COMMISSION IMPLEMENTING REGULATION (EU) 2025/839

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2025/839 | 6.5.2025 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2025/839 of 5 May 2025 granting a Union authorisation for the biocidal product family ‘Oxivir Excel BPF’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (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 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) | On 16 December 2016, Diversey Europe Operations B.V. submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Oxivir Excel BPF’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-DL028504-45 in the Register for Biocidal Products. ---|--- (2) | ‘Oxivir Excel BPF’ contains hydrogen peroxide as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4. ---|--- (3) | On 25 September 2023, 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 Agency. ---|--- (4) | On 20 March 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Oxivir Excel BPF’ 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 ‘Oxivir Excel BPF’ 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(6) of that Regulation. ---|--- (6) | On 15 April 2024, 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 the biocidal product family ‘Oxivir Excel BPF’. ---|--- (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, ---|--- HAS ADOPTED THIS REGULATION: Article 1 A Union authorisation with authorisation number EU-0032483-0000 is hereby granted to Diversey Europe Operations B.V. for the making available on the market and use of the biocidal product family ‘Oxivir Excel BPF’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 26 May 2025 until 30 April 2035. 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, 5 May 2025. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. (2) ECHA opinion of 29 February 2024 on the Union authorisation of ‘Oxivir Excel BPF’ (ECHA/BPC/417/2024), https://echa.europa.eu/opinions-on-union- authorisation. * * * ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Oxivir Excel BPF Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number EU-0032483-0000 R4BP asset number EU-0032483-0000 PART I FIRST INFORMATION LEVEL 1\. ADMINISTRATIVE INFORMATION 1.1. Family name Name | Oxivir Excel BPF ---|--- 1.2. Product type(s) Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area ---|--- 1.3. Authorisation holder Name and address of the authorisation holder | Name | Diversey Europe Operations B.V. ---|---|--- Address | De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL Authorisation number | | EU-0032483-0000 R4BP asset number | | EU-0032483-0000 Date of the authorisation | 26 May 2025 Expiry date of the authorisation | 30 April 2035 1.4. Manufacturer(s) of the product Name of manufacturer | Diversey Europe Operations B.V. ---|--- Address of manufacturer | De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL Location of manufacturing sites | Name of manufacturer | Multifill BV ---|--- Address of manufacturer | Constructieweg 25a 3640 AJ Mijdrecht Netherlands (the) Location of manufacturing sites | | Multifill BV site 1 --- Constructieweg 25a 3640 AJ Mijdrecht Netherlands (the) Name of manufacturer | Pluswipes LTD ---|--- Address of manufacturer | Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the) Location of manufacturing sites | | Pluswipes LTD site 1 --- Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the) Name of manufacturer | Flexible Medical Packaging Ltd ---|--- Address of manufacturer | Unit 8, Hightown - White Cross Industrial Estate LA1 4XS Lancanster, Lancashire United Kingdom of Great Britain and Northern Ireland (the) Location of manufacturing sites | Flexible Medical Packaging Ltd site 1 Unit 8, Hightown - White Cross Industrial Estate LA1 4XS Lancanter, Lancashire United Kingdom of Great Britain and Northern Ireland (the) Name of manufacturer | Entegris Cleaning Process (ECP) S.A.S ---|--- Address of manufacturer | 395 rue Louis Lépine 34000 Montpellier France Location of manufacturing sites | | Entegris Cleaning Process (ECP) S.A.S site 1 --- 395 rue Louis Lépine 34000 Montpellier France Name of manufacturer | Cheport spol s.r.o. ---|--- Address of manufacturer | Lhotsko 93 76312 Vizovice Czechia Location of manufacturing sites | | Cheport spol s.r.o. site 1 --- Lhotsko 93 76312 Vizovice Czechia Name of manufacturer | Helichem ---|--- Address of manufacturer | Kozakkenberg 5 5951 DL Belfeld Netherlands (the) Location of manufacturing sites | | Helichem site 1 --- Kozakkenberg 5 5951 DL Belfeld Netherlands (the) Name of manufacturer | LARA KOZMETİK HİJYENİK ÜRÜNLERİ SAN. VE DIŞ TİC. A.Ş. ---|--- Address of manufacturer | Türkgücü Organize San. Bölgesi 123.Sokak No 4/1 59580 Çorlu, Tekirdağ Türkiye Location of manufacturing sites | | LARA KOZMETİK HİJYENİK ÜRÜNLERİ SAN. VE DIŞ TİC. A.Ş. site 1 --- Türkgücü Organize San. Bölgesi 123.Sokak No:4/1 59580 Çorlu, Tekirdağ Türkiye Name of manufacturer | SAPRO Temizlik Ürünleri Sanayi ve Ticaret A.Ş. ---|--- Address of manufacturer | Ortaköy Mah. İlter Bulvarı No: 27 34592 Silivri, Istanbul Türkiye Location of manufacturing sites | | SAPRO Temizlik Ürünleri Sanayi ve Ticaret A.Ş. site 1 --- Ortaköy Mah. İlter Bulvarı No: 27 34592 Silivri, Istanbul Türkiye Name of manufacturer | ITW Contamination Control BV ---|--- Address of manufacturer | Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the) Location of manufacturing sites | | ITW Contamination Control BV site 1 --- Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the) Name of manufacturer | Arkema ---|--- Address of manufacturer | Tankhoofd 10 Haven 3255 3196 KE Rotterdam Netherlands (the) Location of manufacturing sites | | Arkema site 1 --- Morschheimer Strasse 19 D-67292 Kirchheimbolanden Germany 1.5. Manufacturer(s) of the active substance(s) Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Evonik Operations GmbH Address of manufacturer | Evonik Resource Efficiency GmbH, Rellinghauser Strasse 1-11 D-45128 Essen Germany Location of manufacturing sites | | Evonik Resource Efficiency GmbH site 1 --- Untere Kanalstr. 3 79618 Rheinfelden Germany Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Solvay Chemicals International SA Address of manufacturer | Solvay Chemicals International SA, Rue Ransbeek 310 1120 Brussels Belgium Location of manufacturing sites | | Solvay Chemicals International site 1 --- Via Piave 6 57013 Rosignano Solvay Italy Solvay Chemicals International site 2 Köthensche Strasse 1-3 06406 Bernburg Germany Solvay Chemicals International site 3 Baronet Road WA4 6HB Warrington United Kingdom of Great Britain and Northern Ireland (the) Solvay Chemicals International site 4 Yrjonojantie 2 45911 Voikkaa Finland Solvay Chemicals International site 5 Rua Eng. Clement Dumoulin, 2625-106 Povoa de Santa Iria Portugal Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Kemira Oyj Address of manufacturer | Kemira Oyj, Porkkalankatu 3, PL 330 00101 Helsinki Finland Location of manufacturing sites | | Kemira Oyj site 1 --- Moezelweg 151 3198 LS Rotterdam Netherlands (the) Kemira Oyj site 2 Typpitie PL 171 90101 Oulu Finland Kemira Oyj site 3 Industrigatan 83 25109 Helsingborg Sweden Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Arkema France Address of manufacturer | 420, rue dÉstienne dÓrves F-92705 Colombes Cedex France Location of manufacturing sites | | Arkema b.v. site 1 --- Route National 85 38560 Jarrie France Arkema b.v. site 2 Am Haupttor, Bau 2410 06237 Leuna Germany Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Arkema GmbH Address of manufacturer | Tersteegenstr. 28 D-40474 Düsseldorf Germany Location of manufacturing sites | | Arkema b.v site 1 --- Route National 85 3856 Jarrie France Arkema b.v. site 2 Am Haupttor, Bau 2410 0623 Leuna Germany Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Evonik Antwerpen NV Address of manufacturer | Tijsmanstunnel West 2040 Antwerpen Belgium Location of manufacturing sites | | Evonik Antwerpen site 1 --- Tijsmanstunnel West 2040 Antwerpen Belgium Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Evonik Peroxid GmbH Address of manufacturer | Industriestraße 1 9721 Weißenstein Austria Location of manufacturing sites | | Evonik Peroxid GmbH site 1 --- Industriestrasse 1 9721 Weissenstein Austria Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Evonik Peroxide Netherlands BV Address of manufacturer | Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the) Location of manufacturing sites | | Evonik Peroxide Netherlands BV site 1 --- Oosterhorn 14 9936 HD Farmsum Netherlands (the) Active substance | Hydrogen peroxide ---|--- Name of manufacturer | Evonik Peroxide Spain, S.L.U. Address of manufacturer | C/ Afueras s/h. 50784 La Zaida Spain Location of manufacturing sites | | Evonik Peroxide Spain, S.L.U. site 1 --- Calle Afueras s/n 50784 La Zaida Spain 2\. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Hydrogen peroxide | | active substance | 7722-84-1 | 231-765-0 | 0,36 - 7,2 % (w/w) (C9-C11) Alkyl alcohol ethoxylate | (C9-C11) Alkyl alcohol ethoxylate | Non-Active substance | 68439-46-3 | | 0,09 - 1,8 % (w/w) alkyl benzene sulphonic acid | 2-Dodecylbenzenesulfonic acid | Non-Active substance | 85536-14-7 | 287-494-3 | 0,97 - 19,4 % (w/w) methane sulphonic acid | | Non-Active substance | 75-75-2 | 200-898-6 | 0,12 - 2,4 % (w/w) 2.2. Type(s) of formulation Formulation type(s) | AL Any other liquid SL Soluble concentrate AL (Any other liquid) - RTU wipe ---|--- PART II SECOND INFORMATION LEVEL - META SPC(S) 1\. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier | Meta SPC: Meta-SPC 1: Concentrate ---|--- 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 PT04: Food and feed area ---|--- 2\. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Hydrogen peroxide | | active substance | 7722-84-1 | 231-765-0 | 7,2 - 7,2 % (w/w) alkyl benzene sulphonic acid | 2-Dodecylbenzenesulfonic acid | Non-Active substance | 85536-14-7 | 287-494-3 | 19,4 - 19,4 % (w/w) (C9-C11) Alkyl alcohol ethoxylate | (C9-C11) Alkyl alcohol ethoxylate | Non-Active substance | 68439-46-3 | | 1,8 - 1,8 % (w/w) methane sulphonic acid | | Non-Active substance | 75-75-2 | 200-898-6 | 2,4 - 2,4 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) | SL Soluble concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements | H314: Causes severe skin burns and eye damage. H412: Harmful to aquatic life with long lasting effects. H290: May be corrosive to metals. ---|--- Precautionary statements | P234: Keep only in original packaging. P273: Avoid release to the environment. P280: Wear protective gloves, protective clothing and eye or face protection. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTRE, doctor or physician. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTRE, doctor or physician. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P310: Immediately call a POISON CENTRE, doctor or physician. P363: Wash contaminated clothing before reuse. P390: Absorb spillage to prevent material damage. P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1. Use # 1.1 – Cleaning and disinfection by mopping for healthcare areas. Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces for healthcare areas. Application method(s) | Method: Mopping Detailed description: Mopping with a soaked mop. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Dilute the product with water to reach 4,5 % product Number and timing of application: Frequency of use: 7 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE intermediate bulk container (IBC): 100-1 000 litres 4.1.1. Use-specific instructions Product dilution: bactericidal, yeasticidal and virucidal 4,5% product. For packs with manual dilution system: To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the dilution of 4,5%. Carefully fill up with the rest of the water. Add the concentrated product to the water to avoid splashes of concentrated product. Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. For packs with (semi-)automatic dilution system with 2 settings: Select the right setting on the dosing equipment. Fill a container with the diluted product (4,5%). Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.1.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.2. Use description Table 2. Use # 1.2– Cleaning and disinfection with a cloth or sponge for healthcare areas. Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces for healthcare areas Application method(s) | Method: spreading Detailed description: Spreading with a soaked cloth or sponge. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Dilute the product with water to reach 4,5% product Number and timing of application: Frequency of use: 7 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2.5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.2.1. Use-specific instructions Product dilutions: Bactericidal, yeasticidal & virucidal 4,5% For packs with manual dilution system To prevent foaming, fill a container three quarters full of water. Add the correct amount of product to reach the dilution of 4,5%. Carefully fill up with the rest of the water. Soak the cloth or sponge in the solution. Distribute the liquid on the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. For packs with (semi-)automatic dilution system Select the right setting on the dosing equipment. Fill a container with the diluted product (4,5%). Soak the cloth or sponge in the solution. Distribute the liquid on the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. 4.2.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.3. Use description Table 3. Use # 1.3 – Cleaning and disinfection of small objects by soaking or dipping for healthcare areas. Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for small objects (e.g. scissors and brushes) for healthcare areas. The biocidal use excludes disinfection of medical devices. Application method(s) | Method: Soaking or dipping Detailed description: Soaking or dipping in the solution. Application rate(s) and frequency | Application rate: up to 3 litres Dilute the product with water to reach 4,5% product Number and timing of application: Frequency of use: 1 time a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.3.1. Use-specific instructions Product dilutions: bactericidal, yeasticidal & virucidal 4,5% For packs with manual dilution system: To prevent foaming, fill a container three quarters with water. Add the correct amount of product to reach the dilution of 4,5%. Carefully fill up with the rest of the water. Add the product to the water to avoid splashes of concentrated product. Cover dipping bath with a lid after placing the objects in the disinfection solution. Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. For packs with (semi-)automatic dilution system: Select the right setting on the dosing equipment. Fill a container with the diluted product (4,5%). Cover dipping bath with a lid after placing the objects in the disinfection solution. Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. The solutions for soaking or dipping can be used only once. 4.3.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.4. Use description Table 4. Use # 1.4 – Cleaning and disinfection by foaming for healthcare areas. Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces for healthcare areas. Application method(s) | Method: spraying Detailed description: Spraying using a trigger foam. Optionally wipe to spread the solution. Application rate(s) and frequency | Application rate: 11 ml/m2 Dilute the product with water to reach 4,5% product Number and timing of application: Frequency of use: For use in toilets and bathrooms: 4 times a day For use in hospitals and medical practices: 8 times a day For use in laboratories: 10 times a day For use in cleanrooms: 10 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.4.1. Use-specific instructions Product dilutions: bactericidal, yeasticidal & virucidal 4,5% For packs with manual dilution system: To prevent foaming, fill a foaming spray bottle three quarters full of water. Add the correct amount of concentrated product. to reach the dilution of 4,5%. Carefully fill up with the rest of the water. Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. Only for small surface disinfection. For packs with (semi-)automatic dilution system: Select the right setting on the dosing equipment. Fill a foaming spray bottle with the diluted product. Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. Only for small surface disinfection. 4.4.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.5. Use description Table 5. Use # 1.5 –Cleaning and disinfection using moist wipes (incl. healthcare areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces. Application method(s) | Method: Wiping Detailed description: Wiping with prepared moist wipes. Application rate(s) and frequency | Application rate: 1,5 m2 per wipe Dilute the product with water to reach 5% product. Number and timing of application: Frequency of use: 8 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | Liquid: High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres Dry Wipes are packed in a HDPE bucket with 125 wipes (polypropylene (PP) sold separately). 4.5.1. Use-specific instructions Prepare 1,5 litres dilution by adding 75 ml Oxivir Excel to 1,425 litres water. Apply 1,5 litres diluted product to the Dry Wipes bucket. Distribute the liquid evenly. Close the bucket. Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface and make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.5.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.6. Use description Table 6. Use # 1.6 – Cleaning and disinfection of food contact surfaces using a mop Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces that get into contact with food Application method(s) | Method: Mopping Detailed description: Mopping with a soaked mop. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Dilute the product with water to reach 3,75% product Number and timing of application: Frequency of use: 7 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.6.1. Use-specific instructions Product dilution: bactericidal, yeasticidal & virucidal 3,75% For packs with manual dilution system: To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the dilution of 3,75%. Carefully fill up with the rest of the water. Add the concentrated product to the water to avoid splashes of the concentrated product. Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. For packs with (semi-) automatic dilution system: Select the right setting on the dosing equipment. Fill a container with the diluted product (3,75%). Soak the mop in the solution. Distribute the liquid. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. 4.6.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.7. Use description Table 7. Use # 1.7 – Cleaning and disinfection of food contact surfaces using a cloth or sponge. Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces that get into contact with food. Application method(s) | Method: spreading Detailed description: Spreading with a soaked cloth or sponge. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Dilute the product with water to reach 3,75% product Number and timing of application: Frequency of use: 7 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.7.1. Use-specific instructions Product dilution: bactericidal, yeasticidal & virucidal 3,75% For packs with manual dilution system: To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the dilution of 3,75%. Carefully fill up with the rest of the water. Add the concentrated product to the water to avoid splashes of concentrated product. Soak the cloth or sponge in the solution. Distribute the liquid. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. For packs with (semi-) automatic dilution system: Select the right setting on the dosing equipment. Fill a container with the diluted product (3,75%). Soak the cloth or sponge in the solution. Distribute the liquid. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. 4.7.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.8. Use description Table 8. Use #1.8 – Cleaning and disinfection of food contact small objects by soaking or dipping. Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for small objects (e.g. kitchen utensils) that get into contact with food. Application method(s) | Method: Soaking or dipping Detailed description: Soaking or dipping in the solution. Application rate(s) and frequency | Application rate: up to 3 litres Dilute the product with water to reach 3,75% product Number and timing of application: Use at room temperature Frequency of use: 1 time a day Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.8.1. Use-specific instructions Product dilution: bactericidal, yeasticidal & virucidal 3,75% For packs with manual dilution system: To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product. to reach the dilution of 3,75%. Carefully fill up with the rest of the water. Cover dipping bath with a lid after placing the objects in the disinfection solution. Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. For packs with(semi-) automatic dilution system: Select the right setting on the dosing equipment. Fill a container with diluted product (3,75%). Cover dipping bath with a lid after placing the objects in the disinfection solution. Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. The solutions for soaking or dipping can be used only once. 4.8.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.9. Use description Table 9. Use # 1.9 – Cleaning and disinfection of food contact surfaces by foaming. Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces that get into contact with food. Application method(s) | Method: spraying Detailed description: Spraying using a trigger foam. Optionally wipe to spread the solution. Application rate(s) and frequency | Application rate: 11 ml/m2 Dilute the product with water to reach 3,75% product Number and timing of application: Use at room temperature Frequency of use: For use in kitchens and canteen: 4 times a day For use in food processing industries: 4 times a day For use on a counter in a shop/supermarket: 8 times a day Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.9.1. Use-specific instructions Product dilution: 3,75% For packs with manual dilution system: To prevent foaming, fill a foaming spray bottle three quarters withfull of water. Add the correct amount of the concentrated product. to reach a dilution of 3,75%. Carefully fill up with the rest of the water. Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. Only for small surface disinfection. For packs with full (semi-) automatic dilution system: Select the right setting on the dosing equipment. Fill a foaming spray bottle with the diluted product (3,75%). Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. Only for small surface disinfection. 4.9.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.10. Use description Table 10. Use # 1.10 –Cleaning and disinfection of food contact surfaces with moist wipes Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces that get in contact with food. Application method(s) | Method: Wiping Detailed description: Wiping with prepared moist wipes. Application rate(s) and frequency | Application rate: 1,5 m2 per wipe Dilute the product with water to reach 5% product. Number and timing of application: Frequency of use: 8 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | Oxivir Excel: High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres Dry Wipes are packed in a HDPE bucket with 125 wipes (PP). (sold separately) 4.10.1. Use-specific instructions Product dilution 5% Prepare 1,5 litres dilution by adding 75 ml of the concentrated product to 1,425 litres of water. To prevent foaming , fill a container three quarters full of water. Apply 1,5 litres of the diluted product to the Dry Wipes bucket. Distribute the liquid evenly. Close the bucket. Open the lid, take a single wipe, close the lid after taking a wipe. Only use wet wipes. Wipe the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.10.