COMMISSION IMPLEMENTING REGULATION (EU) 2023/1764

of 12 September 2023

granting a Union authorisation for the biocidal product family ‘Oxy’Pharm H

2

O

2

’ 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 30 January 2017, OXY’PHARM submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Oxy’Pharm H

2

O

2

’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-HC029658-43 in the Register for Biocidal Products.

(2) ‘Oxy’Pharm H

2

O

2

’ contains hydrogen peroxide as the active substance, which is 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 10 March 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

(4) On 17 October 2022, the Agency submitted to the Commission its opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Oxy’Pharm H

2

O

2

’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘Oxy’Pharm H

2

O

2

’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(6) On 31 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Oxy’Pharm H

2

O

2

’.

(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-0029752-0000 is granted to OXY’PHARM for the making available on the market and use of the biocidal product family ‘Oxy’Pharm H

2

O

2

’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 3 October 2023 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 the Member States in accordance with the Treaties.

Done at Brussels, 12 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

(1)  

OJ L 167, 27.6.2012, p. 1

.

(2)  ECHA opinion of 14 June 2022 on the Union authorisation of ‘Oxy’Pharm H

2

O

2

’ (ECHA/BPC/358/2022), https://echa.europa.eu/opinions-on-union-authorisation.

ANNEX

Summary of product characteristics for a biocidal product family

Oxy'Pharm H

2

O

2

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

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0029752-0000

R4BP asset number: EU-0029752-0000

PART I

FIRST INFORMATION LEVEL

1.   

ADMINISTRATIVE INFORMATION

1.1.   

Family name

1.2.   

Product type(s)

1.3.   

Authorisation holder

1.4.   

Manufacturer(s) of the biocidal products

1.5.   

Manufacturer(s) of the active substance(s)

2.   

PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   

Qualitative and quantitative information on the composition of the family

2.2.   

Type(s) of formulation

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1.   

META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 1 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 1 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 1

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

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)

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

3

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

3

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

 (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

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 36ppm (50 mg/m

3

) 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

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 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

7.2.   

Trade name(s), authorisation number and specific composition of each individual product

7.3.   

Trade name(s), authorisation number and specific composition of each individual product

META SPC 2

1.   

META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 2 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 2 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 2

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

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)

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, sporicidal and virucidal activity: 3 ml product/m

3

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

3

and 2 hours contact time.

— Tuberculocidal activity: 5 ml product/m

3

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

3

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

 (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 areas 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 section 5.2 are:

 

EN ISO 16321 - Eye and face protection for occupational users

 

EN 374 – Protective gloves against dangerous 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

7.2.   

Trade name(s), authorisation number and specific composition of each individual product

7.3.   

Trade name(s), authorisation number and specific composition of each individual product

META SPC 3

1.   

META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 3 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 3 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 3

2.2.   

Type(s) of formulation of the meta SPC 3

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

4.   

AUTHORISED USE(S) OF THE META SPC 3

4.1.   

Use description

Table 3

Use # 1 – Use #3.1: Hard surface disinfection by 7.9% Fogging Hydrogen Peroxide (FHP)

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, 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

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 severe 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.

4.2.   

Use description

Table 4

Use # 2 – Use #3.3: Hard surface disinfection by Fogging Hydrogen Peroxide (FHP)

4.2.1.   

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, 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

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

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

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

4.2.5.   

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

 (3)

OF THE META SPC 3

5.1.   

Instructions for use

- 5.2.   

Risk mitigation measures

During the diffusion, keep the room closed and do not enter in. 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 areas 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 36ppm (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 section 5.2 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 3

7.1.   

Trade name(s), authorisation number and specific composition of each individual product

(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.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.