Commission Implementing Regulation (EU) 2026/104 of 8 December 2025 amending Implementing Regulation (EU) 2023/1200 as regards administrative and minor changes to the Union authorisation of the biocidal product family Airedale PAA product family

Image omitted; see official source	Official Journal of the European Union	EN L series
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	2026/104	16.1.2026

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products [^ntr1-L_202600104EN.000101-E0001], and in particular Article 50(2) thereof,

Whereas:

• (1) On 21 June 2023, Commission Implementing Regulation (EU) 2023/1200 [^ntr2-L_202600104EN.000101-E0002] granted a Union authorisation, under number EU-0028970-0000, to Rigest Trading (Ireland) Limited for the making available on the market and use of the biocidal product family ‘Airedale PAA product family’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.

• (2) On 10 June 2024, 20 January 2025 and 22 May 2025, Rigest Trading (Ireland) Limited submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 [^ntr3-L_202600104EN.000101-E0003], notifications of administrative changes to the Union authorisation for the biocidal product family ‘Airedale PAA product family’, as referred to in Title 1 of the Annex to that Regulation. The notifications were recorded in the Register for Biocidal Products (‘the Register’) under case numbers BC-VD095755-21, BC-BW102483-30 and BC-MN106033-46. The notified proposed changes to that authorisation concern the addition of trade names for the biocidal product family.

• (3) On 8 November 2024, Rigest Trading (Ireland) Limited submitted to the Agency, in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, an application for minor changes to the Union authorisation for the biocidal product family ‘Airedale PAA product family’, as referred to in Title 2 of the Annex to that Regulation. The application was recorded in the Register under case number BC-JD101082-71. The proposed changes to that authorisation concern the splitting of two meta-SPCs, the related extension of the shelf life and a reduction in contact time and in-use concentration.

• (4) On 19 July 2024, 29 January 2025 and 14 July 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions [^ntr4-L_202600104EN.000101-E0004] on the notified administrative changes to the Union authorisation for the biocidal product family ‘Airedale PAA product family’, together with a revised summary of the biocidal product characteristics. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

• (5) On 7 May 2025, the Agency submitted, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, an opinion [^ntr5-L_202600104EN.000101-E0005] on the applied minor changes to the Union authorisation for the biocidal product family ‘Airedale PAA product family’ together with a revised summary of the biocidal product characteristics and a revised assessment report. The opinion concludes that the proposed changes are minor changes as referred to in Article 50(3), point (b), of Regulation (EU) No 528/2012 and as specified in Title 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

• (6) On 14 July 2025, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘Airedale PAA product family’ in all official languages of the Union, covering all the administrative changes and minor changes applied for, in accordance with Article 11(6) and Article 12(6) of Implementing Regulation (EU) No 354/2013.

• (7) The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘Airedale PAA product family’ to introduce the administrative and minor changes requested by Rigest Trading (Ireland) Limited.

• (8) Except for the amendments regarding the administrative and minor changes, all other information included in the summary of the biocidal product characteristics of ‘Airedale PAA product family’ as set out in the Annex to Implementing Regulation (EU) 2023/1200 remains unchanged.

• (9) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/1200 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the Register in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.

• (10) Implementing Regulation (EU) 2023/1200 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2023/1200 is replaced by the text in the Annex to this Regulation.

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.

Done at Brussels, 8 December 2025.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202600104EN.000101-E0001]: OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

[^ntr2-L_202600104EN.000101-E0002]: Commission 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 (OJ L 159, 22.6.2023, p. 3, ELI http://data.europa.eu/eli/reg_impl/2023/1200/oj).

[^ntr3-L_202600104EN.000101-E0003]: Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p.4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

[^ntr4-L_202600104EN.000101-E0004]: ECHA Opinions No UAD-C-1752734-32-00/F of 19 July 2024, No UAD-C-1795075-20-00/F of 29 January 2025 and No UAD-C-1839361-19-00/F of 14 July 2025 on the administrative changes of the Union authorisation of the biocidal product family ‘Airedale PAA product family’, https://echa.europa.eu/opinions-on-union-authorisation.

