Commission Implementing Regulation (EU) 2025/1402 of 16 July 2025 concerning the authorisation of tea tree essential oil from Melaleuca alternifolia (Maiden & Betche) Cheel as a feed additive for all animal species

Official Journal EN of the European Union L series 2025/1402 17.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1402 of 16 July 2025 concerning the authorisation of tea tree essential oil from Melaleuca alternifolia(Maiden & Betche) Cheel as a feed additive for all animal species (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2). (2) The substance tea tree essential oil from Melaleuca alternifolia(Maiden & Betche) Cheel was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. This substance was subsequently entered in the Register of Feed Additives as an existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003. (3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of tea tree essential oil from Melaleuca alternifolia(Maiden & Betche) Cheel as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (4) The applicant requested the additive to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of this additive in water for drinking should not be allowed. (5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 September 2024(3)that tea tree essential oil from Melaleuca alternifolia(Maiden & Betche) Cheel is of no concern for target species for fattening and that it is very unlikely to be of safety concern for any other species and for long-living and reproductive animals at certain maximum concentrations further specified for each species. Furthermore, it concluded that no concerns for consumers were identified following the use of tea tree essential oil from Melaleuca alternifolia (Maiden & Betche) Cheel, under the proposed conditions, and that its use, under the proposed conditions, is not expected to pose a risk to the environment. The Authority concluded that tea tree essential oil from Melaleuca alternifolia(Maiden & Betche) Cheel should be considered as irritant to skin and eyes, as a dermal and respiratory sensitiser, and as a reprotoxic substance. The Authority indicated that, when handling the additive, exposure of unprotected users to methyleugenol may occur and that therefore, to reduce the risk, the exposure of the users should be minimised. The Authority further concluded that since tea tree essential oil from Melaleuca alternifolia (Maiden & Betche) Cheel is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1, ELI: http:// data.europa.eu/eli/dir/1970/524/oj). (3) EFSA Journal, 22(10), e9026. https://doi.org/10.2903/j.efsa.2024.9026. ELI: http://data.europa.eu/eli/reg_impl/2025/1402/oj 1/6EN OJ L, 17.7.2025 (6) In view of the above, the Commission considers that tea tree essential oil from Melaleuca alternifolia(Maiden & Betche) Cheel satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. The Commission considers that the presence of methyleugenol, a substance of concern, requires the setting of maximum content in complete feed and that a mixture of tea tree essential oil from Melaleuca alternifolia (Maiden & Betche) Cheel with other botanical additives is permitted provided that the amounts of the same substance of concern in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended content for the species or animal category. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. (7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION: Article 1 Authorisation The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Transitional measures 1. The feed additive tea tree essential oil from Melaleuca alternifolia(Maiden & Betche) Cheel, as authorised pursuant to Directive 70/524/EEC and premixtures containing this additive, which are produced and labelled before 6 February 2026 in accordance with the rules applicable before 6 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted. 2. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 6 August 2026 in accordance with the rules applicable before 6 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals. 3. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 6 August 2027 in accordance with the rules applicable before 6 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals. 2/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1402/ojEN OJ L, 17.7.2025 Article 3 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 July 2025. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2025/1402/oj 3/6ANNEX Minimum Maximum content content End of Identification number of the Additive Composition, chemical formula, description, Species or Maximum mg of additive/kg of Other provisions period of feed additive analytical method category of animal age complete feedingstuff authorisa­ with a moisture content tion of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b275-eo Tea tree Additive composition Turkeys for 1. The additive shall be incorporated 6 August - - 1,5 essential oil fattening into the feed in the form of a 2035 Essential oil from leaves and terminal premixture. branchlets of Melaleuca alternifolia(Maiden & Betche) Cheel (synonym: Melaleuca Chickens for linariifoliavar. alternifolia(Maiden and Bet.) 2. In the directions for use of the fattening and - - 1,1 additive and premixtures, the storage Liquid form minor poultry conditions and stability to heat for fattening treatment shall be indicated. Characterisation of active substance Tea tree essential oil: All poultry 3. Mixture of tea tree essential oil with reared for laying - - 1,1 other botanical additives is Essential oil, as defined by the Council of or breeding permitted provided that the Europe (CoE)(1), obtained from the leaves amounts of methyleugenol in feed and terminal branchlets of Melaleuca materials and compound feed is alternifolia(Maiden & Betche) Cheel by Ornamental lower than the one resulting from steam distillation and further condensation - - 1,1 birds the use of a single additive at the of volatile constituents and separation from maximum or recommended content water by decantation. for the species or animal category. All poultry for CAS number: 68647-73-4 laying or - - 1,7 Einecs number: 285-377-1 breeding FEMA number: 3902 CoE number: 275 Pigs for - - 2,4 fattening Pigs for fattening of - - 2,0 minor Suidae Piglets (suckling and weaned) of - - 2,0 all Suidae 4/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1402/oj EN OJ L, 17.7.2025Minimum Maximum content content End of Identification number of the Additive Composition, chemical formula, description, Species or Maximum mg of additive/kg of Other provisions period of feed additive analytical method category of animal age complete feedingstuff authorisa­ with a moisture content tion of 12 % Specifications: 4. For users of the additive and All Suidaefor — 4-Terpinenol: 30-48 % - - 3,1 premixtures, feed business operators reproduction — γ-Terpinene: 10-28 % shall establish operational — α-Terpinene: 5-13 % procedures and organisational — 1,8-Cineole (eucalyptol): < 15 % Calves for 6 measures to address potential risks - 5,0 — Methyleugenol: ≤ 0,01 % fattening months resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the Analytical method(2) Sheep and goats - - 4,4 additive and premixtures shall be For the determination of 4-terpinenol used with personal skin, eye and (phytochemical marker) in the feed breathing protective equipment. Cattle for additive: fattening; other — gas chromatography coupled with ruminants for flame ionization detection (GC-FID) fattening except (ISO 4730) sheep, goats and - - 4,4 calves for fattening up to 6 months; Camelidae for fattening All other ruminants; - - 2,9 all other Camelidae Equidae - - 4,4 Leporidae - - 1,8 Salmonids and - - 5,0 minor fin fish Crustaceans - - 6,6 Dogs - - 5,3 ELI: http://data.europa.eu/eli/reg_impl/2025/1402/oj 5/6 OJ L, 17.7.2025 ENMinimum Maximum content content End of Identification number of the Additive Composition, chemical formula, description, Species or Maximum mg of additive/kg of Other provisions period of feed additive analytical method category of animal age complete feedingstuff authorisa­ with a moisture content tion of 12 % Cats - - 0,9 Ornamental fish - - 15 Other species - - 1,1 and categories (1) Natural sources of flavourings – Report No 2 (2007). (2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en. 6/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1402/oj EN OJ L, 17.7.2025