Commission Implementing Regulation (EU) 2024/261 of 17 January 2024 concerning the authorisation of black pepper essential oil and black pepper oleoresin from Piper nigrum L. as feed additives for all animal species and black pepper supercritical extract from Piper nigrum L. as a feed additive for cats and dogs
Commission Implementing Regulation (EU) 2024/261of 17 January 2024concerning the authorisation of black pepper essential oil and black pepper oleoresin from Piper nigrum L. as feed additives for all animal species and black pepper supercritical extract from Piper nigrum L. as a feed additive 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 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 black pepper essential oil and black pepper oleoresin from Piper nigrum L. and black pepper supercritical extract from Piper nigrum 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 black pepper essential oil, black pepper oleoresin and black pepper supercritical extract from Piper nigrum 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". 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 black pepper supercritical extract from Piper nigrum L. as regards the use for all animal species except cats and dogs.(4)The applicant requested the additives 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 those additives in water for drinking should not be allowed.(5)The European Food Safety Authority ("the Authority") concluded in its opinion of 27 September 2022EFSA Journal 2022;20(11):7599 that, under the proposed conditions of use, black pepper essential oil, black pepper supercritical extract and black pepper oleoresin from Piper nigrum L. are safe for the target species, consumers and the environment. It also concluded that black pepper essential oil, black pepper supercritical extract and black pepper oleoresin should be considered as irritant to skin and eyes, and as dermal and respiratory sensitisers. 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 black pepper essential oil, black pepper oleoresin and black pepper supercritical extract from Piper nigrum L. satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of these substances should be authorised. The Commission considers that safety reasons do not require the setting of maximum levels for the substances concerned. 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. 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: