2024/1767

27.6.2024

COMMISSION IMPLEMENTING REGULATION (EU) 2024/1767

of 26 June 2024

granting a Union authorisation for the biocidal product family ‘Sure Lactic Family’ 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 April 2019, Diversey Europe Operations B.V submitted to the European Chemicals Agency (‘the Agency’) an application 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 ‘Sure Lactic Family’, of product-types 2, 3 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-EM051406-41 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ later authorised by Commission Implementing Regulation (EU) 2023/1758 (3), recorded in the Register under case number BC-HC051278-51.

(2) The same biocidal product family ‘Sure Lactic Family’ contains L-(+)-lactic acid as the active substances, 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, 3 and 4.

(3) On 19 September 2022, the Agency submitted to the Commission its opinion (4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Sure Lactic Family’ in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.

(4) In its opinion, the Agency concludes that the proposed differences between ‘Sure Lactic Family’ and the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ are limited to information which can be the subject of an administrative change in accordance with Article 11 of Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ and subject to compliance with the draft SPC, ‘Sure Lactic Family’ meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.

(5) On 16 November 2023, the Agency transmitted to the Commission the revised SPCs of ‘Sure Lactic Family’ 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 ‘Sure Lactic Family’.

(7) The expiry date of this authorisation is aligned to the expiry date of the authorisation of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’.

(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-0029485-0000 is hereby granted to Diversey Europe Operations B.V for the making available on the market and use of the same biocidal product family ‘Sure Lactic Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 17 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, 26 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) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (

OJ L 224, 12.9.2023, p. 34

, ELI:

http://data.europa.eu/eli/reg_impl/2023/1758/oj

).

(4)  ECHA opinion of 19.9.2022 on the Union authorisation of the same biocidal product family ‘Sure Lactic Family’,

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

Sure Lactic Family

Product type(s)

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

PT03: Veterinary hygiene

PT04: Food and feed area

Authorisation number:

EU-0029485-0000

R4BP asset number:

EU-0029485-0000

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 product

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)

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

4.1.   

Use description

Table 1

Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas)

4.1.1.   

Use-specific instructions

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

4.1.2.   

Use-specific risk mitigation measures

See general instructions 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

See general instructions for use.

4.1.4.   

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

See general instructions 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 instructions for use.

4.2.   

Use description

Table 2

Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial (food industry) areas)

4.2.1.   

Use-specific instructions

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

4.2.2.   

Use-specific risk mitigation measures

See general instructions 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

See general instructions for use

4.2.4.   

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

See general instructions 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 instructions for use

4.3.   

Use description

Table 3

Disinfectants used to disinfect the materials and surfaces associated with the housing of animals (disinfectants for all washable hard surfaces in veterinary area)

4.3.1.   

Use-specific instructions

— Clean carefully the surfaces before application of the product.

— Apply the product by fully wetting all surface for 30 minutes (apply approx. 18 sprays/m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

4.3.2.   

Use-specific risk mitigation measures

See general instructions for use

4.3.3.   

Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.3.4.   

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

See general instructions for use

4.3.5.   

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

See general instructions for use

5.   

GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   

Instructions for use

— Apply only on non-porous surfaces.

— Inform the authorisation holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

— Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titles of the EN standard are available under section 6.

— PPE material to be specified by the authorisation holder within the product information.

— Wash hands after use of the concentrate product.

— Avoid contact with eyes.

— Avoid splashes and spills during mixing and loading (dilution).

— For outdoor uses, do not apply the product in case rain is expected within 24 hours.

— For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   

Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

— IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

— 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 or an ambulance for medical assistance.

Information to healthcare personnel or a doctor:

 

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

— IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

— IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

5.4.   

Instructions for safe disposal of the product and its packaging

— Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.

— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   

Conditions of storage and shelf-life of the product under normal conditions of storage

— Shelf-life: 2 years.

— Protect from frost.

6.   

OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 ‘Risk mitigation measures’ are:

 

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

 

EN 16321 – Eye and face protection for occupational use

 

EN 14605 – Protective clothing against liquid chemicals – Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

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

ELI: http://data.europa.eu/eli/reg_impl/2024/1767/oj

ISSN 1977-0677 (electronic edition)