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Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT‐L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐d‐mannanase (Hemicell® HT/HT‐L) produced by a genetically‐modified strain of Paenibacillus lentus (DSM 33618) as a zootechnical feed additive for chickens and tur...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9951083/ https://www.ncbi.nlm.nih.gov/pubmed/36846382 http://dx.doi.org/10.2903/j.efsa.2023.7878 |
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author | Bampidis, Vasileios Azimonti, Giovanna de Lourdes Bastos, Maria Christensen, Henrik Durjava, Mojca Dusemund, Birgit Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Anguita, Montserrat Brozzi, Rosella García‐Cazorla, Yolanda Ortuño, Jordi Pettenati, Elisa Vettori, Maria Vittoria Revez, Joana |
author_facet | Bampidis, Vasileios Azimonti, Giovanna de Lourdes Bastos, Maria Christensen, Henrik Durjava, Mojca Dusemund, Birgit Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Anguita, Montserrat Brozzi, Rosella García‐Cazorla, Yolanda Ortuño, Jordi Pettenati, Elisa Vettori, Maria Vittoria Revez, Joana |
collection | PubMed |
description | Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐d‐mannanase (Hemicell® HT/HT‐L) produced by a genetically‐modified strain of Paenibacillus lentus (DSM 33618) as a zootechnical feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, piglets (weaned) and minor porcine species. The production strain was obtained from a Paenibacillus lentus recipient strain that has been evaluated previously by EFSA and considered to be safe. The genetic modification does not raise safety concerns and there were no antibiotic resistance genes from the genetic modification in the production strain. Viable cells and the DNA of the production strain were not found in the intermediate product used to formulate the additive. Hemicell® HT/HT‐L produced by Paenibacillus lentus DSM 33618 is considered safe for the above‐mentioned target species at the intended conditions of use. The use of Hemicell® HT/HT‐L as a feed additive raises no concerns for the consumer or for the environment. Hemicell® HT/HT‐L is not irritant to the skin and eyes but is regarded as a dermal sensitiser and a potential respiratory sensitiser. The additive has a potential to be efficacious at 32,000 U/kg in chickens for fattening, chickens reared for laying, minor poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species, and at 48,000 U/kg in turkeys for fattening, turkeys reared for breeding and weaned piglets. |
format | Online Article Text |
id | pubmed-9951083 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-99510832023-02-25 Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT‐L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH) Bampidis, Vasileios Azimonti, Giovanna de Lourdes Bastos, Maria Christensen, Henrik Durjava, Mojca Dusemund, Birgit Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Anguita, Montserrat Brozzi, Rosella García‐Cazorla, Yolanda Ortuño, Jordi Pettenati, Elisa Vettori, Maria Vittoria Revez, Joana EFSA J Scientific Opinion Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐d‐mannanase (Hemicell® HT/HT‐L) produced by a genetically‐modified strain of Paenibacillus lentus (DSM 33618) as a zootechnical feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, piglets (weaned) and minor porcine species. The production strain was obtained from a Paenibacillus lentus recipient strain that has been evaluated previously by EFSA and considered to be safe. The genetic modification does not raise safety concerns and there were no antibiotic resistance genes from the genetic modification in the production strain. Viable cells and the DNA of the production strain were not found in the intermediate product used to formulate the additive. Hemicell® HT/HT‐L produced by Paenibacillus lentus DSM 33618 is considered safe for the above‐mentioned target species at the intended conditions of use. The use of Hemicell® HT/HT‐L as a feed additive raises no concerns for the consumer or for the environment. Hemicell® HT/HT‐L is not irritant to the skin and eyes but is regarded as a dermal sensitiser and a potential respiratory sensitiser. The additive has a potential to be efficacious at 32,000 U/kg in chickens for fattening, chickens reared for laying, minor poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species, and at 48,000 U/kg in turkeys for fattening, turkeys reared for breeding and weaned piglets. John Wiley and Sons Inc. 2023-02-24 /pmc/articles/PMC9951083/ /pubmed/36846382 http://dx.doi.org/10.2903/j.efsa.2023.7878 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Scientific Opinion Bampidis, Vasileios Azimonti, Giovanna de Lourdes Bastos, Maria Christensen, Henrik Durjava, Mojca Dusemund, Birgit Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Anguita, Montserrat Brozzi, Rosella García‐Cazorla, Yolanda Ortuño, Jordi Pettenati, Elisa Vettori, Maria Vittoria Revez, Joana Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT‐L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH) |
title | Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT‐L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH) |
title_full | Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT‐L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH) |
title_fullStr | Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT‐L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH) |
title_full_unstemmed | Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT‐L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH) |
title_short | Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT‐L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH) |
title_sort | safety and efficacy of a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by paenibacillus lentus dsm 33618 (hemicell® ht/ht‐l) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (elanco gmbh) |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9951083/ https://www.ncbi.nlm.nih.gov/pubmed/36846382 http://dx.doi.org/10.2903/j.efsa.2023.7878 |
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