(Utkast) Kommisjonens gjennomføringsforordning om endring av gjennomføringsforordning (EU) nr. 338/2018 med hensyn til laveste innhold av preparatet av 6-fytase framstilt av Aspergillus niger (DSM 25770) som tilsetningsstoff i fôrvarer for oppfôringskyllinger eller livkyllinger (innehaver av godkjenningen: BASF SE)
(Draft) Commission Implementing Regulation amending Implementing Regulation (EU) No 338/2018 as regards the minimum content of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as a feed additive for chickens for fattening or reared for laying (holder of authorisation BASF SE)
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 11.7.2019
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.
(2) The use of the preparation of 6-phytase, produced by Aspergillus niger (DSM 25770), was authorised for ten years for chickens for fattening or reared for laying by Commission Implementing Regulation (EU) 2018/338 .
(3) The holder of the authorisation has since proposed changing the terms of the authorisation of that preparation by reducing its minimum content from 750 FTU/kg to 125 FTU/kg of feed. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority ('the Authority').
(4) The Authority concluded in its opinion of 23 January 2019 that, under the new proposed conditions of use, the preparation of 6-phytase, produced by Aspergillus niger (DSM 25770), has the potential to be efficacious at the requested minimum doses of 125 FGU/kg of feed on chickens for fattening and that this conclusion can be extended to chickens reared for laying/breeding. 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 Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of the preparation of 6-phytase, produced by Aspergillus niger (DSM 25770), 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) Implementing Regulation (EU) 2018/338 should therefore be amended accordingly.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed
Landbruks- og matdepartementet