[^ntr5-L_202600104EN.000101-E0005]: Biocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the biocidal product family ‘Airedale PAA product family’ of 7 May 2025, ECHA/BPC/458/2025 https://echa.europa.eu/opinions-on-union-authorisation.

ANNEX

‘ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

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

1.1.   Family name

Name	Airedale PAA product family

1.2.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary hygiene

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	Rigest Trading (Ireland) Limited
Name and address of the authorisation holder	Address	Floor 3, Block 3 Miesian Plaza D02 Y754 Dublin 2 IE
Authorisation number		EU-0028970-0000
R4BP asset number		EU-0028970-0000
Date of the authorisation		12 July 2023
Expiry date of the authorisation		30 June 2033

1.4.   Manufacturer(s) of the product

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)

1.5.   Manufacturer(s) of the active substance(s)

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

2.1.   Qualitative and quantitative information on the composition of the family

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)

2.2.   Type(s) of formulation

Formulation type(s)	SL Soluble concentrate

PART II.

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier	Meta SPC: Peracetic Acid 2% Foamy

1.2.   Suffix to the authorisation number

Number	1-4

1.3.   Product type(s)

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

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

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)

2.2.   Type(s) of formulation of the meta SPC 1

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

4.1.   Use description

Table 1

Surface disinfection by spraying or by pouring (followed by wiping for a homogenous distribution) in food and feed industry

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

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See section 5.5 for meta-SPC 1 in this document

4.2.   Use description

Table 2

Disinfection by dipping in food and feed industry

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

4.2.1.   Use-specific instructions for use

See general directions for use

4.2.2.   Use-specific risk mitigation measures

See general directions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.3.   Use description

Table 3

Disinfection of inner surfaces (e.g. tanks, pipes, vessels, filling machines) by CIP in food and feed industry

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

4.3.1.   Use-specific instructions for use

See general directions for use

4.3.2.   Use-specific risk mitigation measures

See general directions for use

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.4.   Use description

Table 4

Surface disinfection by spraying or pouring (followed by wiping for a homogenous distribution) including in pharmaceutical and cosmetic industries

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

4.4.1.   Use-specific instructions for use

See general directions for use

4.4.2.   Use-specific risk mitigation measures

See general directions for use

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.5.   Use description

Table 5

Cleaning in Place (CIP) including pharmaceutical and cosmetic industry

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

4.5.1.   Use-specific instructions for use

See general directions for use

4.5.2.   Use-specific risk mitigation measures

See general directions for use

4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

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

• — Disinfection procedures by dipping:

• — the solution shall not be re-used.

Use only once a day after production and replace it with a fresh solution daily.

• — Disinfection procedures by spraying:

• — wet the surface completely

(application rate > 20 ml/m² but maximum 100ml/m²) in order to keep the surface wet during the required contact time.

• — do not use equipment until product is completely absorbed to the surface or air dried.

5.2.   Risk mitigation measures

• — Wear chemical goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, and chemical resistant gloves classified under European Standard EN 374 or equivalent. Goggles, protective clothing and glove material (preferably butyl rubber) to be specified by the authorisation holder within the product information. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full titles of the EN standards and legislation.

• — Use with adequate ventilation: Use engineering controls to maintain airborne level below exposure limit requirements or guidelines. Atmospheric levels shall be maintained below the exposure guideline. For all wiping and spraying application, a ventilation rate of at least 10 air changes/hour is required in the rooms where the application takes place.

• — When respiratory protection is required (that is when the concentration of PAA and/or hydrogen peroxide are above their respective Acute Exposure Concentration (AEC)inhalation (0,5 mg/m³ and 1,25 mg/m³ respectively), use an approved air-purifying or positive-pressure supplied-air respirator depending on the potential airborne concentration.

• — 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.

• — Keep out of reach of children and non-target animals and pets.

