Commission Implementing Regulation (EU) 2025/1186 of 17 June 2025 granting a Union authorisation for the single biocidal product exeol air cid 01 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-0033504-0000 is hereby granted to SODEL for the making available on the market and use of the same single biocidal product ‘exeol air cid 01’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 8 July 2025 until 30 September 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 exeol air cid 01 Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number: EU-0033504-0000 R4BP asset number: EU-0033504-0000 1.    ADMINISTRATIVE INFORMATION 1.1.    Trade name(s) of the product Trade name(s) exeol air cid 01 1.2.    Authorisation holder Name and address of the authorisation holder Name SODEL Address 190 rue René Barthélémy, 14100 Lisieux, France Authorisation number EU-0033504-0000 R4BP asset number EU-0033504-0000 Date of the authorisation 8 July 2025 Expiry date of the authorisation 30 September 2033 1.3.    Manufacturer(s) of the product Name of manufacturer OXY’PHARM Address of manufacturer 829 rue Marcel Paul, 94500 Champigny-sur-Marne, France Location of manufacturing sites OXY’PHARM site 1 829 rue Marcel Paul, 94500 Champigny-sur-Marne, France 1.4.    Manufacturer(s) of the active substance(s) Active substance Hydrogen peroxide Name of manufacturer Evonik Resource Efficiency GmbH Address of manufacturer Rellinghauser Straße 1-11, 45128 Essen, Germany Location of manufacturing sites Evonik Resource Efficiency GmbH site 1 Evonik Industries AG/BL Active Oxygens, Untere Kanalstraße 3, 79618 Rheinfelden, Germany 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 7,9 % (w/w) 2.2.    Type(s) of formulation AL Any other liquid 3.    HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements H319: Causes serious eye irritation. Precautionary statements P264: Wash hands thoroughly after handling. P280: Wear eye protection. P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337 + P313: If eye irritation persists: Get medical advice. 4.    AUTHORISED USE(S) 4.1.    Use description Table 1 Use #3.1: Hard surface disinfection by 7,9 % Fogging Hydrogen Peroxide (FHP) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: — Common name: Bacteria Development stage: — Scientific name: — Common name: yeasts Development stage: — Scientific name: — Common name: Bacterial spores Development stage: no data Scientific name: — Common name: Mycobacteria Development stage: — Scientific name: — Common name: Viruses Development stage: — Scientific name: — Common name: fungi Development stage: — Field(s) of use indoor use Room disinfection with FHP for rooms with volumes between 4-150 m 3 . It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room: — Hospitals & clinics, — laboratories of research and analysis (including P3 laboratories and white rooms), — healthcare transport, — pharmaceutical industry, — industrial laundries, — dental surgery and implantology centres, — transport vehicles — hotels, — restaurants, — schools, — day nurseries, — veterinary clinics. Application method(s) Method: fogging Detailed description: The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present. Application rate(s) and frequency Application rate: — Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m 3 and 2 hours contact time. — Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m 3 and 2 hours contact time. Droplet size: 1-15 μm Number and timing of application: Disinfect rooms and equipment as frequently as required by the hygiene protocol in place. Category(ies) of users professional Pack sizes and packaging material (1) HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap. (2) HDPE, grey (non-transparent) single-use bottle of 2 litres. (3) HDPE, white (non-transparent) can of 5 litres (refill packaging). (4) HDPE, white (non-transparent) can of 20 litres. 4.1.1.    Use-specific instructions Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols: — Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m 3 and 2 hours contact time. — Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m 3 and 2 hours contact time. Droplet size: 1-15 μm Relative humidity: 25 %-75 % Temperature: room temperature Respect the contact time. The contact time starts when the required amount of product is present in the room. 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. 4.1.2.    Use-specific risk mitigation measures See general directions for use. 4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid: IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. Likely direct or indirect effects: — Causes severe eye irritation. 4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 4.2.    Use description Table 2 Use #3.3: Hard surface disinfection by Fogging Hydrogen Peroxide (FHP) Product type PT04: Food and feed area Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: — Common name: Bacteria Development stage: — Scientific name: — Common name: Yeasts Development stage: — Scientific name: — Common name: Bacterial spores Development stage: — Scientific name: — Common name: Mycobacteria Development stage: — Scientific name: — Common name: Viruses Development stage: — Scientific name: — Common name: bacteriophages Development stage: — Scientific name: — Common name: fungi Development stage: — Field(s) of use indoor use Room disinfection with FHP disinfection of hard non-porous surfaces of equipment and material present in the treated room of a size between 4-150 m 3 : — food industries, — central kitchens, — restaurants. Application method(s) Method: fogging Detailed description: The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present. Application rate(s) and frequency Application rate: — Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m 3 and 2 hours contact time. — Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m 3 and 2 hours contact time. Droplet size: 1-15 μm Number and timing of application: Disinfect rooms and equipment as frequently as required by the hygiene protocol in place. Category(ies) of users professional Pack sizes and packaging material (1) HDPE, white (non-transparent) bottle of 1litre with a degassing screw cap. (2) HDPE, grey (non-transparent) single-use bottle of 2 litres. (3) HDPE, white (non-transparent) can of 5 litres (refill packaging). (4) HDPE, white (non-transparent) can of 20 litres. 4.2.1.    Use-specific instructions Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols: — Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 5 ml product/m 3 and 2 hours contact time. — Mycobactericidal activity: 7 ml product/m 3 and 2 hours contact time. Droplet size: 1-15 μm Relative humidity: 25 %-75 % Temperature: room temperature Respect the contact time. The contact time starts when the required amount of product is present in the room. 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. 4.2.2.    Use-specific risk mitigation measures See general directions for use. 4.2.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid: IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. Likely direct or indirect effects: — Causes severe eye irritation. 4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5.    GENERAL DIRECTIONS FOR USE   ( 1 ) 5.1.    Instructions for use — 5.2.    Risk mitigation measures During the diffusion, keep the room closed and do not enter. Treatment must be conducted with no human or animals present. All gaps present in the room (for example, window frames) from where fog may leak must be sealed before the diffusion. Ensure that access to the fog-treated area is denied during the whole procedure with a warning sign. No access to the treated area should be permitted until the concentration of hydrogen peroxide is ≤ 0,9 ppm (1,25 mg/m 3 ) or a lower relevant national reference value. The professional user may enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m 3 ) and must wear the following PPE: RPE classified under EN 14387 or equivalent with APF 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves classified under European Standard EN 374 or equivalent, eye protection consistent with European Standard EN ISO 16321 or equivalent, coverall). 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. A measuring device should be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value. Unprotected persons/animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m 3 (0,9 ppm) or a lower relevant national reference value. Individual protective equipment: Wear chemical resistant goggles consistent with European Standard EN ISO 16321 or equivalent as eye protection during mixing and loading of the product to the packaging that is directly used in the fogging device (such as Nocospray, Bio-sanitizer, Sanofog, Nocomax or Nocomax Easy). 5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment — 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 regulations. Used product can be flushed to the municipal sewer or disposed of to the manure deposit depending on local regulations. Avoid release to an individual wastewater treatment plant. 5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage — Shelf life: 2 years. 6.    OTHER INFORMATION The full titles of the EN standards referenced in the ‘Risk mitigation measures’ sections are: EN ISO 16321 – Eye and face protection for occupational users EN 374 – Protective gloves against chemicals and micro-organisms EN 14387 – Respiratory protective devices – Gas filter(s) and combined filter(s) – Requirements, testing, marking ( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.