EFSA Opinion on Risk Assessment for Biotech-Based Food and Feed Products

The European Food Safety Authority (EFSA) has launched a public consultation on new developments in biotechnology applied to microorganisms and their products intended for food and feed use. They seek feedback on their draft scientific opinion about novel hazards/risks from new techniques and approaches, and the adequacy of current EFSA risk assessment guidance.

The 50-page document considers CRISPR-Cas techniques, new technologies for mutagenesis, other site-directed nucleases, synthetic biology, genome minimization and genome design, and enabling technologies such as DNA sequencing. It includes the results of “horizon scanning” – a systematic examination of potential threats and opportunities which identified a range of genetically modified microorganisms and precision fermentation products being developed for food and animal feed using new genomic techniques.  Current risk assessment guidelines are flagged as inadequate based on these case studies. Updates are recommended.

The draft scientific opinion concludes that possible hazards relate to the genotypic and phenotypic changes introduced in the microorganism, not to the method used for the modification. It recommends that microbiological risk assessment be based on the strain/product itself, independently of the method used to alter genotypic or phenotypic characteristics. A common risk assessment approach should be taken for strains/products derived from or produced with microorganisms, whether obtained with conventional mutagenesis, established genomic techniques (techniques developed prior to the publication of Directive 2001/18/EC), or the new genomic techniques that are the focus of this analysis.

Interested parties are invited to submit their comments by August 4.