Commission Implementing Regulation (EU) 2022/1248 of 19 July 2022 concerning the authorisation of essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. as a feed additive for certain animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/1248of 19 July 2022concerning the authorisation of essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. as a feed additive 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 an 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 feeding stuffs (OJ L 270, 14.12.1970, p. 1)..(2)Essential oil from Origanum vulgare was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. The additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(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 re-evaluation of essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. for all animal species.(4)The applicant requested 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.(5)The European Food Safety Authority ("the Authority") concluded in its opinion of 12 November 2019EFSA Journal 2019;17(12):5909. that, under the proposed conditions of use, essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. should be considered as an irritant to skin and eyes, and as a potential skin and respiratory sensitizer. Therefore, 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)The Authority also concluded, that essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. is recognised to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(7)The assessment of essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.(8)The additive concerned contains some components such as carvacrol and thymol for which zootechnical effects have been demonstrated in certain additives already authorised. In order to prevent the use of doses of the additive which could potentially lead to such zootechnical effects, it is necessary to establish a maximum content as a condition of use of essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. as a flavouring in feed.(9)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.(10)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: