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Commission Implementing Regulation (EU) 2026/749of 31 March 2026amending Implementing Regulation (EU) 2023/2183 as regards administrative changes to the Union authorisation of the biocidal product family Evonik’s Hydrogen Peroxide Product Family(Text with EEA relevance)

Den Europæiske UnionForordning2026

European Union

Commission Implementing Regulation (EU) 2026/749 of 31 March 2026 amending Implementing Regulation (EU) 2023/2183 as regards administrative changes to the Union authorisation of the biocidal product family Evonik’s Hydrogen Peroxide Product Family (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 OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 50(2) thereof, Whereas: (1) On 18 October 2023, Commission Implementing Regulation (EU) 2023/2183 Commission Implementing Regulation (EU) 2023/2183 of 18 October 2023 granting a Union authorisation for the biocidal product family Evonik’s Hydrogen Peroxide Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2023/2183, 19.10.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2183/oj). granted a Union authorisation, under number EU-0028964-0000, to Evonik Operations GmbH for the making available on the market and use of the biocidal product family Evonik’s Hydrogen Peroxide Product Family. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family. (2) On 10 July 2024 and 20 March 2025, Evonik Operations GmbH submitted to the European Chemicals Agency (the Agency), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj). , notifications of administrative changes to the Union authorisation for the biocidal product family Evonik’s Hydrogen Peroxide Product Family, recorded in the Register for Biocidal Products (Register) under the case numbers BC-DY098630-08 and BC-ER104958-18. The notified proposed changes to that authorisation concern the removal and addition of trade names, the removal and addition of product manufacturers, changes in the names of active substance and product manufacturer and a change in the address of a product manufacturer. (3) On 29 July 2024 and 3 April 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions ECHA opinions UAD-C-1752264-31-00/F and UAD-C-1813642-33-00/F of 29 July 2024 and 3 April 2025 on administrative changes of the Union authorisation of the biocidal product family Evonik’s Hydrogen Peroxide Product family, https://echa.europa.eu/opinions-on-union-authorisation. on the notified administrative changes to the Union authorisation for the biocidal product family Evonik’s Hydrogen Peroxide Product Family. In its opinions, the Agency concluded that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(4) On 10 April 2025, the Agency transmitted to the Commission a revised summary of product characteristics for the biocidal product family Evonik’s Hydrogen Peroxide Product Family in all official languages of the Union, covering the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013. (5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family Evonik’s Hydrogen Peroxide Product Family to introduce the administrative changes requested by Evonik Operations GmbH. (6) Except for the amendments regarding the proposed administrative changes, all other information included in the summary of product characteristics of Evonik’s Hydrogen Peroxide Product Family, as set out in the Annex to Implementing Regulation (EU) 2023/2183, remains unchanged. (7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/2183 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of product characteristics in the Register in February 2024, the summary of product characteristics in that Annex should also include some minor editorial and layout changes. (8) Implementing Regulation (EU) 2023/2183 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2023/2183 is replaced by the text set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 31 March 2026. For the Commission The President Ursula von der Leyen

Annex

ANNEX Summary of product characteristics for a biocidal product family Evonik’s Hydrogen Peroxide Product Family Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number EU-0028964-0000 R4BP asset number EU-0028964-0000 PART I FIRST INFORMATION LEVEL

  1. ADMINISTRATIVE INFORMATION 1.1. Family name NameEvonik’s Hydrogen Peroxide Product Family 1.2. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 1.3. Authorisation holder Name and address of the authorisation holderNameEvonik Operations GmbHAddressRellinghauser Straße 1 - 11 45128 Essen DEAuthorisation numberEU-0028964-0000R4BP asset numberEU-0028964-0000Date of the authorisation8.11.2023Expiry date of the authorisation31.10.2033 1.4. Manufacturer(s) of the product Name of manufacturerEvonik Antwerpen NVAddress of manufacturerTijsmanstunnel West 2040 Antwerpen BelgiumLocation of manufacturing sitesEvonik Antwerpen NV - Site 1 Tijsmanstunnel West 2040 Antwerpen Belgium

Name of manufacturerEvonik Operations GmbHAddress of manufacturerRellinghauser Straße 1-11 45128 Essen GermanyLocation of manufacturing sitesEvonik Operations GmbH - Site 1 Untere Kanalstr. 3 79618 Rheinfelden GermanyName of manufacturerEvonik Peroxid GmbHAddress of manufacturerIndustriestraße 1 9721 Weißenstein AustriaLocation of manufacturing sitesEvonik Peroxid GmbH Industriestraße 1 9721 Weißenstein AustriaName of manufacturerEvonik Peroxide Netherlands BVAddress of manufacturerHettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the)Location of manufacturing sitesEvonik Peroxide Netherlands BV - Site 1 Oosterhorn 14 9936 HD Farmsum Netherlands (the)Name of manufacturerBrenntag Schweizerhall AGAddress of manufacturerElsässerstrasse 231 4013 Basel SwitzerlandLocation of manufacturing sites Brenntag Schweizerhall AG Site 1 Route Industrielle 10 1580 Avenches Switzerland Brenntag Schweizerhall AG Site 2 C/O Infrapark , Baselland, Rothausstrasse 61 4132 Muttenz Switzerland Name of manufacturerBrenntag GmbHAddress of manufacturerMesseallee 11 45131 Essen GermanyLocation of manufacturing sites Brenntag GmbH Site 1 Am Röhrenwerk 46 47259 Duisburg Germany Brenntag GmbH Site 2 Boschstraße 3 08371 Glauchau Germany Brenntag GmbH Site 3 Hannoversche Str. 40 21079 Hamburg Germany Brenntag GmbH Site 4 Dieselstraße 5 74076 Heilbron Germany Brenntag GmbH Site 5 Merkurstraße 47 67663 Kaiserslautern Germany Brenntag GmbH Site 6 Am Fieseler Werk 9 34253 Lohfelden Germany Name of manufacturerBrenntag CEE GmbHAddress of manufacturerLinke Wienzeile 152 1060 Wien AustriaLocation of manufacturing sites Brenntag CEE GmbH Site 1 Bahnstraße 13 2353 Guntramsdorf Austria Brenntag CEE GmbH Site 2 Fabrikstraße 4-6 8111 Judendorf Austria Brenntag CEE GmbH Site 3 Rubensstraße 48 4050 Traun Austria Name of manufacturerBrenntag Slovakia s. r. o.Address of manufacturerGlejovka 902 03 Pezinok SlovakiaLocation of manufacturing sites Brenntag Slovakia s. r. o. Site 1 Glejovka 15 902 03 Pezinok Slovakia Brenntag Slovakia s. r. o. Site 2 Príboj 558 976 13 Slovenská Ľupča Slovakia Brenntag Slovakia s. r. o. Site 3 Južná Trieda 72 042 85 Košice Slovakia Name of manufacturerBrenntag S.p.A.Address of manufacturerVia Cusago, 150/4 20153 Milano ItalyLocation of manufacturing sites Brenntag S.p.A. Site 1 Via San Carlo Borromeo 24040 Levate Italy Brenntag S.p.A. Site 2 Via Galliera 6/2 40010 Bentivoglio Italy Brenntag S.p.A. Site 3 Via del Cimitero 6 80030 Castello di Cisterna Italy Brenntag S.p.A. Site 4 Strada Provinciale di Bonifica 34-36 65010 Villanova di Cepagatti Italy Brenntag S.p.A. Site 5 Via Provinciale per Bitetto 70027 Palo del Colle Italy Brenntag S.p.A. Site 6 Via Paduni 03012 Anagni Italy Name of manufacturerBrenntag Polska Sp. z o.o.Address of manufacturerJózefa Bema 21 47-224 Kędzierzyn-Koźle PolandLocation of manufacturing sites Brenntag Polska Sp. z o.o. Site 1 Józefa Bema 21 47-224 Kędzierzyn-Koźle Poland Brenntag Polska Sp. z o.o. Site 2 Kwasowa 5 95-100 Zgierz Poland Brenntag Polska Sp. z o.o. Site 3 Przemysłowa 2 62-080 Jankowice Poland

Brenntag Polska Sp. z o.o. Site 4 Towarowa 9 05-530 Góra Kalwaria Poland Name of manufacturerBrenntag Lietuva UABAddress of manufacturerPalemono g. 171D 52107 Kaunas LithuaniaLocation of manufacturing sitesBrenntag Lietuva UAB Site 1 Palemono g. 171D 52107 Kaunas Lithuania Name of manufacturerBrenntag Hungária Kft.Address of manufacturerBányalég u. 45 1225 Budapest HungaryLocation of manufacturing sitesBrenntag Hungária Kft. Site 1 Bányalég u. 45 1225 Budapest HungaryName of manufacturerS.C. Brenntag S.R.L.Address of manufacturerGarii Street 1 077040 Chiajna RomaniaLocation of manufacturing sitesS.C. Brenntag S.R.L. Site 1 Garii Street 1 077040 Chiajna RomaniaName of manufacturerBrenntag Hrvatska d.o.o.Address of manufacturerRadnička cesta 173p 10000 Zagreb CroatiaLocation of manufacturing sitesBrenntag Hrvatska d.o.o. Site 1 Radnička cesta 173p 10000 Zagreb CroatiaName of manufacturerBrenntag Bulgaria EOODAddress of manufacturerj.k. Drujba 2, ul. Obikolna 21, et. 1 1582 Sofia BulgariaLocation of manufacturing sitesBrenntag Bulgaria EOOD Site 1 j.k. Drujba 2, ul. Obikolna 21, et. 1 1582 Sofia BulgariaName of manufacturerOQEMA S.P.A.Address of manufacturerVia Roggia Bartolomea 7 20090 Assago ItalyLocation of manufacturing sitesOQEMA S.P.A. Site 1 VIA TORTONA 73 27055 Rivanazzano ItalyName of manufacturerBreustedt Chemie BVAddress of manufacturerIJsseldijk 28 7325 WZ Apeldoorn Netherlands (the)Location of manufacturing sitesBreustedt Chemie BV Site 1 IJsseldijk 28 7325 WZ Apeldoorn Netherlands (the)Name of manufacturerBEAUSEIGNEUR SASAddress of manufacturer6, Rue André Viellard 90140 Froidefontaine FranceLocation of manufacturing sitesBEAUSEIGNEUR SAS Site 1 6, Rue André Viellard 90140 Froidefontaine France Name of manufacturerStaub & Co. - Silbermann GmbHAddress of manufacturerOstendstraße 124 90482 Nürnberg GermanyLocation of manufacturing sitesStaub & Co. - Silbermann GmbH Site 1 Industriestraße 3 6456 Gablingen GermanyName of manufacturerMöller GmbH & Co. KGAddress of manufacturerBürgerkamp 1 48565 Steinfurt GermanyLocation of manufacturing sitesMöller GmbH & Co. KG Site 1 Bürgerkamp 1 48565 48565 GermanyName of manufacturerHäffner GmbH & Co. KGAddress of manufacturerFriedrichstraße 3 71679 Asperg GermanyLocation of manufacturing sitesHäffner GmbH & Co. KG Site 1 Friedrichstraße 3 71679 Asperg GermanyName of manufacturerGaches ChimieAddress of manufacturer17 avenue de la Gare 31750 Escalquens FranceLocation of manufacturing sites Gaches Chimie Site 1 17 avenue de la Gare 31750 Escalquens France Gaches Chimie Site 2 2 Chemin de la Scierie 64150 Os-Marsillon France Name of manufacturerEvonik España y Portugal SAAddress of manufacturerAfueras s/n 50784 La Zaida SpainLocation of manufacturing sitesEvonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida SpainName of manufacturerAmira SrlAddress of manufacturerVia Vecchia Milanese 12 20844 Triuggio (MB) ItalyLocation of manufacturing sitesAmira Srl Site 1 Via Vecchia Milanese 12 20844 Triuggio (MB) ItalyName of manufacturerASiRAL Industriereiniger GmbHAddress of manufacturerHermann-Wehrle-Str. 15 67433 Neustadt/Weinstraße GermanyLocation of manufacturing sitesASiRAL Industriereiniger GmbH Site 1 Hermann-Wehrle-Str. 15 67433 Neustadt/Weinstraße Germany

Name of manufacturerabcr GmbHAddress of manufacturerIm Schlehert 10 76187 Karlsruhe GermanyLocation of manufacturing sitesabcr GmbH Site 1 Im Schlehert 10 76187 Karlsruhe GermanyName of manufacturerAntec International LimitedAddress of manufacturerWindham Road, Chilton Industrial Estate CO1 Sudbury United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sitesAntec International Limited Site 1 Windham Road, Chilton Industrial Estate CO1 Sudbury United Kingdom of Great Britain and Northern Ireland (the)Name of manufacturerOQEMA GmbHAddress of manufacturerAachener Straße 258 41061 Mönchengladbach GermanyLocation of manufacturing sitesOQEMA GmbH Site 1 Gutberletstraße 17 04316 Leipzig GermanyName of manufacturerBrenntag Nordic ABAddress of manufacturerHyllie Boulvevard 34 18 TR SE-215 32 Malmö SwedenLocation of manufacturing sitesBrenntag Nordic AB Site 1 Vevgatan 2 504 64 Boras SwedenName of manufacturerECSA Chemicals SAAddress of manufacturerBurgauerstrasse 17 9230 Flawil SwitzerlandLocation of manufacturing sitesECSA Chemicals SA Site 1 Via Luigi Favre 16 6828 Balerna SwitzerlandName of manufacturerTENSID-CHEMIE GMBHAddress of manufacturerHeinkelstraße 32 76461 Muggensturm GermanyLocation of manufacturing sitesTENSID-CHEMIE GMBH Site 1 Heinkelstraße 32 76461 Muggensturm GermanyName of manufacturerCarl Roth GmbH + Co. KGAddress of manufacturerSchoemperlenstraße 3-5 76185 Karlsruhe GermanyLocation of manufacturing sitesCarl Roth GmbH + Co. KG Site 1 Schoemperlenstraße 3-5 76185 Karlsruhe Germany Name of manufacturerHollu Systemhygiene GmbHAddress of manufacturerHollu Campus 1 6170 Zirl AustriaLocation of manufacturing sitesHollu Systemhygiene GmbH Site 1 Hollu Campus 1 6170 Zirl Austria 1.5. Manufacturer(s) of the active substance(s) Active substanceHydrogen peroxideName of manufacturerEvonik Antwerpen NVAddress of manufacturerTijsmanstunnel West 2040 Antwerpen BelgiumLocation of manufacturing sitesEvonik Antwerpen NV Tijsmanstunnel West 2040 Antwerpen BelgiumActive substanceHydrogen peroxideName of manufacturerEvonik Operations GmbHAddress of manufacturerRellinghauser Straße 1-11 45128 Essen GermanyLocation of manufacturing sitesEvonik Operations GmbH Untere Kanalstr. 3 79618 Rheinfelden GermanyActive substanceHydrogen peroxideName of manufacturerEvonik Peroxid GmbHAddress of manufacturerIndustriestraße 1 9721 Weißenstein AustriaLocation of manufacturing sitesEvonik Peroxid GmbH Industriestraße 1 9721 Weißenstein AustriaActive substanceHydrogen peroxideName of manufacturerEvonik Peroxide Netherlands BVAddress of manufacturerHettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the)Location of manufacturing sitesEvonik Peroxide Netherlands BV Oosterhorn 14 9936 HD Farmsum Netherlands (the)Active substanceHydrogen peroxideName of manufacturerEvonik España y Portugal SAAddress of manufacturerAfueras s/n 50784 La Zaida SpainLocation of manufacturing sitesEvonik España y Portugal SA C/ 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 - 49,9 % (w/w) 2.2. Type(s) of formulation Formulation type(s)SL Soluble concentrate PART II SECOND INFORMATION LEVEL META SPC(S)

  1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier IdentifierMeta SPC: OXTERIL® Group 1 1.2. Suffix to the authorisation number Number1-1 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 - 49,9 % (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 H302: Harmful if swallowed. H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects. H272: May intensify fire; oxidiser. Precautionary statements P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective gloves / eye protection / face protection.. P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell. P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water/ soap. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/ doctor/physician if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER / doctor. P332+P313: If skin irritation occurs: Get medical advice. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P501: Dispose of contents / in accordance with local requirements. P501: Dispose of container / in accordance with local requirements. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish.
  4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Surface disinfection by vaporised hydrogen peroxide (VHP) process Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsWhere relevant, an exact description of the authorised use- Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: -

