EFSA calls on stakeholders to take part in novel genomic techniques survey

EUROPE – The European Food Safety Authority (EFSA) is requesting interested parties to participate in a survey on the use of novel genomic techniques for the synthesis of genetically modified microorganisms (GMMs) intended for food and feed.

The European Commission asked EFSA to issue an opinion on two categories of newly developed biotechnology-applied microorganisms intended for use in food and feed.

These include products derived from GMMs in which GMMs capable of multiplication or of transferring genes are not present, but in which recombinant DNA is still present (e.g., heat-inactivated starter cultures), and products consisting of or containing GMMs capable of multiplication or of transferring genes (e.g., live starter cultures for fermented foods and feed).

EFSA will take the survey’s data into consideration in order to conduct a horizon-scanning exercise on microorganisms and the products made from them thanks to new developments in biotechnology.

This will allow it to formulate an opinion on potential novel hazards and risks from these developments in biotechnology applied to microorganisms as well as the suitability of the agency’s current risk assessment guidance.

The term “new genomic techniques (NGTs)” refers to genetic modification methods that have developed or appeared since 2001.

NGTs include methods for genome editing, in vivo mutagenesis, and epigenetic modification.

Methods utilizing recombinant nucleic acid molecules that were in use prior to 2001, commonly known as “established genomic techniques,” are outside the scope of this document.

The Commission released research on the status of NGTs under EU legislation in light of the Court of Justice of the European Union (CJEU) ruling in 2021 at the request of the Council of the European Union (“Council”).

Many people were shocked when the CJEU decided that organisms created by targeted mutagenesis should be considered GMOs and as such be subject to the rigorous regulations of Regulation 2001/18/EC (“GMO Directive”).

While the Council’s request was more general and alluded to NGTs generally, the decision was focused especially on new mutagenesis techniques, which are NGTs that allow for the generation of a mutation or mutations without the introduction of foreign genetic material.

Such techniques have advanced at a rapid rate in the past twenty years with applications in the agri-food industry currently being marketed in North America and hundreds of applications perhaps reaching market stage in the next 10 years.

The study aims to offer up-to-date, thorough information on NGTs and to aid in deciding on any additional policy-related action.

It was completed with the assistance of focused consultations with the relevant authorities of the Member States and EU stakeholders.

In addition, the study included a variety of expert viewpoints.

Based on the CJEU’s comments, the study came to the conclusion that GMO laws apply to organisms created using new mutagenesis procedures as well as those created by cis- and intragenesis.

Contrary to intragenesis procedures, which reorganize the inserted foreign genetic material, cisgenesis involves the introduction of foreign genetic material (such as a gene) into a recipient organism from a crossable donor.

The survey is open through April 30, 2023.

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