Commission Implementing Regulation (EU) 2026/2042 of 11 September 2026 granting a Union authorisation for the biocidal product OXTERIL® 350 VHP in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Article 1

A Union authorisation with authorisation number EU-0035928-0000 is hereby granted to Evonik Operations GmbH for the making available on the market and use of the biocidal product ‘OXTERIL® 350 VHP’ in accordance with the summary of the product characteristics set out in the Annex. The Union authorisation is valid from 4 October 2026 until 31 October 2033.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT

ANNEXSupplementary provisions

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT OXTERIL® 350 VHP Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number: EU-0035928-0000 R4BP asset number: EU-0035928-0000 1.   ADMINISTRATIVE INFORMATION 1.1.    Trade name(s) of the product Trade name(s) OXTERIL® 350 VHP Amira Hydrogen Peroxide 1.2.    Authorisation holder Name and address of the authorisation holder Name Evonik Operations GmbH Address Rellinghauser Straße 1 - 11 45128 Essen DE Authorisation number   EU-0035928-0000 R4BP asset number   EU-0035928-0000 Date of the authorisation   04.10.2026 Expiry date of the authorisation   31.10.2033 1.3.    Manufacturer(s) of the product Name of manufacturer Evonik Antwerpen NV Address of manufacturer Tijsmanstunnel West 2040 Antwerpen Belgium Location of manufacturing sites Evonik Antwerpen NV - Site 1 Tijsmanstunnel West 2040 Antwerpen Belgium Name of manufacturer Evonik Operations GmbH Address of manufacturer Rellinghauser Straße 1-11 45128 Essen Germany Location of manufacturing sites Evonik Operations GmbH - Site 1 Untere Kanalstr. 3 79618 Rheinfelden Germany Name of manufacturer Evonik Peroxid GmbH Address of manufacturer Industriestraße 1 9721 Weißenstein Austria Location of manufacturing sites Evonik Peroxid GmbH Industriestraße 1 9721 Weißenstein Austria Name of manufacturer Evonik Peroxide Netherlands BV Address of manufacturer Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands Location of manufacturing sites Evonik Peroxide Netherlands BV - Site 1 Oosterhorn 14 9936 HD Farmsum Netherlands Name of manufacturer Evonik España y Portugal SA Address of manufacturer Afueras s/n 50784 La Zaida Spain Location of manufacturing sites Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain Name of manufacturer abcr GmbH Address of manufacturer Im Schlehert 10 76187 Karlsruhe Germany Location of manufacturing sites abcr GmbH Site 1 Im Schlehert 10 76187 Karlsruhe Germany Name of manufacturer Amira Srl Address of manufacturer Via Vecchia Milanese 12 20844 Triuggio (MB) Italy Location of manufacturing sites Amira Srl Site 1 Via Vecchia Milanese 12 20844 Triuggio (MB) Italy 1.4.    Manufacturer(s) of the active substance(s) Active substance Hydrogen peroxide Name of manufacturer Evonik Antwerpen NV Address of manufacturer Tijsmanstunnel West 2040 Antwerpen Belgium Location of manufacturing sites Evonik Antwerpen NV Tijsmanstunnel West 2040 Antwerpen Belgium Active substance Hydrogen peroxide Name of manufacturer Evonik Operations GmbH Address of manufacturer Rellinghauser Straße 1-11 45128 Essen Germany Location of manufacturing sites Evonik Operations GmbH Untere Kanalstr. 3 79618 Rheinfelden Germany Active substance Hydrogen peroxide Name of manufacturer Evonik Peroxid GmbH Address of manufacturer Industriestraße 1 9721 Weißenstein Austria Location of manufacturing sites Evonik Peroxid GmbH Industriestraße 1 9721 Weißenstein Austria Active substance Hydrogen peroxide Name of manufacturer Evonik Peroxide Netherlands BV Address of manufacturer Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands Location of manufacturing sites Evonik Peroxide Netherlands BV Oosterhorn 14 9936 HD Farmsum Netherlands Active substance Hydrogen peroxide Name of manufacturer Evonik España y Portugal SA Address of manufacturer Afueras s/n 50784 La Zaida Spain Location of manufacturing sites Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain 2.   PRODUCT COMPOSITION AND FORMULATION 2.1.    Qualitative and quantitative information on the composition of the product Common name IUPAC name Function CAS number EC number Content (%) Hydrogen peroxide   Active substance 7722-84-1 231-765-0 35 % (w/w) 2.2.    Type(s) of formulation SL Soluble concentrate 3.   HAZARD AND PRECAUTIONARY STATEMENTS 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) 4.1.    Use description Table 1 Surface disinfection by vaporised hydrogen peroxide (VHP) process Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - 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 m 3 . Product concentration: 3 120  mg/m 3 . 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 1 092  mg/m 3 (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 users professional Pack 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 1 000 litres HDPE ISO tank 20 m 3 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 m 3 to 150 m 3 . 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 1 092 mg/m 3 (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/m 3 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/m 3 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/m 3 . 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 type PT04: Food and feed area Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - 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 m 3 . Product concentration: 3 120  mg/m 3 . 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 1 092  mg/m 3 (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 users professional Pack sizes and packaging material HDPE bottle 1,5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m 3 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 m 3 to 150 m 3 . 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 1 092 mg/m 3 (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/m 3 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/m 3 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/m 3 . 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. 5.   GENERAL DIRECTIONS FOR USE  ( 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 , ELI: http://data.europa.eu/eli/dir/1998/24/oj ). ( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.