Field(s) of use indoor use Disinfection of dry surfaces and equipment in hospital rooms, laboratories and other enclosed spaces, which do not come in contact with food and feed. Application method(s) Method: Vaporisation Detailed description: Automated disinfection with Vaporised Hydrogen Peroxide, generated with the aid of a VHP generator. Main specifications of a VHP generator: Diffusion principle: vaporisation, disinfection with gaseous hydrogen peroxide. Room Volume: 30 - 150 m3. Product concentration: 3120 mg/m3. Relative humidity: 40 - 80 %. Temperature: room temperature. Application rate(s) and frequency Application Rate: The ready to use product should be applied in a hydrogen peroxide concentration of 1092 mg/m3 (780 ppm) by the VHP generator. not applicable Number and timing of application: Contact time: at least 4 hours Frequency: daily /if required Maximum 3 times per day Category(ies) of usersprofessionalPack sizes and packaging material High density polyethylene (HDPE) bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.1.1. Use-specific instructions for use The area to disinfect is prepared for decontamination by removing standing liquid and by wiping down any visible dirt. Clean the area before disinfection. Cupboard doors should be opened, surfaces should be dried and wet areas (such as sinks) should be disinfected with suitable alternative products. Specially trained professionals replace the cap of the sealed packaging with a special cap that has a degassing valve and a fast connector. The fast connector is connected to a pipe that connects to the VHP generator. Seal the enclosed space or room and make sure that access to the vapour-treated area is denied during the whole procedure. Room volume ranging from 30 m3 to 150 m3. Diffusion speed can vary from 1,5 to 20 g product /minute. Starting temperature of 20 °C, ± 2 °C. Relative humidity between 40 and 80 %. During the disinfection cycle the VHP generator adjusts the hydrogen peroxide concentration up to the effective levels of 1092 mg/m3 (780 ppm) and keeps it at this level for at least 4 hours. Concentration of hydrogen peroxide is monitored during the disinfection. After disinfection the aeration of the sealed area is required to reduce the concentration of hydrogen peroxide below 1,25 mg/m3 or a lower relevant national reference value before entering the area. This step can be quick but can also last several hours resulting in a total decontamination cycle of 5 - 8 hours. The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable standard room, if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. In the event that there are methods available for chemically monitoring the active substance in the air or on surfaces, chemical validation should be performed besides biological validation, for example with test strips or with a device that measures ppm hydrogen peroxide in the air.

When it concerns a standard room for which a protocol is available, the validation may be limited to only a chemical validation. 4.1.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and Respiratory Protective Equipment (RPE) (Assigned Protection Factor (APF) = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. No access to the treated area is permitted during treatment. During aeration and before permitting re-entry to the treated area it should be checked that the concentration of hydrogen peroxide is below 1,25 mg/m3 or a lower relevant national reference value, using for example test strips. During the operation of the VHP generator or in the event of malfunctions, entry to the room is only possible if wearing chemical protective suits and RPE (APF = 10), when the concentration of hydrogen peroxide is at or below 12,5 mg/m3. Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment.See General directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See General directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See General directions for use. 4.2. Use description Table 2 Surface disinfection by vaporised hydrogen peroxide (VHP) process Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Field(s) of use indoor use Disinfection of dry surfaces in food and feed areas and other enclosed spaces. Application method(s) Method: Vaporisation Detailed description: Automated disinfection with Vaporised Hydrogen Peroxide, generated with the aid of a VHP generator. Main specifications of a VHP generator: Diffusion principle: vaporisation, disinfection with gaseous hydrogen peroxide. Room Volume 30 - 150 m3 . Product concentration: 3120 mg/m3 . Relative humidity: 40 - 80 %.

Temperature: room temperature. Application rate(s) and frequency Application Rate: The ready to use product should be applied in a hydrogen peroxide concentration of 1092 mg/m3 (780 ppm) by the VHP generator Number and timing of application: Contact time: at least 4 hours Frequency: daily /if required Maximum 3 times per day Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.2.1. Use-specific instructions for use The area to disinfect is prepared for decontamination by removing standing liquid and by wiping down any visible dirt. Clean the area before disinfection. Cupboard doors should be opened, surfaces should be dried and wet areas (such as sinks) should be disinfected with suitable alternative products. Specially trained professionals replace the cap of the sealed packaging with a special cap that has a degassing valve and a fast connector. The fast connector is connected to a pipe that connects to the VHP generator. Seal the enclosed space or room and make sure that access to the vapour-treated area is denied during the whole procedure. Room volume ranging from 30 m3 to 150 m3. Diffusion speed can vary from 1,5 to 20 g product /minute. Starting temperature of 20 °C, ± 2 °C. Relative humidity between 40 and 80 %. During the disinfection cycle the VHP generator adjusts the hydrogen peroxide concentration up to the effective levels of 1092 mg/m3 (780 ppm) and keeps it at this level for at least 4 hours. Concentration of hydrogen peroxide is monitored during the disinfection. After disinfection the aeration of the sealed area is required to reduce the concentration of hydrogen peroxide below 1,25 mg/m3 or a lower relevant national reference value before entering the area. This step can be quick but can also last several hours resulting in a total decontamination cycle of 5 - 8 hours. The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable standard room, if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. In the event that there are methods available for chemically monitoring the active substance in the air or on surfaces, chemical validation should be performed besides biological validation, for example with test strips or with a device that measures ppm hydrogen peroxide in the air. When it concerns a standard room for which a protocol is available, the validation may be limited to only a chemical validation. 4.2.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC . No access to the treated area is permitted during treatment. During aeration and before permitting re-entry to the treated area it should be checked that the concentration of hydrogen peroxide is below 1,25 mg/m3 or a lower relevant national reference value, using for example test strips. During the operation of the VHP generator or in the event of malfunctions entry to the room is only possible by wearing chemical protective suits and RPE (APF=10), when the concentration of hydrogen peroxide is at or below 12,5 mg/m3. Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.3. Use description Table 3 Aseptic packaging in food and feed industries Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: Bacterial spores Development stage: Bacterial spores Field(s) of use indoor use Disinfection of food packaging material in closed aseptic packaging systems by sprayed or nebulised product. Application method(s) Method: Nebulising Detailed description: Automated spraying or nebulising in closed systems. Application rate(s) and frequency Application Rate: In-use concentration: 35 % (w/w) hydrogen peroxide. Product concentration in hot air: 10,83 g/kg For disinfection of bacteria, yeasts and bacterial spores the product should be diluted to 35 % (w/w) hydrogen peroxide. For example, for a product containing 49,9 % (w/w) hydrogen peroxide: add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide. Number and timing of application: Automated chemo-thermal disinfectant processes. Temperature: ≥ 100 °C Contact time: at least 5,5 seconds Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.3.1. Use-specific instructions for use The aseptic filling systems are based on the principle of aseptically forming a tube from a sterilised sheet of package material, which is continuously filled with commercially sterile liquid food product and subsequently transversally sealed to form pouches, which in turn are folded into the final package shape. The packaging material are delivered to the aseptic filling machine either in the form of (sheet) reels or in the form of pre-formed packs, tubs and bottles. Then, 35 % (w/w) hydrogen peroxide is sprayed or nebulised to the packaging material gradually via a nozzle. After that, several stages follow to evaporate any excess hydrogen peroxide with sterile hot air.

Depending on the size of the receptacle, an amount of 0,1 - 1 mL of 35 % (w/w) hydrogen peroxide is sprayed or nebulised gradually via a nozzle. Temperature: ≥ 100 °C Contact time: at least 5,5 seconds. For example, for a product containing 49,9 % (w/w) hydrogen peroxide: add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide. The user shall always carry out a microbiological validation of the disinfection, after which a protocol for disinfection of this packaging / system can be made and used thereafter. 4.3.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) when handling concentrated solutions during mixing and loading; chemical resistant gloves classified under European Standard EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, and chemical resistant goggles consistent with European Standard EN 16321 or equivalent face shield during application. During maintenance work, wear chemical resistant gloves classified under EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant goggles consistent with EN 16321 or equivalent face shield and RPE (APF = 4) and spray water for approximately 10 seconds before opening the machine. The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Gloves and coverall material to be specified by the authorisation holder within the product information. Observe label instructions. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.4. Use description Table 4 Disinfection of distribution system for drinking water by cleaning in place (CIP) Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage)

Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Disinfection of distributing and storing installations for drinking water Application method(s) Method: CIP (Cleaning in place) Detailed description: Disinfecting the interior surfaces of closed systems by CIP Application rate(s) and frequency Application Rate: 4,7 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.4.1. Use-specific instructions for use CIP (Cleaning in place): Clean before disinfection (Remove all deposits and dirt by a pre-flush or pre-scrape, and when necessary, a pre-soak treatment). Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w ) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. 4.4.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent. and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 air changes per hour (ACH)). Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.5. Use description Table 5 Disinfection of non-porous hard surfaces and equipment by immersion Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Equipment in both food and drink industries, large scale catering kitchens and large scale canteens. Application method(s) Method: open system: immersion Detailed description: Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths. Application rate(s) and frequency Application Rate: 8,1 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 200 ml product to 738 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: 60 minutes Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.5.1. Use-specific instructions for use For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Immersion: Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of not less than 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection solution in the immersion/dipping bath should be replaced after each disinfection cycle. 4.5.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading and application. Gloves and coverall material to be specified by the authorisation holder within the product information. No access of other worker to the room is permitted during disinfection without wearing adequate PPE and RPE as described above. See section 6 for the full titles of the EN standards.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Dipping bath has to be placed in a separated room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF = 10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge. Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.6. Use description Table 6 Disinfection of surfaces by cleaning in place (CIP) Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Disinfection of food contact inner surfaces of pipe work and tank systems in food and feed industry Application method(s) Method: Cleaning in Place (CIP) Detailed description: Disinfecting the interior surfaces of closed systems by Cleaning In Place (CIP). Application rate(s) and frequency Application Rate: 4,7 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.6.1. Use-specific instructions for use Clean prior to disinfection. The inner surfaces of pipe work and tank systems are disinfected by CIP process. For disinfection of bacteria yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide; add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.

The process is carried out by circulating the disinfection solution through the system under conditions of increased turbulence and flow velocity. The application is automated and a closed process. After 3 hours contact time, pipelines and tanks are rinsed with water under closed system conditions as well. 4.6.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use See use specific instructions for each use. 5.2. Risk mitigation measures See use specific risk mitigation measures for each use. Observe label instructions. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions 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. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. 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. 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. Accidental release measures Large spillage: Collect product in suitable containers (for example made of plastic) using appropriate equipment (for example liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations. Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (for example diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Advice on protection against fire and explosion: Store away from direct sunlight and heat sources. Store away from sources of ignition - No smoking. Store away from flammable substances. Store away from incompatible substances. Storage: Temperature requirement- during storage maximum 40 °C and protect from frost. Store in clean, dry and well-ventilated places. Transport and store container in upright position only. Always close container tightly after removal of product. Avoid leakage and residues of the product on the containers. Advice on common storage: Do not store together with alkalis, reductants, metallic salts (risk of decomposition). Do not store together with organic solvents (risk of explosion). Shelf-life: 24 months 6. OTHER INFORMATION The full titles of the EN standards referenced in the Use-specific mitigation measures sections are: EN 16321 - Eye and face protection for occupational users EN 374 - Protective gloves against chemicals and micro-organisms The Council Directive referenced in the Use-specific mitigation measures sections is: 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[RMJ1], 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)OXTERIL® 350 SPRAYMarket area: EUBIS OKSANMarket area: EUHalades DIMarket area: EU DEPTIL 350 SPRAYMarket area: EUAmira Hydrogen PeroxideMarket area: EUAsiral Des OMarket area: EUOXTERIL® 350 VHPMarket area: EUPERSYNT® 350 VHPMarket area: EUAuthorisation numberEU-0028964-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 % (w/w)

7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)OXTERIL® 350 SPRAY SMarket area: EUDES O HRMarket area: EUAuthorisation numberEU-0028964-0002 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 % (w/w)

  1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier IdentifierMeta SPC: OXTERIL® Group 2 1.2. Suffix to the authorisation number Number1-2 1.3. Product type(s) Product type(s)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 nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 - 49,9 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s)SL Soluble concentrate
  3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H302: Harmful if swallowed. H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects. H272: May intensify fire; oxidiser. Precautionary statements P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective gloves / eye protection / face protection. P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell. P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water/ soap. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor/physician if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P332+P313: If skin irritation occurs: Get medical advice. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P501: Dispose of contents / in accordance with local requirements. P501: Dispose of container / in accordance with local requirements. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish.
  4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Aseptic packaging in food and feed industries Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: Bacterial spores Development stage: Bacterial spores Field(s) of use indoor use Disinfection of food and feed packaging material in closed aseptic packaging systems by dipping, spraying or nebulising

Application method(s) Method: Dipping, nebulising and spraying Detailed description: Automated dipping in closed systems. Automated nebulising and spraying in closed systems. Application rate(s) and frequency Application Rate: In-use concentration: 35% (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and bacterial spores, the product should be diluted to 35 % (w/w) hydrogen peroxide. For example, for a product containing 49,9 % (w/w) hydrogen peroxide; add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Automated chemo-thermal disinfection processes. In-use concentration: 35% (w/w) hydrogen peroxide Spraying or nebulizing: Temperature: ≥100°C Contact time: at least 5,5 seconds Dipping: Temperature: ≥80°C Contact time: at least 2,5 seconds Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.1.1. Use-specific instructions for use The aseptic filling systems are based on the principle of aseptically forming a tube from a sterilised sheet of package material, which is continuously filled with commercially sterile liquid food product and subsequently transversally sealed to form pouches, which in turn are folded into the final package shape. The packaging material are delivered to the aseptic filling machine either in the form of (sheet) reels or in the form of pre-formed packs, tubs and bottles. The packaging material in the form of (sheet) reels passes through a deep bath filled with 35 % (w/w) hydrogen peroxide by dipping. The pre-formed packs, tubs and bottles are sprayed or fogged with 35 % (w/w) hydrogen peroxide stepwise via a nozzle. After that, several stages follow to evaporate any excess hydrogen peroxide with sterile hot air. Depending on the size of the receptacle, an amount of 0,1 - 1 mL of 35 % (w/w) hydrogen peroxide is sprayed or nebulized gradually via a nozzle. Temperature: ≥ 100 °C Contact time: at least 5,5 seconds The packaging material in the form of (sheet) reels passes through a deep bath filled with 35 % (w/w) hydrogen peroxide by dipping. Temperature: ≥ 80 °C Contact time: at least 2,5 seconds For example, for a product containing 49,9 % (w/w) hydrogen peroxide; add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide. The user shall always carry out a microbiological validation of the disinfection, after which a protocol for disinfection of this packaging / system can be made and used thereafter. 4.1.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) when handling concentrated solutions during mixing and loading; chemical resistant gloves classified under European Standard EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, and chemical resistant goggles consistent with European Standard EN 16321 or equivalent face shield during application.

During maintenance work, wear chemical resistant gloves classified under EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant goggles consistent with EN 16321 or equivalent face shield and RPE (APF = 4) and spray water for approximately 10 seconds before opening the machine. The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Gloves and coverall material to be specified by the authorisation holder within the product information. Observe label instructions. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.2. Use description Table 2 Disinfection of distribution system for drinking water by cleaning in place (CIP) Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Cleaning and disinfection of distributing and storing installations for drinking water Application method(s) Method: CIP (Cleaning in place) Detailed description: Disinfecting the interior surfaces of closed systems by CIP Application rate(s) and frequency Application Rate: 4,7 % (w/w) hydrogen peroxide For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 % (w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material

HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.2.1. Use-specific instructions for use CIP (Cleaning in place): Clean prior to disinfection. Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria,yeasts and fungi the product should be diluted to 4,7 % (w/w ) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. 4.2.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.3. Use description Table 3 Disinfection of non-porous hard surfaces and equipment by immersion Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Equipment in both food and drink industries, large scale catering kitchens and large scale canteens. Application method(s) Method: open system: immersion Detailed description: Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths.

