Commission Implementing Regulation (EU) 2020/1370 of 1 October 2020 concerning the authorisation of a preparation of lanthanide citrate as a feed additive for weaned piglets (holder of authorisation Treibacher Industrie AG) (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 such authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of lanthanide citrate. 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 the preparation of lanthanide citrate as a feed additive for weaned piglets to be classified in the additive category ‘zootechnical additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 16 April 2013 (2), 20 April 2016 (3) and 12 November 2019 (4) that, under the proposed conditions of use, the preparation of lanthanide citrate does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that although the acute respiratory toxicity data indicate that the dust is of low toxicity, prolonged or repeated exposure to the additive should be avoided. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive has the potential to be efficacious in improving the growth of weaned piglets. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It 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) The assessment of the preparation of lanthanide citrate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

(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

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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, 1 October 2020.

For the Commission The President Ursula VON DER LEYEN

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

(2) EFSA Journal 2013; 11(5):3206.

(3) EFSA Journal 2016; 14(5):4477.

(4) EFSA Journal 2019; 17(12):5912.