Omicha (Schisandra) tincture (2b61281-t; poultry, horses, dogs, cats) and ginseng tincture (2b318-t; horses, dogs, cats) as flavourings in feed until 19 February 2035: markers determined by HPLC-UV — schisandrin with deoxyschisandrin 0.01–0.15 % and ginsenosides Rg1 + Rb1 0.01–0.5 %; EFSA — GC-MS also found di-isooctyl phthalate in the ginseng tincture (1.42–7.96 µg/mL)
Commission Implementing Regulation (EU) 2025/152, published on 30 January 2025, following a re-evaluation authorises two tinctures previously authorised under Directive 70/524/EEC: from dried fruit of Schisandra chinensis (omicha) for horses, dogs, cats and poultry, and from roots of Panax ginseng for horses, dogs and cats — the applicant withdrew the application for the other species. Use in drinking water was not authorised. The Commission relies on the EFSA opinions of 12 and 13 March 2024; it sets no maximum contents, and recommended maximum contents are stated on the label.
- Omicha tincture (2b61281-t): extraction of dried fruit with water and ethanol, pressing and filtration; dry matter max. 4 %, sum of schisandrin and deoxyschisandrin 0.01–0.15 %; marker determined by HPLC-UV (the EU reference laboratory recommended a method based on Ph. Eur. monograph 01/2009:2428). Recommended maximum contents (mg/kg complete feed): chickens and other poultry for fattening or reared 12, turkeys for fattening 16, poultry for laying or breeding 18, horses and cats 47, dogs 56 — as in EFSA’s safe concentrations. In the Polish version of the act the same category “poultry reared for laying or breeding” appears at both 12 and 18 mg; the English version distinguishes poultry reared (12 mg) from poultry for laying or breeding (18 mg).
- EFSA data for omicha (five batches from China): water/ethanol 55/45 solution, dry matter 2.47–3.26 %, total phenols 107–216 µg/mL; flavonoids by HPLC-UV below the LOD of 0.2 µg/mL; GC-MS quantified 13 identified dibenzocyclooctadiene lignans and three unknown derivatives (sum 919–1379 µg/mL), including deoxyschisandrin 73.5–489.8 and schisandrin 12.9–353.8 µg/mL; organic acids by HPLC-UV 12 999–19 184 µg/mL (citric, quinic, malic, shikimic).
- Ginseng tincture (2b318-t, CoE No 318): extraction of the roots with water and ethanol; dry matter max. 6 %, sum of ginsenosides Rg1 and Rb1 0.01–0.5 %, HPLC-UV according to Ph. Eur. monograph 01/2008:1523. Recommended maximum contents: horses 48, dogs 228, cats 162 mg/kg — EFSA gave 48.6 and 228.7 mg/kg for horses and dogs. EFSA data (five batches from China, water/ethanol 40/60): total ginsenosides 2528–8936 µg/mL, including Rb1 677–2582 and Rg1 376–492 µg/mL; GC-MS — the polyacetylenes panaxynol (falcarinol) 2.74–84.50 and panaxydol 7.64–135.28 µg/mL and di-isooctyl phthalate 1.42–7.96 µg/mL.
- Safety (EFSA): component-based assessment with a combined margin of exposure; for di-isooctyl phthalate the NOAEL of 4.8 mg/kg bw used by the CEP Panel to derive the group TDI for phthalates was applied — margin of exposure in horses approx. 522 000; for ginsenosides a NOAEL of 185 mg/kg bw per day. Both tinctures are safe for consumers when used in poultry and horses and for the environment; they should be considered irritant to skin and eyes and skin and respiratory sensitisers. Transitional period: additives and premixtures produced before 19 August 2025, feed for food-producing animals — before 19 February 2026, for others — before 19 February 2027.