Application rate(s) and frequency Application Rate: 8,1 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 200 ml product to 738 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 60 min Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.3.1. Use-specific instructions for use For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Immersion: Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of at least 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection solution in the immersion/dipping bath should be replaced after each disinfection cycle. 4.3.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading and application. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. No access of other worker to the room is permitted during disinfection without wearing adequate PPE and RPE as described above. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Dipping bath has to be placed in a separate room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF = 10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge. Observe label instructions. 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

No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.4. Use description Table 4 Disinfection of surfaces by cleaning in place (CIP) Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Disinfection of food contact inner surfaces of pipe work and tank systems in food and feed industry Application method(s) Method: Cleaning in Place (CIP) Detailed description: Disinfecting the interior surfaces of closed systems by Cleaning In Place (CIP). Application rate(s) and frequency Application Rate: 4,7 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.4.1. Use-specific instructions for use Clean prior to disinfection. For disinfection of bacteria yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide; add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. The process is carried out by circulating the disinfection solution through the system under conditions of increased turbulence and flow velocity. The application is automated and a closed process. After 3 hours contact time, pipelines and tanks are rinsed with water under closed system conditions as well. 4.4.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use See use specific instructions for each use. 5.2. Risk mitigation measures See use specific risk mitigation measures for each use. Observe label instructions. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions 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. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. 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. 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. Accidental release measures Large spillage: Collect product in suitable containers (e.g. made of plastic) using appropriate equipment (e.g. liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations. Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (e.g. diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal

5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Advice on protection against fire and explosion: Store away from direct sunlight and heat sources. Store away from sources of ignition - No smoking. Store away from flammable substances. Store away from incompatible substances. Storage: Temperature requirement- during storage maximum 40 °C and protect from frost. Store in clean, dry and well-ventilated places. Transport and store container in upright position only. Always close container tightly after removal of product. Avoid leakage and residues of the product on the containers. Advice on common storage: Do not store together with alkalis, reductants, metallic salts (risk of decomposition). Do not store together with organic solvents (risk of explosion). Shelf-life: 24 months 6. OTHER INFORMATION The full titles of the EN standards referenced in the Use-specific mitigation measures sections are: EN 16321 - Eye and face protection for occupational users EN 374 - Protective gloves against chemicals and micro-organisms The Council Directive referenced in the Use-specific mitigation measures sections is: 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[RMJ1], p. 11). 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)OXTERIL® 350 BATHMarket area: EUDES-H2O2 35Market area: EUAuthorisation numberEU-0028964-0003 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)OXTERIL® 350 COMBIMarket area: EUSPECIJAL PTMarket area: EUBrennspec HP 35 asepticMarket area: EUClimax HPO AseptiskMarket area: EUOXTERIL® 350 LRDMarket area: EUAuthorisation numberEU-0028964-0004 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 % (w/w)

  1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier IdentifierMeta SPC: CLARMARIN® Group 1 1.2. Suffix to the authorisation number Number1-3 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 - 49,9 % (w/w)

2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s)SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements H302: Harmful if swallowed. H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects. H272: May intensify fire; oxidiser. Precautionary statements P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective clothing / eye protection / face protection. P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell. P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water/ soap. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor/physician if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER / doctor. P332+P313: If skin irritation occurs: Get medical advice. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P501: Dispose of contents / in accordance with local requirements. P501: Dispose of container / in accordance with local requirements. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Laundry disinfection in closed washing machines by dosing Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: viruses Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Laundry disinfection in washing machines. Application method(s) Method: Loading (dosing) Detailed description: The product is automatically dosed into the closed washing machine during the washing process (main wash). Application rate(s) and frequency Application Rate: 0,019 - 0,029 % (w/w) hydrogen peroxide. The biocidal products are diluted accordingly in order to achieve an in-use concentration in the range of 0,019 - 0,029 % (w/w). For example, in the case of 35 % (w/w) hydrogen peroxide product: 0,5 ml or 0,75 ml concentrate add water up to 1 litre to achieve 0,019 % (w/w) or 0,029 % (w/w). For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Frequency: Daily / if required

Bacteria, yeasts, fungi: In use concentration 0,019 % (w/w) hydrogen peroxide in the wash solution. Alkaline buffering agent: 0,6 ml/l BEIPUR ANP. Contact time: 10 minutes Temperature: 70 °C Viruses: In use concentration 0,029 % (w/w) hydrogen peroxide in the wash solution. Alkaline buffering agent: 0,6 ml/l BEIPUR ANP Contact time: 10 minutes Temperature: 80 °C Cloth: liquid ratio = 1:4 Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.1.1. Use-specific instructions for use The product and alkaline buffering agent (BEIPUR ANP) are automatically dosed into the closed washing machine during the washing process. The dosing of both components, i.e. the biocidal product and the alkaline buffering agent BEIPUR ANP, is realised via two separate pipes and dosing stations. Biocidal product and alkaline buffering agent should not be mixed prior the dosing into the washing machine. Treatment Interval - daily / if required (0,5 hours / day). 4.1.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10 ) during mixing and loading. Glove and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC . Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.2. Use description Table 2 Disinfection of distribution system for drinking water by cleaning in place (CIP) Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts

Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Disinfection of distributing and storing installations for drinking water. Application method(s) Method: CIP (Cleaning in place) in closed systems Detailed description: Disinfecting the interior surfaces of closed systems by CIP Application rate(s) and frequency Application Rate: 4,7 % (w/w ) hydrogen peroxide For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in the case of a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.2.1. Use-specific instructions for use CIP (Cleaning in place): Clean prior to disinfection. Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. 4.2.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. See section 6 for the full titles of the EN standards. Glove and coverall material to be specified by the authorisation holder within the product information. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.3. Use description Table 3 Disinfection of non-porous hard surfaces and equipment by immersion Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Equipment in both food and drink industries, large scale catering kitchens and large scale canteens. Application method(s) Method: Open system: immersion Detailed description: Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths. Application rate(s) and frequency Application Rate: 8,1 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: 60 minutes Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.3.1. Use-specific instructions for use For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Immersion: Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of not less than 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection of the immersion/dipping bath should be replaced after each disinfection cycle. 4.3.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading and application. Glove and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. No access to the room is permitted during disinfection without wearing adequate PPE and RPE as described above. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Dipping bath has to be placed in a separate room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF = 10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge. Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 4.4. Use description Table 4 Disinfection of surfaces by cleaning in place (CIP) Product typePT04: Food and feed areaWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Disinfection of food contact inner surfaces of pipe work and tank systems in food and feed industry. Application method(s) Method: CIP in closed systems Detailed description: Disinfecting the interior surfaces of closed systems by Cleaning In Place (CIP). Application rate(s) and frequency Application Rate: 4,7 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature Category(ies) of usersprofessionalPack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20 m3 4.4.1. Use-specific instructions for use Clean prior to disinfection. The inner surfaces of pipe work and tank systems are disinfected by CIP process. For disinfection of bacteria yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.

The process is carried out by circulating the disinfection solution through the system under conditions of increased turbulence and flow velocity. The application is automated and a closed process. After 3 hours contact time, pipelines and tanks are rinsed with water under closed system conditions as well. 4.4.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. See section 6 for the full titles of the EN standards. Glove and coverall material to be specified by the authorisation holder within the product information. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use See use specific instructions for each use. 5.2. Risk mitigation measures See use specific risk mitigation measures for each use. Observe label instructions. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions 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. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. 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. 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. Accidental release measures Large spillage: Collect product in suitable containers (for example made of plastic) using appropriate equipment (for example liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations. Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (for example diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Advice on protection against fire and explosion Store away from direct sunlight and heat sources. Store away from sources of ignition - No smoking. Store away from flammable substances. Store away from incompatible substances. Storage Temperature requirement- during storage maximum 40 °C and protect from frost. Store in clean, dry and well- ventilated places. Transport and store container in upright position only. Always close container tightly after removal of product. Avoid leakage and residues of the product on the containers. Advice on common storage Do not store together with alkalis, reductants, metallic salts (risk of decomposition). Do not store together with organic solvents (risk of explosion). Shelf-life: 24 months 6. OTHER INFORMATION The full titles of the EN standards referenced in the Use-specific mitigation measures sections are: EN 16321 - Eye and face protection for occupational users EN 374 - Protective gloves against chemicals and micro-organisms The Council Directive referenced in the Use-specific mitigation measures sections is: 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[RMJ1], p.11). 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)CLARMARIN® 350Market area: EUWapo 35 BiozidMarket area: EUCalgonit sporexalinMarket area: EUHollu LG DES 851Market area: EUWapo 35Market area: EUWEICOLUB®-DESMarket area: EUWEICOPER®-OMarket area: EUWP 35Market area: EUBrennspec HP 35Market area: EUBEIBLEACH WP 35Market area: EUSANITER LPMarket area: EUOXY 50Market area: EUOXY 50 PLUSMarket area: EUSTERIL 130Market area: EUOXY 50 DMMarket area: EUPEROXISOLMarket area: EUDEWA-OXMarket area: EUPEROGENO 130Market area: EUEUROXY 50 AG SUPERMarket area: EUEUROGENOMarket area: EUOXICLEAN 2510/AMarket area: EUOXICLEAN 3000/AMarket area: EU

AGRISAN 40Market area: EUOXICLEAN 10Market area: EUENERSAN 2510AMarket area: EUANTIFERMENTATIVO KMarket area: EUANTIFERMENTATIVO K 100Market area: EUACQUAMarket area: EUSBIANCANTE KMarket area: EUOSSIDANTE ATTIVOMarket area: EULAUNDRY 05Market area: EUSYSTEMIC PROFESSIONAL M4 DESMarket area: EULAUNDRY 05 DMarket area: EURAPIDES OXYMarket area: EUDES-H 35Market area: EUSYSTEM PROTEX 4Market area: EUECSO 8670Market area: EUKomponente 2Market area: EUSANOLIFE HOMarket area: EUE-FLOW DETERGENTE SP01Market area: EUCANDOR STERIL BMarket area: EUOXY 70 DMMarket area: EUBLUOXIRAPIDMarket area: EUALFA-O-DUEMarket area: EUBAR-O-DUEMarket area: EUOXY ONEMarket area: EUOXI 50 DMMarket area: EUIdroxan WTMarket area: EUBÜFA-Oxy WSMarket area: EUO 33Market area: EU WAPERSOL® 35Market area: EUGRS 7325 SMarket area: EUTH 830DMarket area: EUKORASIL 3500-KAMarket area: EUAuthorisation numberEU-0028964-0005 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-035 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)CLARMARIN® 500Market area: EUWapo 50 BiozidMarket area: EUWapo 50Market area: EUINO PEROX 50Market area: EUMirasan PeroxMarket area: EUBrennspec HP 50Market area: EUINTERCLEAN® TWMarket area: EUDES-H 50Market area: EUSanivet TM AQUAMarket area: EUOXINEUTROMarket area: EUVet-OxMarket area: EUWAPERSOL® 50Market area: EUKORASIL 5000-GSMarket area: EUAuthorisation numberEU-0028964-0006 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideActive substance7722-84-1231-765-049,9 % (w/w)

Metadata

Type
Forordning
År
2026
Ikrafttrædelsesdato
1. januar 1970
Commission Implementing Regulation (EU) 2026/749of 31 March 2026amending Implementing Regulation (EU) 2023/2183 as regards administrative changes to the Union authorisation of the biocidal product family Evonik’s Hydrogen Peroxide Product Family(Text with EEA relevance) | TheLawyer.sh