Cajuput oil from Melaleuca cajuputi and M. leucadendra (2b276-eo) as a flavouring in feed until 5 March 2035: 1,8-cineole 50–70 % determined by GC-FID (ISO 11024), α-terpineol 4–12 %, d-limonene 3–9 %, and methyleugenol, estragole and safrole ≤ 0.01 mg/kg (EFSA’s GC-MS limit of detection); recommended maximum contents from 5 mg/kg for cats to 78 mg/kg for calves
Commission Implementing Regulation (EU) 2025/279, published on 13 February 2025, following a re-evaluation authorises the essential oil from the leaves of Melaleuca cajuputi and Melaleuca leucadendra as a sensory additive for all animal species; it had previously been authorised under Directive 70/524/EEC. Use in drinking water was not authorised. The Commission relies on the EFSA opinion of 13 March 2024 and sets no maximum contents — recommended maximum contents for individual species are stated on the label. EFSA stipulated that its conclusions apply only to oil in which methyleugenol, estragole and safrole are not detected.
- Annex: oil obtained by steam distillation of the leaves (Council of Europe definition); CAS 8008-98-8, EINECS 931-800-6, FEMA 2225, CoE No 276; specification: 1,8-cineole (eucalyptol) 50–70 %, α-terpineol 4–12 %, d-limonene 3–9 %, methyleugenol, estragole and safrole ≤ 0.01 mg/kg. Method: 1,8-cineole (phytochemical marker) — GC-FID according to ISO 11024. Recommended maximum contents (mg/kg complete feed): turkeys for fattening 23, chickens and poultry for fattening or reared 18, poultry for laying or breeding 26, ornamental birds 18, pigs for fattening 37, piglets 31, Suidae for reproduction 30, calves 78, sheep, goats and cattle for fattening 69, other ruminants 45, Equidae 50, rabbits 28, salmonids 40, dogs 30, cats 5, ornamental fish 50, others 5.
- EFSA data: 1,8-cineole in two batches by GC-FID 51.9 % and 55.5 %; in five batches by GC-MS (% peak area) 1,8-cineole 58.71–63.40 %, α-terpineol 6.53–9.28 %, d-limonene 5.72–6.68 %; up to 59 peaks were detected, all identified (99.96–100 % of the area) — the oil was considered a fully defined mixture. Methyleugenol, estragole and safrole were not detected by GC-MS (LOD 0.01 mg/kg). The EU reference laboratory recommended GC-FID for determining 1,8-cineole.
- Why the limit for substances of concern (EFSA): the EFSA botanical compendium lists methyleugenol as a potential substance of concern in M. leucadendra — Australian chemotypes contained from 1.6 % to 95–97 %; traces of estragole (< 0.05 %) and safrole (0.1 %) were found in an oil from M. leucadendra from Cuba. Therefore the EFSA conclusions apply only to oil without detectable methyleugenol, estragole and safrole, with 1,8-cineole, α-terpineol and d-limonene as the main constituents; EFSA recommended including this in the specification — the act sets ≤ 0.01 mg/kg.
- Safety: the recommended contents correspond to EFSA’s safe concentrations (the levels proposed by the applicant were kept for sows, dogs, horses, fish and cats, lower ones were calculated for the other species). No concerns for consumers and the environment; the oil is a skin and eye irritant and a skin and respiratory sensitiser — the act requires procedures and, where they are not sufficient, skin, eye and respiratory protection. The additive is incorporated into feed as a premixture. Transitional period: additive and premixtures produced before 5 September 2025, feed for food-producing animals — before 5 March 2026, for others — before 5 March 2027.