Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV)
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐lysine monohydrochloride (l‐lysine HCl) and l‐lysine sulfate produced by Corynebacterium glutamicum (C. glutamicum) CGMCC 14498 as a nutritional feed additive for...
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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.2021.6980 |
| _version_ | 1798021506249261056 |
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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 Debora Glandorf Jaume Galobart Elisa Pettenati Jordi Tarrés‐Call |
| 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 Debora Glandorf Jaume Galobart Elisa Pettenati Jordi Tarrés‐Call |
| 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, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐lysine monohydrochloride (l‐lysine HCl) and l‐lysine sulfate produced by Corynebacterium glutamicum (C. glutamicum) CGMCC 14498 as a nutritional feed additive for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). The production strain C. glutamicum CGMCC 14498 and its recombinant DNA were not detected in the final products. The products l‐lysine HCl and l‐lysine sulfate do not pose any safety concern associated with the production strain. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are considered safe for the target species. When using l‐lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are safe for the consumer and the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l‐lysine HCl produced by the strain C. glutamicum CGMCC 14498 to be toxic by inhalation, and on the potential of l‐lysine HCl and l‐lysine sulfate produced by the above‐mentioned strain to be irritant to skin or eyes, or on their potential to be dermal sensitisers. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are considered efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, this would require protection against degradation in the rumen. |
| first_indexed | 2024-04-11T17:14:43Z |
| format | Article |
| id | doaj.art-626356080e004b0c9bc14a2dc3e713fb |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-11T17:14:43Z |
| publishDate | 2021-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-626356080e004b0c9bc14a2dc3e713fb2022-12-22T04:12:42ZengWileyEFSA Journal1831-47322021-12-011912n/an/a10.2903/j.efsa.2021.6980Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV)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 WoutersenDebora GlandorfJaume GalobartElisa PettenatiJordi Tarrés‐CallAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐lysine monohydrochloride (l‐lysine HCl) and l‐lysine sulfate produced by Corynebacterium glutamicum (C. glutamicum) CGMCC 14498 as a nutritional feed additive for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). The production strain C. glutamicum CGMCC 14498 and its recombinant DNA were not detected in the final products. The products l‐lysine HCl and l‐lysine sulfate do not pose any safety concern associated with the production strain. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are considered safe for the target species. When using l‐lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are safe for the consumer and the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l‐lysine HCl produced by the strain C. glutamicum CGMCC 14498 to be toxic by inhalation, and on the potential of l‐lysine HCl and l‐lysine sulfate produced by the above‐mentioned strain to be irritant to skin or eyes, or on their potential to be dermal sensitisers. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are considered efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, this would require protection against degradation in the rumen.https://doi.org/10.2903/j.efsa.2021.6980nutritional additiveamino acidlysine monohydrochloridelysine sulfatesafetyefficacy |
| 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 Debora Glandorf Jaume Galobart Elisa Pettenati Jordi Tarrés‐Call Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV) EFSA Journal nutritional additive amino acid lysine monohydrochloride lysine sulfate safety efficacy |
| title | Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV) |
| title_full | Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV) |
| title_fullStr | Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV) |
| title_full_unstemmed | Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV) |
| title_short | Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV) |
| title_sort | safety and efficacy of a feed additive consisting of l lysine monohydrochloride and l lysine sulfate produced by corynebacterium glutamicum cgmcc 14498 for all animal species kempex holland bv |
| topic | nutritional additive amino acid lysine monohydrochloride lysine sulfate safety efficacy |
| url | https://doi.org/10.2903/j.efsa.2021.6980 |
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