Commission Implementing Regulation (EU) 2026/2115 of 23 September 2026 concerning the renewal of the authorisation of menadione sodium bisulphite (vitamin K3) and menadione nicotinamide bisulphite (vitamin K3) as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/2307

Official Journal EN of the European Union L series 2026/2115 24.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2115 of 23 September 2026 concerning the renewal of the authorisation of menadione sodium bisulphite (vitamin K ) and 3 menadione nicotinamide bisulphite (vitamin K ) as feed additives for all animal species and repealing 3 Implementing Regulation (EU) 2015/2307 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such an authorisation.

(2) Menadione sodium bisulphite (vitamin K ) and menadione nicotinamide bisulphite (vitamin K ) were authorised for 3 3 10 years as feed additives for cats and dogs by Commission Implementing Regulation (EU) 2015/2307(2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of menadione sodium bisulphite (vitamin K ) and menadione nicotinamide bisulphite (vitamin K ) 3 3 for all animal species, requesting the additives to be classified in the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having a similar effect’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation

(EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 November 2025(3) that, the applicant has provided evidence that menadione sodium bisulphite (vitamin K ) and menadione nicotinamide 3 bisulphite (vitamin K ) remain safe for all animal species as well as for the consumers, the users and the environment 3 under the conditions currently authorised. The Authority further concluded that the exposure of users to menadione sodium bisulphite (vitamin K ) and menadione nicotinamide bisulphite (vitamin K ) by any route is considered as risk 3 3 and should be minimised. The Authority stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives. Therefore, it concluded that there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation. The Authority considered that there is no need for specific requirements of post-market monitoring.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the methods of analysis of menadione sodium bisulphite and menadione nicotinamide bisulphite as a feed additives in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation

(EC) No 378/2005(4), the evaluation report of the Reference Laboratory is therefore not required.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) Commission Implementing Regulation (EU) 2015/2307 of 10 December 2015 concerning the authorisation of menadione sodium bisulphite and menadione nicotinamide bisulphite as feed additives for all animal species. (OJ L 326, 11.12.2015, p. 49, ELI: http:// data.europa.eu/eli/reg_impl/2015/2307/oj).

(3) EFSA Journal2025;23(12):e9792 https://doi.org/10.2903/j.efsa.2025.9792.

(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation

(EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additive (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj).

ELI: http://data.europa.eu/eli/reg_impl/2026/2115/oj 1/5EN OJ L, 24.9.2026

(6) In view of the above, the Commission considers that menadione sodium bisulphite (vitamin K ) and menadione 3 nicotinamide bisulphite (vitamin K ) satisfy the conditions provided for in Article 5 of Regulation 3

(EC) No 1831/2003. Accordingly, the authorisation of those additives should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(7) As a consequence of the renewal of the authorisation of menadione sodium bisulphite (vitamin K ) and menadione 3 nicotinamide bisulphite (vitamin K ), Implementing Regulation (EU) 2015/2307 should be repealed.

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(8) Since the specifications of the additives have been modified, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 Renewal of the Authorisation The authorisation of the substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal Implementing Regulation (EU) 2015/2307 is repealed.

Article 3 Transitional measures

1. The feed additives menadione sodium bisulphite (Vitamin K ) and menadione nicotinamide bisulphite (Vitamin K ) as 3 3 authorised by Implementing Regulation (EU) 2015/2307 and premixtures containing those substances, which are produced and labelled before 14 April 2027 in accordance with the rules applicable before 14 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

2. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 14 October 2027 in accordance with the rules applicable before 14 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.

3. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 14 October 2028 in accordance with the rules applicable before 14 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.

2/5 ELI: http://data.europa.eu/eli/reg_impl/2026/2115/ojEN OJ L, 24.9.2026 Article 4 Entry into force 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 September 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/2115/oj 3/5ANNEX Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category of Other provisions additive analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 %

Category: Nutritional additives. Functional group: Vitamins, pro-vitamins and chemically well-defined substances having a similar effect 3a710 ‘Menadione Additive composition All animal — — — 1. In the directions for use of the 14 October sodium species additive and premixtures, the 2036 Menadione sodium bisulphite (MSB) bisulphite’ or storage conditions, and the Chromium III and IV ≤ 45 mg/kg ‘Vitamin K ’ stability to heat treatment shall 3 Solid form be indicated.

