Commission Implementing Regulation (EU) 2024/262 of 17 January 2024 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, the authorisation of that preparation as a feed additive for turkeys for fattening, all poultry species reared for laying or breeding, ornamental birds and suckling piglets (holder of the authorisation: Huvepharma NV) and amending Implementing Regulation (EU) 2015/2305

Official Journal EN of the European Union L series 2024/262 18.1.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/262 of 17 January 2024 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, the authorisation of that preparation as a feed additive for turkeys for fattening, all poultry species reared for laying or breeding, ornamental birds and suckling piglets (holder of the authorisation: Huvepharma NV) and amending Implementing Regulation

(EU) 2015/2305 (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 and renewing such an authorisation.

(2) A preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 (previously taxonomically identified as Trichoderma citrinoviride Bisset (IM SD142)) was authorised for a period of 10 years as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets by Commission Implementing Regulation (EU) 2015/2305(2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 for chickens for fattening, minor poultry species for fattening and weaned piglets, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. In accordance with Article 7 of Regulation (EC) No 1831/2003, that application also concerned the authorisation of new uses of the same preparation as a feed additive for turkeys for fattening, all poultry species reared for laying or breeding, ornamental birds and suckling piglets. That application was accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of that Regulation.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 21 March 2023(3), that the preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 remains safe for chickens for fattening, minor poultry species for fattening and weaned piglets, as well as for the consumers and the environment under the conditions of use currently authorised, and indicated that this conclusion on safety also applies to turkeys for fattening, all poultry species reared for laying or breeding, ornamental birds and suckling piglets. The Authority further concluded that the preparation is not considered skin corrosive or eye irritant. It stated that the preparation should be considered a skin sensitiser and a respiratory sensitiser, while no conclusion could be drawn on the potential of the additive to be a skin irritant. The Authority indicated that there was no need

(1) OJ L 268, 18.10.2003, p. 29.

(2) Commission Implementing Regulation (EU) 2015/2305 of 10 December 2015 concerning the authorisation of a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma Citrinoviride Bisset (IM SD142) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, and amending Regulations (EC) No 2148/2004 and (EC) No 1520/2007 (holder of authorisation Huvepharma NV) (OJ L 326, 11.12.2015, p. 43).

(3) EFSA Journal 2023;21(4):7954.

ELI: http://data.europa.eu/eli/reg_impl/2024/262/oj 1/4EN OJ L, 18.1.2024 for assessing the efficacy of the preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 in the context of the renewal of the authorisation for chickens for fattening, minor poultry species for fattening and weaned piglets, and considered that the conclusions on efficacy reached in chickens for fattening and weaned piglets can be extended to turkeys for fattening, all poultry species reared for laying or breeding, ornamental birds and suckling piglets. The Authority did not consider that there is a need for specific requirements of post- market monitoring.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of endo-1,4-beta- glucanase as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), points (a) and (c), of Commission Regulation (EC) No 378/2005(4), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that the preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that preparation should be renewed for chickens for fattening, minor poultry species for fattening and weaned piglets, and the use of that preparation should be authorised for turkeys for fattening, all poultry species reared for laying or breeding, ornamental birds and suckling piglets. 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) As a consequence of the renewal of the authorisation of the preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, Implementing Regulation (EU) 2015/2305 should be amended.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 for chickens for fattening, minor poultry species for fattening and weaned piglets, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

(9) 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 Renewal of authorisation The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, for chickens for fattening, minor poultry species for fattening and weaned piglets, is renewed subject to the conditions laid down in that Annex.

(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8).

2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/262/ojEN OJ L, 18.1.2024 Article 2 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised for turkeys for fattening, all poultry species reared for laying or breeding, ornamental birds and suckling piglets, subject to the conditions laid down in that Annex.

Article 3 Amendments to Implementing Regulation (EU) 2015/2305 Implementing Regulation (EU) 2015/2305 is amended as follows:

(1) Article 1 is deleted;

(2) the Annex is deleted.

Article 4 Transitional measures

1. The preparation specified in the Annex and premixtures containing that preparation, which are intended for chickens for fattening, minor poultry species for fattening and weaned piglets, and which are produced and labelled before 7 August 2024in accordance with the rules applicable before 7 February 2024may continue to be placed on the market and used until the existing stocks are exhausted.

2. Compound feed and feed materials containing the preparation specified in the Annex, which are intended for chickens for fattening, minor poultry species for fattening and weaned piglets, and which are produced and labelled before 7 February 2025in accordance with the rules applicable before 7 February 2024may continue to be placed on the market and used until the existing stocks are exhausted.

Article 5 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, 17 January 2024.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2024/262/oj 3/44/4

ELI:

http://data.europa.eu/eli/reg_impl/2024/262/oj ANNEX Minimum Maximum Identifica- content content tion Name of the Species or Composition, chemical formula, description, Maximum End of period of number of holder of Additive category of Units of activity/kg of Other provisions analytical method age authorisation the authorisation animal complete feedingstuff additive with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers.

4a1616 Huvepharma Endo-1,4-beta- Additive composition All poultry — 500CU — 1. In the directions for use of 7 February NV glucanase (EC species for the additive and premix­ 2034 Preparation of endo-1,4-beta-glucanase

3.2.1.4) fattening ture, the storage conditions (EC 3.2.1.4) produced by Trichoderma and stability to heat treat­ citrinoviride IMI 360748 having a All poultry ment shall be indicated. minimum activity of 2000 CU(1)/g.

species reared Solid or liquid form. for laying or 2. For users of the additive and breeding premixtures, feed business Characterisation of the active substance operators shall establish op­ Ornamental erational procedures and Endo-1,4-beta-glucanase (EC 3.2.1.4) birds organisational measures to address potential risks re­ produced by Trichoderma citrinoviride Suckling — 350CU — sulting from its use. Where IMI 360748.

piglets those risks cannot be elimi­ nated by such procedures Analytical method(2) Weaned piglets and measures, the additive For the determination of endo-1,4-beta- and premixtures shall be glucanase in feed additive, premixtures used with personal breath­

and compound feeds: colorimetric ing and skin protective method based on the quantification of equipment. water soluble dyed fragments (azurine) produced by the action of endo-1,4-beta-glucanase on azurine- crosslinked cellulose.

(1) One CU is the amount of enzyme that liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.

(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 EN OJ L,

18.1.2024