EFSA statement on the risk posed to humans by a vitamin B(2) produced by a genetically modified strain of Bacillus subtilis used as a feed additive

The detection of recombinant DNA in a vitamin B(2) used as a feed additive was notified by the Belgian national authorities on 2 October 2018 via the Rapid Alert System for Food and Feed (RASFF). The European Commission requested scientific advice from EFSA on the risk posed to humans by the presence of genetically modified material in the feed additive, particularly with regard to antimicrobial resistance (AMR). EFSA assessed the analytical data from RASFF regarding the presence of AMR genes in both additive and feed. Samples of the additive and feed tested positive for the presence of DNA of a genetically modified Bacillus subtilis. The results were compatible with, but did not demonstrate the presence of, a full‐length chloramphenicol resistance gene. No information was made available on the presence of other AMR genes or viable cells of the B. subtilis. The statement provides a risk assessment pathway indicating the events needed to produce adverse human health effects from the presence of AMR genes in feed additives. Data on the likelihood of occurrence of all events are needed to produce an evidence‐based estimate of the risk. All the events are theoretically possible, but there are no scientific data available to estimate the probability of each taking place. Moreover, there is no evidence of the presence of full‐length AMR gene(s) in the vitamin B(2) additive or feed; thus, it is not clear whether the first step towards AMR gene transfer is fulfilled. The sole presence of fragments of AMR genes in a feed additive is not a risk. If a full‐length AMR gene were present in a feed additive, it could lead to risks linked to its transmission to pathogens via the food chain and/or to the environmental spread of AMR bacteria/genes, potentially contributing to the environmental reservoir of AMR determinants.