Safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH)
Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 801...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-12-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2021.6977 |
| _version_ | 1818754674156634112 |
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| author | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes 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 Lieve Herman Montserrat Anguita Jaume Galobart Jordi Tarrés‐Call Elisa Pettenati |
| author_facet | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes 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 Lieve Herman Montserrat Anguita Jaume Galobart Jordi Tarrés‐Call Elisa Pettenati |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is genetically modified, does not carry acquired antimicrobial resistance genes and no viable cells of the production strain were detected in the final product. The FEEDAP Panel could not exclude the presence of recombinant DNA from the production strain in the product. However, since no sequences of concern remain in the final production strain, the potential presence of recombinant DNA in the final product does not raise any safety concerns. The Panel concluded that the additive is safe for the target species, for the consumer and for the environment under the proposed conditions of use. Regarding the use in water, the FEEDAP Panel reiterated its concerns over the safety of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. The FEEDAP Panel concluded that l‐isoleucine produced by C. glutamicum KCCM 80185 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. However, due to the high dusting potential, exposure to dust per se might be a hazard for the user. l‐Isoleucine produced by C. glutamicum KCCM 80185 is considered as an efficacious source of the essential amino acid l‐isoleucine for non‐ruminant animal species. For the supplemental l‐isoleucine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. |
| first_indexed | 2024-12-18T05:27:00Z |
| format | Article |
| id | doaj.art-25d47700e18b4934bd4b8c6c0313138d |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-18T05:27:00Z |
| publishDate | 2021-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-25d47700e18b4934bd4b8c6c0313138d2022-12-21T21:19:31ZengWileyEFSA Journal1831-47322021-12-011912n/an/a10.2903/j.efsa.2021.6977Safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenLieve HermanMontserrat AnguitaJaume GalobartJordi Tarrés‐CallElisa PettenatiAbstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is genetically modified, does not carry acquired antimicrobial resistance genes and no viable cells of the production strain were detected in the final product. The FEEDAP Panel could not exclude the presence of recombinant DNA from the production strain in the product. However, since no sequences of concern remain in the final production strain, the potential presence of recombinant DNA in the final product does not raise any safety concerns. The Panel concluded that the additive is safe for the target species, for the consumer and for the environment under the proposed conditions of use. Regarding the use in water, the FEEDAP Panel reiterated its concerns over the safety of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. The FEEDAP Panel concluded that l‐isoleucine produced by C. glutamicum KCCM 80185 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. However, due to the high dusting potential, exposure to dust per se might be a hazard for the user. l‐Isoleucine produced by C. glutamicum KCCM 80185 is considered as an efficacious source of the essential amino acid l‐isoleucine for non‐ruminant animal species. For the supplemental l‐isoleucine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.https://doi.org/10.2903/j.efsa.2021.6977nutritional additiveamino acidl‐isoleucineCorynebactrium glutamicumsafetyefficacy |
| spellingShingle | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes 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 Lieve Herman Montserrat Anguita Jaume Galobart Jordi Tarrés‐Call Elisa Pettenati Safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH) EFSA Journal nutritional additive amino acid l‐isoleucine Corynebactrium glutamicum safety efficacy |
| title | Safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH) |
| title_full | Safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH) |
| title_fullStr | Safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH) |
| title_full_unstemmed | Safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH) |
| title_short | Safety and efficacy of a feed additive consisting of l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH) |
| title_sort | safety and efficacy of a feed additive consisting of l isoleucine produced by corynebacterium glutamicum kccm 80185 for all animal species cj europe gmbh |
| topic | nutritional additive amino acid l‐isoleucine Corynebactrium glutamicum safety efficacy |
| url | https://doi.org/10.2903/j.efsa.2021.6977 |
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