Commission Implementing Regulation (EU) 2025/1400 of 16 July 2025 concerning the authorisation of peppermint essential oil from Mentha × piperita L., clary sage essential oil from Salvia sclarea L. and sage essential oil from Salvia officinalis L. as feed additives for all animal species

Official Journal EN of the European Union L series 2025/1400 17.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1400 of 16 July 2025 concerning the authorisation of peppermint essential oil from Mentha× piperitaL., clary sage essential oil from Salvia sclareaL. and sage essential oil from Salvia officinalisL. 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 peppermint essential oil from Mentha × piperitaL., clary sage essential oil from Salvia sclareaL. and sage essential oil from Salvia officinalis L. 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 peppermint essential oil from Mentha × piperita L., clary sage essential oil from Salvia sclareaL. and sage essential oil from Salvia officinalisL. 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 16 October 2024(3), 20 November 2024(4), 26 November 2024(5), that peppermint essential oil from Mentha× piperitaL. is safe up to the maximum use level of 12 mg/kg complete feed for all animal species, and that clary sage essential oil from Salvia sclareaL. and sage essential oil from Salvia officinalis L. are safe at certain maximum concentrations further specified for each species. It also concluded that no concerns were identified from the use of peppermint essential oil from Mentha× piperitaL. for consumers up to the maximum use level and that it is not expected to pose a risk to the environment at the maximum proposed use level. The Authority further concluded that the use of clary sage essential oil from Salvia sclarea L. and sage essential oil from Salvia officinalis L. under the proposed conditions of use is safe for the consumers and the environment. The Authority concluded that peppermint essential oil from Mentha × piperita L., clary sage essential oil from Salvia sclarea L. and sage essential oil from Salvia officinalis L. should be considered as (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(11), e9016. https://doi.org/10.2903/j.efsa.2024.9016. (4) EFSA Journal, 23(1), e9076. https://doi.org/10.2903/j.efsa.2025.9076. (5) EFSA Journal, 22(12), e9135.https://doi.org/10.2903/j.efsa.2024.9135. ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj 1/11EN OJ L, 17.7.2025 irritants to skin and eyes, and as dermal and respiratory sensitisers. The Authority further concluded that since peppermint essential oil from Mentha× piperitaL., clary sage essential oil from Salvia sclareaL. and sage essential oil from Salvia officinalis L. 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. (6) In view of the above, the Commission considers that peppermint essential oil from Mentha × piperitaL., clary sage essential oil from Salvia sclareaL. and sage essential oil from Salvia officinalisL. 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 peppermint essential oil from Mentha× piperitaL., clary sage essential oil from Salvia sclareaL. and sage essential oil from Salvia officinalisL.. 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 peppermint essential oil from Mentha× piperitaL., clary sage essential oil from Salvia sclareaL. and sage essential oil from Salvia officinalisL., 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. 2/11 ELI: http://data.europa.eu/eli/reg_impl/2025/1400/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/2025/1400/oj 3/11ANNEX Minimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of Other provisions description, analytical method age mg of additive/kg of complete authorisation feed additive animal feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b282-eo Peppermint Additive composition All animal - - - 1. The additive shall be 6 August 2035 essential oil species incorporated into the feed in the Essential oil from the aerial parts of form of a premixture. Mentha × piperitaL. (basionym: Mentha aquatica× Mentha spicataL.) 2. In the directions for use of the additive and premixtures, the Liquid form storage conditions and the stability to heat treatment shall Characterisation of active substance be indicated. Peppermint essential oil: 3. On the label of the additive, the Essential oil, as defined by the following shall be indicated: Council of Europe(1), obtained from the aerial parts (the leaves with or ‘Recommended maximum without the flowers) of Mentha × content of the active substance piperitaL. by steam distillation and per kg of complete feedingstuff further condensation of volatile with a moisture content of 12 %: constituents and separation from the 12 mg.’ aqueous phase by decantation. 4. The functional group, the CAS number: 8006-90-4 identification number, the name Einecs: 308-770-2 and the added amount of the FEMA number: 2848 active substance shall be CoE number: 282 indicated on the label of the premixture, where the use level Specifications: on the label of the premixture would result in exceeding the Menthol: 30-55 % level referred to in point 3. Menthone: 13-32 % d,l-Isomenthone: 1,5-10 % Menthyl acetate: 2-10 % 4/11 ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj EN OJ L, 17.7.2025Minimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of Other provisions description, analytical method age mg of additive/kg of complete authorisation feed additive animal feedingstuff with a moisture content of 12 % 1,8-Cineole (eucalyptol): 2-8 % 5. For users of the additive and Pulegone: ≤ 1,72 % premixtures, feed business Menthofuran: ≤ 4,54 % operators shall establish β-thujone: ≤ 0,01 % operational procedures and Coumarin: ≤ 0,001 % organisational measures to Estragole: ≤ 0,001 % address potential risks resulting from their use. Where those Analytical method(2) risks cannot be eliminated by such procedures and measures, For the determination of menthol the additive and premixtures and menthone (phytochemical shall be used with personal skin, markers) in the feed additive: eye and breathing protective — Gas chromatography coupled equipment. with flame ionisation detection (GC-FID) (ISO 856) (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. ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj 5/11 OJ L, 17.7.2025 ENMinimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of Other provisions description, analytical method age mg of additive/kg of complete authorisation feed additive animal feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b415-eo Clary sage Additive composition All animal - - - 1. The additive shall be incorporated 6 August 2035 essential oil species into the feed in the form of a Essential oil from flowering stems premixture. of Salvia sclareaL. 2. In the directions for use of the Liquid form additive and premixtures, the storage conditions and the Characterisation of active substance stability to heat treatment shall be Clary sage essential oil: indicated. Essential oil, as defined by the 3. On the label of the additive, the Council of Europe(1), obtained following shall be indicated: from fresh or dried flowering stems of Salvia sclareaL.by steam ‘Recommended maximum distillation and further content of the active substance per condensation of volatile kg of complete feedingstuff with a constituents and separation from moisture content of 12 %: the aqueous phase by decantation. — 7 mg for turkeys for fattening; — 5 mg for chickens for CAS number: 8016-63-5 fattening and minor poultry Einecs: 283-911-8 for fattening; FEMA number: 2321 — 5 mg for all poultry reared for CoE number: 415 laying or breeding; — 5 mg for ornamental birds; Specifications: — 8 mg all poultry for laying or breeding; Linalyl acetate: 55-78 % — 11 mg for pigs for fattening; Linalool: 6,5-25 % — 9 mg for piglets (suckling and Germacra-1(10),4(14),5-triene: weaned) of all Suidae; 1-12 % α-Terpineol: 0-5 % 6/11 ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj EN OJ L, 17.7.2025Minimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of Other provisions description, analytical method age mg of additive/kg of complete authorisation feed additive animal feedingstuff with a moisture content of 12 % Analytical method(2) — 9 mg for pigs for fattening of minor Suidae; For the determination of linalyl — 14 mg for all Suidae for acetate and linalool (phytochemical reproduction; marker) in the feed additive: — 15 mg for calves for fattening — gas chromatography coupled up to 6 months; with flame ionisation — 15 mg for sheep and goats; detection (GC-FID) (European — 15 mg for cattle for fattening, Pharmacopoeia monograph other ruminants for fattening 1850) except sheep, goats and calves for fattening up to 6 months; Camelidaefor fattening; — 13 mg for all other ruminants and all other Camelidae; — 10 mg for Equidae; — 8 mg for Leporidae; — 20 mg for salmonids and minor fin fish; — 20 mg for dogs; — 20 mg for ornamental fish; — 4 mg for cats; — 4 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 level on the label of the premixture would result in exceeding the level referred to in point 3. ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj 7/11 OJ L, 17.7.2025 ENMinimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of Other provisions description, analytical method age mg of additive/kg of complete authorisation feed additive animal feedingstuff with a moisture content of 12 % 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. 8/11 ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj EN OJ L, 17.7.2025Minimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of Other provisions description, analytical method age mg of additive/kg of complete authorisation feed additive animal feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b414-eo Sage essential Additive composition All animal - - - 1. The additive shall be incorporated 6 August 2035 oil species into the feed in the form of a Essential oil from the fresh leaves premixture. of Salvia officinalisL. 2. In the directions for use of the Liquid form additive and premixtures, the storage conditions and the Characterisation of active substance stability to heat treatment shall be Sage essential oil: indicated. Essential oil, as defined by the 3. On the label of the additive, the Council of Europe(1), obtained following shall be indicated: from fresh leaves of Salvia officinalis L. by steam distillation and further ‘Recommended maximum condensation of volatile content of the active substance per constituents and separation from kg of complete feedingstuff with a the aqueous phase by decantation. moisture content of 12 %: — 3 mg for turkeys for fattening; CAS number: 8022-56-8 — 3 mg for chickens for Einecs: 283-291-0 fattening and minor poultry FEMA number: 3001 for fattening; CoE number: 414 — 3 mg for all poultry reared for laying or breeding; Specifications: — 3 mg for ornamental birds; — 4 mg for all poultry for laying α-Thujone: 18-27 % or breeding; Camphor: 4-24,5 % — 6 mg for pigs for fattening; 1,8-Cineole (eucalyptol): 5,5-13 % — 5 mg for piglets (suckling and β-Thujone: 3-7 % weaned) of all Suidae; ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj 9/11 OJ L, 17.7.2025 ENMinimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of Other provisions description, analytical method age mg of additive/kg of complete authorisation feed additive animal feedingstuff with a moisture content of 12 % Analytical method(2) — 5 mg for pigs for fattening of minor Suidae; For the determination of camphor, — 7 mg for all Suidae for alpha-thujone and beta-thujone reproduction; (phytochemical markers) in the — 11 mg for calves for fattening feed additive: up to 6 months; — Gas chromatography coupled — 10 mg for sheep and goats; with flame ionisation — 10 mg for cattle for fattening, detection (GC-FID) (ISO 9909) other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidaefor fattening; — 7 mg for all other ruminants and all other Camelidae; — 10 mg for Equidae; — 4 mg for Leporidae; — 11 mg for salmonids and minor fin fish; — 12 mg for dogs; — 20 mg for ornamental fish; — 2 mg for cats; — 2 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 level on the label of the premixture would result in exceeding the level referred to in point 3. 10/11 ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj EN OJ L, 17.7.2025Minimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of Other provisions description, analytical method age mg of additive/kg of complete authorisation feed additive animal feedingstuff with a moisture content of 12 % 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. ELI: http://data.europa.eu/eli/reg_impl/2025/1400/oj 11/11 OJ L, 17.7.2025 EN