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
In force
Version historyWe hold this version only; in force from 2026-09-23.
Data as of 2026-10-15 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
Repeal
Implementing Regulation (EU) 2015/2307 is repealed.
Transitional measures
1. The feed additives menadione sodium bisulphite (Vitamin K 3 ) and menadione nicotinamide bisulphite (Vitamin K 3 ) as 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.
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 .
ANNEX Identification number of the additive Name of the additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of active substance/kg of 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 sodium bisulphite’ or ‘Vitamin K 3 ’ Additive composition Menadione sodium bisulphite (MSB) Chromium III and IV ≤ 45 mg/kg Solid form Characterisation of the active substance Menadione sodium bisulphite Produced by chemical synthesis C 11 H 9 NaO 5 S·3H 2 O CAS number: 6147-37-1 Purity: minimum 96 % MSB complex which corresponds to minimum 50 % of menadione. Analytical method ( 1 ) For the determination of menadione sodium bisulphite in the feed additive: a spectrophotometric method using a visible detector at 635 nm (VDLUFA – Bd. III 13.7.1). — For the determination of menadione sodium bisulphite in premixtures and compound feed: Normal Phase High-Performance Liquid Chromatograph coupled to UV detector – Decreto 29/4/2010, Gazzetta Ufficiale della Repubblica Italiana No 120, 25.5.2010. — For the determination of total chromium: atomic absorption spectrometry (AAS) – GB/T 13088 All animal species — — — 1. In the directions for use of the additive and premixtures, the storage conditions, and the stability to heat treatment shall be indicated. 2. The additive shall be incorporated into feed in the form of a premixture. 3. The following equivalency shall be used if the amount of the additive is labelled: 1 mg vitamin K 3 = 1 mg of menadione = 2 mg of menadione sodium bisulphite. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. In particular, the exposure to chromium by inhalation or dermal route. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 14 October 2036 ( 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 . Identification number of the additive Name of the additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of active substance/kg of 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 nicotinamide bisulphite’ or ‘Vitamin K 3 ’ Additive composition Menadione nicotinamide bisulphite Chromium III and IV≤ 142 mg/kg Solid form Characterisation of the active substance Menadione nicotinamide bisulphite C 11 H 9 O 5 S·C 6 H 7 N 2 O CAS number: 73581-79-0 Produced by chemical synthesis Purity: min. 96 % menadione nicotinamide bisulphite complex which corresponds to minimum 43,9 % menadione and minimum 31,2 % nicotinamide Analytical method ( 2 ) — For the determination menadione nicotinamide bisulphite in the feed additive: a spectrophotometric method using a visible detector at 635 nm (VDLUFA – Bd.III 13.7.1). — For the determination of menadione nicotinamide bisulphite in premixtures and compound feed: Normal Phase High-Performance Liquid Chromatograph – Decreto 29/4/2010, Gazzetta Ufficiale della Repubblica Italiana No 120, 25.5.2010 — For the determination of total chromium: atomic absorption spectrometry (AAS) – GB/T 13088 All animal species — — — 1. In the directions for use of the additive and premixtures, the storage conditions, and the stability to heat treatment shall be indicated. 2. The additive shall be incorporated into feed in the form of a premixture. 3. The following equivalency shall be used if the amount of the additive is labelled: 1 mg vitamin K 3 = 1 mg of menadione = 2,27 mg of menadione nicotinamide bisulphite 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. In particular, the exposure to chromium by inhalation or dermal route. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 14 October 2036 ( 2 ) 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 .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.