Commission Implementing Regulation (EU) 2022/964 of 10 June 2022 granting a Union authorisation for the biocidal product family ‘SOPUROXID’ (Text with EEA relevance)

22.6.2022 EN Official Journal of the European Union L 166/1 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) 2022/964 of 10 June 2022 granting a Union authorisation for the biocidal product family ‘SOPUROXID’ (Text with EEA relevance) 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 2012concerning the making available on the market and use of biocidal products(1), and in particular the first subparagraph of Article 44(5) thereof, Whereas: (1) On 1 September 2017, SOPURA N.V. submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘SOPUROXID’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-KV033704-17 in the Register for Biocidal Products. (2) ‘SOPUROXID’ contains peracetic acid, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. (3) On 27 August 2020, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). (4) On 31 March 2021, the Agency submitted to the Commission an opinion(2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPUROXID’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. (5) The opinion concludes that ‘SOPUROXID’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. (6) On 28 April 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. (7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘SOPUROXID’. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, (1) OJ L 167, 27.6.2012, p. 1. (2) ECHA opinion of 4 March 2021 on the Union authorisation of ‘SOPUROXID’ (ECHA/BPC/279/2021), https://echa.europa.eu/bpc- opinions-on-union-authorisationL 166/2 EN Official Journal of the European Union 22.6.2022 HAS ADOPTED THIS REGULATION: Article 1 A Union authorisation with authorisation number EU-0026179-0000 is granted to SOPURA N.V. for the making available on the market and use of the biocidal product family ‘SOPUROXID’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 12 July 2022until 30 June 2032. 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, 10 June 2022. For the Commission The President Ursula VON DER LEYEN22.6.2022 EN Official Journal of the European Union L 166/3 ANNEX Summary of product characteristics for a biocidal product family SOPUROXID Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Product type 3 - Veterinary hygiene (Disinfectants) Product type 4 - Food and feed area (Disinfectants) Authorisation number: EU-0026179-0000 R4BP asset number: EU-0026179-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name SOPUROXID 1.2. Product type(s) Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) PT04 - Food and feed area (Disinfectants) 1.3. Authorisation holder Name and address of the authorisation Name SOPURA holder Address rue de Trazegnies 199, 6180 COURCELLES Belgium Authorisation number EU-0026179-0000 R4BP asset number EU-0026179-0000 Date of the authorisation 12 July 2022 Expiry date of the authorisation 30 June 2032L 166/4 EN Official Journal of the European Union 22.6.2022 1.4. Manufacturer(s) of the biocidal products Name of manufacturer SOPURA N.V. Address of manufacturer Rue de Trazegnies 199, 6180 COURCELLES Belgium Location of manufacturing sites Rue de Trazegnies 199, 6180 COURCELLES Belgium Name of manufacturer SOPURA QUIMICA Address of manufacturer Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain Location of manufacturing sites Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain Name of manufacturer HYPRED SAS (KERSIA Group) Address of manufacturer 55, Boulevard Jules Verger (BP 10180), 35803 DINARD France Location of manufacturing sites 55, Boulevard Jules Verger (BP 10180), 35803 DINARD France Niepruszewo, ul. Kasztanowa, 64-320 Buk Poland 1.5. Manufacturer(s) of the active substance(s) Active substance Peracetic acid Name of manufacturer SOPURA N.V. Address of manufacturer Rue de Trazegnies 199, 6180 COURCELLES Belgium Location of manufacturing sites Rue de Trazegnies 199, 6180 COURCELLES Belgium Active substance Peracetic acid Name of manufacturer SOPURA QUIMICA Address of manufacturer Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain Location of manufacturing sites Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain Active substance Peracetic acid Name of manufacturer HYPRED SAS (KERSIA Group) Address of manufacturer 55, Boulevard Jules Verger (BP 10180), 35803 DINARD France Location of manufacturing sites 55, Boulevard Jules Verger (BP 10180), 35803 DINARD France Niepruszewo, ul. Kasztanowa, 64-320 Buk Poland22.6.2022 EN Official Journal of the European Union L 166/5 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Content (%) Common name IUPAC name Function CAS number EC number Min Max Peracetic acid Active Substance 79-21-0 201-186-8 3,2 15,0 Sulphuric acid Non-active 7664-93-9 231-639-5 0,2 24,04 substance Hydrogen peroxide Non-active 7722-84-1 231-765-0 16,5 23,5 substance Acetic acid Non-active 64-19-7 200-580-7 5,5 16,7 substance 2.2. Type(s) of formulation Formulation(s) SL - Soluble concentrate PART II SECOND INFORMATION LEVEL - META SPC(S) META SPC 1 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier Meta SPC1 1.2. Suffix to the authorisation number Number 1-1 1.3. Product type(s) Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) PT04 - Food and feed area (Disinfectants)L 166/6 EN Official Journal of the European Union 22.6.2022 2. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Content (%) Common name IUPAC name Function CAS number EC number Min Max Peracetic acid Active Substance 79-21-0 201-186-8 5,0 5,0 Sulphuric acid Non-active 7664-93-9 231-639-5 0,2 24,04 substance Hydrogen peroxide Non-active 7722-84-1 231-765-0 16,5 22,0 substance Acetic acid Non-active 64-19-7 200-580-7 5,5 9,55 substance 2.2. Type(s) of formulation of the meta SPC 1 Formulation(s) SL - Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements May intensify fire; oxidiser May be corrosive to metals. Harmful if swallowed. Harmful in contact with skin. Harmful if inhaled. Causes severe skin burns and eye damage. Causes serious eye damage. May cause respiratory irritation. Very toxic to aquatic life with long lasting effects. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Wear protective gloves. Wear eye protection. Wear face protection. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. Take any precaution to avoid mixing with combustibles. Avoid breathing vapours. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Specific treatment (see information on this label). Rinse mouth. Wash contaminated clothing before reuse. IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell. IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. IF ON SKIN: Wash with plenty of water.22.6.2022 EN Official Journal of the European Union L 166/7 IF INHALED: Remove person to fresh air and keep comfortable for breathing. Take off immediately all contaminated clothing. And wash it before reuse. Store locked up. Store in a well-ventilated place. Keep container tightly closed. Dispose of contents to in accordance with local/regional/national/international regulations. Wear protective clothing. Dispose of container to in accordance with local/regional/national/international regulations. Keep cool. Avoid release to the environment. Collect spillage. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with shower. Avoid breathing spray. Do not breathe spray. Do not breathe vapours. 4. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1 Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas - manual treatment (mopping) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In Industrial, public and non-medical healthcare areas: Disinfection of hard/non-porous surfaces by manual treatment (mopping) with prior cleaning Application method(s) Method: Manual treatment (mopping). Detailed description: Diluted product is applied by mopping with the appropriate tool (e.g. flat mop or cleaning cloths). After application, the diluted product is drained. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2 Use other than inL 166/8 EN Official Journal of the European Union 22.6.2022 HEALTHCARE With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2 Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.1.1. Use-specific instructions for use Items to be disinfected by mopping have to stay sufficiently wet during the required contact time to allow optimal disinfection. 4.1.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing and loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Re-entry is only permitted once the air concentrations of peracetic acid and hydrogen peroxide have dropped below the respective reference values (AEC). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by the authorization holder). 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.22.6.2022 EN Official Journal of the European Union L 166/9 4.2. Use description Table 2 Use # 2 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (spraying) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In Industrial, public and non-medical healthcare areas: Disinfection of hard/non-porous surfaces by manual treatment (spraying) with prior cleaning Application method(s) Method: Manual treatment (spraying) Detailed description: Diluted product is applied by spraying using a small spraying can Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.2.1. Use-specific instructions for use See general directions for use 4.2.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.L 166/10 EN Official Journal of the European Union 22.6.2022 Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance. “The treated surface should not be allowed to dry prior to rinsing. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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 Use # 3 – Clean in Place (CIP) in the pharmaceutical and cosmetic industry Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In pharmaceutical and cosmetic industry: Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning Application method(s) Method: By CIP procedure Detailed description: Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations. After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.22.6.2022 EN Official Journal of the European Union L 166/11 Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,032 % PAA (Dilution of the product at 0,64 % i.e. 640 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.3.1. Use-specific instructions for use See general directions for use 4.3.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Rinse the pump and disconnect it from the installation before maintenance” 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 Use # 4 – Surface disinfection in greenhouses via spraying by user with personal enclosure (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised useL 166/12 EN Official Journal of the European Union 22.6.2022 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In greenhouses: Disinfection of hard/non-porous surfaces by spraying Application method(s) Method: Open system: spray treatment Detailed description: Diluted product is automatically applied in all directions via a spraying device The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device) Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.4.1. Use-specific instructions for use See general directions for use. 4.4.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application should only take place with the user in a personal enclosure and no other person is present. Rinse the pump and disconnect it from the installation before maintenance”22.6.2022 EN Official Journal of the European Union L 166/13 “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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 Use # 5 – Surface disinfection in greenhouses via spraying by user without personal enclosure (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In greenhouses: Disinfection of hard/non-porous surfaces by spraying Application method(s) Method: Open system: spray treatment Detailed description: Diluted product is automatically applied in all directions via a spraying device. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial ProfessionalL 166/14 EN Official Journal of the European Union 22.6.2022 Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.5.1. Use-specific instructions for use See general directions for use. 4.5.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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. 4.6. Use description Table 6 Use # 6 – Disinfection of agriculture & horticulture equipment by soaking (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use22.6.2022 EN Official Journal of the European Union L 166/15 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning. Application method(s) Method: Open system: immersion Detailed description: The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.6.1. Use-specific instructions for use See general directions for use. 4.6.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post- application phase.L 166/16 EN Official Journal of the European Union 22.6.2022 When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” 4.6.3. 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. 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.6.5. 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. 4.7. Use description Table 7 Use # 7 – Disinfection of surfaces and agriculture/horticulture equipment by spraying (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Open system: spray treatment Detailed description: The diluted product is manually sprayed on the surfaces/equipment using spraying equipment. Spraying is only applied downwards and in a horizontal direction. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time. Number and timing of application: /22.6.2022 EN Official Journal of the European Union L 166/17 Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.7.1. Use-specific instructions for use See general directions for use. 4.7.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. Rinse the pump and disconnect it from the installation before maintenance” The treated surface should not be allowed to dry prior to rinsing. 4.7.3. 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. 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.7.5. 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. 4.8. Use description Table 8 Use # 8 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised useL 166/18 EN Official Journal of the European Union 22.6.2022 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is applied by spraying in an automated way Spraying is only applied downwards and in a horizontal direction. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.8.1. Use-specific instructions for use See general directions for use. 4.8.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” The treated surface should not be allowed to dry prior to rinsing.22.6.2022 EN Official Journal of the European Union L 166/19 4.8.3. 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. 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.8.5. 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. 4.9. Use description Table 9 Use # 9 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (closed room) (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: By spraying. Detailed description: Diluted product is applied by spraying in an automated way without any operator being present Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery.L 166/20 EN Official Journal of the European Union 22.6.2022 4.9.1. Use-specific instructions for use See general directions for use. 4.9.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” The treated surface should not be allowed to dry prior to rinsing. 4.9.3. 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. 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.9.5. 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. 4.10. Use description Table 10 Use # 10 – Disinfection of animal housing – via low-pressure spraying by user with personal enclosure Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor In animal housing: Disinfection of hard/non-porous surfaces by spraying with prior cleaning22.6.2022 EN Official Journal of the European Union L 166/21 Application method(s) Method: Spraying Detailed description: Diluted product is automatically applied in all directions by low-pressure manual spraying via a spraying device The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device) Application rate(s) and Application Rate: Between 20 and 300 mL/m2 frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.10.1. Use-specific instructions for use It has to be assured that animals are not present when treatment takes place. 4.10.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application should only take place with the user in a personal enclosure and no other person is present. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried. Re-entry of the general public only when surfaces are dried and after sufficient ventilation.L 166/22 EN Official Journal of the European Union 22.6.2022 4.10.3. 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. 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.10.5. 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. 4.11. Use description Table 11 Use # 11 – Disinfection of animal housing via low-pressure manual spraying by user without personal enclosure Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor In animal housing: Disinfection of hard/non-porous surfaces by spraying with prior cleaning Application method(s) Method: Open system: spray treatment Detailed description: Diluted product is automatically applied in all directions by low-pressure automatic spraying via a spraying device Application rate(s) and Application Rate: Between 20 and 300 mL/m2 frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e.1 280mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional22.6.2022 EN Official Journal of the European Union L 166/23 Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.11.1. Use-specific instructions for use It has to be assured that animals are not present when treatment takes place. 4.11.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.11.3. 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. 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.11.5. 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. 4.12. Use description Table 12 Use # 12 – Disinfection of boots in footbaths in animal housing/husbandries Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact - description of the authorised useL 166/24 EN Official Journal of the European Union 22.6.2022 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor in animal housing/husbandries: Disinfection of boots by dipping (not for walk-through) with prior cleaning. Application method(s) Method: Dipping Detailed description: Diluted product is put in the footbath No rinse needed Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.12.1. Use-specific instructions for use See general directions for use. 4.12.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post- application phase.22.6.2022 EN Official Journal of the European Union L 166/25 When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.12.3. 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. 4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.12.5. 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. 4.13. Use description Table 13 Use # 13 – Disinfection of equipment by dipping Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning Application method(s) Method: Soaking. Detailed description: The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280mL/100 L) in 60 min contact time. Number and timing of application: /L 166/26 EN Official Journal of the European Union 22.6.2022 Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.13.1. Use-specific instructions for use See general directions for use. 4.13.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post- application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance 4.13.3. 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. 4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.13.5. 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. 4.14. Use description Table 14 Use # 14 – Disinfection in Aseptic Filling Lines (crown corks, cheese moulds and food crates) - Automated spraying closed systems Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use22.6.2022 EN Official Journal of the European Union L 166/27 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food and beverage industry: Disinfection of hard/non-porous surfaces by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is sprayed on the surfaces in an automated way without any operator being present Application rate(s) and Application Rate: - frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.14.1. Use-specific instructions for use See general directions for use. 4.14.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.L 166/28 EN Official Journal of the European Union 22.6.2022 Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance The treated surface should not be allowed to dry prior to rinsing. 4.14.3. 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. 4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.14.5. 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. 4.15. Use description Table 15 Use # 15 – Disinfection of equipment in the food and beverage industry by immersion Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food and beverage industry: Disinfection of hard/non-porous surfaces (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning22.6.2022 EN Official Journal of the European Union L 166/29 Application method(s) Method: Soaking. Detailed description: The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected Application rate(s) and Application Rate: - frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.15.1. Use-specific instructions for use See general directions for use. 4.15.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post- application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance. Re-entry of the general public only when surfaces are dried and after sufficient ventilation.L 166/30 EN Official Journal of the European Union 22.6.2022 4.15.3. 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. 4.15.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.15.5. 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. 4.16. Use description Table 16 Use # 16 – Disinfection of heat and ion exchangers, membrane filters and glass and PET bottles – CIP procedures Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food and beverage industry: Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning Application method(s) Method: Closed system Detailed description: Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations. After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.22.6.2022 EN Official Journal of the European Union L 166/31 Application rate(s) and Application Rate: - frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.16.1. Use-specific instructions for use See general directions for use. 4.16.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Rinse the pump and disconnect it from the installation before maintenance 4.16.3. 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. 4.16.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.16.5. 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.L 166/32 EN Official Journal of the European Union 22.6.2022 4.17. Use description Table 17 Use # 17 – Disinfection of surfaces and equipment by low pressure spraying – spraying with personal enclosure Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device). Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional22.6.2022 EN Official Journal of the European Union L 166/33 Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.17.1. Use-specific instructions for use See general directions for use. 4.17.