Commission Implementing Regulation (EU) 2023/1713 of 7 September 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 for chickens for fattening, chickens reared for laying and minor poultry species (holder of authorisation: Danisco (UK) Ltd represented in the Union by Genencor international B.V.) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/1713of 7 September 2023concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 for chickens for fattening, chickens reared for laying and minor poultry species (holder of authorisation: Danisco (UK) Ltd represented in the Union by Genencor international B.V.)(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 an authorisation.(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease (also known as "subtilisin") produced by Bacillus subtilis ATCC SD-2107 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525. 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 the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis ATCC SD-2107 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 as a feed additive for chickens for fattening, chickens reared for laying, laying hens and minor poultry species, to be classified in the category "zootechnical additives" and in the functional group "digestibility enhancers".(4)The European Food Safety Authority ("the Authority") could not conclude, in its opinion of 25 May 2020EFSA Journal 2020;18(6):6165., on the safety of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis ATCC SD-2107 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 for the target species, consumers, users and the environment. However, in its subsequent opinion of 6 January 2023EFSA Journal 2023;21(2):7816., the Authority reported that the applicant submitted new information to address some of the limitations identified in the opinion of 25 May 2020 and declared a change in the production strain of the protease, substituting Bacillus subtilis ATCC SD-2107 for Bacillus subtilis CBS 148232, and concluded that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 does not have adverse effects on animal health, consumer safety or the environment. It also concluded that that preparation is considered a respiratory sensitiser and, in the absence of data, could not conclude on its irritancy potential to skin and eyes nor on its skin sensitising properties. The Authority also concluded in its opinion of 6 January 2023 with reference to its opinion of 25 May 2020 that the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay, but could not conclude on its efficacy for laying hens. It did 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 applicant withdrew the application, on 14 April 2023, for the authorisation of the preparation for laying hens.(6)The assessment of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 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. 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.(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: