Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.)
Abstract Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha‐amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives a...
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| Format: | Article |
| Language: | English |
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Wiley
2022-02-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.6983 |
| _version_ | 1811295257263865856 |
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| author | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria deLourdes 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 Ruud Woutersen Noël Dierick Miguel Prieto Maradona Jaume Galobart Elisa Pettenati Montserrat Anguita |
| author_facet | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria deLourdes 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 Ruud Woutersen Noël Dierick Miguel Prieto Maradona Jaume Galobart Elisa Pettenati Montserrat Anguita |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha‐amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non‐irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser. |
| first_indexed | 2024-04-13T05:29:50Z |
| format | Article |
| id | doaj.art-e462ed498500459181c1c901407cc98b |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-13T05:29:50Z |
| publishDate | 2022-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-e462ed498500459181c1c901407cc98b2022-12-22T03:00:29ZengWileyEFSA Journal1831-47322022-02-01202n/an/a10.2903/j.efsa.2022.6983Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria deLourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenNoël DierickMiguel Prieto MaradonaJaume GalobartElisa PettenatiMontserrat AnguitaAbstract Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha‐amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non‐irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser.https://doi.org/10.2903/j.efsa.2022.6983zootechnical additivesdigestibility enhancersrenewalAmafermdairy cows |
| spellingShingle | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria deLourdes 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 Ruud Woutersen Noël Dierick Miguel Prieto Maradona Jaume Galobart Elisa Pettenati Montserrat Anguita Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.) EFSA Journal zootechnical additives digestibility enhancers renewal Amaferm dairy cows |
| title | Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.) |
| title_full | Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.) |
| title_fullStr | Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.) |
| title_full_unstemmed | Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.) |
| title_short | Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.) |
| title_sort | safety of the fermentation product of aspergillus oryzae nrrl 458 amaferm r as a feed additive for dairy cows biozyme inc |
| topic | zootechnical additives digestibility enhancers renewal Amaferm dairy cows |
| url | https://doi.org/10.2903/j.efsa.2022.6983 |
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