Characterisation of the active substance

2. The additive shall be Menadione sodium bisulphite incorporated into feed in the Produced by chemical synthesis form of a premixture.

C H NaO S·3H O 11 9 5 2

CAS number: 6147-37-1

3. The following equivalency shall

Purity: minimum 96 % MSB complex be used if the amount of the which corresponds to minimum 50 % of

additive is labelled: 1 mg menadione. vitamin K = 1 mg of 3 menadione = 2 mg of Analytical method(1) menadione sodium bisulphite.

For the determination of menadione

sodium bisulphite in the feed additive: a

4. For users of the additive and spectrophotometric method using a premixtures, feed business visible detector at 635 nm (VDLUFA – operators shall establish Bd. III 13.7.1). operational procedures and — For the determination of menadione organisational measures to sodium bisulphite in premixtures and address potential risks resulting

compound feed: Normal Phase High- from their use. In particular, the Performance Liquid Chromatograph exposure to chromium by coupled to UV detector – Decreto inhalation or dermal route.

29/4/2010, Gazzetta Ufficiale della Where those risks cannot be Repubblica Italiana No 120, eliminated by such procedures

25.5.2010. and measures, the additive and — For the determination of total premixtures shall be used with

chromium: atomic absorption personal breathing, eye and spectrometry (AAS) – GB/T 13088 skin protective equipment.

(1) Details of the analytical methods for the additives are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/ eurl-fa-evaluation-reports_en.

4/5

ELI:

http://data.europa.eu/eli/reg_impl/2026/2115/oj EN OJ L,

24.9.2026Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category of Other provisions additive analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 %

Category: Nutritional additives. Functional group: Vitamins, pro-vitamins and chemically well-defined substances having a similar effect 3a711 ‘Menadione Additive composition All animal — — — 1. In the directions for use of the 14 October nicotinamide species additive and premixtures, the 2036 Menadione nicotinamide bisulphite bisulphite’ or storage conditions, and the Chromium III and IV≤ 142 mg/kg ‘Vitamin K ’ stability to heat treatment shall 3 Solid form be indicated.

Characterisation of the active substance

2. The additive shall be Menadione nicotinamide bisulphite incorporated into feed in the C H O S·C H N O form of a premixture.

11 9 5 6 7 2

CAS number: 73581-79-0

3. The following equivalency shall Produced by chemical synthesis be used if the amount of the

Purity: min. 96 % menadione

additive is labelled: 1 mg nicotinamide bisulphite complex which vitamin K = 1 mg of corresponds to minimum 43,9 % 3 menadione = 2,27 mg of menadione and minimum 31,2 % menadione nicotinamide nicotinamide bisulphite Analytical method(1)

4. For users of the additive and — For the determination menadione premixtures, feed business nicotinamide bisulphite in the feed operators shall establish

additive: a spectrophotometric operational procedures and method using a visible detector at organisational measures to 635 nm (VDLUFA – Bd.III 13.7.1). address potential risks resulting from their use. In particular, the — For the determination of menadione exposure to chromium by nicotinamide bisulphite in inhalation or dermal route.

premixtures and compound feed:

Where those risks cannot be Normal Phase High-Performance eliminated by such procedures Liquid Chromatograph – Decreto and measures, the additive and 29/4/2010, Gazzetta Ufficiale della premixtures shall be used with Repubblica Italiana No 120, personal breathing, eye and

25.5.2010 skin protective equipment. — For the determination of total

chromium: atomic absorption spectrometry (AAS) – GB/T 13088

(1) Details of the analytical methods for the additives are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/ eurl-fa-evaluation-reports_en.

ELI:

http://data.europa.eu/eli/reg_impl/2026/2115/oj 5/5 OJ L,

24.9.2026 EN