Commission Implementing Regulation (EU) 2025/1186

Contents

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^note, and in particular Article 44(5), first subparagraph, thereof,Whereas:

(1)On 12 June 2024, SODEL submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013^note for Union authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘exeol air cid 01’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012, referring to the single biocidal product with the asset number EU-0029752-0007, which is a part of the related reference biocidal product family ‘Oxy’Pharm H₂O₂’. The application was recorded under case number BC-NA095946-30 in the Register for Biocidal Products. The application also indicated the authorisation number of the related reference biocidal product family ‘Oxy’Pharm H₂O₂’ authorised by Commission Implementing Regulation (EU) 2023/1764^note, with authorisation number EU-0029752-0000.

(2)The single biocidal product ‘exeol air cid 01’ contains hydrogen peroxide as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

(3)On 25 October 2024, the Agency submitted to the Commission its opinion^note and the draft summary of the biocidal product characteristics (‘SPC’) of ‘exeol air cid 01’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

(4)In its opinion, the Agency concludes that the proposed differences between the single biocidal product ‘exeol air cid 01’ and the related single reference biocidal product with the asset number EU-0029752-0007, which is a part of the related reference biocidal product family ‘Oxy’Pharm H₂O₂’, are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013^note, and that based on the assessment of the related reference biocidal product family ‘Oxy’Pharm H₂O₂’and subject to compliance with the draft SPC, the same single biocidal product ‘exeol air cid 01’ meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

(5)On 25 October 2024, the Agency also transmitted to the Commission the draft SPC of ‘exeol air cid 01’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘exeol air cid 01’.

(7)The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Oxy’Pharm H₂O₂’.

(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1 #

A Union authorisation with authorisation number EU-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

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 1829 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 1Evonik 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
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: BacteriaDevelopment stage: —Scientific name: —Common name: yeastsDevelopment stage: —Scientific name: —Common name: Bacterial sporesDevelopment stage: no dataScientific name: —Common name: MycobacteriaDevelopment stage: —Scientific name: —Common name: VirusesDevelopment stage: —Scientific name: —Common name: fungiDevelopment stage: —
Field(s) of use	indoor useRoom disinfection with FHP for rooms with volumes between 4-150 m³. 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 vehicleshotels,restaurants,schools,day nurseries,veterinary clinics.
Application method(s)	Method: foggingDetailed 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/m3 and 2 hours contact time.Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.Droplet size: 1-15 μmNumber 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

—Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m³ and 2 hours contact time.

—Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m³ and 2 hours contact time.

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:

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

—Causes severe eye irritation.

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:

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
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: BacteriaDevelopment stage: —Scientific name: —Common name: YeastsDevelopment stage: —Scientific name: —Common name: Bacterial sporesDevelopment stage: —Scientific name: —Common name: MycobacteriaDevelopment stage: —Scientific name: —Common name: VirusesDevelopment stage: —Scientific name: —Common name: bacteriophagesDevelopment stage: —Scientific name: —Common name: fungiDevelopment stage: —
Field(s) of use	indoor useRoom disinfection with FHP disinfection of hard non-porous surfaces of equipment and material present in the treated room of a size between 4-150 m³:food industries,central kitchens,restaurants.
Application method(s)	Method: foggingDetailed 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/m3 and 2 hours contact time.Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.Droplet size: 1-15 μmNumber 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

—Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 5 ml product/m³ and 2 hours contact time.

—Mycobactericidal activity: 7 ml product/m³ 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

—Causes severe eye irritation.

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:

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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.

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/m³) 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/m³) 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/m³ (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