Godkjenning av et preparat av endo-1,4-beta-xylanase som fôrtilsetning til visse fjørfe og griser

Tittel

Kommisjonens gjennomføringsforordning (EU) 2019/1324 av 5. august 2019 om godkjenning av et preparat av endo-1,4-beta-xylanase tilvirket av Bacillus subtilis LMG S-27588 som tilsetningsstoff i fôrvarer til oppfôringskyllinger eller livkyllinger, oppfôringskalkuner eller livkalkuner, mindre utbredte fjørfearter til oppfôring, avl og verping, avvent smågris, slaktegris og mindre utbredte grisearter (innehaver av godkjenningen: Puratos)

Commission Implementing Regulation (EU) 2019/1324 of 5 August 2019 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, minor poultry species for fattening or reared for laying or for breeding, weaned piglets, pigs for fattening and minor porcine species (holder of authorisation Puratos)

Siste nytt

Kommisjonsforordning publisert i EU-tidende 6.8.2019

Nærmere omtale

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, applications were submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG S-27588). Those applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation.

(3) Those applications concern the authorisation of a preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, minor poultry species for fattening or reared for laying or for breeding, weaned piglets, pigs for fattening and minor porcine species, to be classified in the additive category 'zootechnical additives'.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 6 July 2017 and of 23 January 2019 that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 does not have an adverse effect on animal health, consumer safety or the environment. It was also concluded that the additive is considered as a potential respiratory sensitiser and that no conclusion could be drawn on dermal sensitisation potential by the additive. 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 also concluded that the additive showed improvements of zootechnical performance in chickens for fattening, turkeys for fattening or reared for breeding, weaned piglets and pigs for fattening. The Authority considered that these conclusions can be extrapolated to chickens reared for laying, minor growing poultry species and minor porcine species weaned and for fattening. 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 endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 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) 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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