COMMISSION IMPLEMENTING REGULATION (EU) 2024/2179

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2024/2179 | 3.9.2024 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2024/2179 of 2 September 2024 amending Implementing Regulation (EU) 2022/1452 as regards the recommended maximum content of 4-hydroxy–2,5-dimethylfuran-3(2H)-one for cats and dogs (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 13(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 or modifying such authorisation. ---|--- (2) | The substance 4-hydroxy–2,5-dimethylfuran-3(2H)-one was authorised by Commission Implementing Regulation (EU) 2022/1452 (2) as a feed additive for cats and dogs. ---|--- (3) | In accordance with Article 13(1) of Regulation (EC) No 1831/2003, the Commission requested the European Food Safety Authority (‘the Authority’) to issue an opinion on whether the authorisation of 4-hydroxy–2,5-dimethylfuran-3(2H)-one as a feed additive for cats and dogs would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, if the terms of that authorisation were modified. The modification relates to the increase of the recommended maximum content from 5 to 25 mg/kg complete feed for cats and dogs. The request was accompanied by the relevant supporting data. ---|--- (4) | The Authority concluded in its opinion of 13 March 2024 (3) that 4-hydroxy–2,5-dimethylfuran-3(2H)-one is safe for dogs at the recommended maximum content of 25 mg/kg complete feed and for cats at 18 mg/kg complete feed. It also concluded that the additive is irritant to skin, eyes and to the respiratory tract and is a skin sensitiser. The Authority concluded that since 4-hydroxy–2,5-dimethylfuran-3(2H)-one 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. ---|--- (5) | The Commission considers that the authorisation of 4-hydroxy–2,5-dimethylfuran-3(2H)-one still meets the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, when modifying the terms thereof as regards an increase of the maximum recommended content to 25 mg/kg complete feed for dogs and at 18 mg/kg complete feed for cats. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. ---|--- (6) | Implementing Regulation (EU) 2022/1452 should therefore be amended accordingly. ---|--- (7) | 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 Amendment to Implementing Regulation (EU) 2022/1452 Implementing Regulation (EU) 2022/1452 is amended as follows: In the Annex, the entry of the additive 2b13010, column “other provisions”, point 3 is replaced by the following: “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 %: | — | cats: 18 mg ---|--- — | dogs: 25 mg’ ” ---|--- Article 2 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, 2 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) Commission Implementing Regulation (EU) 2022/1452 of 1 September 2022 concerning the authorisation of 3-ethylcyclopentan–1,2-dione, 4-hydroxy–2,5-dimethylfuran-3(2H)- one, 4,5-dihydro-2-methylfuran-3(2H)-one, eugenol, 1-methoxy-4-(prop-1(trans)-enyl)benzene, α-pentylcinnamaldehyde, α-hexylcinnamaldehyde and 2-acetylpyridine as feed additives for certain animal species (OJ L 228, 2.9.2022, p. 17), ELI: http://data.europa.eu/eli/reg_impl/2022/1452/oj. (3) EFSA Journal. 2024;22:e8721. * * * ELI: http://data.europa.eu/eli/reg_impl/2024/2179/oj ISSN 1977-0677 (electronic edition) * * *