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.11. Use description Table 11. Use # 1.11 – Cleaning and disinfection of hard surfaces by mopping in non- health care areas. Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces. Application method(s) | Method: Mopping Detailed description: Mopping with a soaked mop. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Dilute the product with water to reach the following concentration of the product Bactericidal – 1,5% product Yeasticidal – 3,75% product Virucidal – 2% product Number and timing of application: Frequency of use: 7 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.11.1. Use-specific instructions Product dilutions: Bactericidal – 1,5% product Yeasticidal – 3,75% product Virucidal – 2% product For packs with manual dilution system: To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the appropriate dilution of the product. Carefully fill up with the rest of the water. Add the concentrated product to the water to avoid splashes of the concentrated product. Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. For packs with (semi-) automatic dilution system: Select the right setting on the dosing equipment. Fill a container with the diluted product. Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.11.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.12. Use description Table 12. Use # 1.12 – Cleaning and disinfection of hard surfaces with a cloth or sponge in non-health care areas. Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces Application method(s) | Method: spreading Detailed description: Spreading with a soaked cloth or sponge. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Dilute the product with water to reach the following concentration of the product bactericidal – 1,5% product yeasticidal – 3,75% product virucidal – 2% product Number and timing of application: Use at room temperature Frequency of use: 7 times a day Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.12.1. Use-specific instructions Product dilutions: bactericidal 1,5%; yeasticidal 3,75%; virucidal 2% For packs with manual dilution system: To prevent foaming, fill a container three quarters full of water.

Add the correct amount of the concentrated product to reach the appropriate dilution of the product. Carefully fill up with the rest of the water. Soak the cloth or sponge in the solution. Distribute the liquid. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. For packs with(semi-) automatic dilution system: Select the right setting on the dosing equipment. Fill a container with the diluted product. Soak the cloth or sponge in the solution. Distribute the liquid. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. 4.12.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.13. Use description Table 13. Use # 1.13 – Cleaning and disinfection of small objects by soaking or dipping in non-health care areas Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for small objects (e.g. scissors and brushes). Application method(s) | Method: Soaking or dipping Detailed description: Soaking or dipping in the solution. Application rate(s) and frequency | Application rate: up to 3 litres Dilute the product with water to reach the following concentration of the product Bactericidal – 1,5% product. Yeasticidal – 3,75% product. Virucidal – 2% product Number and timing of application: Frequency of use: 1 time a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.13.1. Use-specific instructions Product dilution: Bactericidal – 1,5% product. Yeasticidal – 3,75% product. Virucidal – 2% product For packs with manual dilution system: To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the appropriate dilution of the product. Carefully fill up with the rest of the water. Cover dipping bath with a lid after placing the objects in the disinfection solution. Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. For packs with (semi-) automatic dilution system: Select the right setting on the dosing equipment. Fill a container with the diluted product. Cover dipping bath with a lid after placing the objects in the disinfection solution. Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. The solutions for soaking or dipping can be used only once. 4.13.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.14. Use description Table 14. Use # 1.14 – Cleaning and disinfection of surfaces by foaming in non-health care areas. Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces. Application method(s) | Method: spraying Detailed description: Spraying using a trigger foam. Optionally wipe to spread out the solution. Application rate(s) and frequency | Application rate: 11 ml/m2 Dilute the product with water to reach the following concentration of the product Bactericidal - 1,5% product, Yeasticidal - 3,75% product, Virucidal - 2% product Number and timing of application: Use at room temperature Frequency of use: If product is intended for use in toilets and bathrooms: 4 times a day If product is intended for use in cosmetic/pharmaceutical manufacturing facilities: 8 times a day If product is intended for use in laboratories: 10 times a day If product is intended for use in cleanrooms: 10 times a day Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.14.1. Use-specific instructions Product dilutions: bactericidal 1.5%; yeasticidal 3.75%; virucidal 2% For packs with manual dilution system: To prevent foaming, fill a foaming spray bottle three quarters full of water. Add the correct amount of the concentrated product to reach the appropriate dilution of the product. Carefully fill up with the rest of the water. Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. Only for small surfaces disinfection. For packs with (semi) automatic dilution system: Select the right setting on the dosing equipment. Fill a foaming spray bottle with the diluted product. Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. Only for small surfaces disinfection. 4.14.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.15. Use description Table 15. Use # 1.15 – Disinfection of pre-cleaned hard surfaces. Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Disinfection product for pre-cleaned hard surfaces (incl. healthcare areas, pharmaceutical industry, cosmetic industry, laboratories and cleanrooms) Application method(s) | Method: Spreading, dipping and foam spraying Detailed description: Spreading using a soaked mop.Spreading using a soaked cloth or sponge.Dipping in a solution.Foam spraying, optionally wipe to spread the solution Application rate(s) and frequency | Application rate: Application using a soaked mop: 11 to 40 ml/m2, application using a soaked cloth or sponge: 11 to 40 ml/m2, dipping in a solution: 3 litres, foam spraying: 11 ml/m2. Dilute the product with water to reach 2,5% Number and timing of application: Frequency of use: Application using a soaked mop: 7 times a day Application using a soaked cloth/sponge: 7 times a day Dipping: 1 time a day Foam spraying: bathrooms & toilets 4 times a day healthcare 8 times a day laboratories & cleanrooms 10 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.15.1. Use-specific instructions Product dilutions: Bactericidal, yeasticidal & virucidal 2,5% For packs with manual dilution system: To prevent foaming, fill a container three quaters full of water. Add the correct amount of concentrated product to reach the dilution of 2,5%. Carefully fill up with the rest of the water. For packs with (semi-)automatic dilution system: Select the right setting on the dosing equipment. Fill a container eith the diluted product (2,5%). Application using a soaked mop: Dip the mop into the container. Squeeze the surplus solution. Apply onto floor. Make sure to wet the surface completely. Allow to act for 5 minutes. Application using a soaked cloth/sponge: Soak the cloth or sponge in the solution. Distribute the liquid on the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Dipping: Cover dipping bath with a lid after placing the objects in the disinfection solution. Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. The solutions for soaking or dipping can be used only once. Foam spraying: Fill a spray bottle with foam head. Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Only for small surfaces disinfection. Wipe dry or let air dry. No rinsing needed after disinfection 4.15.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 4.15.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 1 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 of Meta-SPC 1 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use For professional use: Keep away from food, drink and animal feeding stuffs. Wash hands after handling. Keep only in original container. Do not mix with other products. 5.2. Risk mitigation measures The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. The use of eye protection (consistent with the European Standard EN 166)16 321 or equivalent during handling of the concentrated product is mandatory. Wear protective chemical resistant gloves (classified under the European Standard EN ISO 374) or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). Wear chemical-resistant clothing (consistent with the European Standard EN 14605) or equivalent and wear suitable protective footwear (consistent with the European Standards EN 13832) or equivalent when handling concentrated products. See section 6 for the full titles of the EN standards. Keep pets away from treated surfaces until dried. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid: IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid Environmental precautions: Do not allow to enter drainage system, surface or groundwater. Do not allow to enter the ground/soil. Dilute with plenty of water. Inform responsible authorities in case undiluted product reaches drainage system, surface or ground water or the ground/soil. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a hazardous waste disposal service in accordance with the statutory regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage 2 year shelf life. Store in the dark. Do not store at temperatures above 30°C. 6\. OTHER INFORMATION The products of this meta-SPC may also be intended for the disinfecting of Medical Device surfaces in medical and clinical areas. In such a case, their placing on the market or putting into service must comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 05/05/2017, p. 1) and they are medical devices classified as class IIa. Those uses are out of the scope of this biocidal registration.product family authorisation and are not covered by it. With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation. The full titles of the EN standards referenced in section 5.2 “Risk mitigation measures” are: EN 13832 - Footwear protecting against chemicals EN ISO 374 - Protective gloves against dangerous chemicals and micro-organisms EN ISO 16321 - Eye and face protection for occupational use EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]). Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11). 7\. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | Oxivir Excel | Market area: EU ---|---|--- Oxivir Excel H+ | Market area: EU Oxivir Excel J-flex | Market area: EU Oxivir Excel SmartDose | Market area: EU Oxivir Excel SD | Market area: EU Oxivir Excel Conc | Market area: EU Oxivir Excel Concentrate | Market area: EU Oxivir Excel IBC | Market area: EU Oxivir Excel Acti | Market area: EU Oxivir Excel Des | Market area: EU Oxivir Excel Duo | Market area: EU Clinell H2O2 concentrate | Market area: EU Antibac Oxivir concentrate | Market area: EU Divosan AHP VS70 | Market area: EU TASKI Sani AHP-Des | Market area: EU TASKI Sprint AHP-Des | Market area: EU Suma AHP D10.7 | Market area: EU Suma AHP | Market area: EU Suma San AHP D10.7 | Market area: EU Suma San AHP | Market area: EU ClearKlens AHP Conc | Market area: EU ClearKlens Excel Conc | Market area: EU DOMESTOS Expert Conc | Market area: EU GLORIX Expert Conc | Market area: EU KLINEX Expert Conc | Market area: EU LYSOFORM Expert Conc | Market area: EU SAVO Expert Conc | Market area: EU CIF Expert Conc | Market area: EU VISS Expert Conc | Market area: EU JIF Expert Conc | Market area: EU FLORASZEPT Expert Conc | Market area: EU ANDY Expert Conc | Market area: EU SUPERANDY Expert Conc | Market area: EU LIFEBUOY Expert Conc | Market area: EU ANDYSAN Expert Conc | Market area: EU Authorisation number | | EU-0032483-0001 1-1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) Hydrogen peroxide | | active substance | 7722-84-1 | 231-765-0 | 7,2 % (w/w) alkyl benzene sulphonic acid | 2-Dodecylbenzenesulfonic acid | Non-Active substance | 85536-14-7 | 287-494-3 | 19,4 % (w/w) (C9-C11) Alkyl alcohol ethoxylate | (C9-C11) Alkyl alcohol ethoxylate | Non-Active substance | 68439-46-3 | | 1,8 % (w/w) methane sulphonic acid | | Non-Active substance | 75-75-2 | 200-898-6 | 2,4 % (w/w) 1\. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier | Meta SPC: Meta-SPC 2: RTU ---|--- 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 PT04: Food and feed area ---|--- 2\. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Hydrogen peroxide | | active substance | 7722-84-1 | 231-765-0 | 0,36 - 0,36 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) | AL Any other liquid ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements | H290: May be corrosive to metals. ---|--- Precautionary statements | P102: Keep out of reach of children. P234: Keep only in original packaging. P390: Absorb spillage to prevent material damage. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1. Use # 2.1 – Cleaning and disinfection by mopping (incl. healthcare areas). Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces (incl. healthcare areas) Application method(s) | Method: Mopping Detailed description: Mopping with a soaked mop. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Ready to use product Number and timing of application: Use at room temperature Frequency of use: 7 times a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Professional and non-professional users: High Density Polyethene (HDPE)Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres Professional users: HDPE canister 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres 4.1.1. Use-specific instructions Fill a container with the product. Dip the mop into the container. Squeeze the surplus of the product. Mop the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.1.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.2. Use description Table 2. Use # 2.2 – Cleaning and disinfection with a cloth or sponge (incl. healthcare areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for hard surfaces (incl. healthcare areas). Application method(s) | Method: spreading Detailed description: Spreading with a soaked cloth or sponge. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Ready to use product Number and timing of application: Use at room temperature Frequency of use: 1 time a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Professional and non-professional users: High Density Polyethene (HDPE) Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres Professional users: HDPE canister 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres 4.2.1. Use-specific instructions Soak the cloth or sponge in the product by dipping. Distribute the liquid on the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. 