Commission Implementing Regulation (EU) 2019/454 of 20 March 2019 concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage additives for all animal species (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2019/454of 20 March 2019concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage 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(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives.(2)In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of alpha-amylase (EC 3.2.1.1) produced by the following strains of Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 were entered in the Register of feed additives as existing products belonging to the functional group of silage additives, for all animal species.(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 authorisation of the three preparations of alpha-amylase (EC 3.2.1.1) and a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) as feed additives for all animal species.(4)The application concerns the authorisation of preparations of alpha-amylase (EC 3.2.1.1) produced by Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 as feed additives for all animal species, to be classified in the additive category "technological additives". The 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 7 March 2018EFSA Journal 2018; 16(4):5224. that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations concerned have the potential to improve the production of silage from easy, moderate and difficult to ensile forage materials. 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.(6)The assessment of the preparations of alpha-amylase (EC 3.2.1.1) produced by Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 show that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex to this Regulation.(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: