Spanish type origanum oil (Thymbra capitata) 2b454-eo: carvacrol 60–75 % and thymol 0–5 % determined by GC-FID (ISO 14717), recommended up to 125 mg/kg feed for salmonids — no use in water for drinking
Commission Implementing Regulation (EU) 2025/1417, published on 18 July 2025, authorises until 7 August 2035 the essential oil from the flowering tops of Thymbra capitata (L.) Cav. — so far “origanum oil” authorised without a time limit under Directive 70/524/EEC — as a flavouring compound for all animal species. The request for use in water for drinking was rejected because Regulation (EC) No 1831/2003 does not provide for flavouring compounds there. EFSA (opinion of 17 September 2024) found the oil safe at the proposed levels, but irritant to skin and eyes and a dermal and respiratory sensitiser.
- Specification in the annex: carvacrol 60–75 %, thymol 0–5 %, p-cymene 5.5–9 %, γ-terpinene 3.5–10 %, β-caryophyllene 2–5 %; CAS 8007-11-2, FEMA 2828, CoE 454. The EINECS number in the act is 290-371-7, in the EFSA opinion 290-371-1. The phytochemical markers thymol and carvacrol in the additive are determined by gas chromatography with flame ionisation detection (GC-FID) with reference to ISO 14717 — the standard for oil of origanum, Spanish type; the method was recommended by the EURL in a partial report of August 2024. Five batches (GC-FID, % peak area): carvacrol 69.9 % (69.1–70.3), thymol 1.4 % (1.1–1.6); refractive index at 20 °C 1.504–1.508.
- Full GC-MS analysis of the same five batches: up to 65 peaks, 62 identified — on average 99.2 % of the area, so EFSA treats the oil as a fully defined mixture; the five specified constituents — 89.5 %, carvacrol by GC-MS 72.14 % (71.22–73.10). α-Thujone up to 0.19 % and β-thujone up to 0.03 % — substances in Annex III to Regulation (EC) No 1334/2008. For impurities (metals, dioxins, pesticides, aflatoxins, ochratoxin A) the applicant referred to “periodic testing” of premixtures but submitted no data; shelf-life of “at least 12 months” — without data.
- Safety was assessed with a component-based approach (MOE/MOET), without tolerance studies: thymol and carvacrol are safe up to 125 mg/kg feed (trials with the “Herbal” mixture). The lowest combined margin of exposure is for group CG 8 (borneol, camphor, dihydrocarvone, carvenone): 220 for chickens at 15 mg/kg and 116 for salmonids at 125 mg/kg. For cats, because of poor glucuronidation, EFSA requires an MOET of 500 — at 25 mg/kg the result is 521.
- Recommended maximum content on the label (mg/kg complete feed): 15 — poultry, ornamental birds and other species; 30 — Suidae and Equidae; 20 — ruminants and Camelidae; 25 — Leporidae, dogs, cats, ornamental fish; 125 — salmonids and minor fin fish. The PL list contains the item “all poultry reared for laying or breeding” twice; in EN they are “reared for laying or breeding” and “for laying or breeding”. The additive only via premixture; skin, eye and respiratory protection. Transitional periods: 7 February 2026 (additive, premixtures), 7 August 2026 and 7 August 2027 (compound feed).