Commission Implementing Regulation (EU) 2024/260 of 12 January 2024 concerning the authorisation of cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, dong quai tincture from Angelica sinensis (Oliv.) Diels, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., asafoetida essential oil from Ferula-assa-foetida L., dill herb essential oil from Anethum graveolens L. and dill tincture from Anethum graveolens L. as feed additives for certain animal species
Commission Implementing Regulation (EU) 2024/260of 12 January 2024concerning the authorisation of cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, dong quai tincture from Angelica sinensis (Oliv.) Diels, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., asafoetida essential oil from Ferula-assa-foetida L., dill herb essential oil from Anethum graveolens L. and dill tincture from Anethum graveolens L. as feed additives for certain 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 nutritionOJ L 268, 18.10.2003, p. 29., 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/EECCouncil Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1)..(2)The substances cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., dill tincture from Anethum graveolens, dong quai tincture from Angelica sinensis (Oliv.) Diels, asafoetida essential oil from Ferula-assa-foetida L., and dill herb essential oil from Anethum graveolens L. were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These substances were subsequently entered in the Register of Feed Additives as existing products 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 cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., dill tincture from Anethum graveolens, dong quai tincture from Angelica sinensis (Oliv.) Diels, asafoetida essential oil from Ferula-assa-foetida L., and dill herb essential oil from Anethum graveolens L. for all animal species, requesting the additives 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. The applicant subsequently withdrew the application for authorisation of dong quai tincture from Angelica sinensis (Oliv.) Diels as regards the use for all animal species except poultry, horses dogs and cats, for authorisation of asafoetida essential oil from Ferula-assa-foetida L. as regards the use for all animal species except dogs and cats and for authorisation of dill herb essential oil from Anethum graveolens L. as regards all animal species except dogs and cats.(4)The applicant requested the additives to be authorised for use also in water for drinking. In addition, for dong quai tincture from Angelica sinensis (Oliv.) Diels the request for authorisation for poultry was only for a use 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 those additives in water for drinking should not be allowed.(5)The European Food Safety Authority ("the Authority") concluded in its opinions of 22 November 2022EFSA Journal 2022;20(12):7690, EFSA Journal 2023;21(1):7691, EFSA Journal 2022;20(12):7692, EFSA Journal 2023;21(1):7693, EFSA Journal 2023;21(1):7694, EFSA Journal 2022;20(12):7695, EFSA Journal 2022;20(12):7689, EFSA Journal 2022;20(12):7688. that, under the proposed conditions of use, cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, dong quai tincture from Angelica sinensis (Oliv.) Diels, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., dill herb essential oil from Anethum graveolens L. and dill tincture from Anethum graveolens L., are safe for the target species, consumers and the environment. As regards asafoetida essential oil from Ferula-assa-foetida L., the Authority considered that the substance is safe for dogs and cats and that there is no evidence of concern for the environment. The Authority also concluded that dill herb essential oil, cumin essential oil, dill tincture, sweet fennel tincture, asafoetida oil, dong quai tincture, parsley tincture and star anise tincture should be considered as irritant to skin and eyes, and as dermal and respiratory sensitisers. The Authority concluded that when handling the cumin essential oil, dill herb essential oil, dill tincture, sweet fennel tincture and star anise tincture, exposure of unprotected users to estragole (and dillapiole) cannot be excluded and that therefore, to reduce the risk, the exposure of the users should be minimised. In addition, the Authority concluded that when handling parsley tincture, the exposure of unprotected users to apiole, elemicin and myristicin cannot be excluded and that therefore, to reduce the risk, the exposure of the users should be minimised. The Authority further concluded that since the substances are recognised to flavour food and since 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 cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, dong quai tincture from Angelica sinensis (Oliv.) Diels, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., asafoetida oil from Ferula-assa-foetida L., dill herb essential oil from Anethum graveolens L. and dill tincture from Anethum graveolens L. satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 for certain animal species. Accordingly, the use of these substances should be authorised for those animal species. The Commission considers that safety reasons do not require the setting of maximum contents for asafoetida essential oil from Ferula-assa-foetida L. and for dill herb essential oil from Anethum graveolens L.. The large margin of exposure and the lack of substances of concern permit to establish maximum recommended contents. In order to allow better control, the 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. For cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., dong quai tincture from Angelica sinensis (Oliv.) Diels and dill tincture from Anethum graveolens L., the Commission considers that the presence of substances of concern requires to set a maximum content in complete feed and to limit the combination of these additives with others containing the same substances of concern. 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)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.(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:
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