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. The application should only take place with the user in a personal enclosure and no other person is present. Rinse the pump and disconnect it from the installation before maintenance” The treated surface should not be allowed to dry prior to rinsing. 4.17.3. 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. 4.17.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.17.5. 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. 4.18. Use description Table 18 Use # 18 – Disinfection of surfaces and equipment by low pressure spraying – spraying without personal enclosure Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage:L 166/34 EN Official Journal of the European Union 22.6.2022 Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.18.1. Use-specific instructions for use See general directions for use. 4.18.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.22.6.2022 EN Official Journal of the European Union L 166/35 Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. Rinse the pump and disconnect it from the installation before maintenance The treated surface should not be allowed to dry prior to rinsing. 4.18.3. 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. 4.18.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.18.5. 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. 4.19. Use description Table 19 Use # 19 – Disinfection of surfaces and equipment by low pressure spraying, manually Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Manual application - spraying. Detailed description: Diluted product is manually applied by low-pressure spraying, only downwards and horizontal.L 166/36 EN Official Journal of the European Union 22.6.2022 Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.19.1. Use-specific instructions for use See general directions for use. 4.19.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. Rinse the pump and disconnect it from the installation before maintenance” The treated surface should not be allowed to dry prior to rinsing. 4.19.3. 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. 4.19.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.19.5. 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.22.6.2022 EN Official Journal of the European Union L 166/37 4.20. Use description Table 20 Use # 20 – Disinfection of surfaces and equipment by low pressure spraying, automatically Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: The diluted product is sprayed on the equipment, on conveyor belt, automatically. The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device). Spraying is only applied downwards and in a horizontal direction. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial ProfessionalL 166/38 EN Official Journal of the European Union 22.6.2022 Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.20.1. Use-specific instructions for use See general directions for use. . 4.20.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. RPE are not mandatory during the application phase, on the condition that the operator remains in the control room and do not enter the treated area. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” The treated surface should not be allowed to dry prior to rinsing. 4.20.3. 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. 4.20.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.20.5. 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. 4.21. Use description Table 21 Use # 21 – Disinfection of surfaces and equipment by low pressure spraying – automatic spraying (closed room) Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact - description of the authorised use22.6.2022 EN Official Journal of the European Union L 166/39 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: The diluted solution is sprayed on the surfaces in an automated way without any user being present. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.21.1. Use-specific instructions for use See general directions for use. 4.21.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.L 166/40 EN Official Journal of the European Union 22.6.2022 Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) is not mandatory during the application phase, on condition that the operator do not enter the treated area and remains in the control room. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. Rinse the pump and disconnect it from the installation before maintenance” The treated surface should not be allowed to dry prior to rinsing. 4.21.3. 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. 4.21.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.21.5. 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. 4.22. Use description Table 22 Use # 22 – Disinfection of inner surfaces (pipelines, tanks, vessels, …) by CIP Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning22.6.2022 EN Official Journal of the European Union L 166/41 Application method(s) Method: Closed system Detailed description: Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations. After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions. Application rate(s) and Application Rate: - frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i. e. 1 280mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.22.1. Use-specific instructions for use See general directions for use. 4.22.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading phase. Respiratory protection: Rinse the pump and disconnect it from the installation before maintenance” Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. 4.22.3. 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. 4.22.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use.L 166/42 EN Official Journal of the European Union 22.6.2022 4.22.5. 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. 4.23. Use description Table 23 Use # 23 – Disinfection of water used for rinsing of recycled items during the washing process Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In food industry: Disinfection of water (in clean conditions) used for rinsing of recycled items = Water from drinking water quality shortly stored in tanks until use to rinse items such as bottles. The water should be disinfected to avoid recontamination and in an extent to avoid cross-contamination of inner bottle surfaces Application method(s) Method: Closed system Detailed description: Concentrated product will be pumped into a reservoir from which it is continuously dosed into the water stream. Dilution of the product to the intended in-use concentration occurs in the water stream. This application is a closed, automated process. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0.008 % PAA (Dilution of the product at 0.16 % i.e. 160 mL/100 L) at Room Temperature in 15 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery.22.6.2022 EN Official Journal of the European Union L 166/43 4.23.1. Use-specific instructions for use See general directions for use. 4.23.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Not mandatory. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” 4.23.3. 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. 4.23.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.23.5. 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(1)OF THE META SPC 1 5.1. Instructions for use 1. All the surfaces to be disinfected must be cleaned before the disinfection procedure 2. Disinfection cycle: — Products must be diluted in potable water before use. — Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use. — Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use. Only for use in areas that are inaccessible to the general public and companion animals. No access for the general public during treatment. 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 bath is not intended to be re-used. Use the bath only once a day after work & replace it by a fresh solution daily. Disinfection procedures by spraying: the surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution. The Application Rate for spraying of diluted product must be between 20 and 30 mL/m2 (1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.L 166/44 EN Official Journal of the European Union 22.6.2022 5.2. Risk mitigation measures Dermal protection: Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information). 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Indirect effects The two theoretical products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion. Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self- accelerated, exothermic decomposition and the formation of oxygen. In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst. First aid measures Ø General advice Move out of dangerous area. Take care of your own personal safety. Take off immediately all contaminated clothing. Ø Inhalation Take affected persons out into the fresh air. Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough. If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately. Ø Skin contact After contact with skin, wash immediately with plenty of water. Consult a physician. Take off immediately all contaminated clothing. Immediately rinse contaminated or saturated clothing with water. Ø Eye contact With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes. Protect unharmed eye. Continue rinsing process with eye rinsing solution. Call ambulance (caustic burn of the eyes) Immediate further treatment in ophthalmic hospital/ophthalmologist. Continue rinsing eye until arrival at ophthalmic hospital.22.6.2022 EN Official Journal of the European Union L 166/45 Ø Ingestion Do not induce vomiting. Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation. Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest. Notify ambulance immediately (key word: acid burn). Ø Notes to physician Therapy as for chemical burn. Following inhalation: Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area). Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone). If substance has been swallowed: Aspiration hazard. Risk of gaseous embolisms. In case of excessive strain on the stomach due to gas evolution, insert siphon tube. Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear. If necessary, suck away leftover substance. Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide. Emergency measures to protect the environment Observe regulations on prevention of water pollution (collect, dam up, cover up). Do not allow to run into water channels, surface water or into the ground. Ø Methods for cleaning up Clean contaminated surface thoroughly; recommended cleaning agent is water. In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations. Ø Additional advice Make safe or remove all sources of ignition. Isolate defective containers immediately, if possible and safe to do. Shut off leak, if possible and safe to do. Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal). Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition). Product taken out should not be returned into container. Never return spilled product into its original container for re-use (risk of decomposition).L 166/46 EN Official Journal of the European Union 22.6.2022 5.4. Instructions for safe disposal of the product and its packaging Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition The shelf life of the biocidal product is 6 months. The products must be stored at temperatures below + 30 °C. 6. OTHER INFORMATION Reference values of peracetic acid and hydrogen peroxide used for the risk assessment: PAA: AECinhal = 0,5 mg/m3 HP: AECinhal = 1,25 mg/m3 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) SOPUROXID 5 Market area: EU HyPro Biocide 5-22 Market area: EU AGRIOXID 5 Market area: EU TECMA CUAR HPA Market area: EU Authorisation number EU-0026179-0001 1-1 CAS Common name IUPAC name Function EC number Content (%) number Peracetic acid Active Substance 79-21-0 201-186-8 5,0 Sulphuric acid Non-active substance 7664-93-9 231-639-5 0,2 Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 22,0 Acetic acid Non-active substance 64-19-7 200-580-7 9,55 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) SOPUROXID 5C Market area: EU DEPTIL TR 5 Market area: EU DIS OXI-5+ Market area: EU ANTI-GERM DES OXI-50 TC Market area: EU Peracid ATR + Market area: EU22.6.2022 EN Official Journal of the European Union L 166/47 FOR-Acid TR + Market area: EU X-CID TR 50 + Market area: EU Authorisation number EU-0026179-0002 1-1 CAS Common name IUPAC name Function EC number Content (%) number Peracetic acid Active Substance 79-21-0 201-186-8 5,0 Sulphuric acid Non-active substance 7664-93-9 231-639-5 24,04 Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 16,5 Acetic acid Non-active substance 64-19-7 200-580-7 5,8 META SPC 2 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier Meta SPC2 1.2. Suffix to the authorisation number Number 1-2 1.3. Product type(s) Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) 2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Content (%) Common name IUPAC name Function CAS number EC number Min Max Peracetic acid Active Substance 79-21-0 201-186-8 3,2 3,2 Sulphuric acid Non-active 7664-93-9 231-639-5 0,8 1,0 substanceL 166/48 EN Official Journal of the European Union 22.6.2022 Hydrogen peroxide Non-active 7722-84-1 231-765-0 23,5 23,5 substance Acetic acid Non-active 64-19-7 200-580-7 6,45 7,5 substance 2.2. Type(s) of formulation of the meta SPC 2 Formulation(s) SL - Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements May intensify fire; oxidiser May be corrosive to metals. Causes severe skin burns and eye damage. Causes serious eye damage. May cause respiratory irritation. Very toxic to aquatic life with long lasting effects. Harmful if swallowed. Harmful in contact with skin. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Wear face protection. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. Wear eye protection. Wear protective gloves. Take any precaution to avoid mixing with combustibles. Avoid breathing vapours. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Specific treatment (see information on this label). Rinse mouth. Wash contaminated clothing before reuse. IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell. IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. IF ON SKIN: Wash with plenty of water. IF INHALED: Remove person to fresh air and keep comfortable for breathing. Take off contaminated clothing. And wash it before reuse. Store locked up. Store in a well-ventilated place. Keep container tightly closed. Dispose of contents to in accordance with local/regional/national/international regulations. Wear protective clothing. Dispose of container to in accordance with local/regional/national/international regulations. Keep cool. Avoid release to the environment. Collect spillage. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with shower.22.6.2022 EN Official Journal of the European Union L 166/49 Avoid breathing spray. Do not breathe spray. Do not breathe vapours. 4. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 24 Use # 1 – Room Disinfection by fogging - In industrial, public and non-medical healthcare areas. (pharmaceutical and cosmetic industry) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Field(s) of use Indoor In industrial, public and non-medical healthcare areas: Disinfection of hard/non-porous surfaces by fogging. Application method(s) Method: Fogging Detailed description: By fogging with the diluted product Application rate(s) and Application Rate: - frequency Dilution (%): Active against bacteria (including bacterial spores) and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion) Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.1.1. Use-specific instructions for use See general directions for use.L 166/50 EN Official Journal of the European Union 22.6.2022 4.1.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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 25 Use # 2 – Room Disinfection by fogging - In agriculture & horticulture areas (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces by fogging with prior cleaning Application method(s) Method: Fogging Detailed description: By fogging with the diluted product22.6.2022 EN Official Journal of the European Union L 166/51 Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion) Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.2.1. Use-specific instructions for use See general directions for use. 4.2.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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.L 166/52 EN Official Journal of the European Union 22.6.2022 4.3. Use description Table 26 Use # 3 – Room Disinfection by fogging – In animal housing Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In animal housing: Disinfection of hard/non-porous surfaces by fogging with prior cleaning Application method(s) Method: Fogging Detailed description: By fogging with the diluted product Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion) Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.3.1. Use-specific instructions for use See general directions for use. 4.3.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.22.6.2022 EN Official Journal of the European Union L 166/53 When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance. Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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 27 Use # 4 – Room Disinfection by fogging – In storage rooms with special device in storage cellar or room Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact .. description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Field(s) of use Indoor In food/feed areas (storage rooms): Disinfection of hard/non-porous surfaces by fogging. Application method(s) Method: Fogging Detailed description: By fogging with the diluted product Application rate(s) and Application Rate: - frequency Dilution (%): Active against bacteria (including bacterial spores) and yeasts With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)L 166/54 EN Official Journal of the European Union 22.6.2022 Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.4.1. Use-specific instructions for use See general directions for use. 4.4.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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. 5. GENERAL DIRECTIONS FOR USE(2)OF THE META SPC 2 5.1. Instructions for use 1. All the surfaces to be disinfected must be cleaned before the disinfection procedure. For exceptions, please refer to the description of application method related to each use. (2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.22.6.2022 EN Official Journal of the European Union L 166/55 2. Disinfection cycle: — Products must be diluted in potable water before use. — Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use. — Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use. Meta SPC2: Disinfection procedures by fogging The product SOPUROXID 3.2 is a liquid disinfectant to be applied (after dilution at 40 %) by fogging for airborne surface disinfection and to be used indoor by professional users only. Always check compatibility of the products with the hard/non-porous surfaces to be disinfected. The product SOPUROXID 3.2 has been developed and demonstrated as efficacious (via efficacy studies performed according to the NF T 72 281standard), using one device HYSPRAY, for rooms with a volume between 30 & 150 m3 (volume per application and per device) with a flow rate of 0,047 mL/min/m3. The use of other devices is possible. They must be designed to work with PAA-based products and to ensure a fog production able to stay suspended in the air and provided that these devices meet following characteristics: 1) Particle (medium droplet) size: between 1 and 15 μm 2) Flow rate: 0,047 mL/min/m3 3) Application rate: 5,6 mL/m3 4) Room volume between 30 and 150 m3 per application and per device (i.e. diffusion time between 5 and 30 min) — Airborne disinfection should be done only after thorough cleaning and rinsing. The surfaces to be disinfected should be dried before the disinfection procedure. Please pay attention to open the cupboard doors. Please check the temperature and the relative room humidity (to be set between 40 and 80 %) to obtain an optimal level for the product efficiency. — The room where the fogging activity takes place is tightly sealed during fogging, no user is present: Before the start of the disinfection cycle by fogging, the treated room is sealed. All the safety tasks for the implementation of decontamination are entrusted to an user who has completed the necessary training. Among them, first step is shutting down the air handling units and closing the air intake and return, so the product is not spread in the other rooms. The door or doors to the outside of the area are then locked and, if the joints are not tight enough, they are taped to seal. An orange tape, or bright colour, is preferably chosen to attract attention and a sign "Access ban, room disinfection in progress" is put on. Only for use in areas that are inaccessible to the general public and companion animals”. — The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. 5.2. Risk mitigation measures Dermal protection: Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).L 166/56 EN Official Journal of the European Union 22.6.2022 + Additional specific RMM for fogging applications: Only for use in areas that are inaccessible to the general public and companion animals. — After disinfection product’s application by fogging & required contact time for optimal disinfection (2h), the room must be ventilated, preferably by mechanical ventilation at least for 60 min. The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by the authorisation holder within the product information). — After ventilation, re-entry in the disinfected area is only permitted after the air concentrations of peracetic acid and hydrogen peroxide have been checked and seen as dropped below the respective reference values (AEC): — The air concentration of PAA must have dropped to 0,5 mg/m3. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Indirect effects The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion. Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self- accelerated, exothermic decomposition and the formation of oxygen. In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst. First aid measures Ø General advice Move out of dangerous area. Take care of your own personal safety. Take off immediately all contaminated clothing. Ø Inhalation Take affected persons out into the fresh air. Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough. If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately. Ø Skin contact After contact with skin, wash immediately with plenty of water. Consult a physician. Take off immediately all contaminated clothing. Immediately rinse contaminated or saturated clothing with water. Ø Eye contact With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes. Protect unharmed eye. Continue rinsing process with eye rinsing solution. Call ambulance (caustic burn of the eyes)22.6.2022 EN Official Journal of the European Union L 166/57 Immediate further treatment in ophthalmic hospital/ophthalmologist. Continue rinsing eye until arrival at ophthalmic hospital. Ø Ingestion Do not induce vomiting. Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation. Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest. Notify ambulance immediately (key word: acid burn). Ø Notes to physician Therapy as for chemical burn. Following inhalation: Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area). Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone). If substance has been swallowed: Aspiration hazard. Risk of gaseous embolisms. In case of excessive strain on the stomach due to gas evolution, insert siphon tube. Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear. If necessary, suck away leftover substance. Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide. Emergency measures to protect the environment Observe regulations on prevention of water pollution (collect, dam up, cover up). Do not allow to run into water channels, surface water or into the ground. Ø Methods for cleaning up Clean contaminated surface thoroughly; recommended cleaning agent is water. In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations. Ø Additional advice Make safe or remove all sources of ignition. Isolate defective containers immediately, if possible and safe to do. Shut off leak, if possible and safe to do. Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal). Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition). Product taken out should not be returned into container. Never return spilled product into its original container for re-use (risk of decomposition).L 166/58 EN Official Journal of the European Union 22.6.2022 5.4. Instructions for safe disposal of the product and its packaging Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition The shelf life of the biocidal product is 6 months. The products must be stored at temperatures below + 30 °C. 6. OTHER INFORMATION Reference values of peracetic acid and hydrogen peroxide used for the risk assessment: PAA: AECinhal = 0,5 mg/m3 HP: AECinhal = 1,25 mg/m3 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) SOPUROXID 3.2 Market area: EU HyPro Biocide 3.2-23 Market area: EU Authorisation number EU-0026179-0003 1-2 CAS Common name IUPAC name Function EC number Content (%) number Peracetic acid Active Substance 79-21-0 201-186-8 3,2 Sulphuric acid Non-active substance 7664-93-9 231-639-5 0,8 Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 23,5 Acetic acid Non-active substance 64-19-7 200-580-7 6,45 META SPC 3 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier Meta SPC3 1.2. Suffix to the authorisation number Number 1-322.6.2022 EN Official Journal of the European Union L 166/59 1.3. Product type(s) Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) 2. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Content (%) Common name IUPAC name Function CAS number EC number Min Max Peracetic acid Active Substance 79-21-0 201-186-8 3,2 3,2 Sulphuric acid Non-active 7664-93-9 231-639-5 0,6 1,0 substance Hydrogen peroxide Non-active 7722-84-1 231-765-0 23,5 23,5 substance Acetic acid Non-active 64-19-7 200-580-7 5,5 7,1 substance 2.2. Type(s) of formulation of the meta SPC 3 Formulation(s) SL - Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements May intensify fire; oxidiser May be corrosive to metals. Harmful if swallowed. Harmful in contact with skin. Causes severe skin burns and eye damage. Causes serious eye damage. May cause respiratory irritation. Very toxic to aquatic life with long lasting effects. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Wear protective gloves. Wear face protection. Wear eye protection. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. Take any precaution to avoid mixing with combustibles. Avoid breathing vapours.L 166/60 EN Official Journal of the European Union 22.6.2022 Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Specific treatment (see information on this label). Rinse mouth. Wash contaminated clothing before reuse. IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell. IF ON SKIN: Wash with plenty of water. IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. IF INHALED: Remove person to fresh air and keep comfortable for breathing. Take off immediately all contaminated clothing. And wash it before reuse. Store locked up. Store in a well-ventilated place. Keep container tightly closed. Dispose of contents to in accordance with local/regional/national/international regulations. Wear protective clothing. Dispose of container to in accordance with local/regional/national/international regulations. Keep cool. Avoid release to the environment. Collect spillage. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with shower. Avoid breathing spray. Do not breathe vapours. Do not breathe vapours. 4. AUTHORISED USE(S) OF THE META SPC 3 4.1. Use description Table 28 Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. – foam application on surfaces Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In industrial, public and non-medical healthcare areas: Disinfection of hard/non-porous surfaces by foaming with prior cleaning Application method(s) Method: Foam application Detailed description: By foaming via a small foaming can with the diluted product22.6.2022 EN Official Journal of the European Union L 166/61 Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1500 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2 Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2 Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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.L 166/62 EN Official Journal of the European Union 22.6.2022 4.2. Use description Table 29 Use # 2 – Disinfection of surfaces and agriculture/horticulture equipment by foaming, manually (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by foaming with prior cleaning Application method(s) Method: Foam application Detailed description: By foaming via a small foaming can with the diluted product Foaming is only applied downwards and in a horizontal direction. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.2.1. Use-specific instructions for use See general directions for use. 4.2.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.22.6.2022 EN Official Journal of the European Union L 166/63 Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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 30 Use # 3 – Disinfection of surfaces and agriculture/horticulture equipment by automatic foaming (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by automatic foaming with prior cleaning Application method(s) Method: Foam application Detailed description: The diluted product is foamed on the equipment in an automated way while the user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).L 166/64 EN Official Journal of the European Union 22.6.2022 Foaming is only applied downwards and in a horizontal direction. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.3.1. Use-specific instructions for use See general directions for use. 4.3.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. 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.22.6.2022 EN Official Journal of the European Union L 166/65 4.4. Use description Table 31 Use # 4 – Disinfection of surfaces and agriculture/horticulture equipment by automatic foaming (closed rooms) (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by automatic foaming with prior cleaning Application method(s) Method: Foam application Detailed description: The diluted product is foamed on the surfaces in an automated way without any user being present. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.4.1. Use-specific instructions for use See general directions for use. 4.4.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection:L 166/66 EN Official Journal of the European Union 22.6.2022 Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. 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 32 Use # 5 – Disinfection of animal houses by foaming – foaming with personal enclosure Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor In animal housing Disinfection of hard/non-porous surfaces by foaming with prior cleaning Application method(s) Method: Foam application Detailed description: The diluted product is automatically foamed in all directions on the surfaces/walls, via a foaming device. The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)22.6.2022 EN Official Journal of the European Union L 166/67 Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.5.1. Use-specific instructions for use It has to be assured that animals are not present when treatment takes place. 4.5.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading and of a factor of 10 during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken The application should only take place with the user in a personal enclosure and no other person is present. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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.L 166/68 EN Official Journal of the European Union 22.6.2022 4.6. Use description Table 33 Use # 6 – Disinfection of animal houses by foaming – foaming without personal enclosure Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor In animal housing Disinfection of hard/non-porous surfaces by foaming with prior cleaning Application method(s) Method: Foam application Detailed description: The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.6.1. Use-specific instructions for use It has to be assured that animals are not present when treatment takes place. 4.6.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.22.6.2022 EN Official Journal of the European Union L 166/69 Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.6.3. 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. 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.6.5. 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. 4.7. Use description Table 34 Use # 7 – Disinfection of surfaces by foaming – foaming with personal enclosure Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces by foaming with prior cleaningL 166/70 EN Official Journal of the European Union 22.6.2022 Application method(s) Method: Foam application Detailed description: The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device. The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device) Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria & yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Against bacteria (including bacterial spores), yeasts and viruses (including bacteriophages): With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000mL/100 L) at Room Temperature in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.7.1. Use-specific instructions for use See general directions for use. 4.7.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Respiratory protection with an APF of 10 is required during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application should only take place with the user in a personal enclosure and no other person is present. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation.22.6.2022 EN Official Journal of the European Union L 166/71 4.7.3. 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. 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.7.5. 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. 4.8. Use description Table 35 Use # 8 – Disinfection of surfaces by foaming – without personal enclosure Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor Indoor – In food industry: Disinfection of hard/non-porous surfaces by foaming with prior cleaning Application method(s) Method: Foam application Detailed description: The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria & yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Against bacteria (including bacterial spores), yeasts and viruses (including bacteriophages): With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000mL/100 L) at Room Temperature in 60 min contact time.L 166/72 EN Official Journal of the European Union 22.6.2022 Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.8.1. Use-specific instructions for use See general directions for use. 4.8.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.8.3. 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. 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.8.5. 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(3)OF THE META SPC 3 5.1. Instructions for use 1. All the surfaces to be disinfected must be cleaned before the disinfection procedure (3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.22.6.2022 EN Official Journal of the European Union L 166/73 2. Disinfection cycle: — Products must be diluted in potable water before use. — Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use. — Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use. Meta SPC 3: Disinfection procedures by foaming Only for use in areas that are inaccessible to the general public and companion animals. No access for the general public during treatment. The surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution. 5.2. Risk mitigation measures Dermal protection: Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information). 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Indirect effects The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion. Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self- accelerated, exothermic decomposition and the formation of oxygen. In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst. First aid measures Ø General advice Move out of dangerous area. Take care of your own personal safety. Take off immediately all contaminated clothing. Ø Inhalation Take affected persons out into the fresh air. Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough. If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately. Ø Skin contact After contact with skin, wash immediately with plenty of water. Consult a physician.L 166/74 EN Official Journal of the European Union 22.6.2022 Take off immediately all contaminated clothing. Immediately rinse contaminated or saturated clothing with water. Ø Eye contact With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes. Protect unharmed eye. Continue rinsing process with eye rinsing solution. Call ambulance (caustic burn of the eyes) Immediate further treatment in ophthalmic hospital/ophthalmologist. Continue rinsing eye until arrival at ophthalmic hospital. Ø Ingestion Do not induce vomiting. Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation. Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest. Notify ambulance immediately (key word: acid burn). Ø Notes to physician Therapy as for chemical burn. Following inhalation: Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area). Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone). If substance has been swallowed: Aspiration hazard. Risk of gaseous embolisms. In case of excessive strain on the stomach due to gas evolution, insert siphon tube. Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear. If necessary, suck away leftover substance. Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide. Emergency measures to protect the environment Observe regulations on prevention of water pollution (collect, dam up, cover up). Do not allow to run into water channels, surface water or into the ground. Ø Methods for cleaning up Clean contaminated surface thoroughly; recommended cleaning agent is water. In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.22.6.2022 EN Official Journal of the European Union L 166/75 Ø Additional advice Make safe or remove all sources of ignition. Isolate defective containers immediately, if possible and safe to do. Shut off leak, if possible and safe to do. Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal). Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition). Product taken out should not be returned into container. Never return spilled product into its original container for re-use (risk of decomposition). 5.4. Instructions for safe disposal of the product and its packaging Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition The shelf life of the biocidal product is 6 months. The products must be stored at temperatures below + 30 °C. 6. OTHER INFORMATION Reference values of peracetic acid and hydrogen peroxide used for the risk assessment: PAA: AECinhal = 0,5 mg/m3 HP: AECinhal = 1,25 mg/m3 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) ACIDOFOAM CF Market area: EU HyPro Biocide 3.2-23a Market area: EU TECHMA OXI PB Market area: EU Authorisation number EU-0026179-0004 1-3 CAS Common name IUPAC name Function EC number Content (%) number Peracetic acid Active Substance 79-21-0 201-186-8 3,2 Sulphuric acid Non-active substance 7664-93-9 231-639-5 0,8 Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 23,5 Acetic acid Non-active substance 64-19-7 200-580-7 6,1L 166/76 EN Official Journal of the European Union 22.6.2022 META SPC 4 1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier Meta SPC4 1.2. Suffix to the authorisation number Number 1-4 1.3. Product type(s) Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) PT04 - Food and feed area (Disinfectants) 2. META SPC 4 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Content (%) Common name IUPAC name Function CAS number EC number Min Max Peracetic acid Active Substance 79-21-0 201-186-8 15,0 15,0 Sulphuric acid Non-active 7664-93-9 231-639-5 0,78 0,78 substance Hydrogen peroxide Non-active 7722-84-1 231-765-0 22,0 22,0 substance Acetic acid Non-active 64-19-7 200-580-7 16,7 16,7 substance 2.2. Type(s) of formulation of the meta SPC 4 Formulation(s) SL - Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements Heating may cause a fire. May be corrosive to metals. Harmful if swallowed. Harmful if inhaled. Causes severe skin burns and eye damage. Causes serious eye damage. May cause respiratory irritation.22.6.2022 EN Official Journal of the European Union L 166/77 Very toxic to aquatic life with long lasting effects. Flammable liquid and vapour. Toxic in contact with skin. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Wear protective gloves. Wear eye protection. Wear face protection. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. Take any precaution to avoid mixing with combustibles. Avoid breathing vapours. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Specific treatment (see information on this label). Rinse mouth. Wash contaminated clothing before reuse. IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell. IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. IF ON SKIN: Wash with plenty of water. IF INHALED: Remove person to fresh air and keep comfortable for breathing. Take off immediately all contaminated clothing. And wash it before reuse. Store locked up. Store in a well-ventilated place. Keep container tightly closed. Dispose of contents to local/regional/national/international regulations. Wear protective clothing. Dispose of container to local/regional/national/international regulations. Keep cool. Avoid release to the environment. Collect spillage. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with shower. Do not breathe spray. Avoid breathing spray. Do not breathe vapours. 4. AUTHORISED USE(S) OF THE META SPC 4 4.1. Use description Table 36 Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (mopping) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised useL 166/78 EN Official Journal of the European Union 22.6.2022 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In Industrial, public and non-medical healthcare areas: Disinfection of hard/non-porous surfaces by manual treatment (mopping) with prior cleaning Application method(s) Method: Manual treatment (mopping). Detailed description: Diluted product is applied by mopping with the appropriate tool (e.g. flat mops or cleaning cloths). After application, the diluted product is drained. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.1.1. Use-specific instructions for use Items to be disinfected by mopping have to stay sufficiently wet during the required contact time to allow optimal disinfection. 4.1.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.22.6.2022 EN Official Journal of the European Union L 166/79 When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” Re-entry is only permitted once the air concentrations of peracetic acid and hydrogen peroxide have dropped below the respective reference values (AEC). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by authorization holder). Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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 37 Use # 2 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (spraying) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In Industrial, public and non-medical healthcare areas: Disinfection of hard/non-porous surfaces by manual treatment (spraying) with prior cleaning Application method(s) Method: Manual treatment (spraying) Detailed description: Diluted product is applied by spraying using a small spraying can. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than inL 166/80 EN Official Journal of the European Union 22.6.2022 HEALTHCARE With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.2.1. Use-specific instructions for use See general directions for use. 4.2.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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.22.6.2022 EN Official Journal of the European Union L 166/81 4.3. Use description Table 38 Use # 3 – Clean in Place (CIP) in the pharmaceutical and cosmetic industry Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In pharmaceutical and cosmetic industry: Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning Application method(s) Method: By CIP procedure Detailed description: Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations. After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria & yeasts: With 0,032 % PAA (Dilution of the product at 0.2133 % i.e.213.33 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.3.1. Use-specific instructions for use See general directions for use. 4.3.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.L 166/82 EN Official Journal of the European Union 22.6.2022 Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Rinse the pump and disconnect it from the installation before maintenance. 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 39 Use # 4 – Surface disinfection in greenhouses via spraying by user with personal enclosure (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In greenhouses: Disinfection of hard/non-porous surfaces by spraying with prior cleaning Application method(s) Method: Open system: spray treatment Detailed description: Diluted product is automatically applied in all directions by spraying via a spraying device The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device) Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time. Number and timing of application: /22.6.2022 EN Official Journal of the European Union L 166/83 Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.4.1. Use-specific instructions for use See general directions for use. 4.4.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application should only take place with the user in a personal enclosure and no other person is present. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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 40 Use # 5 – Surface disinfection in greenhouses via spraying by user without personal enclosure (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised useL 166/84 EN Official Journal of the European Union 22.6.2022 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In greenhouses: Disinfection of hard/non-porous surfaces by spraying with prior cleaning Application method(s) Method: Open system: spray treatment Detailed description: Diluted product is automatically applied in all directions by spraying via a spraying device. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.5.1. Use-specific instructions for use See general directions for use. 4.5.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance”22.6.2022 EN Official Journal of the European Union L 166/85 “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 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. 4.6. Use description Table 41 Use # 6 – Disinfection of agriculture & horticulture equipment by soaking (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning Application method(s) Method: Open system: immersion Detailed description: The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 60 min contact time. Number and timing of application: /L 166/86 EN Official Journal of the European Union 22.6.2022 Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.6.1. Use-specific instructions for use See general directions for use. 4.6.