• — Re-entrance into treated area is only allowed once the levels of peracetic acid and hydrogen peroxide in the air are below the AEC inhalation (respectively 0,5 mg/m³ for PAA & 1,25 mg/m³ for hydrogen peroxide)

• — No bystanders are allowed in treated area during the application phase.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

• — IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

• — IF ON SKIN: Immediately wash skin with plenty of water. Take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. After washing the skin: Call 112/ambulance for medical assistance.

• — Information to healthcare personnel/doctor: Initiate life support measures, thereafter call a POISON CENTRE

• — IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

• — Information to healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

• — IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Immediately call 112/ambulance for medical assistance.

• — Information to healthcare personnel/doctor: Immediately initiate life support measures, thereafter call a POISON CENTRE.

• — If symptoms: Call 112/ambulance for medical assistance.

• — If no symptoms: Call a POISON CENTRE or a doctor.

• — Information to healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.

5.4.   Instructions for safe disposal of the product and its packaging

• — This biocidal product, when being disposed of in its unused and uncontaminated state, should be treated as a hazardous waste in accordance with Directive 2008/98/EC of the European Parliament and of the Council. Any disposal practices must be in compliance with all national and provincial laws and any municipal or local by-laws governing hazardous waste. Do not dump into any sewers, on the ground, or into any body of water. Avoid release to the environment. High-temperature incineration is an acceptable practice.

• — Containers are non-refillable. Do not reuse or refill the containers. Containers should be triple or pressure rinsed with water promptly after they are emptied. They can then be offered for recycling or reconditioning for biocidal products, or they can be punctured and disposed of in a sanitary landfill or by other procedures approved by national and local authorities. Send waste liquid from rinsing of used containers to an approved waste handling facility.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

• — Store between 0°C and 30°C

• — Store in dark conditions

• — Keep in a well-ventilated place. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted.

• — Do not store in and avoid contact with aluminium, carbon steel, copper, mild steel, iron.

• — Avoid contact with amines, ammonia, strong acids, strong bases, strong oxidizers.

• — Shelf-life: Meta-SPC 1 (2% PAA Foamy): 6 months

6. OTHER INFORMATION

With respect to the “Category (ies) of users” note:

Professionals (including industrial users) means trained professionals if this is required by national legislation.

Full titles of EN standards and legislation referred to in section 5.2:

EN 16321– Eye and face protection for occupational users – Part 1: general requirements.

EN 374 – Protective gloves against dangerous chemicals and micro-organisms. Part 1: terminology and performance requirements for chemical risks.

Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives, (OJ L 312, 22.11.2008, p. 3).

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Trade name(s)	Trade name(s)	Peracetic Acid 2% Foamy	Peracetic Acid 2% Foamy	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	PAA Foam 2.4%	PAA Foam 2.4%	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Primuzon PE foam	Primuzon PE foam	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	FC 4001	FC 4001	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	iMClean Pxs	iMClean Pxs	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Sterilfoam	Sterilfoam	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Contact PA	Contact PA	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Assure PA	Assure PA	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Terminal PA	Terminal PA	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	NAYSEPT FOAM 2%	NAYSEPT FOAM 2%	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	DS 628+	DS 628+	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	AIROCIDE 2F	AIROCIDE 2F	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	DES PEROX FOAM	DES PEROX FOAM	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	OXYSTERIL 2	OXYSTERIL 2	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	PERADES FOAM	PERADES FOAM	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	OXYDES FOAM	OXYDES FOAM	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	PERACYLL 2 FOAM	PERACYLL 2 FOAM	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	PERACYL 2 FOAM	PERACYL 2 FOAM	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	PERACINET 2 FOAM	PERACINET 2 FOAM	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	PERAKYL 2 FOAM	PERAKYL 2 FOAM	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0028970-0001 1-4	EU-0028970-0001 1-4	EU-0028970-0001 1-4
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Peracetic acid		Active substance	Active substance	79-21-0	79-21-0	201-186-8	2 % (w/w)
Hydrogen peroxide	Hydrogen Peroxide	Non-active substance	Non-active substance	7722-84-1	7722-84-1	231-765-0	9,105 % (w/w)
Acetic Acid	Acetic Acid	Non-active substance	Non-active substance	64-19-7	64-19-7	200-580-7	14,421 % (w/w)
HEDP	etidronic acid	Non-active substance	Non-active substance	2809-21-4	2809-21-4	220-552-8	0,99 % (w/w)

