Safety and efficacy of a feed additive consisting of endo-1,4-b-xylanase produced by Bacillus subtilis LMG S-27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV).
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| Title: | Safety and efficacy of a feed additive consisting of endo-1,4-b-xylanase produced by Bacillus subtilis LMG S-27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV). |
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| Authors: | Bampidis, Vasileios, Azimonti, Giovanna, de Lourdes Bastos, Maria, Christensen, Henrik, Dusemund, Birgit, Durjava, Mojca Fašmon, 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, Dierick, Noël, Herman, Lieve, Martelli, Giovanna |
| Source: | EFSA Journal. Nov2021, Vol. 19 Issue 11, p1-10. 10p. |
| Subject Terms: | *Animal industry, *Allergens, Hens, Bacillus subtilis, Swine breeding, Feed additives, Recombinant DNA, Soybean meal, Animal products |
| Company/Entity: | European Food Safety Authority , European Commission |
| Abstract: | Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-b-xylanase (Beltherm MP/ML), produced by a genetically-modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panel concluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panel concluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panel concluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panel concluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panel could not conclude on the efficacy of the product for the target species for which the application was made. [ABSTRACT FROM AUTHOR] |
| Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
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| Header | DbId: 8gh DbLabel: GreenFILE An: 153742751 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Safety and efficacy of a feed additive consisting of endo-1,4-b-xylanase produced by Bacillus subtilis LMG S-27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Bampidis%2C+Vasileios%22">Bampidis, Vasileios</searchLink><br /><searchLink fieldCode="AR" term="%22Azimonti%2C+Giovanna%22">Azimonti, Giovanna</searchLink><br /><searchLink fieldCode="AR" term="%22de+Lourdes+Bastos%2C+Maria%22">de Lourdes Bastos, Maria</searchLink><br /><searchLink fieldCode="AR" term="%22Christensen%2C+Henrik%22">Christensen, Henrik</searchLink><br /><searchLink fieldCode="AR" term="%22Dusemund%2C+Birgit%22">Dusemund, Birgit</searchLink><br /><searchLink fieldCode="AR" term="%22Durjava%2C+Mojca+Fašmon%22">Durjava, Mojca Fašmon</searchLink><br /><searchLink fieldCode="AR" term="%22Kouba%2C+Maryline%22">Kouba, Maryline</searchLink><br /><searchLink fieldCode="AR" term="%22López-Alonso%2C+Marta%22">López-Alonso, Marta</searchLink><br /><searchLink fieldCode="AR" term="%22López+Puente%2C+Secundino%22">López Puente, Secundino</searchLink><br /><searchLink fieldCode="AR" term="%22Marcon%2C+Francesca%22">Marcon, Francesca</searchLink><br /><searchLink fieldCode="AR" term="%22Mayo%2C+Baltasar%22">Mayo, Baltasar</searchLink><br /><searchLink fieldCode="AR" term="%22Pechová%2C+Alena%22">Pechová, Alena</searchLink><br /><searchLink fieldCode="AR" term="%22Petkova%2C+Mariana%22">Petkova, Mariana</searchLink><br /><searchLink fieldCode="AR" term="%22Ramos%2C+Fernando%22">Ramos, Fernando</searchLink><br /><searchLink fieldCode="AR" term="%22Sanz%2C+Yolanda%22">Sanz, Yolanda</searchLink><br /><searchLink fieldCode="AR" term="%22Villa%2C+Roberto+Edoardo%22">Villa, Roberto Edoardo</searchLink><br /><searchLink fieldCode="AR" term="%22Woutersen%2C+Ruud%22">Woutersen, Ruud</searchLink><br /><searchLink fieldCode="AR" term="%22Dierick%2C+Noël%22">Dierick, Noël</searchLink><br /><searchLink fieldCode="AR" term="%22Herman%2C+Lieve%22">Herman, Lieve</searchLink><br /><searchLink fieldCode="AR" term="%22Martelli%2C+Giovanna%22">Martelli, Giovanna</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Nov2021, Vol. 19 Issue 11, p1-10. 10p. – Name: Subject Label: Subject Terms Group: Su Data: *<searchLink fieldCode="DE" term="%22Animal+industry%22">Animal industry</searchLink><br />*<searchLink fieldCode="DE" term="%22Allergens%22">Allergens</searchLink><br /><searchLink fieldCode="DE" term="%22Hens%22">Hens</searchLink><br /><searchLink fieldCode="DE" term="%22Bacillus+subtilis%22">Bacillus subtilis</searchLink><br /><searchLink fieldCode="DE" term="%22Swine+breeding%22">Swine breeding</searchLink><br /><searchLink fieldCode="DE" term="%22Feed+additives%22">Feed additives</searchLink><br /><searchLink fieldCode="DE" term="%22Recombinant+DNA%22">Recombinant DNA</searchLink><br /><searchLink fieldCode="DE" term="%22Soybean+meal%22">Soybean meal</searchLink><br /><searchLink fieldCode="DE" term="%22Animal+products%22">Animal products</searchLink> – Name: SubjectCompany Label: Company/Entity Group: Su Data: <searchLink fieldCode="DE" term="%22European+Food+Safety+Authority%22">European Food Safety Authority</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Commission%22">European Commission</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-b-xylanase (Beltherm MP/ML), produced by a genetically-modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panel concluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panel concluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panel concluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panel concluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panel could not conclude on the efficacy of the product for the target species for which the application was made. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.2903/j.efsa.2021.6906 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 10 StartPage: 1 Subjects: – SubjectFull: Animal industry Type: general – SubjectFull: Allergens Type: general – SubjectFull: Hens Type: general – SubjectFull: Bacillus subtilis Type: general – SubjectFull: Swine breeding Type: general – SubjectFull: Feed additives Type: general – SubjectFull: Recombinant DNA Type: general – SubjectFull: Soybean meal Type: general – SubjectFull: Animal products Type: general – SubjectFull: European Food Safety Authority Type: general – SubjectFull: European Commission Type: general Titles: – TitleFull: Safety and efficacy of a feed additive consisting of endo-1,4-b-xylanase produced by Bacillus subtilis LMG S-27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Bampidis, Vasileios – PersonEntity: Name: NameFull: Azimonti, Giovanna – PersonEntity: Name: NameFull: de Lourdes Bastos, Maria – PersonEntity: Name: NameFull: Christensen, Henrik – PersonEntity: Name: NameFull: Dusemund, Birgit – PersonEntity: Name: NameFull: Durjava, Mojca Fašmon – PersonEntity: Name: NameFull: Kouba, Maryline – PersonEntity: Name: NameFull: López-Alonso, Marta – PersonEntity: Name: NameFull: López Puente, Secundino – PersonEntity: Name: NameFull: Marcon, Francesca – PersonEntity: Name: NameFull: Mayo, Baltasar – PersonEntity: Name: NameFull: Pechová, Alena – PersonEntity: Name: NameFull: Petkova, Mariana – PersonEntity: Name: NameFull: Ramos, Fernando – PersonEntity: Name: NameFull: Sanz, Yolanda – PersonEntity: Name: NameFull: Villa, Roberto Edoardo – PersonEntity: Name: NameFull: Woutersen, Ruud – PersonEntity: Name: NameFull: Dierick, Noël – PersonEntity: Name: NameFull: Herman, Lieve – PersonEntity: Name: NameFull: Martelli, Giovanna IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 11 Text: Nov2021 Type: published Y: 2021 Identifiers: – Type: issn-print Value: 18314732 Numbering: – Type: volume Value: 19 – Type: issue Value: 11 Titles: – TitleFull: EFSA Journal Type: main |
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