Commission Implementing Regulation (EU) 2026/156 of 23 January 2026 granting a Union authorisation for the single biocidal product Nutrinova® Potassium Sorbate BFX Granules in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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 [^ntr1-L_202600156EN.000101-E0001], and in particular Article 44(5), first subparagraph, thereof,

Whereas:

• (1) On 27 January 2023, Nutrinova Germany GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a single biocidal product named ‘Nutrinova® Potassium Sorbate BFX Granules’ of product-type 6, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Denmark had agreed to evaluate the application. The application was recorded under case number BC-LX084176-02 in the Register for Biocidal Products.

• (2) ‘Nutrinova® Potassium Sorbate BFX Granules’ contains potassium sorbate 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 6.

• (3) On 12 November 2024, 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 5 June 2025, the Agency submitted to the Commission its opinion [^ntr2-L_202600156EN.000101-E0002], the draft summary of the biocidal product characteristics (‘SPC’) of ‘Nutrinova® Potassium Sorbate BFX Granules’ and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

• (5) The opinion concludes that ‘Nutrinova® Potassium Sorbate BFX Granules’ is a single biocidal product within the meaning of Article 3(1), point (r), 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) of that Regulation.

• (6) On 18 June 2025, 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 the single biocidal product ‘Nutrinova® Potassium Sorbate BFX Granules’.

• (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-0035029-0000 is hereby granted to Nutrinova Germany GmbH for the making available on the market and use of the single biocidal product ‘Nutrinova® Potassium Sorbate BFX Granules’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 15 February 2026 until 31 January 2036.

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, 23 January 2026.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202600156EN.000101-E0001]: OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

[^ntr2-L_202600156EN.000101-E0002]: Opinion of 15 May 2025 on the Union authorisation of the single biocidal product ‘Nutrinova® Potassium Sorbate BFX Granules’ (ECHA/BPC/477/2025), https://echa.europa.eu/opinions-on-union-authorisation.

ANNEX

Summary of product characteristics for a biocidal product

Nutrinova® Potassium Sorbate BFX Granules

Product type(s)

PT06: Preservatives for products during storage

Authorisation number: EU-0035029-0000

R4BP asset number: EU-0035029-0000

1. ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

1.2.   Authorisation holder

1.3.   Manufacturer(s) of the product

1.4.   Manufacturer(s) of the active substance(s)

2. PRODUCT COMPOSITION AND FORMULATION

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

2.2.   Type(s) of formulation

SG Water soluble granule

3. HAZARD AND PRECAUTIONARY STATEMENTS

4. AUTHORISED USE(S)

4.1.   Use description

Table 1

Washing and cleaning fluids and other detergents, and the raw materials thereof

4.1.1.   Use-specific instructions for use

See general direction for use.

4.1.2.   Use-specific risk mitigation measures

See general direction 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 direction for use.

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

See general direction 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 direction for use.

4.2.   Use description

Table 2

Enzyme preparations

4.2.1.   Use-specific instructions for use

See general direction for use.

4.2.2.   Use-specific risk mitigation measures

See general direction 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 direction for use.

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

See general direction 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 direction for use.

5. GENERAL DIRECTIONS FOR USE [^ntr1-L_202600156EN.000301-E0001]

5.1.   Instructions for use

Ensure that the final formulation does not exceed pH 6,5, since the preventive properties of the active substance against growth of microorganisms diminishes at pH above 7.

Microbiological tests to prove adequacy of preservation have to be undertaken by the user in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the authorisation holder (as specified in the label).

Comply with the instructions for use.

5.2.   Risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).

Wear a protective coverall (at least type 6, EN 13034 or equivalent) which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).

The use of eye protection (chemical resistant google) meeting the requirements of European Standard EN ISO 16321 or equivalent during handling of the product is mandatory.

The use of these protective equipment is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to this act and the European Standards.

The biocidal product must not be used for the preservation of products or materials which may come in direct contact with food, feed and livestock.

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

IF SWALLOWED: 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.

5.4.   Instructions for safe disposal of the product and its packaging

Dispose of contents and container in accordance with national regulation

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

The product shall be stored in the originally closed packaging.

Store dry (max. 65 % relative humidity) and at temperatures not exceeding 30 °C.

Shelf life: 1 year.

6. OTHER INFORMATION

Full titles of EN standards referenced in section ‘Use-specfic risk mitigation measures’ are:

EN ISO 16321 – Eye and face protection for occupational use – Part 1: General requirements.

EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms. Part 1: terminology and performance requirements for chemical risks.

EN 13034 – Protective clothing against liquid chemicals. Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment).

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

With respect to the ‘Category(ies) of users’ note: ‘Professionals (including industrial users)’ means trained professionals if this is required by national legislation.

[^ntr1-L_202600156EN.000301-E0001]: Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.

ELI: http://data.europa.eu/eli/reg_impl/2026/156/oj

ISSN 1977-0677 (electronic edition)