Commission Implementing Regulation (EU) 2019/849 of 24 May 2019 amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids (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 13(2) thereof,

Whereas:

(1) Commission Implementing Regulation (EU) 2017/1492 (2) authorises cholecalciferol (vitamin D3) as nutritional additive for all animal species. In that Regulation, the maximum authorised content of vitamin D3 for fish is 3 000 IU/kg of complete feedingstuff.

(2) The Norwegian Food Safety Authority (NFSA) submitted studies on the safety of vitamin D3 for fish and consumers at substantially higher levels (60 000 IU/kg of complete feedingstuff) than the maximum authorised content.

(3) For control purposes the results of calculation of tolerance levels can lead to a discrepancy in values between the two units (mg or IU). For this reason, the levels in the authorisation should be established only in International Units.

(4) On the basis of the data submitted by the NFSA, the European Food Safety Authority concluded in its opinions of 25 January 2017 (3) and 29 November 2018 (4) that a total level of 60 000 IU of vitamin D3 per kg of complete feedingstuff is safe for consumers and the environment. The European Food Safety Authority also concluded that the levels proposed were safe for salmonids. For other fish, no sufficient data were available to conclude on the safety for a total level of 60 000 IU vitamin D3/kg of complete feedingstuff. Consequently, the authorisation should be restricted to salmonids. It also concluded in the opinion of 13 November 2012 (5) that vitamin D3 is not an irritant to skin and eyes and is not a skin sensitiser. For some formulations of vitamin D3 there is a potential for workers to be exposed to high levels of vitamin D3 by inhalation. Inhaled vitamin D3 is highly toxic. Exposure to dust is harmful to persons handling the additive. As the levels of vitamin D3 have been increased this may have implications for user safety, 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.

(5) The Annex to Implementing Regulation (EU) 2017/1492 should therefore be amended accordingly.

(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 Annex to Implementing Regulation (EU) 2017/1492 is replaced by the text set out in the Annex to this Regulation.

Article 2

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, 24 May 2019.

For the Commission The President Jean-Claude JUNCKER

(1) OJ L 268, 18.10.2003, p. 29.

(2) Commission Implementing Regulation (EU) 2017/1492 of 21 August 2017 concerning the authorisation of cholecalciferol as a feed additive for all animal species (OJ L 216, 22.8.2017, p. 19).

(3) EFSA Journal 2017;15(3):4713.

(4) EFSA Journal 2019;17(1):5540.

(5) EFSA Journal 2012;10(12):2968