【发布文号】 (EU) No 1249/2014
【发布日期】 2014-11-22
【生效日期】
【废止日期】
【替代法规】
【效 力】
【食品伙伴网解读】
根据指令70/524/EEC，无限期地批准肌醇作为营养添加剂用于所有动物种类，属于“维生素、维生素原以及有相似作用的有明确化学定义的物质”组。之后，根据(EC) No 1831/2003第10(1)条的规定，肌醇作为现有产品登记在欧共体饲料添加剂登记簿中。欧盟委员会收到一份，根据条例(EC) No 1831/2003第10(2)条和第7条的规定，关于重新评价肌醇作为饲料添加剂用于鱼类、甲壳类动物、猫和狗的申请，申请人请求将此饲料添加剂归类在“营养型添加剂”分类下。该申请同时附带了(EC) No 1831/2003第7（3）条所要求的资料和文件。2014年9月4日，欧洲食品安全局发布意见认为在拟定的饲料使用条件下，肌醇不会对动物和人类健康或环境产生不利影响，并且它可作为鱼类和甲壳类动物必需微量元素的有效来源。欧洲食品安全局认为没有必要制定售后监测的具体要求。因此，批准肌醇作为饲料添加剂用于鱼类和甲壳类动物。
COMMISSION IMPLEMENTING REGULATION (EU) No 1249/2014
of 21 November 2014
concerning the authorisation of inositol as a feed additive for fish and crustaceans
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European unio,
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 nutrition (1), and in particular Article 9(2) thereof,
wheras:
(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/EEC (2).
(2)
Inositol was authorised without a time limit in accordance with Directive 70/524/EEC as a nutritional additive for use in all animal species as part of the group ‘Vitamins, pro-vitamins and chemically well-defined substances having similar effect’. That substance was subsequently entered in the Community Register of feed additives as an existing product, 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, an application was submitted for the re-evaluation of Inositol as feed additive for fish, crustaceans, cats and dogs. The applicant requested that additive to be classified in the additive category ‘nutritional additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4)
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 April 2014 (3) that, under the proposed conditions of use in feed, Inositol does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that Inositol is regarded as an effective source of essential micronutrient for fish and crustaceans. 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 submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5)
The assessment of Inositol shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.
(6)
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 the disposal of existing stocks of the additives, pre-mixtures and compound feed containing them, as authorised by Directive 70/524/EEC.
(7)
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:
Article 1
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
The substance specified in the Annex and feed containing that substance, and which are produced and labelled before 12 June 2015 in accordance with the rules applicable before 12 December 2014 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European unio.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 November 2014.
For the Commission
The President
Jean-Claude JUNCKER