Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl
Abstract The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2019-01-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2019.5532 |
| _version_ | 1818718665760047104 |
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| author | EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Maryline Kouba Mojca Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Sirpa Kärenlampi Lubomir Leng Alberto Mantovani Robert John Wallace Jaime Aguilera Jordi Tarrés‐Call Fernando Ramos |
| author_facet | EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Maryline Kouba Mojca Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Sirpa Kärenlampi Lubomir Leng Alberto Mantovani Robert John Wallace Jaime Aguilera Jordi Tarrés‐Call Fernando Ramos |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel) |
| collection | DOAJ |
| description | Abstract The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic modification does not introduce any safety concern and no introduced antibiotic resistance genes remain in its genome. Even if uncertainty remains concerning the absence/presence of the production strain and/or its recombinant DNA in the final products, these would not raise safety concerns. The liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP or C. glutamicum KCCM 11117P; and l‐lysine HCl produced by C. glutamicum NRRL B‐50547 are considered safe for the target species, consumers and the environment. Regarding the safety for the user, concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP, C. glutamicum NRRL B‐50547 or C. glutamicum KCCM 11117P are not irritant to skin or eyes and they are not skin sensitisers. l‐Lysine HCl is not hazardous by inhalation. The use of C. glutamicum DSM 24990 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users or the environment. No negative effects are to be expected for the target species within the proposed inclusion levels of 0.5–30 g lysine sulfate/kg complete feed provided that the total S intake complies with the recommendations of established scientific bodies. The use of C. glutamicum KCCM 10227 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users and the environment with regard to antimicrobial resistance. No negative effects are to be expected for the target species within common inclusion levels provided that the total S intake complies with the recommendations of established scientific bodies. |
| first_indexed | 2024-12-17T19:54:40Z |
| format | Article |
| id | doaj.art-d9eb8c1de040406aab54d45da52f37f4 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-17T19:54:40Z |
| publishDate | 2019-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-d9eb8c1de040406aab54d45da52f37f42022-12-21T21:34:38ZengWileyEFSA Journal1831-47322019-01-01171n/an/a10.2903/j.efsa.2019.5532Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asblEFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMaryline KoubaMojca Kos DurjavaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaYolanda SanzRoberto Edoardo VillaRuud WoutersenLucio CostaNoël DierickGerhard FlachowskyBoet GlandorfLieve HermanSirpa KärenlampiLubomir LengAlberto MantovaniRobert John WallaceJaime AguileraJordi Tarrés‐CallFernando RamosAbstract The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic modification does not introduce any safety concern and no introduced antibiotic resistance genes remain in its genome. Even if uncertainty remains concerning the absence/presence of the production strain and/or its recombinant DNA in the final products, these would not raise safety concerns. The liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP or C. glutamicum KCCM 11117P; and l‐lysine HCl produced by C. glutamicum NRRL B‐50547 are considered safe for the target species, consumers and the environment. Regarding the safety for the user, concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP, C. glutamicum NRRL B‐50547 or C. glutamicum KCCM 11117P are not irritant to skin or eyes and they are not skin sensitisers. l‐Lysine HCl is not hazardous by inhalation. The use of C. glutamicum DSM 24990 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users or the environment. No negative effects are to be expected for the target species within the proposed inclusion levels of 0.5–30 g lysine sulfate/kg complete feed provided that the total S intake complies with the recommendations of established scientific bodies. The use of C. glutamicum KCCM 10227 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users and the environment with regard to antimicrobial resistance. No negative effects are to be expected for the target species within common inclusion levels provided that the total S intake complies with the recommendations of established scientific bodies.https://doi.org/10.2903/j.efsa.2019.5532nutritional additiveamino acidsconcentrated liquid l‐lysine baseconcentrated liquid l‐lysine HCll‐lysine HCll‐lysine sulfate |
| spellingShingle | EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Maryline Kouba Mojca Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Sirpa Kärenlampi Lubomir Leng Alberto Mantovani Robert John Wallace Jaime Aguilera Jordi Tarrés‐Call Fernando Ramos Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl EFSA Journal nutritional additive amino acids concentrated liquid l‐lysine base concentrated liquid l‐lysine HCl l‐lysine HCl l‐lysine sulfate |
| title | Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl |
| title_full | Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl |
| title_fullStr | Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl |
| title_full_unstemmed | Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl |
| title_short | Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl |
| title_sort | safety of concentrated l lysine base l lysine monohydrochloride and l lysine sulfate produced using different strains of corynebacterium glutamicum for all animal species based on a dossier submitted by fefana asbl |
| topic | nutritional additive amino acids concentrated liquid l‐lysine base concentrated liquid l‐lysine HCl l‐lysine HCl l‐lysine sulfate |
| url | https://doi.org/10.2903/j.efsa.2019.5532 |
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