Assessment of the application for renewal of authorisation of endo‐1,4‐β‐xylanase produced by Aspergillus nigerCBS 109.713 and endo‐1,4‐β‐glucanase produced by Aspergillus nigerDSM 18404 for poultry species, ornamental birds and weaned piglets, from BASF SE

zootechnical additives, digestibility enhancers, endo‐1,4-β‐xylanase, endo‐1,4-β‐glucanase, renewal
First published in the EFSA Journal
15 dicembre 2020
Adopted
18 novembre 2020
Type
Scientific Opinion

Legal notice: 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.

Abstract

Natugrain®TS/TS L is the trade name of the feed additive under assessment and contains endo‐1,4‐β‐xylanase and endo‐1,4‐β‐glucanase produced by genetically modified strains of Aspergillus niger. The product is currently authorised for use as a feed additive for poultry species, ornamental birds, weaned piglets and pigs for fattening. This scientific opinion concerns the renewal of the authorisation of this additive for poultry species, ornamental birds and weaned piglets. The applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment under the authorised conditions of use. The additive is safe for the target species for which the renewal of the authorisation is requested, the consumers and the environment. The additive is a potential skin and a respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Panel members at the time of adoption

Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, 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.2020.6331
EFSA Journal 2020;18(12):6331
Question Number
On request from
European Commission