View in EDS HTML Full Text PDF Full Text

Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525 (Axtra® XAP 104 TPT) for chickens for fattening, laying hens and minor poultry species (Genencor international B.V.)

Saved in:
Bibliographic Details
Title: Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525 (Axtra® XAP 104 TPT) for chickens for fattening, laying hens and minor poultry species (Genencor international B.V.)
Authors: Bampidis, Vasileios (AUTHOR), Azimonti, Giovanna (AUTHOR), Bastos, Maria de Lourdes (AUTHOR), Christensen, Henrik (AUTHOR), Dusemund, Birgit (AUTHOR), Fašmon Durjava, Mojca (AUTHOR), Kouba, Maryline (AUTHOR), López‐Alonso, Marta (AUTHOR), Puente, Secundino López (AUTHOR), Marcon, Francesca (AUTHOR), Mayo, Baltasar (AUTHOR), Pechová, Alena (AUTHOR), Petkova, Mariana (AUTHOR), Ramos, Fernando (AUTHOR), Sanz, Yolanda (AUTHOR), Villa, Roberto Edoardo (AUTHOR), Woutersen, Ruud (AUTHOR), Dierick, Noël (AUTHOR), Saarela, Maria (AUTHOR), Brozzi, Rosella (AUTHOR)
Source: EFSA Journal. Feb2023, Vol. 21 Issue 2, p1-13. 13p.
Subject Terms: *Animal industry, Hens, Bacillus licheniformis, Trichoderma reesei, Bacillus subtilis, Feed additives, Agricultural egg production, Poultry products, Fried chicken
Company/Entity: European Commission , European Food Safety Authority
Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525, Axtra® XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the ■■■■■ used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase. Moreover, the Panel could not conclude on the efficacy in laying hens. The applicant submitted some new information to address some of the limitations previously identified. Moreover, the applicant declared a change in the production strain of the protease, substituting B. subtilis ATCC SD‐2107 for B. subtilis CBS 148232. The Panel concluded that the additive is safe for the target species at the recommended use level (1,000 xylanase U, 100 amylase U and 2,000 protease U per kg feed). The additive is safe for the consumers of food products obtained from animals fed with the additive and raises no concerns for the environment. The Panel could not conclude on the skin/eye irritancy potential of the additive nor on its dermal sensitisation potential. Owing to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level). Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens. [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.)
Database: GreenFILE
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: 8gh
DbLabel: GreenFILE
An: 162145621
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525 (Axtra® XAP 104 TPT) for chickens for fattening, laying hens and minor poultry species (Genencor international B.V.)
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Bampidis%2C+Vasileios%22">Bampidis, Vasileios</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Azimonti%2C+Giovanna%22">Azimonti, Giovanna</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bastos%2C+Maria+de+Lourdes%22">Bastos, Maria de Lourdes</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Christensen%2C+Henrik%22">Christensen, Henrik</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dusemund%2C+Birgit%22">Dusemund, Birgit</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fašmon+Durjava%2C+Mojca%22">Fašmon Durjava, Mojca</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kouba%2C+Maryline%22">Kouba, Maryline</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22López‐Alonso%2C+Marta%22">López‐Alonso, Marta</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Puente%2C+Secundino+López%22">Puente, Secundino López</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Marcon%2C+Francesca%22">Marcon, Francesca</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mayo%2C+Baltasar%22">Mayo, Baltasar</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pechová%2C+Alena%22">Pechová, Alena</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Petkova%2C+Mariana%22">Petkova, Mariana</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ramos%2C+Fernando%22">Ramos, Fernando</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sanz%2C+Yolanda%22">Sanz, Yolanda</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Villa%2C+Roberto+Edoardo%22">Villa, Roberto Edoardo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Woutersen%2C+Ruud%22">Woutersen, Ruud</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dierick%2C+Noël%22">Dierick, Noël</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Saarela%2C+Maria%22">Saarela, Maria</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brozzi%2C+Rosella%22">Brozzi, Rosella</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Feb2023, Vol. 21 Issue 2, p1-13. 13p.
– Name: Subject
  Label: Subject Terms
  Group: Su
  Data: *<searchLink fieldCode="DE" term="%22Animal+industry%22">Animal industry</searchLink><br /><searchLink fieldCode="DE" term="%22Hens%22">Hens</searchLink><br /><searchLink fieldCode="DE" term="%22Bacillus+licheniformis%22">Bacillus licheniformis</searchLink><br /><searchLink fieldCode="DE" term="%22Trichoderma+reesei%22">Trichoderma reesei</searchLink><br /><searchLink fieldCode="DE" term="%22Bacillus+subtilis%22">Bacillus subtilis</searchLink><br /><searchLink fieldCode="DE" term="%22Feed+additives%22">Feed additives</searchLink><br /><searchLink fieldCode="DE" term="%22Agricultural+egg+production%22">Agricultural egg production</searchLink><br /><searchLink fieldCode="DE" term="%22Poultry+products%22">Poultry products</searchLink><br /><searchLink fieldCode="DE" term="%22Fried+chicken%22">Fried chicken</searchLink>
– Name: SubjectCompany
  Label: Company/Entity
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22European+Commission%22">European Commission</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Food+Safety+Authority%22">European Food Safety Authority</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 endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525, Axtra® XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the ■■■■■ used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase. Moreover, the Panel could not conclude on the efficacy in laying hens. The applicant submitted some new information to address some of the limitations previously identified. Moreover, the applicant declared a change in the production strain of the protease, substituting B. subtilis ATCC SD‐2107 for B. subtilis CBS 148232. The Panel concluded that the additive is safe for the target species at the recommended use level (1,000 xylanase U, 100 amylase U and 2,000 protease U per kg feed). The additive is safe for the consumers of food products obtained from animals fed with the additive and raises no concerns for the environment. The Panel could not conclude on the skin/eye irritancy potential of the additive nor on its dermal sensitisation potential. Owing to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level). Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens. [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.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=8gh&AN=162145621
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.2903/j.efsa.2023.7816
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 13
        StartPage: 1
    Subjects:
      – SubjectFull: Animal industry
        Type: general
      – SubjectFull: Hens
        Type: general
      – SubjectFull: Bacillus licheniformis
        Type: general
      – SubjectFull: Trichoderma reesei
        Type: general
      – SubjectFull: Bacillus subtilis
        Type: general
      – SubjectFull: Feed additives
        Type: general
      – SubjectFull: Agricultural egg production
        Type: general
      – SubjectFull: Poultry products
        Type: general
      – SubjectFull: Fried chicken
        Type: general
      – SubjectFull: European Commission
        Type: general
      – SubjectFull: European Food Safety Authority
        Type: general
    Titles:
      – TitleFull: Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525 (Axtra® XAP 104 TPT) for chickens for fattening, laying hens and minor poultry species (Genencor international B.V.)
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Bampidis, Vasileios
      – PersonEntity:
          Name:
            NameFull: Azimonti, Giovanna
      – PersonEntity:
          Name:
            NameFull: Bastos, Maria de Lourdes
      – PersonEntity:
          Name:
            NameFull: Christensen, Henrik
      – PersonEntity:
          Name:
            NameFull: Dusemund, Birgit
      – PersonEntity:
          Name:
            NameFull: Fašmon Durjava, Mojca
      – PersonEntity:
          Name:
            NameFull: Kouba, Maryline
      – PersonEntity:
          Name:
            NameFull: López‐Alonso, Marta
      – PersonEntity:
          Name:
            NameFull: Puente, Secundino López
      – 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: Saarela, Maria
      – PersonEntity:
          Name:
            NameFull: Brozzi, Rosella
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 02
              Text: Feb2023
              Type: published
              Y: 2023
          Identifiers:
            – Type: issn-print
              Value: 18314732
          Numbering:
            – Type: volume
              Value: 21
            – Type: issue
              Value: 2
          Titles:
            – TitleFull: EFSA Journal
              Type: main
ResultId 1