Commission Implementing Regulation (EU) 2016/1833 of 17 October 2016 concerning the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets (holder of authorisation Biolek Sp. z o.o.) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2016/1833of 17 October 2016concerning the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets (holder of authorisation Biolek Sp. z o.o.)(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.(2)In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)That application concerns the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets to be classified in the additive category "zootechnical additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinions of 29 October 2014EFSA Journal 2015;13(1):3903. and 22 October 2015EFSA Journal 2015;13(11):4276. that, under the proposed conditions of use, the preparation of kidney bean lectins (Phaseolus vulgaris lectins) does not have an adverse effect on animal health, human health or the environment. It further concluded that the additive should be considered as a respiratory sensitizer and there is a potential hazard by inhalation exposure. The Authority has also concluded that it can have some potential to improve the performance of the piglets during the post-weaning period. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(5)The assessment of the preparation of kidney bean lectins (Phaseolus vulgaris lectins) 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 preparation should be authorised as specified in the Annex to this Regulation.(6)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: