Refusal for great burdock root extract in feed for dogs and cats: up to 77 % of the additive uncharacterised, marker inulin determined by AOAC 997.08 (IEC-PAD), no method for feed — withdrawal by 5 October 2026
Commission Implementing Regulation (EU) 2026/548, published on 16 March 2026, refuses authorisation of great burdock (Arctium lappa L.) extract — a flavouring compound previously authorised without a time limit under Directive 70/524/EEC — for cats and dogs. In its opinion of 17 March 2021 EFSA could not conclude on safety or efficacy; the applicant gave no substantive reply to the Commission letter of 3 September 2021, the message of 4 February 2025 or later reminders.
- Withdrawal dates: stocks of the additive and premixtures containing it for dogs and cats — by 5 July 2026; feed materials and compound feed produced with them before that date — by 5 October 2026. Applicant’s specification: at least 2 % inulin (marker), loss on drying ≤ 5 %, ash ≤ 15 %. Four batches averaged 33.2 % inulin (22.9–39.9 %) but without certificates of analysis; the amount of added maltodextrin was not given — hence uncertainty about the nature of up to 77 % of the additive.
- Methods (EURL report): inulin in the additive is determined by the ring-trial validated AOAC Official Method 997.08 (fructans — inulin and FOS in processed foods), based on ion exchange chromatography with pulsed amperometric detection (IEC-PAD); from three batches the EURL calculated an RSDr of 7.5 %. For premixtures and feed the applicant provided no method, as unambiguous determination of the additive in these matrices is not achievable — the EURL could recommend none.
- Commercial specification, without analytical results: lead ≤ 3.0 mg/kg, cadmium ≤ 1.0 mg/kg, mercury ≤ 0.1 mg/kg, aflatoxin B1 ≤ 5.0 µg/kg, sum of aflatoxins ≤ 10.0 µg/kg, aerobic bacteria ≤ 50 000 CFU/g (according to EFSA “very high”), yeasts and moulds ≤ 500 CFU/g, Salmonella absent in 25 g. 39–53 % of particles passed a 50 µm sieve; no dusting data.
- Proposed dose — up to 40 mg/kg complete feed. No tolerance or toxicity studies were submitted; the only root carcinogenicity data (Hirono, 1977) were judged inadequate by EFSA. Efficacy as a flavour was not shown: burdock has no FEMA number and EINECS lists it only as a cosmetic ingredient.