Commission Implementing Regulation (EU) 2024/1541 of 3 June 2024 granting a Union authorisation for the biocidal product family Sanoserv H202 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Image omitted; see official source	Official Journal of the European Union	EN L series
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	2024/1541	4.6.2024

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ¹, and in particular Article 44(5), first subparagraph, thereof,

Whereas:

• (1) On 31 January 2017, Sanoserv International franchising Ltd 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 ² for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Sanoserv H202’ of product-type 2, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-CQ029788-15 in the Register for Biocidal Products. The application also indicated the case number of the related reference biocidal product family ‘Oxy’Pharm H202’ later authorised by Commission Implementing Regulation (EU) 2023/1764 ³, recorded in that register under case number BC-HC029658-43.

• (2) The biocidal product family ‘Sanoserv H202’ 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-type 2.

• (3) On 29 November 2022, the Agency submitted to the Commission its opinion ⁴ and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Sanoserv H202’ 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 biocidal product family ‘Sanoserv H202’ and the related reference biocidal product family ‘Oxy’Pharm H202’ are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 ⁵, and that based on the assessment of the related reference biocidal product family ‘Oxy’Pharm H202’ and subject to compliance with the draft SPC, the biocidal product family ‘Sanoserv H202’ meets the conditions laid down in Article 19(6) of Regulation (EU) No 528/2012.

• (5) On 2 February 2024, the Agency transmitted to the Commission the revised SPC of ‘Sanoserv H202’ 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 biocidal product family ‘Sanoserv H202’.

• (7) The expiry date of the authorisation should be aligned to the expiry date of the authorisation of the related reference biocidal product family ‘Oxy’Pharm H202’.

• (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-0030027-0000 is hereby granted to Sanoserv International franchising Ltd for the making available on the market and use of the same biocidal product family ‘Sanoserv H202’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 24 June 2024 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 3 June 2024.

For the Commission

The President

Ursula VON DER LEYEN

’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 225, 13.9.2023, p. 21, ELI: http://data.europa.eu/eli/reg_impl/2023/1764/oj).

ANNEX

Summary of product characteristics for a biocidal product family

Sanoserv H2O2

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

Authorisation number: EU-0030027-0000

R4BP asset number: EU-0030027-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	Sanoserv H2O2

1.2.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	Sanoserv International franchising Ltd
Name and address of the authorisation holder	Address	SANONDAF HQ, Tereza Court 1015 Triq Id Dghejf Naxxar NXR MT
Authorisation number		EU-0030027-0000
R4BP asset number		EU-0030027-0000
Date of the authorisation		24 June 2024
Expiry date of the authorisation		30 September 2033

1.4.   Manufacturer(s) of the product

Name of manufacturer	Sanoserv Int Franchising Ltd
Address of manufacturer	SANONDAF HQ, Tereza Court, Triq Id Dghejf NXR 1015 Naxxar, Malta
Location of manufacturing sites	829 rue Marcel Paul, 94500 Champigny-sur-Marne, France

1.5.   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 Industries AG/BL Active Oxygens, Untere Kanalstrasse 3, 79618 Rheinfelden, Germany

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active substance	7722-84-1	231-765-0	6-12 % (w/w)
Silver		Non-active substance	7440-22-4	231-131-3	0,0017-0,0017 % (w/w)

2.2.   Type(s) of formulation

Formulation type(s)	AL Any other liquid

PART II

SECOND INFORMATION LEVEL – META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier	Meta SPC: Sanoserv H2O2 6 %

1.2.   Suffix to the authorisation number

Number	1-1

1.3.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals

2. META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active substance	7722-84-1	231-765-0	6-6 % (w/w)
Silver		Non-active substance	7440-22-4	231-131-3	0,0017-0,0017 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 1

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	H319: Causes serious eye irritation. H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P264: Wash hands thoroughly after handling. P273: Avoid release to the environment. 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. P501: Dispose of contents to hazardous or special waste collection point in accordance with national regulations. P501: Dispose of container to hazardous or special waste collection point in accordance with national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use #1.1: Hard surface disinfection by 6 % 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: Tuberculosis bacilli 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 fogging hydrogen peroxide (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, - hotels, - schools, - day nurseries.
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: Application Rate: - Bactericidal, yeasticidal, fungicidal, tuberculocidal and virucidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 5 ml product/m3 and 2 hours contact time. The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially. Droplet size: 1-15μM Dilution (%): - 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) High density polyethylene 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, tuberculocidal and virucidal activity: 5 ml product/m³ and 2 hours contact time. Treat a second time at 5 ml product/m³ and 2 hours contact time.

The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.

Droplet size: 1-15μM

Relative Humidity: 25 %-75 %

Temperature: room temperature

Respect the advised 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

Please refer to general directions for use of this Meta SPC.

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 serious eye irritation

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to general directions for use of this Meta SPC.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to general directions for use of this Meta SPC.

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 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/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 Personal Protective Equipment (PPE): Respiratory Protective Equipment (RPE) classified under EN 14387 or equivalent with an Assigned Protection Factor (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 mentioned in section 5.2 are listed below:

EN 374 – Protective gloves against dangerous chemicals and micro-organisms

EN ISO 16321 – Eye and face protection for occupational use

EN 14387 – Respiratory protective devices – Gas filter(s) and combined filter(s) – Requirements, testing, marking

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)	Trade name(s)	Trade name(s)	Sanochem S06	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Sanochem S06 6 %	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number	EU-0030027-0001 1-1	EU-0030027-0001 1-1	EU-0030027-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active substance	7722-84-1	231-765-0	6
Silver		Non-active substance	7440-22-4	231-131-3	0,0017

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier	Meta SPC: Sanoserv H2O2 12 %

1.2.   Suffix to the authorisation number

Number	1-2

1.3.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals

2. META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active substance	7722-84-1	231-765-0	12-12 % (w/w)
Silver		Non-active substance	7440-22-4	231-131-3	0,0017-0,0017 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 2

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements	H272: May intensify fire; oxidiser. H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	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. P273: Avoid release to the environment. 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. P310: Immediately call a POISON CENTER. P310: Immediately call a doctor. P501: Dispose of contents to hazardous or special waste collection point in accordance with national regulations. P501: Dispose of container to hazardous or special waste collection point in accordance with national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use #2.1: Hard surface disinfection by 12 % 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: - Scientific name: - Common name: Tuberculosis bacilli 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 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, - hotels, - schools, - day nurseries.
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: 3 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time. - Tuberculocidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time. The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially. Droplet size: 1-15 μm Dilution (%): - 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: 3 ml product/m³ and 2 hours contact time. Treat a second time at 3 ml product/m³ and 2 hours contact time.

• — Tuberculocidal activity: 5 ml product/m³ and 2 hours contact time. Treat a second time at 3 ml product/m³ and 2 hours contact time.

The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.

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

Please refer to general directions for use of this Meta SPC.

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 112/ambulance for medical assistance.

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: IF symptoms occur 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.

Likely direct or indirect effects

• — Causes serious eye irritation

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to general directions for use of this Meta SPC.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to general directions for use of this Meta SPC.

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

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

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)	Trade name(s)	Trade name(s)	Sanochem S12	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Sanochem S12 12 %	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number	EU-0030027-0002 1-2	EU-0030027-0002 1-2	EU-0030027-0002 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active substance	7722-84-1	231-765-0	12
Silver		Non-active substance	7440-22-4	231-131-3	0,0017

ELI: http://data.europa.eu/eli/reg_impl/2024/1541/oj

ISSN 1977-0677 (electronic edition)