Commission Implementing Regulation (EU) 2023/1682 of 29 June 2023 concerning the renewal of the authorisation of dimethylglycine sodium salt as a feed additive for chickens for fattening (holder of the authorisation: Taminco BV) and repealing Implementing Regulation (EU) No 371/2011 (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 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 authorisation.

(2) Dimethylglycine sodium salt was authorised for a period of 10 years as a feed additive for chickens for fattening by Commission Implementing Regulation (EU) No 371/2011 (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 dimethylglycine sodium salt as a feed additive for chickens for fattening, requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives: (improvement of zootechnical parameters)’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 (3) that the applicant had provided evidence that the additive remains safe for chickens for fattening, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additive is not a skin irritant but may be an eye irritant and skin sensitiser.

(5) The Annex to Implementing Regulation (EU) No 371/2011 erroneously provides for the description of the functional group ‘zootechnical additives (improvement of zootechnical parameters)’. The opinion of the European Food Safety Authority (‘the Authority’) of 7 December 2010 (4) stated that the additive has the potential to increase performance in chickens for fattening. The term ‘zootechnical’ is too generic and may encompass different functions, while not expressing the specific effects of the additive. Therefore, in order to be in line with the opinion of the Authority, the functional group of the feed additive should refer to the improvement of performance parameters. In addition, the Authority concluded in its opinion of 7 December 2020 (5) that the additive is efficacious at a level of 1 000 mg/kg, consequently, a minimum level should be established.

(6) In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (6), the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment are applicable for the current application.

(7) The assessment of dimethylglycine sodium salt shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. 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.

(8) As a consequence of the renewal of the authorisation of dimethylglycine sodium salt as a feed additive, Implementing Regulation (EU) No 371/2011 should be repealed.

(9) Considering that the functional group should appear on the label of the feed additive, of the premixtures and compound feed containing it, it is necessary to provide for a transitional period allowing feed business operators to make the necessary adaptations to the labels.

(10) 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 the authorisation

The authorisation of the substance specified in the Annex, belonging to the additive category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives: (improvement of performance parameters)’, is renewed subject to the conditions laid down in that Annex.

Article 2

Repeal of Implementing Regulation (EU) No 371/2011

Implementing Regulation (EU) No 371/2011 is repealed.

Article 3

Transitional measures

Article 4

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, 29 June 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 268, 18.10.2003, p. 29.

(2) Commission Implementing Regulation (EU) No 371/2011 of 15 April 2011 concerning the authorisation of dimethylglycine sodium salt as a feed additive for chickens for fattening (OJ L 102, 16.4.2011, p. 6).

(3) EFSA Journal 2021;19(5):6621

(4) EFSA Journal (2011); 9(1):1950

(5) EFSA Journal 2021;19(5):6621

(6) 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).