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier	Meta SPC: Peracetic acid 2%

1.2.   Suffix to the authorisation number

Number	1-1

1.3.   Product type(s)

Product type(s)	PT04: Food and feed area PT02: Disinfectants and algaecides not intended for direct application to humans or animals

2. META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

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	1,2 - 1,2 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 2

Formulation type(s)	SL Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

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

4.1.   Use description

Table 1

Surface disinfection by spraying or by pouring (followed by wiping for a homogenous distribution) in food and feed industry

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

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See section 5.5 for meta-SPC 1 in this document

4.2.   Use description

Table 2

Disinfection by dipping in food and feed industry

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 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

4.2.1.   Use-specific instructions for use

See general directions for use

4.2.2.   Use-specific risk mitigation measures

See general directions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.3.   Use description

Table 3

Disinfection of inner surfaces (e.g. tanks, pipes, vessels, filling machines) by CIP in food and feed industry

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

4.3.1.   Use-specific instructions for use

See general directions for use

4.3.2.   Use-specific risk mitigation measures

See general directions for use

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.4.   Use description

Table 4

Surface disinfection by spraying or pouring (followed by wiping for a homogenous distribution) including in pharmaceutical and cosmetic industries

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

4.4.1.   Use-specific instructions for use

See general directions for use

4.4.2.   Use-specific risk mitigation measures

See general directions for use

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.5.   Use description

Table 5

Cleaning in Place (CIP) including pharmaceutical and cosmetic industry

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)	Common name: bacteria Development stage: - - Common name: yeasts Development stage: - - Common name: fungi Development stage: - - 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

4.5.1.   Use-specific instructions for use

See general directions for use

4.5.2.   Use-specific risk mitigation measures

See general directions for use

4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

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

• — Disinfection procedures by dipping:

• — the solution shall not be re-used.

Use only once a day after production and replace it with a fresh solution daily.

• — Disinfection procedures by spraying:

• — wet the surface completely

(application rate > 20 ml/m² but maximum 100ml/m²) in order to keep the surface wet during the required contact time.

• — do not use equipment until product is completely absorbed to the surface or air dried.

5.2.   Risk mitigation measures

• — Wear chemical goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, and chemical resistant gloves classified under European Standard EN 374 or equivalent. Goggles, protective clothing and glove material (preferably butyl rubber) to be specified by the authorisation holder within the product information. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full titles of the EN standards and legislation.

• — Use with adequate ventilation: Use engineering controls to maintain airborne level below exposure limit requirements or guidelines. Atmospheric levels shall be maintained below the exposure guideline. For all wiping and spraying application, a ventilation rate of at least 10 air changes/hour is required in the rooms where the application takes place.

• — When respiratory protection is required (that is when the concentration of PAA and/or hydrogen peroxide are above their respective Acute Exposure Concentration (AEC)inhalation (0,5 mg/m³ and 1,25 mg/m³ respectively), use an approved air-purifying or positive-pressure supplied-air respirator depending on the potential airborne concentration.

• — 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.

• — Keep out of reach of children and non-target animals and pets.

• — Re-entrance into treated area is only allowed once the levels of peracetic acid and hydrogen peroxide in the air are below the AEC inhalation (respectively 0,5 mg/m³ for PAA & 1,25 mg/m³ for hydrogen peroxide)

• — No bystanders are allowed in treated area during the application phase.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

• — IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

• — IF ON SKIN: Immediately wash skin with plenty of water. Take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. After washing the skin: Call 112/ambulance for medical assistance.

