LegalizeCommission Implementing Regulation (EU) 2019/49 of 4 January 2019 concerning the authorisation of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine as feed additives for all animal species (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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
(2) Sodium selenite was authorised without a time limit as a feed additive for all animal species in accordance with Directive 70/524/EEC. This substance was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of sodium selenite as a feed additive for all animal species. In the framework of the re-evaluation an application was submitted also for a coated granulated form of sodium selenite.
(4) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of zinc-L-selenomethionine as a feed additive for all animal species.
(5) The applicants requested that sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine be classified in the additive category ‘nutritional additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(6) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 20 October 2015 (3), 28 January 2016 (4), 8 March 2016 (5) and 20 February 2018 (6) that, under the proposed conditions of use, sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine do not have adverse effects on animal health, human health or the environment. With respect to the limitation of the supplementation with organic selenium established for other organic compounds of selenium, the Authority concluded that it should also apply to zinc-L-selenomethionine. Moreover, the Authority concluded that sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine may be considered as efficient sources of selenium for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(7) The assessment of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substance sodium selenite, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from 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
Authorisation
The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
Sodium selenite and premixtures containing that substance, which are produced and labelled before 3 August 2019 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted.
Feed materials and compound feed containing sodium selenite which are produced and labelled before 3 February 2020 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
Feed materials and compound feed containing sodium selenite which are produced and labelled before 3 February 2021 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3
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, 4 January 2019.
For the Commission The President Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) EFSA Journal 2015;13(11):4271.
(4) EFSA Journal 2016;14(2):4398.
(5) EFSA Journal 2016;14(3):4442.
(6) EFSA Journal 2018;16(3):5197.
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