Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

zootechnical additives, digestibility enhancers, xylanase, safety, efficacy, poultry
First published in the EFSA Journal
1. März 2019
Adopted
23. Januar 2019
Type
Scientific Opinion

Abstract

Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detected in the final additive, but recombinant DNA from the production strain was detected. Considering that the production strain does not carry genetic sequences of concern, the presence of DNA was considered per se of no safety concern by the Panel. The safety of the additive for the target species, consumers and environment was established, but the Panel concluded that the additive should be considered as a respiratory sensitiser. Regarding the efficacy, it was concluded that the additive has a potential to be efficacious in chickens for fattening and extended/extrapolated the conclusion to chickens reared for laying and minor poultry species for fattening. However, the Panel could not conclude on the efficacy of the additive in turkeys for fattening, reared for breeding or for breeding purposes. The Panel concluded, based on the new guidance on the efficacy for feed additives, that the conclusion on the efficacy in chickens for fattening can be extrapolated to turkeys for fattening/reared for breeding purposes. New data in turkeys for fattening would support the extrapolation. No data has been provided to support the efficacy in turkeys for breeding purposes and therefore no conclusion could be drawn. Finally, the applicant has proposed, in the current submission, a modification of the manufacturing process to remove the presence of DNA from the production strain in the final product, the removal was confirmed by analyses.

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5609
EFSA Journal 2019;17(3):5609
Question Number
On request from
European Commission
Disclaimer
Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.