4.2.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.3. Use description Table 3. Use # 2.3 – Cleaning and disinfection of small objects by soaking or dipping (incl. healthcare areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Cleaning and disinfection product for small objects (e.g. scissors, brushes. ) incl. objects for healthcare areas. The biocidal use excludes disinfection of medical devices. Application method(s) | Method: Soaking or dipping Detailed description: Soaking or dipping in the solution. Application rate(s) and frequency | Application rate: up to 3 litres Ready to use product Number and timing of application: Use at room temperature Frequency of use: 1 time a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Professional and non-professional users: High Density Polyethene (HDPE)Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres Professional users: HDPE canister 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres 4.3.1. Use-specific instructions Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. The solutions for soaking or dipping can be used only once. 4.3.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.4. Use description Table 4. Use # 2.4 – Cleaning and disinfection by foaming (incl. healthcare areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Ready to use cleaning and disinfection product for hard surfaces (incl. healthcare areas). Application method(s) | Method: spraying Detailed description: Spraying using a trigger foam. Optionally wipe to spread the solution. Application rate(s) and frequency | Application rate: 11 ml/m2 Ready to use product Number and timing of application: Use at room temperature Frequency of use: For use in toilets and bathrooms: 4 times a day For use for cosmetic/pharmaceutical manufacturing facilities: 8 times a day For use in laboratories: 10 times a day For use in cleanrooms: 10 times a day For use on a counter in a shop/supermarket: 8 times a day For use in hospitals and medical practices: 8 times a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Professional and non-professional users: 750 ml High Density Polyethene (HDPE) trigger spray with foam head HDPE Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres Professional users: HDPE canister 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres 4.4.1. Use-specific instructions Apply the product on the surface. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. Only for small surface disinfection. 4.4.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.5. Use description Table 5. Use # 2.5 – Cleaning and disinfection using moist wipes (incl. healthcare areas). Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Ready to use cleaning and disinfection product for hard surfaces (incl. healthcare areas). Application method(s) | Method: Wiping Detailed description: Wiping with prepared moist wipes. Application rate(s) and frequency | Application rate: 1,5 m2 per wipe Ready to use product Number and timing of application: Frequency of use: 8 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | HDPE Canister 1L - 1,5 L – 2 L - 2,5 L – 3 L – 5 L – 10 L - 20 L – 50 L – 100 L – 200 L HDPE IBC 100 - 1 000 Liter Dry Wipes are packed in a HDPE bucket with 125 wipes (PP) sold separately. 4.5.1. Use-specific instructions Apply 1,5 litres product to the Dry Wipes bucket. Distribute the liquid evenly. Close the bucket. Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface and make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.5.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.6. Use description Table 6. Use # 2.6 – Cleaning and disinfection by mopping (incl. food contact surfaces) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Ready to use cleaning and disinfection product (incl. food contact surfaces) Application method(s) | Method: Mopping Detailed description: Mopping with a soaked mop. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Ready to use product Number and timing of application: Use at room temperature Frequency of use: 1 time a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Professional and non-professional users: High Density Polyethene (HDPE) canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres Professional users: HDPE canister 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres 4.6.1. Use-specific instructions Fill a container with the product. Dip the mop into the container. Squeeze the surplus solution. Mop the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes and let it air dry. No rinsing needed after disinfection. 4.6.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.7. Use description Table 7. Use # 2.7 – Cleaning and disinfection with a cloth or sponge (incl. food contact surfaces) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Ready to use cleaning and disinfection product for hard surfaces (incl. food contact surfaces). Application method(s) | Method: spreading Detailed description: Spreading with a soaked cloth or sponge. Application rate(s) and frequency | Application rate: 11 to 40 ml/m2 Ready to use product Number and timing of application: Use at room temperature Frequency of use: 1 time a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Professional and non-professional users: High Density Polyethene (HDPE) canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres Professional users: HDPE canister 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres 4.7.1. Use-specific instructions Soak the cloth or sponge in the product by dipping. Distribute the liquid on the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. 4.7.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.8. Use description Table 8. Use # 2.8 – Cleaning and disinfection by soaking or dipping of small objects (incl. food contact surfaces) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Ready to use cleaning and disinfection product for small objects (e.g. kitchen utensils) incl. food contact surfaces). Application method(s) | Method: Soaking or dipping Detailed description: Soaking or dipping in the product. Application rate(s) and frequency | Application rate: up to 3 litres Ready to use product Number and timing of application: Use at room temperature Frequency of use: 1 time a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Professional and non-professional users: High Density Polyethene (HDPE) canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres Professional users: HDPE canister 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres 4.8.1. Use-specific instructions Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. The solutions for soaking or dipping can be used only once. 4.8.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.9. Use description Table 9. Use # 2.9 – Cleaning and disinfection by foaming (incl. food contact surfaces) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Ready to use cleaning and disinfection product for hard surfaces (incl. food contact surfaces). Application method(s) | Method: spraying Detailed description: Spraying using a trigger foam. Optionally wipe to spread out the solution. Application rate(s) and frequency | Application rate: 11 ml/m2 Ready to use product Number and timing of application: Use at room temperature Frequency of use for: For use in kitchens and canteen: 4 times a day For use in food processing industries: 4 times a day For use on a counter in a shop/supermarket: 8 times a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Professional and non-professional users: 750 ml High Density Polyethene (HDPE) trigger foam HDPE Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres Professional users: HDPE canister 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres 4.9.1. Use-specific instructions Apply the product on the surface. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Wipe dry or let it air dry. No rinsing needed after disinfection. Only for small surface disinfection. 4.9.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.10. Use description Table 10. Use # 2.10 – Cleaning and disinfection with moist wipes (incl. food contact surfaces) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Ready to use cleaning and disinfection product for hard surfaces (incl. food contact surfaces). Application method(s) | Method: Wiping Detailed description: Wiping with prepared moist wipes. Application rate(s) and frequency | Application rate: 1,5 m2 per wipe Ready to use product Number and timing of application: Use at room temperature Frequency of use: 8 times a day Category(ies) of users | professional Pack sizes and packaging material | RTU liquid: High Density Polyethene (HDPE) Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres - 20 litres – 50 litres – 100 litres – 200 litres HDPE IBC 100 - 1 000 litres Dry Wipes are packed in a HDPE bucket with 125 wipes (PP). (sold separately) 4.10.1. Use-specific instructions Apply 1,5 litres product to the Dry Wipes bucket. Distribute the liquid evenly. Close the bucket. Open the lid, take a single wipe, close the lid after taking a wipe. Only use wet wipes. Wipe the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.10.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.11. Use description Table 11. Use # 2.11 – Disinfection of pre-cleaned hard surfaces Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Disinfection product for pre-cleaned hard surfaces (incl. healthcare areas, pharmaceutical industry, cosmetic industry, laboratories and cleanrooms) Application method(s) | Method: Spreading, dipping and foam spraying Detailed description: Spreading with a soaked mop.Spreading with a soaked cloth or sponge.Dipping in a solution.Foam spraying, optionally wipe to spread the solution. Application rate(s) and frequency | Application rate: Application using a soaked mop: 11 to 40 ml/m2, application using a soaked cloth/sponge: 11 to 40 ml/m2, dipping: 3 litres, foam spraying: 11 ml/m2 ready to use product Number and timing of application: Frequency of use: Application using a soaked mop: 7 times a day Application using a soaked cloth/sponge: 7 times a day Dipping: 1 time a day Foam spraying: bathrooms & toilets 4 times a day healthcare 8 times a day laboratories & cleanrooms 10 times a day Use at room temperature Category(ies) of users | professional Pack sizes and packaging material | High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres HDPE bottle (J-Flex): 1,5 litres HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres HDPE IBC: 100-1 000 litres 4.11.1. Use-specific instructions Contact time: 5 minutes Mopping: Dip the mop into the container. Squeeze the surplus solution. Apply onto floor. Make sure to wet the surface completely. Allow to act for the required contact time. Cloth/sponge application: Soak the cloth or sponge in the solution. Distribute the liquid on the surface. Make sure to wet the surface completely. Allow to act for the required contact time. Dipping: Cover dipping bath with a lid after placing the objects in the disinfection solution. Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. The solutions for soaking or dipping can be used only once. Foam spraying: Apply the product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for the required contact time. Only for small surfaces disinfection. Wipe dry or let air dry. No rinsing needed after disinfection. 4.11.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 2 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 of Meta-SPC 2 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use For professional use: Keep away from food, drink and animal feeding stuffs. Wash hands after handling. Keep only in original container. Do not mix with other products. See use-specific instructions for use. For non-professional use: Comply with the instructions for use. Keep away from food, drink and animal feeding stuffs. Wash hands after handling. Keep only in original container. Do not mix with other products. See use-specific instructions for use. 5.2. Risk mitigation measures Keep pets away from treated surfaces until dried. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.. If medical advice is needed, have product container or label at hand. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a hazardous waste disposal service in accordance with the statutory regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage 2 years shelf life. Store in the dark. Do not store at temperatures above 50°C. Keep out of reach of children and non-target animals/pets. 6\. OTHER INFORMATION The products of this meta-SPC may also be intended for the disinfection of medical devices’ surfaces in medical and clinical areas. In such a case, their placing on the market or putting into service must comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 05/05/2017, p. 1) and they are medical devices classified as class IIa. Those uses are out of the scope of this biocidal product family authorisation and are not covered by it. With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation. 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) | Oxivir Excel Foam | Market area: EU ---|---|--- Oxivir Excel Foam H+ | Market area: EU Oxivir Excel Spray | Market area: EU Oxivir Excel Spray H+ | Market area: EU Oxivir Excel RTU | Market area: EU Oxivir Excel RTU H+ | Market area: EU Oxivir Excel RTU IBC | Market area: EU Oxivir Excel Foam Acti | Market area: EU Oxivir Excel Foam Des | Market area: EU Oxivir Excel Foam Duo | Market area: EU Clinell H2O2 RTU | Market area: EU Antibac Oxivir RTU | Market area: EU Divosan AHP Foam RTU VS71 | Market area: EU TASKI Sani AHP-Des Spray | Market area: EU TASKI Sprint AHP-Des Spray | Market area: EU Suma AHP RTU D10.7 | Market area: EU Suma AHP Spray D10.7 | Market area: EU Suma AHP RTU | Market area: EU Suma AHP Spray | Market area: EU ClearKlens AHP RTU | Market area: EU ClearKlens Excel RTU | Market area: EU DOMESTOS Expert | Market area: EU GLORIX Expert | Market area: EU KLINEX Expert | Market area: EU LYSOFORM Expert | Market area: EU SAVO Expert | Market area: EU CIF Expert | Market area: EU VISS Expert | Market area: EU JIF Expert | Market area: EU FLORASZEPT Expert | Market area: EU ANDY Expert | Market area: EU SUPERANDY Expert | Market area: EU LIFEBUOY Expert | Market area: EU ANDYSAN Expert | Market area: EU Authorisation number | | EU-0032483-0002 1-2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) Hydrogen peroxide | | active substance | 7722-84-1 | 231-765-0 | 0,36 % (w/w) 1\. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier | Meta SPC: Meta-SPC 3: Wipes ---|--- 1.2. Suffix to the authorisation number Number | 1-3 ---|--- 1.3. Product type(s) Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area ---|--- 2\. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Hydrogen peroxide | | active substance | 7722-84-1 | 231-765-0 | 0,36 - 0,36 % (w/w) 2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s) | AL (Any other liquid) - RTU wipe ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements | H290: May be corrosive to metals. ---|--- Precautionary statements | P102: Keep out of reach of children. P234: Keep only in original packaging. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1. Use # 3.1 – Cleaning and disinfection using moist wipes on hard surfaces incl. healthcare areas Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Wipe for cleaning-disinfecting for hard surfaces incl. healthcare areas. Application method(s) | Method: Wiping Detailed description: Wiping with ready to use moist wipes. Application rate(s) and frequency | Application rate: 1,5 m2 per wipe Ready to use wipe. Number and timing of application: Frequency of use: 8 times a day Use at room temperature Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | High Density Polyethene (HDPE) bucket or tub with 100 PP wipes Polyethylene terephthalate (PET)/low-density polyethylene (LDPE) flow-pack with 100 polypropylene (PP) wipes PET/LDPE standing bag with 100 PP wipes All packages are both for professional and non-professional use 4.1.1. Use-specific instructions Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.1.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 3 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 of Meta-SPC 3 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 3 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 of Meta-SPC 3 4.2. Use description Table 2. Use # 3.2 – Cleaning and disinfection using moist wipes on hard surfaces incl. food contact surfaces Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Wipe for cleaning-disinfecting hard surfaces (incl. food contact surfaces) Application method(s) | Method: Wiping Detailed description: Wiping with ready to use moist wipes. Application rate(s) and frequency | Application rate: 1,5 m2 per wipe Ready to use wipe. Number and timing of application: Use at room temperature Frequency of use: 8 times a day Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | High Density Polyethene (HDPE) bucket or tub with 100 PP wipes PET or LDPE flow-pack with 100 PP wipes PET or LDPE standing bag with 100 PP wipes All packages are both for professional and non-professional use 4.2.1. Use-specific instructions Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface. Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection. 4.2.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 3 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 of Meta-SPC 3 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 3 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 of Meta-SPC 3 4.3. Use description Table 3. Use # 3.3 – Wipe for disinfecting pre-cleaned hard surfaces Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use | indoor use Disinfection wipe for pre-cleaned hard surfaces (incl. healthcare areas, pharmaceutical industry, cosmetic industry, laboratories and cleanrooms) Application method(s) | Method: Wiping Detailed description: Wiping with ready to use moist wipes. Application rate(s) and frequency | Application rate: 1,5 m2 per wipe Ready to use Number and timing of application: Use at room temperature Frequency of use: 8 times a day Category(ies) of users | professional Pack sizes and packaging material | HDPE bucket/tub with 100 PP wipes PET/LDPE flow-pack with 100 PP wipes PET/LDPE standing bag with 100 PP wipes 4.3.1. Use-specific instructions Contact time: 5 minutes Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface. Make sure to wet the surface completely. Allow to act for the required contact time. Let it air dry. No rinsing needed after disinfection. 4.3.2. Use-specific risk mitigation measures See general directions for use of Meta-SPC 3 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 of Meta-SPC 3 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta-SPC 3 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 of Meta-SPC 3 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use For professional use: Keep away from food, drink and animal feeding stuffs. Wash hands after handling. Keep only in original container. Do not mix with other products. See use-specific instructions for use. For non-professional use: Comply with the instructions for use. Wash hands after handling. Keep only in original container. Do not mix with other products. See use-specific instructions for use. 5.2. Risk mitigation measures Keep pets away from treated surfaces until dried. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. If medical advice is needed, have product container or label at hand. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a hazardous waste disposal service in accordance with the statutory regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage 2 years shelf life. Store in the dark. Do not store at temperatures above 50°C. Keep out of reach of children and non-target animals/pets. 6\. OTHER INFORMATION The products of this meta-SPC may also be intended for the disinfection of medical devices’ surfaces in medical and clinical areas. In such a case, their placing on the market or putting into service must comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 05/05/2017, p. 1) and they are medical devices classified as class IIa. Those uses are out of the scope of this biocidal product family authorisation and are not covered by it. With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation. The following types of wipes are included: Wipe with size 15 x 25 cm; weight is 1,52 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 15,2 x 17,7 cm; weight is 1,51 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 15,2 x 20,3 cm; weight is 1,51 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 17,7 x 20,3 cm; weight is 1,50 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 19 x 25,4 cm; weight is 1,49 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 20 x 26,7 cm; weight is 1,49 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 20 x 30 cm; weight is 1,50 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 25 x 25 cm; weight is 1,51 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 25,4 x 25,4 cm; weight is 1,51 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%) Wipe with size 15 x 25 cm; weight is 1,52 gr; 6 ml liquid per wipe (wipe liquid load is 400%) Wipe with size 15,2 x 17,7 cm; weight is 1,51 gr; 6 ml liquid per wipe (wipe liquid load is 400%) Wipe with size 15,2 x 20,3 cm; weight is 1,51 gr; 6 ml liquid per wipe (wipe liquid load is 400%) Wipe with size 17,7 x 20,3 cm; weight is 1,50 gr; 6 ml liquid per wipe (wipe liquid load is 400%) Wipe with size 19 x 25,4 cm; weight is 1,49 gr; 6 ml liquid per wipe (wipe liquid load is 400%) Wipe with size 20 x 26,7 cm; weight is 1,49 gr; 6 ml liquid per wipe (wipe liquid load is 400%) Wipe with size 20 x 30 cm; weight is 1,50 gr; 6 ml liquid per wipe (wipe liquid load is 400%) Wipe with size 25 x 25 cm; weight is 1,51 gr; 6 ml liquid per wipe (wipe liquid load is 400%) Wipe with size 25,4 x 25,4 cm; weight is 1,51 gr; 6 ml liquid per wipe (wipe liquid load is 400%) 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) | Oxivir Excel Wipe | Market area: EU ---|---|--- Oxivir Excel Wipe H+ | Market area: EU Oxivir Excel Wipe Acti | Market area: EU Oxivir Excel Wipe Des | Market area: EU Oxivir Excel Wipe Duo | Market area: EU Clinell H2O2 wipes | Market area: EU Antibac Oxivir wipes | Market area: EU Divosan AHP Wipes VS72 | Market area: EU Suma AHP Wipes | Market area: EU Suma San AHP Wipes | Market area: EU ClearKlens AHP Wipes | Market area: EU ClearKlens Excel Wipes | Market area: EU DOMESTOS Expert Wipes | Market area: EU GLORIX Expert Wipes | Market area: EU KLINEX Expert Wipes | Market area: EU LYSOFORM Expert Wipes | Market area: EU SAVO Expert Wipes | Market area: EU CIF Expert Wipes | Market area: EU VISS Expert Wipes | Market area: EU JIF Expert Wipes | Market area: EU FLORASZEPT Expert Wipes | Market area: EU ANDY Expert Wipes | Market area: EU SUPERANDY Expert Wipes | Market area: EU LIFEBUOY Expert Wipes | Market area: EU ANDYSAN Expert Wipes | Market area: EU Authorisation number | | EU-0032483-0003 1-3 Common name | IUPAC name | Function | CAS number | EC number | Content (%) Hydrogen peroxide | | active substance | 7722-84-1 | 231-765-0 | 0,36 % (w/w) * * * ELI: http://data.europa.eu/eli/reg_impl/2025/839/oj ISSN 1977-0677 (electronic edition) * * *