Commission Implementing Regulation (EU) 2026/2044 of 11 September 2026 amending Implementing Regulation (EU) 2024/1767 as regards administrative changes to the Union authorisation of the biocidal product family Sure Lactic Family

of 11 September 2026

amending Implementing Regulation (EU) 2024/1767 as regards administrative changes to the Union authorisation of the biocidal product family ‘Sure Lactic Family’

(Text with EEA relevance)

Preamble

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 50(2) thereof,

Whereas:

(1) On 26 June 2024, Commission Implementing Regulation (EU) 2024/1767 ² granted a Union authorisation, under number EU-0029485-0000, to Diversey Europe Operations B.V. for the making available on the market and use of the biocidal product family ‘Sure Lactic Family’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.

(2) Commission Implementing Regulation (EU) No 354/2013 ³ lays down the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012.

(3) On 10 October 2024 and 15 April 2025, Diversey Europe Operations B.V. submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) 354/2013, notifications of administrative changes to the Union authorisation of the biocidal product family ‘Sure Lactic Family’. The notifications were recorded in the Register for Biocidal Products (‘Register’) under case numbers BC-QN100379-26 and BC-MN105456-31. The notified proposed changes to that authorisation concern the change in the pack size, the modification of the address of the authorisation holder and the modification of the office address of the biocidal product manufacturer.

(4) On 25 October 2024 and 14 May 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions ⁴ on the notified administrative changes to the Union authorisation for the biocidal product family ‘Sure Lactic Family’. In its opinions, the Agency concluded that the proposed changes are administrative changes as referred to in Article 3(1)(aa), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(5) On 14 May 2025, the Agency transmitted to the Commission a revised summary of product characteristics for the biocidal product family ‘Sure Lactic Family’ in all official languages of the Union, covering the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

(6) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family ‘Sure Lactic Family’ to introduce the administrative changes requested by Diversey Europe Operations B.V.

(7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2024/1767 should be replaced in its entirety.

(8) Implementing Regulation (EU) 2024/1767 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2024/1767 is replaced by the text set out in the Annex to this Regulation.

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 .

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 September 2026. 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) 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 ( OJ L, 2024/1767, 27.6.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/1767/oj ).

³ 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 ).

⁴ ECHA opinions UAD-C-1775118-30-00/F of 25 October 2024 and UAD-C-1820616-40-00/F of 14 May 2025 on administrative changes of the Union authorisation of the biocidal product family ‘Sure Lactic Family’, https://echa.europa.eu/opinions-on-union-authorisation .

Sure Lactic Family

Product type(s)

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

PT04: Food and feed area

PT03: Veterinary hygiene

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 for use

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 for use

— 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 for use

— 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 titless 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

Footnotes

1. , ELI: . ↩ ↩²

2. 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 (). ↩ ↩²

3. 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 (, ELI: ). ↩ ↩²

4. ECHA opinions UAD-C-1775118-30-00/F of 25 October 2024 and UAD-C-1820616-40-00/F of 14 May 2025 on administrative changes of the Union authorisation of the biocidal product family ‘Sure Lactic Family’, . ↩ ↩²