The European Food Safety Authority (EFSA) Panel on Genetically Modified Organisms (GMO) published a scientific opinion on ‘New developments in biotechnology applied to microorganisms’ used in food and feed, reviewing the adequacy of current EFSA risk assessment guidance. The Opinion considers the risks and safety of new genomic techniques (NGTs) for category 3 and 4 products or category 4 micro-organisms to be placed on the market as or in food and feed, and for category 4 micro-organisms and their products intended to be released into the environment. Category 3 refers to products derived from genetically modified micro-organisms (GMMs) where the ability of multiplication or of transferring genes is not present, but newly introduced genes are present. Category 4 refers to products consisting of or containing GMMs capable of multiplication or transferring genes.

The 39-page document considers the novel hazards/risks from new techniques and approaches such as 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 a “horizon scanning” activity – a systematic examination of potential threats and opportunities which identified a range of GMMs and precision fermentation products being developed for food and animal feed using new genomic techniques.

EFSA guidance was concluded as ‘partially applicable’; fewer requirements may be needed on a case-by-case basis for specific micro-organisms obtained through new genomic techniques. However, updates to the guidance are recommended for risk assessment of GMM using any type of modification technique.

The EFSA GMO Panel did not identify any novel potential hazards compared to EGTs or conventional mutagenesis, related to the technique itself. Some NGTs can produce mutations in micro-organisms that also occur in nature. Due to the higher efficiency, specificity and predictability of NGTs, hazards are less likely than with existing techniques or conventional mutagenesis; no novel potential risks to humans, animals and the environment are expected.

The Scientific Opinion concludes that possible hazards relate to the genotypic and phenotypic changes introduced in the micro-organism, not to the method used for the modification. It recommends that microbiological risk assessment be based on the strain/product itself, independent 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 micro-organisms, whether obtained with conventional mutagenesis, established genomic techniques (techniques developed prior to the publication of Directive 2001/18/EC), or new genomic techniques.