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post- application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” 4.6.3. 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. 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.6.5. 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. 4.7. Use description Table 42 Use # 7 – Disinfection of surfaces and agriculture/horticulture equipment by spraying (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use22.6.2022 EN Official Journal of the European Union L 166/87 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Open system: spray treatment Detailed description: The diluted product is manually sprayed on the surfaces/equipment using spraying equipment. Spraying is only applied downwards and in a horizontal direction. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.7.1. Use-specific instructions for use See general directions for use. 4.7.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance “The treated surface should not be allowed to dry prior to rinsing”.L 166/88 EN Official Journal of the European Union 22.6.2022 4.7.3. 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. 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.7.5. 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. 4.8. Use description Table 43 Use # 8 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is applied by spraying in an automated way Spraying is only applied downwards and in a horizontal direction. Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging Pack sizes and packaging material material HDPE with screw and venting caps (weight depends on density of product): Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery.22.6.2022 EN Official Journal of the European Union L 166/89 4.8.1. Use-specific instructions for use See general directions for use. 4.8.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. 4.8.3. 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. 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.8.5. 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. 4.9. Use description Table 44 Use # 9 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (closed room) (in absence of plants - for general hygiene purpose only) Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In agriculture/horticulture areas: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaningL 166/90 EN Official Journal of the European Union 22.6.2022 Application method(s) Method: By spraying. Detailed description: Diluted product is applied by spraying in an automated way without any operator being present Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.9.1. Use-specific instructions for use See general directions for use. 4.9.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. 4.9.3. 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. 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use.22.6.2022 EN Official Journal of the European Union L 166/91 4.9.5. 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. 4.10. Use description Table 45 Use # 10 – Disinfection of animal housing via low-pressure spraying by user with personal enclosure Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor In animal housing: Disinfection of hard/non-porous surfaces by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is automatically applied in all directions by low-pressure manual spraying via a spraying device. The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device) Application rate(s) and Application Rate: Between 20 and 300 mL/m2 frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.10.1. Use-specific instructions for use It has to be assured that animals are not present when treatment takes place.L 166/92 EN Official Journal of the European Union 22.6.2022 4.10.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.10.3. 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. 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.10.5. 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. 4.11. Use description Table 46 Use # 11 – Disinfection of animal housing via low-pressure manual spraying by user without personal enclosure Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor In animal housing: Disinfection of hard/non-porous surfaces by spraying with prior cleaning22.6.2022 EN Official Journal of the European Union L 166/93 Application method(s) Method: Open system: spray treatment Detailed description: Diluted product is automatically applied in all directions by low-pressure automatic spraying via a spraying device. Application rate(s) and Application Rate: Between 20 and 300 mL/m2 frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.11.1. Use-specific instructions for use It has to be assured that animals are not present when treatment takes place. 4.11.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.11.3. 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.L 166/94 EN Official Journal of the European Union 22.6.2022 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.11.5. 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. 4.12. Use description Table 47 Use # 12 – Disinfection of boots in footbaths in animal houses/husbandries Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor in animal housing/husbandries: Disinfection of boots by dipping (not for walk-through) with prior cleaning. Application method(s) Method: Dipping Detailed description: Diluted product is put in the footbath No rinse needed Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.12.1. Use-specific instructions for use See general directions for use.22.6.2022 EN Official Journal of the European Union L 166/95 4.12.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post- application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.12.3. 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. 4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.12.5. 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. 4.13. Use description Table 48 Use # 13 – Disinfection of equipment by dipping Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Field(s) of use Indoor Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaningL 166/96 EN Official Journal of the European Union 22.6.2022 Application method(s) Method: Soaking. Detailed description: The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.13.1. Use-specific instructions for use See general directions for use. 4.13.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post- application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance. 4.13.3. 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. 4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use.22.6.2022 EN Official Journal of the European Union L 166/97 4.13.5. 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. 4.14. Use description Table 49 Use # 14 – Disinfection in Aseptic Filling Lines (crown corks, cheese moulds and food crates) - Automated spraying closed systems Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food and beverage industry: Disinfection of hard/non-porous surfaces by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is sprayed on the surfaces in an automated way without any user being present. Application rate(s) and Application Rate: - frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial ProfessionalL 166/98 EN Official Journal of the European Union 22.6.2022 Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.14.1. Use-specific instructions for use See general directions for use. 4.14.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. 4.14.3. 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. 4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.14.5. 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. 4.15. Use description Table 50 Use # 15 – Disinfection of equipment in the food and beverage industry by immersion Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact - description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage:22.6.2022 EN Official Journal of the European Union L 166/99 Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food and beverage industry: Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning Application method(s) Method: Soaking. Detailed description: The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected Application rate(s) and Application Rate: - frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.15.1. Use-specific instructions for use See general directions for use. 4.15.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.L 166/100 EN Official Journal of the European Union 22.6.2022 Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase. Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post- application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.15.3. 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. 4.15.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.15.5. 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. 4.16. Use description Table 51 Use # 16 – Disinfection of heat and ion exchangers, membrane filters and glass and PET bottles – CIP procedures Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage:22.6.2022 EN Official Journal of the European Union L 166/101 Field(s) of use Indoor In food and beverage industry: Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning Application method(s) Method: Closed system Detailed description: Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations. After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions. Application rate(s) and Application Rate: - frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.16.1. Use-specific instructions for use See general directions for use. 4.16.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Rinse the pump and disconnect it from the installation before maintenance” 4.16.3. 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.L 166/102 EN Official Journal of the European Union 22.6.2022 4.16.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.16.5. 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. 4.17. Use description Table 52 Use # 17 – Disinfection of surfaces and equipment by low pressure spraying – spraying with personal enclosure Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device) Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.22.6.2022 EN Official Journal of the European Union L 166/103 Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.17.1. Use-specific instructions for use See general directions for use. 4.17.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning The application should only take place with the user in a personal enclosure and no other person is present. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.17.3. 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. 4.17.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.17.5. 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.L 166/104 EN Official Journal of the European Union 22.6.2022 4.18. Use description Table 53 Use # 18 – Disinfection of surfaces and equipment by low pressure spraying – spraying without personal enclosure Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning Application method(s) Method: Spraying Detailed description: Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery.22.6.2022 EN Official Journal of the European Union L 166/105 4.18.1. Use-specific instructions for use See general directions for use. 4.18.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.18.3. 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. 4.18.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.18.5. 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. 4.19. Use description Table 54 Use # 19 – Disinfection of surfaces and equipment by low pressure spraying, manually Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage:L 166/106 EN Official Journal of the European Union 22.6.2022 Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning Application method(s) Method: Manual application - spraying. Detailed description: Diluted product is manually applied by low-pressure spraying, only downwards and horizontal. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.19.1. Use-specific instructions for use See general directions for use. 4.19.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing, loading & application phase. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.22.6.2022 EN Official Journal of the European Union L 166/107 When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.19.3. 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. 4.19.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.19.5. 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. 4.20. Use description Table 55 Use # 20 – Disinfection of surfaces and equipment by low pressure spraying, automatically Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning Application method(s) Method: Spraying Detailed description: The diluted product is sprayed on the equipmentL 166/108 EN Official Journal of the European Union 22.6.2022 The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device). Spraying is only applied downwards and in a horizontal direction. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.20.1. Use-specific instructions for use See general directions for use. 4.20.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. RPE are not mandatory during the application phase, on the condition that the user remains in the control room and do not enter the treated area. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. The application is automatic and should only take place when no one is present in the treated area. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.20.3. 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.22.6.2022 EN Official Journal of the European Union L 166/109 4.20.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.20.5. 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. 4.21. Use description Table 56 Use # 21 – Disinfection of surfaces and equipment by low pressure spraying – automatic spraying (closed room) Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning Application method(s) Method: Spraying Detailed description: The diluted solution is sprayed on the surfaces in an automated way without any user being present. Application rate(s) and Application Rate: Between 20 and 200 mL/m2 frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: /L 166/110 EN Official Journal of the European Union 22.6.2022 Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.21.1. Use-specific instructions for use See general directions for use. 4.21.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading. RPE are not mandatory during the application phase, on the condition that the user remains in the control room and do not enter the treated area. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. Rinse the pump and disconnect it from the installation before maintenance” “The treated surface should not be allowed to dry prior to rinsing”. Re-entry of the general public only when surfaces are dried and after sufficient ventilation. 4.21.3. 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. 4.21.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.21.5. 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. 4.22. Use description Table 57 Use # 22 – Disinfection of inner surfaces (pipelines, tanks, vessels, …) by CIP Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use22.6.2022 EN Official Journal of the European Union L 166/111 Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Common name: Bacterial spores Development stage: Common name: Viruses Development stage: Common name: Bacteriophages Development stage: Field(s) of use Indoor In food industry: Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning Application method(s) Method: Closed system Detailed description: Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations. After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions. Application rate(s) and Application Rate: - frequency Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i. e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.22.1. Use-specific instructions for use See general directions for use.L 166/112 EN Official Journal of the European Union 22.6.2022 4.22.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. Rinse the pump and disconnect it from the installation before maintenance” 4.22.3. 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. 4.22.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.22.5. 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. 4.23. Use description Table 58 Use # 23 – Disinfection of water used for rinsing of recycled items during the washing process Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact . description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor In food industry: Disinfection of water (in clean conditions) used for rinsing of recycled items = Water from drinking water quality shortly stored in tanks until use to rinse items such as bottles. The water should be disinfected to avoid recontamination and in an extent to avoid cross-contamination of inner bottle surfaces Application method(s) Method: Closed system Detailed description: Concentrated product will be pumped into a reservoir from which it is continuously dosed into the water stream. Dilution of the product to the intended in-use concentration occurs in the water stream. This application is a closed, automated process.22.6.2022 EN Official Journal of the European Union L 166/113 Application rate(s) and Application Rate: - frequency Dilution (%): Against bacteria and yeasts: With 0.008 % PAA (Dilution of the product at 0.0533 % i.e. 53.3 mL/100L) at Room Temperature in 15 min contact time. Number and timing of application: / Category(ies) of users Industrial Professional Pack sizes and packaging HDPE with screw and venting caps (weight depends on density of product): material Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000to 1 200kg), 1 L bottles, bulk delivery. 4.23.1. Use-specific instructions for use See general directions for use. 4.23.2. Use-specific risk mitigation measures Dermal protection: Use appropriate safety glasses and/or face shield during the mixing & loading. Respiratory protection: Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading. When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning. Rinse the pump and disconnect it from the installation before maintenance” 4.23.3. 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. 4.23.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.23.5. 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(4)OF THE META SPC 4 5.1. Instructions for use 1. All the surfaces to be disinfected must be cleaned before the disinfection procedure. (4) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.L 166/114 EN Official Journal of the European Union 22.6.2022 1. Disinfection cycle: — Products must be diluted in potable water before use. — Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use. — Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use. Only for use in areas that are inaccessible to the general public and companion animals. No access for the general public during treatment. 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 bath is not intended to be re-used. Use the bath only once a day after work & replace it by a fresh solution daily. Disinfection procedures by spraying: the surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution. The Application Rate for spraying of diluted product must be between 20 and 30 mL/m2 5.2. Risk mitigation measures Dermal protection: Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information). 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Indirect effects The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion. Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self- accelerated, exothermic decomposition and the formation of oxygen. In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst. First aid measures Ø General advice Move out of dangerous area. Take care of your own personal safety. Take off immediately all contaminated clothing. Ø Inhalation Take affected persons out into the fresh air. Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.22.6.2022 EN Official Journal of the European Union L 166/115 If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately. Ø Skin contact After contact with skin, wash immediately with plenty of water. Consult a physician. Take off immediately all contaminated clothing. Immediately rinse contaminated or saturated clothing with water. Ø Eye contact With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes. Protect unharmed eye. Continue rinsing process with eye rinsing solution. Call ambulance (caustic burn of the eyes) Immediate further treatment in ophthalmic hospital/ophthalmologist. Continue rinsing eye until arrival at ophthalmic hospital. Ø Ingestion Do not induce vomiting. Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation. Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest. Notify ambulance immediately (key word: acid burn). Ø Notes to physician Therapy as for chemical burn. Following inhalation: Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area). Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone). If substance has been swallowed: Aspiration hazard. Risk of gaseous embolisms. In case of excessive strain on the stomach due to gas evolution, insert siphon tube. Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear. If necessary, suck away leftover substance. Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide. Emergency measures to protect the environment Observe regulations on prevention of water pollution (collect, dam up, cover up). Do not allow to run into water channels, surface water or into the ground.L 166/116 EN Official Journal of the European Union 22.6.2022 Ø Methods for cleaning up Clean contaminated surface thoroughly; recommended cleaning agent is water. In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations. Ø Additional advice Make safe or remove all sources of ignition. Isolate defective containers immediately, if possible and safe to do. Shut off leak, if possible and safe to do. Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal). Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition). Product taken out should not be returned into container. Never return spilled product into its original container for re-use (risk of decomposition). 5.4. Instructions for safe disposal of the product and its packaging Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original packaging tightly closed in a cool and well-ventilated place. Keep products away from direct sunlight, source of heat and ignition The shelf life of the biocidal product is 6 months. The products must be stored at Ambient Temperature. 6. OTHER INFORMATION Reference values of peracetic acid and hydrogen peroxide used for the risk assessment: PAA: AECinhal = 0,5 mg/m3 HP: AECinhal = 1,25 mg/m3 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) SOPUROXID 15 Market area: EU HORTICLEAN 15 FORT Market area: EU AGRIOXID 15 Market area: EU HyPro Biocide 15-22 Market area: EU Authorisation number EU-0026179-0005 1-422.6.2022 EN Official Journal of the European Union L 166/117 CAS Common name IUPAC name Function EC number Content (%) number Peracetic acid Active Substance 79-21-0 201-186-8 15,0 Sulphuric acid Non-active substance 7664-93-9 231-639-5 0,78 Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 22,0 Acetic acid Non-active substance 64-19-7 200-580-7 16,7 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Oxypur CS Market area: EU Authorisation number EU-0026179-0006 1-4 CAS Common name IUPAC name Function EC number Content (%) number Peracetic acid Active Substance 79-21-0 201-186-8 15,0 Sulphuric acid Non-active substance 7664-93-9 231-639-5 0,78 Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 22,0 Acetic acid Non-active substance 64-19-7 200-580-7 16,7