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
Date: 2026-01-23
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, market approval, polishing and scouring preparations, preservative, storage








L_202600156EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/156


26.1.2026







            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
(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 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 (2), 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
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  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







Trade name(s)


Nutrinova® Potassium Sorbate BFX Granules
Nutrinova® Potassium Sorbate BFX MB




1.2.   Authorisation holder








Name and address of the authorisation holder


Name


Nutrinova Germany GmbH




Address


Am Unisys Park 1 65843 Sulzbach (Taunus) Germany




Authorisation number


 


EU-0035029-0000





R4BP asset number



 


EU-0035029-0000




Date of the authorisation


 


15 February 2026




Expiry date of the authorisation


 


31 January 2036




1.3.   Manufacturer(s) of the product







Name of manufacturer


Nutrinova Germany GmbH




Address of manufacturer


Am Unisys Park 1 65843 Sulzbach (Taunus) Germany




Location of manufacturing sites


Frankfurt Hoechst FI Industriepark Höchst 65926 Frankfurt/Main Germany




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







Active substance


potassium (E,E)-hexa-2,4-dienoate




Name of manufacturer


Nutrinova Germany GmbH




Address of manufacturer


Am Unisys Park 1 65843 Sulzbach (Taunus) Germany




Location of manufacturing sites


Frankfurt Hoechst FI Industriepark Höchst 65926 Frankfurt/Main Germany




2.   PRODUCT COMPOSITION AND FORMULATION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




potassium (E,E)-hexa-2,4-dienoate


potassium hexa-2,4-dienoate


Active substance


24634-61-5


246-376-1


100  % (w/w)




2.2.   Type(s) of formulation

SG Water soluble granule
3.   HAZARD AND PRECAUTIONARY STATEMENTS







Hazard statements


H319: Causes serious eye irritation.




Precautionary statements


P264: Wash face, hands and any exposed skin thoroughly after handling.
P280: Wear eye protection/face protection.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice.
P337+P313: If eye irritation persists: Get medical attention.




4.   AUTHORISED USE(S)

4.1.   Use description


Table 1


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







Product type


PT06: Preservatives for products during storage




Target organism(s) (including development stage)


Common name: yeasts




Field(s) of use


indoor use
In-can preservation of aqueous cleaning products and detergents during shelf life. This includes dishwashing liquids, fabric conditioners, fabric detergents and hard surface cleaners.




Application method(s)


Method: - Manual or automated dosage
Detailed description:
The product is added manually to the mixing tank containing the product to be preserved. If necessary, an aqueous pre-solution containing a maximum of 50 % (w/w) of the product can be made before it is added manually or semi-automatically to the mixing tank. The product or pre-solution is added at a suitable point during the production cycle, with good stirring to ensure an even distribution. The addition can take place at any stage of the production of the product. For optimal preservation, the earliest possible addition is recommended.




Application rate(s) and frequency


Application Rate: 0,1 - 0,8 % (w/w) active substance
Number and timing of application:
One application per batch produced.




Category(ies) of users


industrial




Pack sizes and packaging material


25 kg flexible LDPE (low-density polyethylene) bags




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







Product type


PT06: Preservatives for products during storage




Target organism(s) (including development stage)


Common name: Bacteria
Common name: yeasts




Field(s) of use


indoor use
In-can preservation of enzyme preparations for the production of detergents, paper and textile treatment and fuel ethanol production.




Application method(s)


Method: - Manual or automated dosage
Detailed description:
The product is added manually to the mixing tank containing the product to be preserved. If necessary, an aqueous pre-solution containing a maximum of 50 % (w/w) of the product can be made before it is added manually or semi-automatically to the mixing tank. The product or pre-solution is added at a suitable point during the production cycle, with good stirring to ensure an even distribution. The addition can take place at any stage of the production of the product. For optimal preservation, the earliest possible addition is recommended.




Application rate(s) and frequency


Application Rate: 0,1 - 1,2 % (w/w) active substance
Number and timing of application:
One application per batch produced.




Category(ies) of users


industrial




Pack sizes and packaging material


25 kg flexible LDPE (low-density polyethylene) bags




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 (1)

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.


(1)  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)