COMMISSION IMPLEMENTING REGULATION (EU) 2025/1400

| Official Journal of the European Union | EN 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 × 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 (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 × piperita L., clary sage essential oil from Salvia sclarea L. 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 sclarea L. and sage essential oil from Salvia officinalis L. 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 × piperita L. 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 sclarea L. 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 × piperita L. 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 irritants to skin and eyes, and as dermal and respiratory sensitisers. The Authority further concluded that since peppermint essential oil from Mentha × piperita L., clary sage essential oil from Salvia sclarea L. 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 × piperita L., clary sage essential oil from Salvia sclarea L. and sage essential oil from Salvia officinalis L. 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 × piperita L., clary sage essential oil from Salvia sclarea L. and sage essential oil from Salvia officinalis L.. 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 × piperita L., clary sage essential oil from Salvia sclarea L. and sage essential oil from Salvia officinalis L., 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. 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 * * * (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. * * * ANNEX Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|--- mg of additive/kg of complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b282-eo | Peppermint essential oil | Additive composition Essential oil from the aerial parts of Mentha × piperita L. (basionym: Mentha aquatica × Mentha spicata L.) Liquid form Characterisation of active substance Peppermint essential oil: Essential oil, as defined by the Council of Europe (1), obtained from the aerial parts (the leaves with or without the flowers) of Mentha × piperita L. by steam distillation and further condensation of volatile constituents and separation from the aqueous phase by decantation. CAS number: 8006-90-4 Einecs: 308-770-2 FEMA number: 2848 CoE number: 282 Specifications: Menthol: 30-55 % Menthone: 13-32 % d,l-Isomenthone: 1,5-10 % Menthyl acetate: 2-10 % 1,8-Cineole (eucalyptol): 2-8 % Pulegone: ≤ 1,72 % Menthofuran: ≤ 4,54 % β-thujone: ≤ 0,01 % Coumarin: ≤ 0,001 % Estragole: ≤ 0,001 % Analytical method (2) For the determination of menthol and menthone (phytochemical markers) in the feed additive: | — | Gas chromatography coupled with flame ionisation detection (GC-FID) (ISO 856) ---|--- All animal species | - | - | - | | 1. | The additive shall be incorporated into the feed in the form of a premixture. ---|--- 2. | In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated. ---|--- 3. | On the label of the additive, the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 12 mg.’ ---|--- 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. ---|--- 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. ---|--- 6 August 2035 Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|--- mg of additive/kg of complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b415-eo | Clary sage essential oil | Additive composition Essential oil from flowering stems of Salvia sclarea L. Liquid form Characterisation of active substance Clary sage essential oil: Essential oil, as defined by the Council of Europe (3), obtained from fresh or dried flowering stems of Salvia sclarea L.by steam distillation and further condensation of volatile constituents and separation from the aqueous phase by decantation. CAS number: 8016-63-5 Einecs: 283-911-8 FEMA number: 2321 CoE number: 415 Specifications: Linalyl acetate: 55-78 % Linalool: 6,5-25 % Germacra-1(10),4(14),5-triene: 1-12 % α-Terpineol: 0-5 % Analytical method (4) For the determination of linalyl acetate and linalool (phytochemical marker) in the feed additive: | — | gas chromatography coupled with flame ionisation detection (GC-FID) (European Pharmacopoeia monograph 1850) ---|--- All animal species | - | - | - | | 1. | The additive shall be incorporated into the feed in the form of a premixture. ---|--- 2. | In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated. ---|--- 3. | On the label of the additive, the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: | — | 7 mg for turkeys for fattening; ---|--- — | 5 mg for chickens for fattening and minor poultry for fattening; ---|--- — | 5 mg for all poultry reared for laying or breeding; ---|--- — | 5 mg for ornamental birds; ---|--- — | 8 mg all poultry for laying or breeding; ---|--- — | 11 mg for pigs for fattening; ---|--- — | 9 mg for piglets (suckling and weaned) of all Suidae; ---|--- — | 9 mg for pigs for fattening of minor Suidae; ---|--- — | 14 mg for all Suidae for reproduction; ---|--- — | 15 mg for calves for fattening up to 6 months; ---|--- — | 15 mg for sheep and goats; ---|--- — | 15 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidae for 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. ---|--- 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. ---|--- 6 August 2035 Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|--- mg of additive/kg of complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b414-eo | Sage essential oil | Additive composition Essential oil from the fresh leaves of Salvia officinalis L. Liquid form Characterisation of active substance Sage essential oil: Essential oil, as defined by the Council of Europe (5), obtained from fresh leaves of Salvia officinalis L. by steam distillation and further condensation of volatile constituents and separation from the aqueous phase by decantation. CAS number: 8022-56-8 Einecs: 283-291-0 FEMA number: 3001 CoE number: 414 Specifications: α-Thujone: 18-27 % Camphor: 4-24,5 % 1,8-Cineole (eucalyptol): 5,5-13 % β-Thujone: 3-7 % Analytical method (6) For the determination of camphor, alpha-thujone and beta-thujone (phytochemical markers) in the feed additive: | — | Gas chromatography coupled with flame ionisation detection (GC-FID) (ISO 9909) ---|--- All animal species | - | - | - | | 1. | The additive shall be incorporated into the feed in the form of a premixture. ---|--- 2. | In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated. ---|--- 3. | On the label of the additive, the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: | — | 3 mg for turkeys for fattening; ---|--- — | 3 mg for chickens for fattening and minor poultry for fattening; ---|--- — | 3 mg for all poultry reared for laying or breeding; ---|--- — | 3 mg for ornamental birds; ---|--- — | 4 mg for all poultry for laying or breeding; ---|--- — | 6 mg for pigs for fattening; ---|--- — | 5 mg for piglets (suckling and weaned) of all Suidae; ---|--- — | 5 mg for pigs for fattening of minor Suidae; ---|--- — | 7 mg for all Suidae for reproduction; ---|--- — | 11 mg for calves for fattening up to 6 months; ---|--- — | 10 mg for sheep and goats; ---|--- — | 10 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidae for 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. ---|--- 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. ---|--- 6 August 2035 * * * (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. (3) Natural sources of flavourings – Report No 2 (2007). (4) 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. (5) Natural sources of flavourings – Report No 2 (2007). (6) 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 ISSN 1977-0677 (electronic edition) * * *