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

Abstract

Riboflavin (80%) is a feed additive produced by fermentation of a genetically modified Bacillus 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.