team) 3621 ZB Breukelen Netherlands (the) |
| Location of manufacturing sites | Diversey Europe Operations B.V. site 1 Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy Diversey Europe Operations B.V. site 2 Rembrandtlaan 414 7545 ZW Enschede Netherlands (the) 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 AvenidaConde Duque 5, 7 y 9 ; Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain Diversey Europe Operations B.V. site 5 Morschheimer Strasse 12 67292 Kirchheimbolanden Germany |
| Name of manufacturer | Solenis Sweden AB |
| --- | --- |
| Address of manufacturer | Högastensgatan 18 S-25232 Helsingborg Sweden |
| Location of manufacturing sites | Solenis Sweden AB Högastensgatan 18 S-25232 Helsingborg Sweden |
| Name of manufacturer | Solenis Germany GmbH & Co. KG |
| --- | --- |
| Address of manufacturer | Fütingsweg 20 D-47508 Krefeld Germany |
| Location of manufacturing sites | Solenis Germany GmbH & Co. KG Fütingsweg 20 D-47508 Krefeld Germany |
| Name of manufacturer | Solenis Finland Oy |
| --- | --- |
| Address of manufacturer | Kolmihaarankatu 7 FIN-33330 Tampere Finland |
| Location of manufacturing sites | Solenis Finland Oy Kolmihaarankatu 7 FIN-33330 Tampere Finland |
| 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 | 4,5 - 15,9 % (w/w) | |
| Hydrogen peroxide | Hydrogen Peroxide | Non-active substance | 7722-84-1 | 231-765-0 | 21,62 - 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 - 0,99 % (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 5% |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area |
| --- | --- |
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 | 4,5 - 5,5 % (w/w) | |
| Hydrogen peroxide | Hydrogen Peroxide | Non-active substance | 7722-84-1 | 231-765-0 | 21,62 - 24,38 % (w/w) |
| Acetic Acid | Acetic Acid | Non-active substance | 64-19-7 | 200-580-7 | 7,7 - 9,4 % (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 | H242: Heating may cause a fire. H290: May be corrosive to metals. H302+H312+H332: Harmful if swallowed, in contact with skin or if inhaled. H314: Causes severe skin burns and eye damage. H410: Very 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. 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]. 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. P411: Store at temperatures not exceeding 30 °C/86 °F. P501: Dispose of contents a licensed hazardous-waste collection point. P501: Dispose of container a licensed hazardous-waste collection point. |
4. AUTHORISED USE(S) OF THE META SPC
| 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 CIP procedures (with circulation) |
| Application method(s) | Method: CIP - Manual or automated dosing Detailed description: The diluted product shall be transferred to equipment 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 15 minutes contact time Active against bacteria and yeasts 0,02 % PAA (e.g. 0,4 % product with 5 % PAA, that is 4 ml product/litre) Active against bacteria, yeasts and fungi : 0,1 % PAA (e.g. 2 % product with 5 % PAA, that is 20 ml product/litre) Active against bacteria, yeasts, fungi and viruses: 0,15 % PAA (e.g. 3 % product with 5 % PAA, that is 30 ml product/litre). The dilution instructions in brackets must be adapted when using a product with a different concentration of PAA. 0,4-3 % 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 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). |
| Application rate(s) and frequency | Application Rate: at room temperature, for 15 minutes contact time Active against bacteria, yeasts, fungi and viruses: 0,15 % PAA (e.g. 3 % product with 5 % PAA, that is 30 ml product/litre). The dilution instructions in brackets must be adapted when using a product with a different concentration of PAA. 3 % 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 | PT03: Veterinary hygiene |
|---|---|
| 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: Viruses Development stage: - |
| Field(s) of use | indoor use WITH prior cleaning By spraying: On hard and non-porous and porous surfaces By pouring: ONLY on hard/non-porous surfaces |
| Application method(s) | Method: Spraying or pouring (followed by wiping for 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 homogenous distribution).Cleaning of the surface prior to disinfection is mandatory.Do not use equipment and surfaces, or allow animals/poultry to enter the treated area until product is completely absorbed to the surface or air dried. |
| Application rate(s) and frequency | Application Rate: at + 10 °C for 5 minutes contact time Active against bacteria, yeasts and viruses: 0,2 % PAA (e.g. 4 % product with 5 % PAA, that is 40 ml product/litre). The dilution instructions in brackets must be adapted when using a product with a different concentration of PAA. 4 % Number and timing of application: Disinfection of animal housing takes place once animals have been moved out and the building has been cleaned and cleared of objects not to be disinfected, maximum 1-2 times 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 | PT03: Veterinary hygiene |
|---|---|
| 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: Viruses Development stage: - |
| Field(s) of use | indoor use Disinfection of equipment (hard and non-porous and porous surfaces by dipping), WITH prior cleaning |
| Application method(s) | Method: Dipping Detailed description: The equipment to be disinfected must be placed in a dipping bath. Cleaning prior to use is mandatory. |
| Application rate(s) and frequency | Application Rate: at + 10 °C for 5 min contact time. Active against bacteria, yeasts and viruses: 0,2 % PAA (e.g. 4 % product with 5 % PAA, that is 40 ml product/litre). The dilution instructions in brackets must be adapted when using a product with a different concentration of PAA. 4 % Number and timing of application: 1-2 applications per day maximum |
| 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
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