Commission Implementing Regulation (EU) 2025/1417 of 17 July 2025 concerning the authorisation of Spanish type origanum essential oil from Thymbra capitata (L.) Cav. as a feed additive for all animal species

Official Journal EN of the European Union L series 2025/1417 18.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1417 of 17 July 2025 concerning the authorisation of Spanish type origanum essential oil from Thymbra capitata(L.) Cav. 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 Spanish type origanum essential oil, previously identified as thymus origanum oil, from Thymbra capitata(L.) Cav. 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 Spanish type origanum essential oil from Thymbra capitata (L.) Cav. 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 17 September 2024(3)that, under the proposed conditions of use further specified for each species, Spanish type origanum essential oil from Thymbra capitata(L.) Cav. is safe for the target species, consumers and the environment. The Authority concluded that Spanish type origanum essential oil from Thymbra capitata(L.) Cav. should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The Authority further concluded that since the Thymbra capitata (L.) Cav. and its preparations are recognised to flavour food and their 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 additives 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), e9018. https://doi.org/10.2903/j.efsa.2024.9018. ELI: http://data.europa.eu/eli/reg_impl/2025/1417/oj 1/6EN OJ L, 18.7.2025 (6) In view of the above, the Commission considers that Spanish type origanum essential oil from Thymbra capitata(L.) Cav. 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. 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) The Commission considers that safety reasons do not require the setting of maximum levels for Spanish type origanum essential oil from Thymbra capitata(L.) Cav. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additives. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned. (8) 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. (9) 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 Spanish type origanum essential oil from Thymbra capitata (L.) Cav., as authorised pursuant to Directive 70/524/EEC, and premixtures containing that additive, which are produced and labelled before 7 February 2026 in accordance with the rules applicable before 7 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 7 August 2026 in accordance with the rules applicable before 7 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 7 August 2027 in accordance with the rules applicable before 7 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/2025/1417/ojEN OJ L, 18.7.2025 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, 17 July 2025. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2025/1417/oj 3/6ANNEX Minimum Maximum Identification Species or Maxi­ content content End of period Composition, chemical formula, description, number of the Additive analytical method category of mum mg of additive/kg of complete Other provisions of feed additive animal age feedingstuff with a moisture authorisation content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b454-eo Spanish type Additive composition All animal - - - 1. The additive shall be 7 August origanum species incorporated into the feed in 2035 Essential oil from the flowering tops of essential oil the form of a premixture. Thymbra capitata(L.) Cav. (synonyms: Coridothymus capitatusRchb.f.; Thymus 2. In the directions for use of capitatusHoffmanns. & Link.) the additive and premixtures, Liquid form the storage conditions and stability to heat treatment Characterisation of active substance shall be indicated. Spanish type origanum essential oil: 3. On the label of the additive, Essential oil, as defined by the Council of the following shall be Europe (CoE)(1), obtained from the indicated: flowering tops of Thymbra capitata(L.) ‘Recommended maximum Cav. by steam distillation and further content of the active condensation of volatile constituents and substance per kg of separation from the aqueous phase by complete feedingstuff with a decantation. moisture content of 12 %: CAS number: 8007-11-2 — 15 mg for turkeys for Einecs number: 290-371-7 fattening; FEMA number: 2828 — 15 mg for chickens for CoE number: 454 fattening and minor poultry for fattening; Specifications: — 15 mg for all poultry Carvacrol: 60–75 % reared for laying or Thymol: 0–5 % breeding; p-Cymene (1-isopropyl- — 15 mg for ornamental 4-methylbenzene): 5,5–9 % birds; γ-Terpinene: 3,5–10 % — 15 mg for all poultry for β-Caryophyllene: 2-5 % laying or breeding; 4/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1417/oj EN OJ L, 18.7.2025Minimum Maximum Identification Species or Maxi­ content content End of period Composition, chemical formula, description, number of the Additive analytical method category of mum mg of additive/kg of complete Other provisions of feed additive animal age feedingstuff with a moisture authorisation content of 12 % Analytical method(2) — 30 mg for pigs for fattening; For the determination of thymol and — 30 mg for piglets carvacrol (phytochemical markers) in the (suckling and weaned) feed additive: of all Suidae; — gas chromatography coupled with — 30 mg for pigs for flame ionisation detection (GC–FID) fattening of minor (ISO 14717) Suidae; — 30 mg for all Suidaefor reproduction; — 20 mg for calves for fattening up to 6 months; — 20 mg for sheep and goats; — 20 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidaefor fattening; — 20 mg for all other ruminants; all other Camelidae; — 30 mg for Equidae; — 25 mg for Leporidae; — 125 mg for salmonids and minor fin fish; ELI: http://data.europa.eu/eli/reg_impl/2025/1417/oj 5/6 OJ L, 18.7.2025 ENMinimum Maximum Identification Species or Maxi­ content content End of period Composition, chemical formula, description, number of the Additive analytical method category of mum mg of additive/kg of complete Other provisions of feed additive animal age feedingstuff with a moisture authorisation content of 12 % — 25 mg for dogs; — 25 mg for cats; — 25 mg for ornamental fish; — 15 mg for other species and categories.’. 4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture, where the use levels on the label of the premixture would result in exceeding the levels referred to in point 3. 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. (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/2025/1417/oj EN OJ L, 18.7.2025