Ginseng extract for dogs and cats rejected: up to 73 % of the extract of unknown composition, ginsenosides determined spectrophotometrically as Rg1, no method for premixtures and feed; withdrawal by 5 October 2026
Commission Implementing Regulation (EU) 2026/585, published on 16 March 2026, refuses authorisation of an extract from the roots of Panax ginseng C.A. Meyer as a flavouring for cats and dogs and orders the withdrawal of the additive and premixtures by 5 July 2026, and of feed materials and compound feed made with them by 5 October 2026. EFSA could not assess safety because the applicant did not provide a full characterisation of the additive.
- Applicant’s specification: 27–30 % total ginsenosides (as ginsenoside Rg1), loss on drying ≤ 5 %, ash ≤ 5 %; in 5 batches 27.2–29.7 %, but without certificates of analysis. The additive contains maltodextrin in an unknown amount, so the composition of up to 73 % of the extract remained unknown — EFSA could not assess safety at the proposed level of up to 20 mg/kg complete feed, nor user safety.
- Method: the EU reference laboratory recommended for official control the spectrophotometric determination of total ginsenosides in the additive (procedure from the Deutsche Apotheker-Zeitung, equivalent to the Italian Pharmacopoeia, 10th edition). It recommended no method for premixtures and feed, because unambiguous determination of the additive in these matrices is not achievable experimentally.
- Limits from a commercial information sheet, without analytical data: lead ≤ 3.0, cadmium ≤ 1.0, mercury ≤ 0.1 mg/kg, aflatoxin B1 ≤ 5.0 µg/kg, sum of aflatoxins B1, B2, G1 and G2 ≤ 10.0 µg/kg, ethanol ≤ 0.5 %, aerobic bacteria ≤ 50 000 CFU/g (EFSA: very high), yeasts and moulds ≤ 500 CFU/g, Salmonella absent in 25 g. 90 % of particles pass a 300 µm sieve; dusting potential was not tested.
- Course: the dossier reached EFSA on 5 November 2010; in June 2018 EFSA requested supplementary data (characterisation, safety, efficacy), in October 2019 the applicant said it would not provide them; opinion of 17 March 2021. The Commission offered the applicant the chance to supplement on 12 October 2021 and announced the refusal on 4 February 2025 — no substantive reply came.