Commission Implementing Regulation (EU) 2025/1403 of 16 July 2025 concerning the authorisation of Spanish sage essential oil from Salvia officinalis ssp. lavandulifolia (Vahl) Gams and lavender essential oil from Lavandula angustifolia Mill. as feed additives for all animal species

Official Journal EN of the European Union L series 2025/1403 17.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1403 of 16 July 2025 concerning the authorisation of Spanish sage essential oil from Salvia officinalisssp. lavandulifolia (Vahl) Gams and lavender essential oil from Lavandula angustifoliaMill. as feed additives 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 substances Spanish sage essential oil from Salvia officinalisssp. lavandulifolia(Vahl) Gams and lavender essential oil from Lavandula angustifolia Mill. were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products, 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 sage essential oil from Salvia officinalisssp. lavandulifolia (Vahl) Gams and lavender essential oil from Lavandula angustifolia Mill. as feed additives for all animal species, requesting the additives 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 substances concerned 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 these additives in water for drinking should not be allowed. (5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 17 September 2024(3),(4) that Spanish sage essential oil from Salvia officinalisssp. lavandulifolia(Vahl) Gams is safe up to the use level of 14 mg/kg complete feed for all animal species, and that lavender essential oil from Lavandula angustifoliaMill. is safe at certain maximum concentrations further specified for each species. It also found that the use of Spanish sage essential oil from Salvia officinalisssp. lavandulifolia(Vahl) Gams and lavender essential oil from Lavandula angustifoliaMill. under the proposed conditions of use is safe for the consumers and the environment. The Authority concluded that Spanish sage essential oil from Salvia officinalis ssp. lavandulifolia (Vahl) Gams and lavender essential oil from Lavandula angustifolia Mill. should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The Authority further concluded that since the oil of the leaves of Salvia officinalisssp. lavandulifolia(Vahl) Gams and the oil of flowering tops of Lavandula angustifoliaMill 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 2024:22(10), e9015, https://doi.org/10.2903/j.efsa.2024.9015. (4) EFSA Journal 2024:22(10), e9017, https://doi.org/10.2903/j.efsa.2024.9017. ELI: http://data.europa.eu/eli/reg_impl/2025/1403/oj 1/8EN OJ L, 17.7.2025 (6) In view of the above, the Commission considers that Spanish sage essential oil from Salvia officinalisssp. lavandulifolia (Vahl) Gams and lavender essential oil from Lavandula angustifoliaMill. satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances 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 additives. (7) The Commission considers that safety reasons do not require the setting of maximum levels for Spanish sage essential oil from Salvia officinalisssp. lavandulifolia(Vahl) Gams and lavender essential oil from Lavandula angustifoliaMill. 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 substances 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 substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Transitional measures 1. The feed additives Spanish sage essential oil from Salvia officinalisssp. lavandulifolia(Vahl) Gams and lavender essential oil from Lavandula angustifolia Mill., as authorised pursuant to Directive 70/524/EEC and premixtures containing these additives, 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 additives 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 additives 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. 2/8 ELI: http://data.europa.eu/eli/reg_impl/2025/1403/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/2025/1403/oj 3/8ANNEX Minimum Maximum content content Identification Species or Maxi­ End of period Composition, chemical formula, description, number of the Additive category of mum Other provisions of analytical method mg of additive/kg of complete feed additive animal age authorisation feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b413-eo Spanish sage Additive composition All animal — — — 1. The additive shall be 6 August essential oil species incorporated into the feed in 2035 Essential oil from leaves of Salvia the form of a premixture. officinalisssp. lavandulifolia(Vahl) Gams (synonym: S. lavandulifoliaVahl.) 