COMMISSION IMPLEMENTING REGULATION (EU) 2024/2427

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2024/2427 | 17.9.2024 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2024/2427 of 16 September 2024 concerning the authorisation of coriander essential oil from Coriandrum sativum L. 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 coriander essential oil from Coriandrum sativum L. was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of Feed Additives as an existing product belonging to the category ‘sensory additives’ and to the functional group ‘flavouring compounds’, 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 coriander essential oil from Coriandrum sativum L. 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’. That 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 28 September 2023 (3) that coriander essential oil from Coriandrum sativum L. is safe for all animal species at certain maximum concentrations further specified for each species. Furthermore, it concluded that coriander essential oil from Coriandrum sativum L.is safe for consumers and for the environment at the proposed use level in feed. It also concluded that coriander essential oil from Coriandrum sativum L. should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The Authority further concluded that since the fruit of Coriandrum sativum L. and its oil 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 for the essential oil under assessment. The Authority 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. ---|--- (6) | In view of the above, the Commission considers that coriander essential oil from Coriandrum sativum L. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. The Commission considers that safety reasons do not require the setting of maximum contents for coriander essential oil from Coriandrum sativum L. In order to allow better control, a recommended maximum content should be indicated on the label of the feed additives. Where such contents are exceeded, certain information should be indicated on the label of the premixtures concerned. 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 coriander essential oil from Coriandrum sativum L., 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 coriander essential oil from Coriandrum sativum L. as authorised pursuant to Directive 70/524/EEC and premixtures containing that substance, which are produced and labelled before 7 April 2025 in accordance with the rules applicable before 7 October 2024 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 October 2025 in accordance with the rules applicable before 7 October 2024 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 October 2026 in accordance with the rules applicable before 7 October 2024 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 September 2024. 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 2023;21(10):8349. * * * 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 active substance/kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b154-eo | Coriander essential oil | Additive composition Coriander essential oil from the fruit of Coriandrum sativum L. Liquid form Characterisation of the active substance Coriander essential oil Essential oil as defined by the Council of Europe (1) from the fruit of Coriandrum sativum L. produced by steam distillation. CAS number: 8008-52-4 EINECS number: 283-880-0 FEMA number: 2334 CoE number:154 Specifications | — | Linalool: 65,78 % ---|--- — | α-Pinene: 4-8,5 % ---|--- — | γ-Terpinene: 3,7 % ---|--- — | Camphor: 3,6 % ---|--- — | Geranyl acetate: 0,5-6,1 % ---|--- — | d-Limonene: 0,5,4 % ---|--- — | Geraniol: 0,1,3 % ---|--- — | Myrcene: 0,1,2 % ---|--- — | α-Terpineol: maximum 1 % ---|--- Analytical method (2) For the determination of linalool (phytochemical marker) in the feed additive: gas chromatography coupled to flame ionisation detection (GC-FID) (ISO 3516) 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 %: | — | 26 mg for all poultry for laying or breeding purposes ---|--- — | 18 mg for all poultry reared for laying or breeding; ---|--- — | 18 mg for chickens for fattening and minor poultry for fattening; ---|--- — | 24 mg for turkeys for fattening; ---|--- — | 18 mg for ornamental birds; ---|--- — | 30 mg for all Suidae; ---|--- — | 30 mg for all ruminants and Camelidae; ---|--- — | 30 mg for Equidae; ---|--- — | 30 mg for salmonids and minor fin fish; ---|--- — | 30 mg for ornamental fish; ---|--- — | 28 mg for rabbits; ---|--- — | 30 mg for dogs; ---|--- — | 14 mg for cats; ---|--- — | 14 mg for other animal species or 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 the 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 breathing, eye and skin protective equipment. ---|--- 7 October 2034 * * * (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/2024/2427/oj ISSN 1977-0677 (electronic edition) * * *