Commission Implementing Regulation (EU) 2024/1743 of 21 June 2024 concerning the authorisation of a preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 as a feed additive for all poultry species for fattening and ornamental birds (holder of authorisation: BASF SE)

Official Journal EN of the European Union L series 2024/1743 24.6.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1743 of 21 June 2024 concerning the authorisation of a preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 as a feed additive for all poultry species for fattening and ornamental birds (holder of authorisation: BASF SE) (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 2003on additives for use in animal nutrition(1), 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 with Thermothelomyces thermophilus DSM 33149. 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 with Thermothelomyces thermophilus DSM 33149 as a feed additive for chickens and turkeys for fattening, minor poultry species for fattening and ornamental birds, 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 1 February 2023(2) that the preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 is safe for the environment and has the potential to be efficacious in chickens for fattening, turkeys for fattening, minor poultry species for fattening and ornamental birds at a use level of 800 TMU/kg. After the assessment of newly submitted data by the applicant, the Authority concluded in its opinion of 30 January 2024(3) that the preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 is safe for the target species at the proposed use level, and for the consumer. The Authority also concluded that the preparation of endo-1,4-beta- mannanase produced with Thermothelomyces thermophilus DSM 33149 is not irritant to the eyes or skin. Owing to the proteinaceous nature of the active substance, the additive should be considered a respiratory sensitiser. The Authority was not able to conclude on the potential of the additive to be a skin sensitiser. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority 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) In view of the above, the Commission considers that the preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all poultry species for fattening and ornamental birds. 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. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal 2023;21(2):7873. (3) EFSA Journal 2024;22:e8632. ELI: http://data.europa.eu/eli/reg_impl/2024/1743/oj 1/4EN OJ L, 24.6.2024 (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: Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 21 June 2024. For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/1743/ojANNEX Maxi- Minimum mum Identifica- content Name of the Composition, chemical Species or content tion number Maximum End of period of holder of Additive formula, description, category of Other provisions of the feed age authorisation authorisation analytical method animal Units of activity/kg of additive complete feedingstuff with a moisture content of 12 % Category: zootechnical additives. Functional group: digestibility enhancers. 4a47 BASF SE Endo-1,4-beta- Additive composition All poultry spe­ - 800 TMU - 1. In the directions for 14 July 2034 mannanase (EC cies for fatten­ use of the additive Preparation of 3.2.1.78) ing and premixture, the endo-1,4-beta-manna­ storage conditions nase (EC 3.2.1.78) pro­ Ornamental and stability to heat duced with Thermothelo­ birds treatment shall be in­ myces thermophilus DSM dicated. 33149 having a mini­ 2. For users of the addi­ mum activity of: 8 000 tive and premixtures, TMU/g(1). feed business opera­ Solid form and Liquid tors shall establish form operational proce­ Characterisation of the active dures and organisa­ substance tional measures to Endo-1,4-beta-manna­ address the potential nase (EC 3.2.1.78) pro­ risks resulting from duced with Thermothelo­ their use. Where myces thermophilus DSM those risks cannot be 33149 eliminated by such procedures and mea­ Analytical method(2) sures, the additive and For the determination of premixtures shall be the endo-1,4-beta-man­ used with personal nanase activity in the feed breathing and skin additive, premixtures and protective equip­ compound feed: ment. ELI: http://data.europa.eu/eli/reg_impl/2024/1743/oj 3/4 OJ L, 24.6.2024 EN— Enzymatic hydroly­ sis of dyed carob ga­ lactomannan with endo-1,4-beta-man­ nanase followed by photometry. (1) One Thermostable Mannanase Unit (TMU) is defined as the amount of enzyme that produces reducing carbohydrates having a reducing power corresponding to 1 μΜ mannose from locust bean gum (0,3 g/100 mL buffer solution) in 1 min at 50 °C and pH 3,5. (2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en. 4/4 ELI: http://data.europa.eu/eli/reg_impl/2024/1743/oj EN OJ L, 24.6.2024