Tea tree oil in feed: terpinen-4-ol determined by GC-FID according to ISO 4730, methyleugenol ≤ 0.01 %, maximum contents from 0.9 mg/kg for cats to 15 mg/kg for ornamental fish
Commission Implementing Regulation (EU) 2025/1402, published on 17 July 2025, after re-evaluation authorises until 6 August 2035 the essential oil from the leaves and terminal branchlets of Melaleuca alternifolia as a flavouring for all species — with maximum contents because of methyleugenol. Use in water for drinking was not authorised; products under the old rules may be sold until stocks are exhausted if produced before 6 February 2026 (additive, premixtures), 6 August 2026 (feed for food-producing animals) and 6 August 2027 (other feed).
- Method and specification: terpinen-4-ol (phytochemical marker) in the additive — GC-FID according to ISO 4730; terpinen-4-ol 30–48 %, γ-terpinene 10–28 %, α-terpinene 5–13 %, 1,8-cineole < 15 %, methyleugenol ≤ 0.01 %. In seven batches (GC-MS, % peak area) terpinen-4-ol 37.34–41.87 %, γ-terpinene 18.15–21.77 %, α-terpinene 9.20–10.63 %, 1,8-cineole 1.55–3.16 %; methyleugenol was detected in one batch at the LOD of 0.01 %.
- Maximum contents (mg/kg complete feed): chickens for fattening and other species 1.1, turkeys for fattening 1.5, laying poultry 1.7, pigs for fattening 2.4, breeding pigs 3.1, cattle for fattening, sheep, goats and equids 4.4, salmonids 5.0, crustaceans 6.6, dogs 5.3, cats 0.9, ornamental fish 15. EFSA derived them from a NOAEL of 10 mg/kg bw per day (fertility, two-generation study) and a factor of 100, plus 5 for cats; for ornamental fish the result was 19.6 mg/kg, but the applicant proposed 15.
- Users: the oil irritates skin and eyes and is a skin and respiratory sensitiser; RAC (ECHA) classified it as toxic to reproduction category 1B (H360Fd). When mixed with other botanical additives, the amount of methyleugenol may not exceed that resulting from a single additive at the maximum content.
- According to EFSA, in 128 commercial samples of the oil methyleugenol ranged from < 0.01 to 0.06 % (mean 0.02 %). For methyleugenol — a genotoxic carcinogen — the Panel used a BMDL10 of 22.2 mg/kg bw per day (hepatocellular carcinomas in male rats) and for long-living and reproductive animals considers a margin of exposure > 10 000 indicative of low concern.