Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species
Abstract The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by genetically modified stra...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2019-11-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2019.5886 |
| _version_ | 1818669839749742592 |
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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 Maryline Kouba Mojca Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Francesco Cubadda Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Alberto Mantovani Montserrat Anguita Jordi Tarrés‐Call Fernando Ramos |
| 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 Maryline Kouba Mojca Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Francesco Cubadda Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Alberto Mantovani Montserrat Anguita Jordi Tarrés‐Call Fernando Ramos |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by genetically modified strains of Corynebacterium glutamicum (NRRL‐B‐67439 or NRRL B‐67535). They are intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains C. glutamicum strains NRRLB‐67439 or NRRL B‐67535; nor their recombinant DNA were detected in the final products. Therefore, those products do not pose any safety concern associated with the genetic modification of the production strains. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l‐lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535. Concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535, due to its high pH (10.7 and 10.9, respectively) is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered as 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, it would require protection against degradation in the rumen. |
| first_indexed | 2024-12-17T06:58:36Z |
| format | Article |
| id | doaj.art-25d0678b8cbe489c8bfe34b18a17b06c |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-17T06:58:36Z |
| publishDate | 2019-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-25d0678b8cbe489c8bfe34b18a17b06c2022-12-21T21:59:19ZengWileyEFSA Journal1831-47322019-11-011711n/an/a10.2903/j.efsa.2019.5886Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal speciesEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMaryline KoubaMojca Kos DurjavaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenLucio CostaFrancesco CubaddaNoël DierickGerhard FlachowskyBoet GlandorfLieve HermanAlberto MantovaniMontserrat AnguitaJordi Tarrés‐CallFernando RamosAbstract The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by genetically modified strains of Corynebacterium glutamicum (NRRL‐B‐67439 or NRRL B‐67535). They are intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains C. glutamicum strains NRRLB‐67439 or NRRL B‐67535; nor their recombinant DNA were detected in the final products. Therefore, those products do not pose any safety concern associated with the genetic modification of the production strains. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l‐lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535. Concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535, due to its high pH (10.7 and 10.9, respectively) is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered as 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, it would require protection against degradation in the rumen.https://doi.org/10.2903/j.efsa.2019.5886nutritional additiveamino acidlysine monohydrochloridelysine basesafetyefficacy |
| 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 Maryline Kouba Mojca Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Francesco Cubadda Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Alberto Mantovani Montserrat Anguita Jordi Tarrés‐Call Fernando Ramos Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species EFSA Journal nutritional additive amino acid lysine monohydrochloride lysine base safety efficacy |
| title | Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species |
| title_full | Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species |
| title_fullStr | Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species |
| title_full_unstemmed | Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species |
| title_short | Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species |
| title_sort | safety and efficacy of l lysine monohydrochloride and concentrated liquid l lysine base produced by fermentation using corynebacterium glutamicum strains nrrl b 67439 or nrrl b 67535 for all animal species |
| topic | nutritional additive amino acid lysine monohydrochloride lysine base safety efficacy |
| url | https://doi.org/10.2903/j.efsa.2019.5886 |
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