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EFSA Journal
Article . 2016 . Peer-reviewed
License: CC BY ND
Data sources: Crossref
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EFSA Journal
Article
License: CC BY ND
Data sources: UnpayWall
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Safety and efficacy of RONOZYME® WX (endo-1,4-beta-xylanase) as a feed additive for chickens and turkeys for fattening, minor poultry species for fattening, weaned piglets and pigs for fattening

Authors: Gabriele Aquilina; Giovanna Azimonti; Vasileios Bampidis; Maria de Lourdes Bastos; Georges Bories; Andrew Chesson; Pier Sandro Cocconcelli; +14 Authors

Safety and efficacy of RONOZYME® WX (endo-1,4-beta-xylanase) as a feed additive for chickens and turkeys for fattening, minor poultry species for fattening, weaned piglets and pigs for fattening

Abstract

The additive RONOZYME® WX is a preparation of endo-1,4-beta-xylanase produced with a genetically modified strain of Aspergillus oryzae, currently authorised for poultry for fattening, weaned piglets and pigs for fattening. The applicant has requested to change the production strain. The manufacturing process and the composition of the additive have not been modified and therefore the formulations of the additive remain as those previously reported. The new production strain derives from the same parental strain as the previous one and harbours the same xylanase gene, but the sequence of genetic modifications is different. The safety of the recipient strain was previously evaluated by EFSA. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that RONOZYME® WX, manufactured with the new production strain, does not give rise to safety concerns with regard to genetic modification. Neither the production strain nor its recombinant DNA was detected in the fermentation product used to formulate the additive. Based on tolerance and efficacy studies performed with the additive obtained with the previous production strain, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that the additive is safe for poultry for fattening at 200 FXU/kg feed and in weaned piglets and pigs for fattening at 400 FXU/kg feed and efficacious in poultry species for fattening at 100 FXU/kg feed and in weaned piglets and pigs for fattening at 200 FXU/kg. Based on toxicological studies performed with the fermentation product obtained with the new production strain, the Panel concluded that there is no reason for concern for consumer safety arising from the use of the product as a feed additive. The additive poses no risk to the environment. The additive is not a skin or an eye irritant but the Panel could not conclude on its skin sensitisation potential. Because of the proteinaceous nature of the active substance, the additive is considered a potential respiratory sensitiser.

Country
Italy
Related Organizations
Keywords

zootechnical additives; digestibility enhancers; endo-1,4-beta-xylanase; poultry; pigs

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    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    3
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
3
Average
Average
Average
Green
gold