Safety and efficacy of ENZY CARBOPLUS® (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) as a feed additive for avian species, weaned piglets and minor weaned porcine species

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Article
zootechnical additive, digestibility enhancers, safety, efficacy, endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase
First published in the EFSA Journal
21 December 2017
Adopted
30 November 2017
Type
Scientific Opinion
Abstract

ENZY CARBOPLUS® is an additive available in liquid and solid forms that contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase which are produced by two genetically modified strains of Komagataella pastoris. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the production strains are safe and the genetic modifications raise no safety concerns. The Panel also concluded that the additive is safe for the target species at the recommended dosages and that its use as a feed additive raises no concern for consumers. The additive in either form is not a skin or eye irritant nor a dermal sensitiser; however, it is considered as a potential respiratory sensitiser. The production strains and their recombinant DNA were not detectable in the additive; moreover, the active substances of the additive will be degraded/inactivated during passage through the digestive tract of animals or in the environment, consequently, the Panel concluded that the additive poses no concerns to the environment. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in chickens for fattening at 4,000 LXU and 375 LGU per kg feed, in turkeys for fattening at 1,400 LXU and 120 LGU per kg feed, and in weaned piglets at 700 LXU and 60 LGU per kg feed. The Panel extended these conclusions to chickens reared for laying and turkeys reared for breeding at the corresponding doses. Since the mode of action of xylanase and glucanase can be reasonably assumed to be the same within avian or within porcine species, the Panel extrapolated the conclusions on the efficacy to all avian species up to the point of lay and to all porcine species. Owing to the lack of data, no conclusions could be drawn on the efficacy of the additive in laying hens.

Panel members at the time of adoption
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Marta López-Alonso, Secundino López Puente, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2017.5097
EFSA-Q-2013-00528 [20 pp.].
Question Number
On request from
European Commission
Disclaimer
This scientific opinion has been amended following the adoption of the decision of the Commission on confidentiality claims submitted by the applicant, in accordance with Article 8(6) and Article 18 of Regulation (EC) No 1831/2003. The modified sections is indicated in the text.
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Number of Pages
20