Safety and efficacy of vitamin B2 (riboflavin and riboflavin 5’-phosphate ester monosodium salt) produced by Bacillus subtilis for all animal species based on a dossier submitted by DSM

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Article
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal
EFSA Journal 2016;14(1):4349 [26 pp.].
doi
10.2903/j.efsa.2016.4349
Panel members at the time of adoption
Gabriele Aquilina, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Vitamins 2012-2015, including Mikolaj Antoni Gralak, Derek Renshaw and Kristen Sejrsen, and the members of the Working Group on Genetically Modified Microorganisms of the FEEDAP Panel, including Boet Glandorf, Lieve Herman, Sirpa Kärenlampi and Christoph Tebbe, for the preparatory work on this scientific output.

Contact
feedap@efsa.europa.eu
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2010-01319
Adopted
3 December 2015
Published
15 January 2016
Last Updated
23 March 2016. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Riboflavin is produced by two genetically modified Bacillus subtilis strains. Neither the production strains nor their recombinant DNA were detected in the final riboflavin products. Riboflavin 5’-phosphate sodium is prepared by phosphorylation of riboflavin. The additives are safe for target animals with a wide margin of safety provided that the current use levels for riboflavin are not exceeded. Toxicological studies with the additive under assessment show that it has a low toxicity and do not indicate a genotoxic potential. The use of the additives in animal nutrition will not significantly alter the riboflavin content of food of animal origin. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the use of the additives in animal nutrition is not of safety concern for consumers. The additives containing riboflavin and riboflavin 5’-phosphate sodium are not irritant to skin and eyes. In the absence of data, the FEEDAP Panel cannot conclude on skin sensitisation. Riboflavin is a recognised photosensitiser, which may elicit skin and eye photoallergic reactions. Workers might be exposed to a respirable dust when handling riboflavin and riboflavin 5’-phosphate sodium; in the absence of data on inhalation toxicity, the FEEDAP Panel cannot conclude on a possible risk by inhalation. The use of riboflavin and riboflavin 5’-phosphate sodium in animal nutrition does not pose a risk to the environment. The additives are regarded as an effective source of riboflavin in covering the animal’s requirement when administered orally.

Summary

Following a request from the European Commssion, 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 and riboflavin 5’-phosphate ester monosodium salt, produced by two genetically modified strains of Bacillus subtilis, as an additive to feed and water for drinking for all animal species and categories.

Riboflavin is primarily found as an integral component of the coenzymes flavin adenine dinucleotide and flavin mononucleotide. Flavocoenzymes participate in redox reactions of carbohydrates, fats and proteins. Riboflavin is therefore involved in the energy metabolism of men and animals.

The products under consideration are riboflavin produced by two genetically modified Bacillus subtilis strains and riboflavin 5'-phosphate ester monosodium salt (hereafter referred as to riboflavin 5'-phosphate sodium). Riboflavin 5'-phosphate sodium is prepared by phosphorylation of riboflavin.

Neither the production strains nor their recombinant DNA were detected in the final riboflavin products. Therefore, riboflavin under assessment does not give rise to safety concerns with respect to the genetic modification of the production strain.

Compositional data on riboflavin containing products produced by either strain did not indicate any substantial difference. Consequently, the conclusions below do not differentiate between products originating from the two strains used for fermentation.

Riboflavin and riboflavin 5’-phosphate sodium are safe for the target animals with a wide margin of safety, of about 20–60 compared to the supplementation levels.

Toxicological studies with the additive under assessment (containing 80% riboflavin) showed that it has a low toxicity and do not indicate a genotoxic potential. The use of the additives in animal nutrition will not significantly alter the riboflavin content of food of animal origin. The FEEDAP Panel considers that the use of the additives in animal nutrition is not of safety concern for consumers.

The FEEDAP Panel considers the additive containing riboflavin and riboflavin 5’-phosphate sodium as not irritant to skin and eyes. In the absence of data, the FEEDAP Panel cannot conclude on skin sensitisation. Riboflavin is a recognised photosensitiser, which may elicit skin and eye photoallergic reactions. Workers might be exposed to a respirable dust when handling riboflavin and riboflavin 5’-phosphate sodium; in the absence of data on inhalation toxicity, the FEEDAP Panel cannot conclude on a possible risk by inhalation.

The use of riboflavin and riboflavin 5’-phosphate sodium in animal nutrition does not pose a risk to the environment.

Riboflavin and riboflavin 5’-phosphate sodium are regarded as effective in covering the animal’s requirement when administered orally.

Keywords
enzyme, vitamin B2, riboflavin, riboflavin 5’-phosphate ester monosodium salt, food safety, Bacillus subtilis, genetically modified micro-organism
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Number of Pages
26