2. In the directions for use of Liquid form the additive and premixtures, the storage conditions and Characterisation of active substance stability to heat treatment shall be indicated. Spanish sage essential oil: Essential oil, as defined by the Council of Europe (CoE)(1), obtained from leaves of 3. On the label of the additive, Salvia officinalisssp. lavandulifolia(Vahl) the following shall be Gams by steam distillation and further indicated: condensation of volatile constituents and ‘Recommended maximum separation from the aqueous phase by content of the active decantation. substance per kg of CAS number: 8016-65-7 complete feedingstuff with a Einecs number: 290-272-9 moisture content of 12 %: FEMA number: 3003 14 mg’. CoE number: 413 4. The functional group, the Specifications: identification number, the — Camphor: 11-36 % name and the added amount — 1,8-cineole (eucalyptol): 10-30 % of the active substance shall — α-Pinene (pin-2(3)-ene): 4-11 % be indicated on the label of — d-Limonene: 2-6 % the premixture, where the — Thujones: 0,001 % use levels on the label of the premixture would result in exceeding the levels referred to in point 3. 4/8 ELI: http://data.europa.eu/eli/reg_impl/2025/1403/oj EN OJ L, 17.7.2025Minimum Maximum content content Identification Species or Maxi­ End of period Composition, chemical formula, description, number of the Additive category of mum Other provisions of analytical method mg of additive/kg of complete feed additive animal age authorisation feedingstuff with a moisture content of 12 % Analytical method(2) 5. For users of the additive and premixtures, feed business For the determination of 1,8-cineoleand operators shall establish camphor (phytochemical markers) in the operational procedures and feed additive: organisational measures to — gas chromatography coupled with address potential risks flame ionisation detection (GC–FID) resulting from their use. (ISO 3526) 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. Minimum Maximum content content Identification Species or Maxi­ End of period Composition, chemical formula, description, number of the Additive category of mum Other provisions of analytical method mg of additive/kg of complete feed additive animal age authorisation feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b257-eo Lavender Additive composition All animal — — — 1. The additive shall be 6 August essential oil species incorporated into the feed in 2035 Essential oil from the fresh flowering the form of a premixture. tops of Lavandula angustifoliaMill. Liquid form ELI: http://data.europa.eu/eli/reg_impl/2025/1403/oj 5/8 OJ L, 17.7.2025 ENMinimum Maximum content content Identification Species or Maxi­ End of period Composition, chemical formula, description, number of the Additive category of mum Other provisions of analytical method mg of additive/kg of complete feed additive animal age authorisation feedingstuff with a moisture content of 12 % Characterisation of active substance 2. In the directions for use of the additive and premixtures, Lavender essential oil: the storage conditions and Essential oil, as defined by the Council of stability to heat treatment Europe(1), obtained from the fresh shall be indicated. flowering tops of Lavandula angustifolia Mill.by steam distillation and further condensation of volatile constituents and 3. On the label of the additive, separation from the aqueous phase by the following shall be decantation. indicated: ‘Recommended maximum CAS number: 8000-28-0 content of the active Einecs number: 289-995-2 substance per kg of FEMA number: 2622 complete feedingstuff with a CoE number: 257 moisture content of 12 %: Specifications: — 12 mg for turkeys for — Linalyl acetate: 25-47 % fattening; — Linalool: 20-45 % — 9 mg for chickens for — 4-Terpinenol: 0,1-8 % fattening and minor — (Z)-β-Ocimene: < 10 % poultry for fattening; — 9 mg for all poultry Analytical method(2) reared for laying or breeding; For the determination of linalyl acetate — 9 mg for ornamental and linalool (phytochemical markers) in birds; the feed additive: — 13 mg for all poultry for — gas chromatography coupled with laying or breeding; flame ionisation detection (GC-FID) — 19 mg for pigs for (ISO 3515) fattening; 6/8 ELI: http://data.europa.eu/eli/reg_impl/2025/1403/oj EN OJ L, 17.7.2025Minimum Maximum content content Identification Species or Maxi­ End of period Composition, chemical formula, description, number of the Additive category of mum Other provisions of analytical method mg of additive/kg of complete feed additive animal age authorisation feedingstuff with a moisture content of 12 % — 16 mg for piglets (suckling and weaned) of all Suidae; — 16 mg for pigs for fattening of minor Suidae — 23 mg for all Suidaefor reproduction; — 39 mg for calves for fattening up to 6 months; — 35 mg for sheep and goats; — 35 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidaefor fattening; — 22 mg for all other ruminants; all other Camelidae; — 35 mg for Equidae; — 14 mg for Leporidae; — 39 mg for Salmonids and minor fin fish; — 30 mg for dogs; — 7 mg for cats; — 30 mg for ornamental fish; — 7 mg for other species and categories.’. ELI: http://data.europa.eu/eli/reg_impl/2025/1403/oj 7/8 OJ L, 17.7.2025 ENMinimum Maximum content content Identification Species or Maxi­ End of period Composition, chemical formula, description, number of the Additive category of mum Other provisions of analytical method mg of additive/kg of complete feed additive animal age authorisation feedingstuff with a moisture content of 12 % 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. 8/8 ELI: http://data.europa.eu/eli/reg_impl/2025/1403/oj EN OJ L, 17.7.2025