Kommisjonens gjennomføringsforordning (EU) 2019/781 av 15. mai 2019 om godkjenning av et preparat av 3-fytase framstilt av Komagataella phaffii (CECT 13094) som tilsetningsstoff i fôrvarer for oppfôringskyllinger eller livkyllinger, verpehøner og mindre utbredte fjørfearter til oppfôring, avl og verping (innehaver av godkjenningen: Fertinagro Nutrientes S.L.)
Commission Implementing Regulation (EU) 2019/781 of 15 May 2019 concerning the authorisation of a preparation of 3-phytase produced by Komagataella phaffii (CECT 13094) as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species for fattening, for breeding and reared for laying (holder of authorisation Fertinagro Nutrientes S.L.)
Kommisjonsforordning publisert i EU-tidende 16.5.2019
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) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of 3-phytase produced by Komagataella phaffii (CECT 13094). That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.
(3) That application concerns the authorisation of a preparation of 3-phytase produced by Komagataella phaffii (CECT 13094) as a feed additive for chickens for fattening, chickens reared for laying, laying hens and minor poultry species for fattening, for breeding and reared for laying, to be classified in the additive category “zootechnical additives”.
(4) The preparation of 3-phytase as liquid formulation was already authorised as a feed additive by Commission Implementing Regulation (EU) 2017/895 for chickens for fattening and laying hens.
(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 November 2018 that, under the proposed conditions of use, 3-phytase produced by Komagataella phaffii (CECT 13094), previously identified as Komagataella pastoris, does not have an adverse effect on animal health, consumer safety or the environment. It was also concluded that the additive may have a dermal and respiratory sensitisation potential. 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. The Authority has also concluded that as the solid and liquid formulations are equivalent in terms of efficacy, the solid formulation of the additive has a potential to be efficacious for the target species. 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.
(6) The assessment of the 3-phytase shows that the conditions for authorisation of 3-phytase produced by Komagataella phaffii (CECT 13094), 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.
(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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