COMMISSION IMPLEMENTING REGULATION (EU) 2024/2385

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2024/2385 | 10.9.2024 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2024/2385 of 9 September 2024 concerning the authorisation of 4-methyl-5-vinylthiazole 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 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 4-methyl-5-vinylthiazole 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 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 4-methyl-5-vinylthiazole 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 applicant withdrew the application for water for drinking for 4-methyl-5-vinylthiazole. ---|--- (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 May 2023 (3) that 4-methyl-5-vinylthiazole is safe at certain maximum concentrations further specified for each species. Furthermore, it concluded that 4-methyl-5-vinylthiazole is safe for consumers and for the environment at the proposed use level in feed. It concluded that 4-methyl-5-vinylthiazole should be considered as an irritant to skin and eyes and the respiratory tract, and as a dermal and respiratory sensitiser. The Authority further concluded that since the additive under assessment is used in food as a flavouring and its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary. 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 4-methyl-5-vinylthiazole satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. 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) | The Commission considers that safety reasons do not require the setting of maximum contents for 4-methyl-5-vinylthiazole. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additive. 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 4-methyl-5-vinylthiazole, 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 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 4-methyl-5-vinylthiazole, as authorised pursuant to Directive 70/524/EEC and premixtures containing that additive, which are produced and labelled before 30 March 2025 in accordance with the rules applicable before 30 September 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 30 September 2025 in accordance with the rules applicable before 30 September 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 30 September 2026 in accordance with the rules applicable before 30 September 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, 9 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(6):8051. * * * 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 active substance/kg of complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b15018 | 4-Methyl-5-vinylthiazole | Additive composition 4-Methyl-5-vinylthiazole Liquid form Characterisation of active substance 4-Methyl-5-vinylthiazole Produced by chemical synthesis Purity: min. 97 % Chemical formula: C6H7NS CAS number: 1759-28-0 FLAVIS: 15.018 Analytical method (1) For the identification of 4-methyl-5-vinylthiazole in the feed additive and flavouring premixtures: gas chromatography-mass spectrometry with retention time locking (GC-MS-RTL). | 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 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 %: | — | 0,2 mg for all poultry for laying or breeding purposes; ---|--- — | 0,1 mg for all poultry reared for laying or breeding; ---|--- — | 0,1 mg for all poultry for fattening; ---|--- — | 0,1 mg for ornamental birds; ---|--- — | 0,3 mg for all Suidae for reproduction; ---|--- — | 0,2 mg for piglets of all Suidae; ---|--- — | 0,2 mg for all Suidae for fattening; ---|--- — | 0,5 mg for calves for fattening up to 6 months; ---|--- — | 0,4 mg for all ruminants for fattening and Camelidae for fattening; ---|--- — | 0,3 mg for all other ruminants and Camelidae; ---|--- — | 0,4 mg for Equidae; ---|--- — | 0,5 mg for salmonids and minor fin fish; ---|--- — | 0,5 mg for ornamental fish; ---|--- — | 0,2 mg for rabbits; ---|--- — | 0,5 mg for dogs; ---|--- — | 0,4 mg for cats; ---|--- — | 0,1 mg for other animal 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 breathing, eye and skin protective equipment. ---|--- 30 September 2034 * * * (1) 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/2024/2385/oj ISSN 1977-0677 (electronic edition) * * *