Vitamin K3 in feed for another 10 years: Regulation (EU) 2026/2115 renews the authorisation of two forms of menadione, with a chromium limit and methods of analysis — spectrophotometry at 635 nm, HPLC and AAS
Commission Implementing Regulation (EU) 2026/2115 of 23 September 2026, published on 24 September, renews until 14 October 2036 the authorisation of menadione sodium bisulphite (3a710) and menadione nicotinamide bisulphite (3a711) as nutritional additives for all animal species. It is based on EFSA’s opinion of 19 November 2025: the additives remain safe for animals, consumers and the environment, but user exposure by any route is considered a risk to be minimised.
- Specification: menadione sodium bisulphite (CAS 6147-37-1) — purity at least 96% of the complex, i.e. at least 50% menadione, chromium III and IV at most 45 mg/kg; menadione nicotinamide bisulphite (CAS 73581-79-0) — at least 96%, i.e. at least 43.9% menadione and 31.2% nicotinamide, chromium at most 142 mg/kg. On labels: 1 mg vitamin K3 = 1 mg menadione = 2 mg MSB or 2.27 mg MNB.
- Methods of analysis in the annex: in the feed additive — spectrophotometry with visible detection at 635 nm (VDLUFA, Volume III 13.7.1); in premixtures and compound feed — normal-phase HPLC (with UV detection for MSB) under the Italian decree of 29 April 2010; total chromium — AAS under GB/T 13088. The EU reference laboratory considered its evaluation of the methods from the previous authorisation still valid.
- In the data submitted to EFSA, total chromium averaged 27.3 mg/kg (13.4–41.2) in 13 MSB batches and 73.9 mg/kg (29.6–128) in 19 MNB batches. The FEEDAP Panel reiterated its recommendation to monitor chromium in all production batches and reduce hexavalent chromium as much as possible; it also pointed to the high dusting potential and the lack of inhalation toxicity data.
- The additive is incorporated into feed only via premixtures, and feed business operators must limit user exposure to chromium by inhalation and through the skin. Transitional periods: additives and premixtures labelled before 14 April 2027, compound feed for food-producing animals before 14 October 2027, and for other animals before 14 October 2028 — until stocks are exhausted.