Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species

Abstract Endofeed® DC is a preparation of endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase to be used as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species. In a previous assessment, the safety of the additive for the target species, user...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Guido Rychen, 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, Secundino López Puente, Marta López‐Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace, Pieter Wester, Paul Brantom, Noël Albert Dierick, Montserrat Anguita
Format: Article
Language:English
Published: Wiley 2017-03-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2017.4706
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Guido Rychen
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
Secundino López Puente
Marta López‐Alonso
Alberto Mantovani
Baltasar Mayo
Fernando Ramos
Maria Saarela
Roberto Edoardo Villa
Robert John Wallace
Pieter Wester
Paul Brantom
Noël Albert Dierick
Montserrat Anguita
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Guido Rychen
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
Secundino López Puente
Marta López‐Alonso
Alberto Mantovani
Baltasar Mayo
Fernando Ramos
Maria Saarela
Roberto Edoardo Villa
Robert John Wallace
Pieter Wester
Paul Brantom
Noël Albert Dierick
Montserrat Anguita
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract Endofeed® DC is a preparation of endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase to be used as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species. In a previous assessment, the safety of the additive for the target species, user and environment as well as the efficacy were established. In that assessment, the applicant provided in order to address the safety for the consumer, a bacterial reverse mutation assay and an in vitro micronucleus test, and a subchronic oral toxicity study. However, considering the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided, the Panel could not conclude on the safety for the consumer. The applicant provided new data/information on the manufacturing process, characterisation of the additive and new toxicological studies, to support the safety for the consumer, which was the main subject of this opinion. Complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products were provided. With the new information on the manufacturing and on the test items used in the toxicological studies evaluated in 2013, the Panel identified the need for new genotoxicity studies, while confirmed the appropriateness of the test item used in the subchronic oral toxicity study. New genotoxicity studies were submitted by the applicant and the results of the tests showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study previously submitted can be considered valid; the results showed no evidence for adverse effects. Therefore, the Panel concluded that the additive is safe for the consumers when used as a feed additive.
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spelling doaj.art-9ecd5d356c434987817a055bb257f3812022-12-21T18:29:09ZengWileyEFSA Journal1831-47322017-03-01153n/an/a10.2903/j.efsa.2017.4706Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine speciesEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Guido RychenGabriele AquilinaGiovanna AzimontiVasileios BampidisMaria de Lourdes BastosGeorges BoriesAndrew ChessonPier Sandro CocconcelliGerhard FlachowskyJürgen GroppBoris KolarMaryline KoubaSecundino López PuenteMarta López‐AlonsoAlberto MantovaniBaltasar MayoFernando RamosMaria SaarelaRoberto Edoardo VillaRobert John WallacePieter WesterPaul BrantomNoël Albert DierickMontserrat AnguitaAbstract Endofeed® DC is a preparation of endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase to be used as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species. In a previous assessment, the safety of the additive for the target species, user and environment as well as the efficacy were established. In that assessment, the applicant provided in order to address the safety for the consumer, a bacterial reverse mutation assay and an in vitro micronucleus test, and a subchronic oral toxicity study. However, considering the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided, the Panel could not conclude on the safety for the consumer. The applicant provided new data/information on the manufacturing process, characterisation of the additive and new toxicological studies, to support the safety for the consumer, which was the main subject of this opinion. Complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products were provided. With the new information on the manufacturing and on the test items used in the toxicological studies evaluated in 2013, the Panel identified the need for new genotoxicity studies, while confirmed the appropriateness of the test item used in the subchronic oral toxicity study. New genotoxicity studies were submitted by the applicant and the results of the tests showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study previously submitted can be considered valid; the results showed no evidence for adverse effects. Therefore, the Panel concluded that the additive is safe for the consumers when used as a feed additive.https://doi.org/10.2903/j.efsa.2017.4706zootechnical additivedigestibility enhancerendo‐1,3(4)‐β‐glucanaseendo‐1,4‐β‐xylanasesafety
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Guido Rychen
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
Secundino López Puente
Marta López‐Alonso
Alberto Mantovani
Baltasar Mayo
Fernando Ramos
Maria Saarela
Roberto Edoardo Villa
Robert John Wallace
Pieter Wester
Paul Brantom
Noël Albert Dierick
Montserrat Anguita
Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species
EFSA Journal
zootechnical additive
digestibility enhancer
endo‐1,3(4)‐β‐glucanase
endo‐1,4‐β‐xylanase
safety
title Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species
title_full Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species
title_fullStr Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species
title_full_unstemmed Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species
title_short Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species
title_sort safety of endofeed r dc endo 1 3 4 β glucanase and endo 1 4 β xylanase as a feed additive for chickens for fattening laying hens pigs for fattening and minor poultry and porcine species
topic zootechnical additive
digestibility enhancer
endo‐1,3(4)‐β‐glucanase
endo‐1,4‐β‐xylanase
safety
url https://doi.org/10.2903/j.efsa.2017.4706
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