• — Information to healthcare personnel/doctor: Initiate life support measures, thereafter call a POISON CENTRE

• — IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

• — Information to healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

• — IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Immediately call 112/ambulance for medical assistance.

• — Information to healthcare personnel/doctor: Immediately initiate life support measures, thereafter call a POISON CENTRE.

• — If symptoms: Call 112/ambulance for medical assistance.

• — If no symptoms: Call a POISON CENTRE or a doctor.

• — Information to healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.

5.4.   Instructions for safe disposal of the product and its packaging

• — This biocidal product, when being disposed of in its unused and uncontaminated state, should be treated as a hazardous waste in accordance with Directive 2008/98/EC of the European Parliament and of the Council. Any disposal practices must be in compliance with all national and provincial laws and any municipal or local by-laws governing hazardous waste. Do not dump into any sewers, on the ground, or into any body of water. Avoid release to the environment. High-temperature incineration is an acceptable practice.

• — Containers are non-refillable. Do not reuse or refill the containers. Containers should be triple or pressure rinsed with water promptly after they are emptied. They can then be offered for recycling or reconditioning for biocidal products, or they can be punctured and disposed of in a sanitary landfill or by other procedures approved by national and local authorities. Send waste liquid from rinsing of used containers to an approved waste handling facility.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

• — Store between 0°C and 30°C

• — Store in dark conditions

• — Keep in a well-ventilated place. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted.

• — Do not store in and avoid contact with aluminium, carbon steel, copper, mild steel, iron.

• — Avoid contact with amines, ammonia, strong acids, strong bases, strong oxidizers.

• — Shelf-life: Meta-SPC 2 (2% PAA): 12 months

6. OTHER INFORMATION

With respect to the “Category (ies) of users” note:

Professionals (including industrial users) means trained professionals if this is required by national legislation.

Full titles of EN standards and legislation referred to in section 5.2:

EN 16321– Eye and face protection for occupational users – Part 1: general requirements.

EN 374 – Protective gloves against dangerous chemicals and micro-organisms. Part 1: terminology and performance requirements for chemical risks.

Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives, (OJ L 312, 22.11.2008, p. 3).

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Trade name(s)	Trade name(s)	Peracetic Acid 2%	Peracetic Acid 2%	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Talogen 2	Talogen 2	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	iMClean Px	iMClean Px	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	NAYSEPT 2%	NAYSEPT 2%	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	AIROCIDE 2	AIROCIDE 2	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0028970-0002 1-1	EU-0028970-0002 1-1	EU-0028970-0002 1-1
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Peracetic acid		Active substance	Active substance	79-21-0	79-21-0	201-186-8	2 % (w/w)
Hydrogen peroxide	Hydrogen Peroxide	Non-active substance	Non-active substance	7722-84-1	7722-84-1	231-765-0	9,105 % (w/w)
Acetic Acid	Acetic Acid	Non-active substance	Non-active substance	64-19-7	64-19-7	200-580-7	14,421 % (w/w)
HEDP	etidronic acid	Non-active substance	Non-active substance	2809-21-4	2809-21-4	220-552-8	1,2 % (w/w)

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier	Meta SPC: Airocide PAAD

1.2.   Suffix to the authorisation number

Number	1-5

1.3.   Product type(s)

Product type(s)	PT04: Food and feed area PT03: Veterinary hygiene PT02: Disinfectants and algaecides not intended for direct application to humans or animals

2. META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

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)

2.2.   Type(s) of formulation of the meta SPC 3

Formulation type(s)	SL Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

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]. 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 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

4.1.   Use description

Table 1

Disinfection by dipping in food and feed industry

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 contact time • Active against bacteria and yeasts 0,02% PAA (e.g. 0,4% product with 5% PAA i.e. 4 ml product/litre) At room temperature, in 15 minutes contact time • Active against bacteria, yeasts, fungi and viruses : 0,15% PAA (e.g. 3% product with 5% PAA i.e. 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

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.2.   Use description

Table 2

Surface disinfection by spraying or pouring (followed by wiping for a homogenous distribution) in food and feed industry