EU Commission launches consultation on the regulation of new genomic techniques

Such new plant breeding techniques have emerged or have been developed since 2001 when the Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted.

The Commission said it is seeking views and evidence from citizens along with stakeholders on how to best regulate plants obtained from NGTs. 

It wants to get feedback on the topic from EU and national public authorities, breeders, farmers and other economic operators in the agri-food chain, academia and researchers, non-governmental organizations, both inside and outside the EU.

Polarized debate

NGTs are seen in some quarters as a promising innovative field for the agri-food industry, offering great technical potential, critical tools to help breeders and farmers to do more with less inputs.

There is, however, considerable debate as to how these new techniques should be regulated, and whether some or all of them should fall within the scope of EU legislation on GMOs.

Those who say NGTs should be exempt from existing GMO rules argue that the end product is very similar to products generated using conventional breeding techniques, or that similar changes could also occur naturally. Those who consider that NGTs should fall within the scope of GMO legislation say, due to the processes used, plants bred that way are genetically modified.

Premise for consultation ​

A study on NGTs undertaken by the Commission in April 2021 is the premise for this feedback phase. That review concluded that such plant breeding technology could contribute to a more sustainable food system under the EU Green Deal and the EU Farm to Fork Strategy.

That study also determined the current GMO legislation, adopted in 2001, is “not fit for purpose”​ for these technologies: It is hampering plant breeding research potential in the EU and it does not consider whether products have the potential to contribute to sustainability.

The public consultation process​​ will help inform the design of an appropriate legislation for plants obtained from NGTs such as targeted mutagenesis and cisgenesis and their food and feed products, said the Commission.

Stakeholders have until 22 July 2022 to contribute to the initiative. Publication of an impact assessment and of a potential EU legislative proposal for NGTs is expected in Q2 2023.

Commenting, Stella Kyriakides, EU commissioner for health and food safety, said: “Plants obtained with new genomic techniques could help build a more resilient and sustainable agri-food system. Our guiding principle will remain the safety of the environment and of consumers.”​

Sounding the warning bell​

The European non-GMO Association (ENGA) warns of the risks posed to the non-GMO sector in Europe if NGTs are not regulated under the existing GMO legislation. It is actively calling on retailers and food producers to take part in the consultation.

Heike Moldenhauer, secretary general of ENGA, commented: “If the EU Commission goes ahead and effectively de-regulates new GMOs, then food coming from new GM techniques will no longer be clearly labelled and ingredients traceable.​

"In a post de-regulation world, untested and invisible GMOs will find their way onto European fields and into markets, supermarket shelves and plates. This poses a huge threat to consumer confidence and also a potentially disastrous impact on the non-GMO and organic food sectors, who will ultimately pay the price. ​

"Now is the moment for the conventional and organic non-GMO food sector to stand up for itself and have its voice heard through the impact assessment process.”​

Safety assessment ​

For NGT applications in plants, the European Food Safety Authority (EFSA) found there are no new hazards specifically linked with targeted mutagenesis and cisgenesis, compared with conventional breeding.

In addition, it reported that unintended effects during modification of the genome with targeted mutagenesis are of the same type, and fewer, than the unintended effects occurring with conventional, non-GM breeding techniques.

Moreover, the type of modifications introduced with targeted mutagenesis and cisgenesis can also take place naturally in the environment without human intervention, said the Parma-based risk assessor.

Novel products ​

There are a few products obtained by NGTs marketed outside the EU: a soybean with a healthier fatty acid profile, a tomato fortified with gamma-aminobutyric acid, and a bacterium for fertilizing agricultural soil.