EFSA - European Food Safety Authority

11/07/2022 | Press release | Distributed by Public on 11/07/2022 04:27

Safety and efficacy of a feed additive consisting of riboflavin‐5′‐phosphate ester monosodium salt (vitamin B2) (from riboflavin 98%, produced by Bacillus subtilis KCCM 10445)[...]

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Metadata

EFSA Journal 2022;20(11):7608
DOI:
https://doi.org/10.2903/j.efsa.2022.7608
Keywords:
vitamin B2/riboflavin, Bacillus subtilis, nutritional additive, vitamins, safety, efficacy
On request from:
European Commission
Question Number:
EFSA‐Q‐2020‐00838
Contact:
feedap[at] efsa.europa.eu

Panel members at the time of adoption

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 and Ruud Woutersen.

Legal notice Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.

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 vitamin B2 in the form of riboflavin‐5′‐phosphate ester monosodium salt. The additive is manufactured by chemical synthesis from riboflavin 98%, produced by fermentation with a genetically modified strain of Bacillus subtilis (KCCM 10445). Riboflavin 98% has been previously evaluated by the FEEDAP Panel for its use as feed additive for all animal species. Since the additive under assessment contains the phosphate ester monosodium salt of a riboflavin (98%) preparation already considered safe, the FEEDAP Panel concluded that the addition of the salt does not add any toxicological property to the final additive. Therefore, the additive is safe for the target species, the consumer and the environment. The additive is not a skin/eye irritant and it is not considered a respiratory sensitiser. Riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The additive under assessment is effective in covering the animals' requirements for vitamin B2 when administered via feed and/or water for drinking.

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