Commission Implementing Regulation (EU) 2023/2645 of 28 November 2023 concerning the authorisation of a preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 as a feed additive for all poultry species for fattening and reared for laying or breeding, weaned piglets, weaned piglets of minor porcine species, pigs for fattening and minor porcine species for fattening (holder of authorisation: Elanco GmbH)
Commission Implementing Regulation (EU) 2023/2645of 28 November 2023concerning the authorisation of a preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 as a feed additive for all poultry species for fattening and reared for laying or breeding, weaned piglets, weaned piglets of minor porcine species, pigs for fattening and minor porcine species for fattening (holder of authorisation: Elanco GmbH)(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-mannanase produced by Paenibacillus lentus DSM 33618 as a feed additive available in a solid formulation and a liquid formulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)The application concerns the authorisation of a preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 as a feed additive for all poultry species for fattening and reared for laying or breeding, weaned piglets, weaned piglets of minor porcine species, pigs for fattening and minor porcine species for fattening ("the target species"), requesting that additive to be classified in the category "zootechnical additives" and in the functional group "digestibility enhancers".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 2 February 2023EFSA Journal 2023;21(2):7878. that, under the proposed conditions of use, the preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 is safe for the target species, for the consumers and for the environment. The Authority also concluded that the preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 is not irritant to the skin and eyes but is regarded as a dermal sensitiser and a potential respiratory sensitiser. The Authority further concluded that the preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 has a potential to be efficacious at 32000 U/kg complete feed in chickens for fattening, chickens reared for laying, minor poultry species for fattening or reared for laying or breeding, pigs for fattening and minor porcine species for fattening, and at 48000 U/kg complete feed in turkeys for fattening, turkeys reared for breeding, weaned piglets and weaned piglets of minor porcine species. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(5)The applicant informed the Commission by a letter of 10 July 2023 of their intention to propose a re-formulation of the liquid formulation of the preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618, and requested that the authorisation process of the solid formulation of that additive be continued separately.(6)In view of the above, the Commission considers that the solid formulation of the preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of the solid formulation of that preparation should be authorised for the target species. 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: