Prováděcí nařízení Komise (EU) 2024/221 ze dne 12. ledna 2024 o obnovení povolení přípravku z endo–1,4-beta-xylanázy, endo–1,3(4)-beta-glukanázy a endo–1,4-beta-glukanázy z Trichoderma reesei ATCC 74444 jako doplňkové látky pro výkrm všech druhů drůbeže, všechny druhy drůbeže určené ke snášce a odstavená selata (držitel povolení: DSM Nutritional Products) a o změně prováděcího nařízení (EU) č. 403/2013

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,

The authorisation of the preparation specified in the Annex, belonging to the additive category zootechnical additives and to the functional group digestibility enhancers, is renewed subject to the conditions laid down in that Annex.

OJ L 268, 18.10.2003, p. 29 .

(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-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, was authorised for 10 years as a feed additive for poultry for fattening and for laying and for weaned piglets by Commission Implementing Regulation (EU) No 403/2013Commission Implementing Regulation (EU) No 403/2013 of 2 May 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) as a feed additive for poultry for fattening and for laying and for weaned piglets and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005 and (EC) No 1876/2006 (holder of authorisation DSM Nutritional Products) (OJ L 121, 3.5.2013, p. 26 ). .

(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-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, as a feed additive. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (the Authority) concluded in its opinion of 11 May 2023 EFSA Journal 2023;21(6):8043. that the preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, remains safe for poultry for fattening and for laying and for weaned piglets, the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, should be considered a potential respiratory sensitiser. In absence of data the Authority could not conclude on the potential of that preparation to cause skin and eye irritation or dermal sensitisation. It also indicated that there is no need for assessing the efficacy of the preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, in the context of the renewal of the authorisation. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It 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) In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. 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.

(6) As a consequence of the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, as a feed additive, Implementing Regulation (EU) No 403/2013 should be amended.

(7) 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-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, 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.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

Implementing Regulation (EU) No 403/2013 is amended as follows:

Commission Implementing Regulation (EU) No 403/2013 of 2 May 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) as a feed additive for poultry for fattening and for laying and for weaned piglets and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005 and (EC) No 1876/2006 (holder of authorisation DSM Nutritional Products) (OJ L 121, 3.5.2013, p. 26 ).

Article 1 Article 1 Renewal of authorisation

Article 2 Article 2 Amendment to Implementing Regulation (EU) No 403/2013

Article 3 Article 3 Transitional measures 1.The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 4 August 2024 in accordance with the rules applicable before 4 February 2024 may 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 produced and labelled before 4 February 2025 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4 Article 4 Entry into force

(1) Article 1 is deleted;

(2) the Annex is deleted.

The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 4 August 2024 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 4 February 2025 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

EFSA Journal 2023;21(6):8043.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

HAS ADOPTED THIS REGULATION: