Commission Implementing Regulation (EU) 2026/2113 of 23 September 2026 concerning the authorisation of rosemary essential oil from Salvia rosmarinus Spenn. as a feed additive for all animal species

Official Journal EN of the European Union L series 2026/2113 24.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2113 of 23 September 2026 concerning the authorisation of rosemary essential oil from Salvia rosmarinusSpenn. 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 rosemary essential oil from Salvia rosmarinusSpenn., previously identified as Rosmarinus officinalisL., 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 rosemary essential oil from Salvia rosmarinus Spenn. 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 also for use 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 16 September 2025(3) that rosemary essential oil from Salvia rosmarinusSpenn. is considered of no safety concern for target short-living animals and very unlikely to induce adverse effects for target long-living and reproductive animals and any other animal species at certain maximum concentrations further specified in that opinion for each species. Furthermore, it concluded that no safety concern would be expected for consumers of animal products from the use of rosemary essential oil from Salvia rosmarinus Spenn., under the proposed conditions of use, and that its use, under the proposed conditions of use, is not expected to pose a risk to the environment. The Authority concluded that rosemary essential oil from Salvia rosmarinusSpenn. should be considered as irritant to skin and eyes and as skin and respiratory sensitiser. It also stated that unprotected users may be exposed to methyleugenol and estragole when handling rosemary essential oil from Salvia rosmarinusSpenn.. The Authority further concluded that since rosemary 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 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, 23(10), e9685. https://doi.org/10.2903/j.efsa.2025.9685.

ELI: http://data.europa.eu/eli/reg_impl/2026/2113/oj 1/6EN OJ L, 24.9.2026

(6) In view of the above, the Commission considers that rosemary essential oil from Salvia rosmarinusSpenn. 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 estragole and methyleugenol, substances of concern belonging to the group of p-allylalkoxybenzenes, in rosemary essential oil from Salvia rosmarinusSpenn. requires the setting of maximum content for this feed additive in complete feed. It also considers that a simultaneous use of rosemary essential oil from Salvia rosmarinusSpenn. with other feed additives is permitted provided that the combined content of p-allylalkoxybenzenes (methyleugenol, estragole, elemicin, safrole, myristicin, dillapiole, and apiole) in feed materials and compound feed remains below the content that would result from using the authorised feed additive with the highest content of those substances at its maximum or recommended maximum content for the relevant animal species or 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 rosemary essential oil from Salvia rosmarinus Spenn., as authorised pursuant to Directive 70/524/EEC and premixtures containing this additive, which are produced and labelled before 14 April 2027 in accordance with the rules applicable before 14 October 2026 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 14 October 2027 in accordance with the rules applicable before 14 October 2026 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 14 October 2028 in accordance with the rules applicable before 14 October 2026 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/2026/2113/ojEN OJ L, 24.9.2026 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, 23 September 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/2113/oj 3/6ANNEX Minimum Maximum content content Identification Species or End of period Name of the Composition, chemical formula, description, Maximum number of the category of Other provisions of additive analytical method. age mg active substance/kg of additive animal authorisation complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b406-eo Rosemary Additive composition Turkeys for - - 20,8 1. The additive shall be 14.10.2036 essential oil fattening incorporated into the feed Essential oil from the aerial parts of Salvia in the form of a premixture.

rosmarinusSpenn. (homotypic syn.

Chickens for - - 18,0 Rosmarinus officinalisL.) fattening and 2. In the directions for use of Liquid form minor poultry the additive and for fattening premixtures, the storage Characterisation of the active substance conditions and the stability All poultry - - 20,8 to heat treatment shall be

Rosemary essential oil: reared for indicated.

Essential oil, as defined by the Council of laying or Europe(1), obtained from the fresh or breeding 3. Simultaneous use of dried flowering aerial parts of Salvia rosemary essential oil with rosmarinusSpenn. by steam distillation Ornamental - - 20,8 other feed additives is and further condensation of volatile birds permitted provided that the constituents and separation from the combined content of aqueous phase by decantation. All poultry for - - 20,8 p-allylalkoxybenzenes laying or (methyleugenol, estragole,

EC numbers: 942-976-9 / 616-767-5/ breeding elemicin, safrole, 283-291-9(2) myristicin, dillapiole, and

CAS numbers: 8000-25-7(2) Pigs for - - 20,8 apiole) in feed materials and

FEMA number: 2992 fattening compound feed remains

CoE number: 406 below the content that

Specifications: Pigs for - - 20,8 would result from using the — 1,8-Cineole (eucalyptol): 14-62 % fattening of authorised feed additive — Camphor: 5-24 % minor Suidae with the highest content of — α-Pinene: 7-26 % those substances at its — Camphene: < 15 % Piglets - - 20,8 maximum or — β-Pinene: 1-12 % (suckling and recommended maximum — Methyleugenol: ≤ 0,039 % weaned) of all content for the relevant — Estragole: ≤ 0,027 % Suidae animal species or category.

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http://data.europa.eu/eli/reg_impl/2026/2113/oj EN OJ L,

24.9.2026Minimum Maximum content content Identification Species or End of period Name of the Composition, chemical formula, description, Maximum number of the category of Other provisions of additive analytical method. age mg active substance/kg of additive animal authorisation complete feed with a moisture content of 12 % Analytical method(3) All Suidaefor - - 20,8 4. For users of the additive and reproduction premixtures, feed business For the determination of 1,8-cineole and operators shall establish camphor (phytochemical markers) in the Calves for 6 months - 20,8 operational procedures and

feed additive: fattening organisational measures to — Gas chromatography coupled with address potential risks flame ionisation detection (GC-FID) Sheep and - - 20,8 resulting from their use. (ISO 1342) goats Where those risks cannot be eliminated by such Cattle for - - 20,8 procedures and measures, fattening; the additive and other premixtures shall be used ruminants for with personal skin, eye and fattening breathing protective except sheep, equipment.

goats and calves for fattening up to 6 months old;

Camelidaefor fattening All other - - 20,8 ruminants; all other Camelidae Equidae - - 20,8 Leporidae - - 20,8 Salmonids and - - 20,8 minor fin fish

ELI:

http://data.europa.eu/eli/reg_impl/2026/2113/oj 5/6 OJ L,

24.9.2026 ENMinimum Maximum content content Identification Species or End of period Name of the Composition, chemical formula, description, Maximum number of the category of Other provisions of additive analytical method. age mg active substance/kg of additive animal authorisation complete feed with a moisture content of 12 % Dogs - - 20,8 Cats - - 14,1 Ornamental - - 20,8 fish Other species - - 14,1 and categories

(1) Natural sources of flavourings – Report No 2 (2007).

(2) Here it only refers to the essential oil from the aerial parts of Salvia rosmarinusSpenn.

(3) 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.

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http://data.europa.eu/eli/reg_impl/2026/2113/oj EN OJ L,

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