TY - JOUR

T1 - Safety of vitamin B12 (in the form of cyanocobalamin) produced by Ensifer adhaerensCNCM-I 5541 for all animal species

AU - Bampidis, Vasileios

AU - Azimonti, Giovanna

AU - de Lourdes Bastos, Maria

AU - Christensen, Henrik

AU - Dusemund, Birgit

AU - Durjava, Mojca Fašmon

AU - Kouba, Maryline

AU - López-Alonso, Marta

AU - López Puente, Secundino

AU - Marcon, Francesca

AU - Mayo, Baltasar

AU - Pechová, Alena

AU - Petkova, Mariana

AU - Ramos, Fernando

AU - Sanz, Yolanda

AU - Villa, Roberto Edoardo

AU - Woutersen, Ruud

AU - Cocconcelli, Pier Sandro

AU - Glandorf, Boet

AU - Herman, Lieve

AU - Prieto Maradona, Miguel

AU - Saarela, Maria

AU - Anguita, Montserrat

AU - Galobart, Jaume

AU - Holczknecht, Orsolya

AU - Manini, Paola

AU - Pizzo, Fabiola

AU - Tarrés-Call, Jordi

AU - Pettenati, Elisa

AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

PY - 2020

Y1 - 2020

N2 - The vitamin B12 (in the form of cyanocobalamin) under assessment is produced by fermentation with a genetically modified strain of Ensifer adhaerens and it is intended to be used as a nutritional additive for all animal species. In 2018, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers and the environment due to uncertainties on the safety of the production strain and the resulting product. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, the additive was considered to pose a risk to user safety. The applicant provided supplementary data on the identity of the production strain, its susceptibility to antibiotics and toxigenic potential, as well as on the absence of cells and recombinant DNA of the production strain in the final product. The production strain is not expected to produce any toxic compound during fermentation but harbours antimicrobial resistance genes. However, viable cells and recombinant DNA of the strain were not detected in the most concentrated form of the additive. With this new information, the FEEDAP Panel concluded that vitamin B12 produced by E. adhaerensCNCM I-5541 (identified as SCM 2034 in the previous opinion) is safe for all animal species, the consumers and the environment. The applicant did not provide new evidence that would lead the FEEDAP Panel to reconsider previous conclusions regarding the safety for the user.

AB - The vitamin B12 (in the form of cyanocobalamin) under assessment is produced by fermentation with a genetically modified strain of Ensifer adhaerens and it is intended to be used as a nutritional additive for all animal species. In 2018, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers and the environment due to uncertainties on the safety of the production strain and the resulting product. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, the additive was considered to pose a risk to user safety. The applicant provided supplementary data on the identity of the production strain, its susceptibility to antibiotics and toxigenic potential, as well as on the absence of cells and recombinant DNA of the production strain in the final product. The production strain is not expected to produce any toxic compound during fermentation but harbours antimicrobial resistance genes. However, viable cells and recombinant DNA of the strain were not detected in the most concentrated form of the additive. With this new information, the FEEDAP Panel concluded that vitamin B12 produced by E. adhaerensCNCM I-5541 (identified as SCM 2034 in the previous opinion) is safe for all animal species, the consumers and the environment. The applicant did not provide new evidence that would lead the FEEDAP Panel to reconsider previous conclusions regarding the safety for the user.

KW - cyanocobalamin

KW - Ensifer adhaerens

KW - Nutritional additive

KW - safety

KW - vitamin B

U2 - 10.2903/j.efsa.2020.6335

DO - 10.2903/j.efsa.2020.6335

M3 - Journal article

C2 - 33343732

AN - SCOPUS:85098290703

VL - 18

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 12

M1 - e06335

ER -