(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om fornyelse av godkjenningen av et preparat av L-tyrosin som tilsetningsstoff i fôr til alle dyrearter og om oppheving av gjennomføringsforordning (EU) nr. 101/2014
Fornyet godkjenning av L-tyrosin som tilsetningsstoff i fôr til alle dyrearter
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 13.3.2025
Bakgrunn
(fra kommisjonsforordningen)
(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 and renewing such authorisation.
(2) L-tyrosine was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 101/2014.
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-tyrosine as a feed additive for all animal species, requesting that additive to be classified in the category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 June 20243 that the use of the feed additive in animal nutrition remains safe for the target species, consumers, and the environment. As regards the safety for the user, the Authority considered that L-tyrosine was not an irritant to skin or eyes, but it could not conclude on the potential of L-tyrosine to be a dermal sensitiser. Exposure to the additive by inhalation of persons handling it is likely. The Authority considered that there is no need to assess the efficacy of L-tyrosine, as the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation. The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of L-tyrosine as a feed additive in the context of the previous authorisation are still valid and applicable for the current application. In accordance with Article 5(4), point (c) of Commission Regulation (EC) No 378/20054 , an evaluation report of the Reference Laboratory is therefore not required.
(5) In view of the above, the Commission considers that L-tyrosine satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
(6) As a consequence of the renewal of the authorisation of L-tyrosine as a feed additive, Implementing Regulation (EU) No 101/2014 should be repealed.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,