(Utkast) Kommisjonens gjennomføringsforordning om godkjenning av Norbixin (annatto F) som tilsetningsstoff i fôrvarer for katter og hunder
(Draft) Commission Implementing Regulation concerning the authorisation of Norbixin (annatto F) as a feed additive for cats and dogs
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 14.2.2020
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(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(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC .
(2) Norbixin (annatto F) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for dogs and cats belonging to the group ‘colourants, including pigments’, under the heading ‘colouring agents authorised for colouring foodstuffs by Community rules other than Patent blue V, Acid brilliant green BS, and Canthaxanthin’. This colourant was not specifically authorised but entered in this generic entry. The additive was subsequently entered in the Register of feed additives as an existing product, 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 Norbixin (annatto F) as a feed additive for dogs and cats. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘colourants’. 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 opinion of 22 March 2017 that, under the proposed conditions of use, Norbixin (annatto F) does not have an adverse effect on animal health. It also concluded that the substance is a strong alkaline solution that makes it corrosive and therefore harmful for the user. 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. In accordance with Commission Regulation (EC) No 429/2008 , phase I of the environmental risk assessment has determined that Norbixin (annatto F), as an additive intended for non-food producing animals, is exempted from further assessment due to the unlikelihood of a significant environmental effect, there being no scientifically-based evidence for concern having been identified by the Authority in its above-mentioned opinion. The Authority further concluded that the additive concerned is effective in adding colour to feedingstuffs. The Authority does 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 European Union Reference Laboratory set up by Regulation (EC) No 1831/2003. The report of the European Union Reference Laboratory for Feed Additives (EURL-FA) showed that the applicant did not submit any experimental data for the quantification of Norbixin (annatto F) in feedingstuffs. The applicant was requested to provide such data and the method was validated and included in an addendum of the EURL-FA report.
(5) The assessment of Norbixin (annatto F) 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 additive should be authorised as specified in the Annex to this Regulation.
(6) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance concerned, it is appropriate to allow 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
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