Commission Implementing Regulation (EU) 2015/1060 of 2 July 2015 concerning the authorisation of betaine anhydrous and betaine hydrochloride as feed additives for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2015/1060of 2 July 2015concerning the authorisation of betaine anhydrous and betaine hydrochloride as feed additives for all 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 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)Betaine anhydrous and betaine hydrochloride were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) 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, three applications were submitted for the re-evaluation of betaine anhydrous and betaine hydrochloride and preparations of these substances as feed additives for all animal species and, in accordance Article 7 of that Regulation, for a new use in water for drinking. The applicants requested these additives to be classified in the additive category "nutritional additives". Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(4)Genetically modified sugar beet KM-ØØØH71-4 and feed produced from it were authorised to be placed on the market by Commission Decision 2007/692/ECCommission Decision 2007/692/EC of 24 October 2007 authorising the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 283, 27.10.2007, p. 69).. In accordance with Article 9(6) of Regulation (EC) No 1831/2003 the authorisation of betaine anhydrous produced from genetically modified sugar beet KM-ØØØH71-4 is to include the name of the holder of the authorisation "Trouw Nutritional International BV" and the unique identifier attributed to the genetically modified organism (GMO).(5)The European Food Safety Authority ("the Authority") concluded in its opinions of 17 April 2013 and 18 April 2013EFSA Journal 2013;11(5):3209;EFSA Journal 2013;11(5):3210;EFSA Journal 2013;11(5):3211. that under the proposed conditions of use in feed, betaine anhydrous and betaine hydrochloride do not have adverse effects on animal health, human health or the environment.(6)The Authority further concluded that betaine anhydrous and betaine hydrochloride have the potential to be efficacious for all animal species. The Authority also concluded that no safety concerns would arise for users. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed and water submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(7)The assessment of betaine anhydrous and betaine hydrochloride shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of these substances should be authorised as specified in the Annex to this Regulation. Maximum recommended contents of supplementation of betaine anhydrous and betaine hydrochloride in feedingstuffs and water for drinking should be set up.(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.(9)KM-ØØØH71-4 sugar beet is authorized to be used in the production of foods, food ingredients and feed for a period of 10 years from the date of the notification of Decision 2007/692/EC. That decision was notified to the authorization holders on 23 October 2007. The period of authorization of betaine anhydrous produced from KM-ØØØH71-4 sugar beet as a feed additive should not be longer than the period of authorization of KM-ØØØH71-4 sugar beet.(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: