2024/1710

20.6.2024

COMMISSION IMPLEMENTING REGULATION (EU) 2024/1710

of 19 June 2024

granting a Union authorisation for the biocidal product family ‘Saniswiss H2O2’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(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 (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 31 January 2017, Saniswiss SA 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 ‘Saniswiss H2O2’ of product-type 2, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-JG029784-36 in the Register for Biocidal Products. The application also indicated the case number of the related reference biocidal product family ‘Oxy’Pharm H

’ 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 ‘Saniswiss H2O2’ 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 ‘Saniswiss H2O2’ 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 ‘Saniswiss H2O2’ and the related reference biocidal product family ‘Oxy’Pharm H

’ 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 H

’ and subject to compliance with the draft SPC, the biocidal product family ‘Saniswiss H2O2’ meets the conditions laid down in Article 19(6) of Regulation (EU) No 528/2012.

(5) On 6 February 2024, the Agency transmitted to the Commission the revised SPC of ‘Saniswiss H2O2’ 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 ‘Saniswiss H2O2’.

(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 H

’.

(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-0030024-0000 is hereby granted to Saniswiss SA for the making available on the market and use of the same biocidal product family ‘Saniswiss H2O2’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 10 July 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, 19 June 2024.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 167, 27.6.2012, p. 1

, ELI:

http://data.europa.eu/eli/reg/2012/528/oj

(2) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (

OJ L 125, 7.5.2013, p. 4

, ELI:

http://data.europa.eu/eli/reg_impl/2013/414/oj

(3) Commission Implementing Regulation (EU) 2023/1764 of 12 September 2023 granting a Union authorisation for the biocidal product family ‘Oxy’Pharm H

’ 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

(4) European Chemicals Agency opinion of 29 November 2022 on the Union authorisation of the same biocidal product family ‘Saniswiss H2O2’,

https://echa.europa.eu/opinions-on-union-authorisation

(5) 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

ANNEX

Summary of product characteristics for a biocidal product family

Saniswiss H2O2

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Authorisation number: EU-0030024-0000

R4BP asset number: EU-0030024-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name	Saniswiss H2O2

1.2. Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

1.3. Authorisation holder

Name and address of the authorisation holder	Name	Saniswiss SA
	Address	Route de Frontenex 41A, 1207 Geneva Switzerland
Authorisation number	EU-0030024-0000
R4BP asset number	EU-0030024-0000
Date of the authorisation	10 July 2024
Expiry date of the authorisation	30 September 2033

1.4. Manufacturer(s) of the biocidal products

Name of manufacturer	Saniswiss SA
Address of manufacturer	Chemin des Tulipiers 19, 1208 Geneva Switzerland
Location of manufacturing sites	Rue Marcel Paul, 829, 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 (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	6,0	12,0
Silver		Non-active substance	7440-22-4	231-131-3	0,0017	0,0017

2.2. Type(s) of formulation

Formulation(s)

AL - Any other liquid

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

Identifier

Saniswiss H2O2 6 %

1.2. Suffix to the authorisation number

Number

1-1

1.3. Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

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

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

Formulation(s)

AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

Causes serious eye irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Wash hands thoroughly after handling.

Avoid release to the environment.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice.

Dispose of contents to hazardous or special waste collection point in accordance with national regulations.

Dispose of container to hazardous or special waste collection point in accordance with national regulations.

4. AUTHORISED USE(S) OF THE META SPC 1

4.1. Use description

Table 1.

Use # 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 (Disinfectants)

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

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:

—	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 for use

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/m

and 2 hours contact time. Treat a second time at 5 ml product/m

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 those 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

(1)

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/m

) 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 36ppm (50 mg/m

) 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/m

(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)	Biosanitizer aHP P		Market area: EU
	Biosanitizer aHP P 6 %		Market area: EU
Authorisation number	EU-0030024-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	6,0
Silver		Non-active substance	7440-22-4	231-131-3	0,0017

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

Identifier

Saniswiss H2O2 12 %

1.2. Suffix to the authorisation number

Number

1-2

1.3. Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

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

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

Formulation(s)

AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

May intensify fire; oxidiser.

Causes serious eye damage.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Avoid release to the environment.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

Immediately call a doctor.

Dispose of contents to hazardous or special waste collection point in accordance with national regulations.

Dispose of container to hazardous or special waste collection point in accordance with national regulations.

4. AUTHORISED USE(S) OF THE META SPC 2

4.1. Use description

Table 2.

Use # 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 (Disinfectants)

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

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:

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 for use

— Bactericidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 3 ml product/m

and 2 hours contact time. Treat a second time at 3 ml product/m

and 2 hours contact time.

— Tuberculocidal activity: 5 ml product/m

and 2 hours contact time. Treat a second time at 3 ml product/m

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.

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 or 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

(2)

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/m

) 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

) 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.

(0,9 ppm) or a lower relevant national reference value.

Individual protective equipment:

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

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)	Biosanitizer aHP C		Market area: EU
	Biosanitizer aHP C 12 %		Market area: EU
Authorisation number	EU-0030024-0002 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	12,0
Silver		Non-active substance	7440-22-4	231-131-3	0,0017

(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

ELI: http://data.europa.eu/eli/reg_impl/2024/1710/oj

ISSN 1977-0677 (electronic edition)