(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om godkjenning av sodium ferrocyanid og potassium ferrocyanid som tilsetningsstoff i fôr til alle dyrearter, og oppheving av kommisjonsforordning (EF) nr. 1810/2005
Godkjenning av sodium ferrocyanid og potassium ferrocyanid i fôr til alle dyrearter
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 14.3.2025
Bakgrunn
(fra kommisjonsforordningen)
(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 an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC.
(2) Sodium ferrocyanide and potassium ferrocyanide were authorised without a time limit by Commission Regulation (EC) No 1810/2005, in accordance with Directive 70/524/EEC, as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products belonging to the group of binders, anti-caking agents and coagulants, in accordance with Article 10(1)(b) 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 ferrocyanide and potassium ferrocyanide as feed additives for all animal species. The applicant requested the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘anticaking agents’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 21 March 2023 and 4 June 2024 that the use of sodium ferrocyanide and potassium ferrocyanide was safe for animals, when added to sodium chloride at the maximum contents further specified in the opinions and that, under the proposed conditions of use, they were of no concern to consumer safety. The Authority also concluded that sodium and potassium ferrocyanide were neither skin and eye irritants nor skin sensitisers. However, owing to the presence of nickel, sodium ferrocyanide was considered a dermal and respiratory sensitiser. No conclusions could be reached on safety for the user exposed via inhalation to potassium ferrocyanide. The use of sodium and potassium ferrocyanide as feed additives was considered safe for the environment. Sodium and potassium ferrocyanide were considered to be efficacious as anticaking agents when included in sodium chloride at the proposed use levels. The Authority 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) In view of the above, the Commission considers that sodium ferrocyanide and potassium ferrocyanide satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of those additives.
(6) As there are no safety issues that require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,