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Safety of vitamin B2 (80%) as riboflavin produced by Bacillus subtilis KCCM‐10445 for all animal species

on the Wiley Online Library


Panel members at the time of adoption

Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.


Riboflavin (80%) is a feed additive produced by fermentation of a genetically modifiedBacillus subtilis strain. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of riboflavin (80%) based on a dossier supplied by the applicant. The Panel concluded that neither the production strain nor its recombinant DNA was detected in the final product, and therefore, the additive does not give rise to any safety concern with regard to the genetic modification of the production strain. The Community Reference Laboratory on Feed additives, in the context of an official control, reported on the presence of recombinant DNA in samples of the additive. The European Commission asked EFSA to deliver a new opinion on the safety of Vitamin B2 (80%) based on the new data, complementing the former one. The analysed samples contained DNA belonging to the production strain, including the genetic modification. Moreover, one of the samples contained viable cells from the production strain. Because the production strain carries antimicrobial resistance genes introduced by the genetic modification, the FEEDAP Panel considers that Riboflavin (80%) poses a risk for the spread of viable cells and DNA of a genetically modified strain‐harbouring genes coding for resistance to antimicrobials.

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