EU-Commission takes first step to deregulate genetically engineered plants and food

In an “Inception Impact Assessment” published on the 24th September, the European Commission informs the public and interested parties about its intention to prepare new legislation that would waive the standard risk assessment and labelling requirements for genetically modified organisms on “plants obtained by targeted mutagenesis and cisgenesis”. With these new terms the Commission describes results of the new genetic engineering technologies CRISPR/Cas and other “gene editing” techniques which effect either the single or multiple alteration of short DNA strands or the transfer of strands which already exist in an organisms DNA, but may not be activated or located in a different context. Cisgenesis describes genetic engineering that does not introduce new DNA from another organism (transgenesis) but alters and “rewrites” existing DNA.

The Commission invites the public to comment on its plan, goals and assumptions before October 22nd. 

Important points to consider concerning the EU-Commission´s plan in a nutshell:

  1. This proposal is a first step towards deregulating the approval of genetically engineered plants, animals and microorganisms. It lacks an overall concept for GMO regulation and does not take into account novel risks and hazards emerging from the application of new GM technologies.
  2. Artificial distinctions between different forms of genetic engineering (directed mutagenesis, cisgenesis) only confuse the basic EU definition of GMOs as organisms in which the “genetic material has been altered in a way that does not occur naturally”, as confirmed by the European Court of Justice in 2018. 
  3. The Commissions description of these specific GMOs sounds like direct PR for their potential benefits and lacks the critical distance to be expected from a public institution and impartial regulator.
  4. The precautionary principle as the constitutional basis of EU environmental risk assessment is no longer mentioned in the proposal.
  5. It would be desirable to take into account as part of any technology assessment and approval processes, social and sustainability criteria in a systematic way. However, the proposal to single out a narrow class of GMOs for such an approach seems arbitrary. It lacks a sound scientific, systematic and coherent new approach to product and technology evaluation.

Examples of items to be communicated to the Commission: 

  1. All GMOs obtained from older or newer genetic engineering technologies should be subject to the standard case by case approval and risk assessment procedures for GMOs.
  2. All GMO products should be clearly labelled so as to allow for an informed choice of consumers,  and farmers. The traceability of all GMOs should be a mandatory prerequisite for approval. 
  3. An adaptation of GMO risk assessment procedures to newer technological developments and new scientific evidence must be based upon solid scientific criteria and concepts and must include the assessment of new and additional risks emerging from new technologies.
  4. The assessment of socio-economic as well as sustainability benefits and risks must be planned and designed in a broad, inclusive and integrated way. To guarantee its integrity and credibility it should not be limited to the regulation of one specific category of GMOs.

Further reading:

Commission policy paper, sometimes referred to as study, on new genomic techniques (April 2021)

Biosafety of Genome Editing Applications … a critical scientific assessment from members of five national regulatory institutions within the EU (June 2021)

Biased from the outset… critical response from 51 environmental, consumer and farmer organisations (Sept 2021)

Background papers on CRISPR/Cas technologies and risks Scientific but comprehensible general background papers of the FGU project genetic engineering and the environment (2020/2021)

Write to the public consultation on the new GMOs

This online form is intended to make it easier for you to participate in the EU Commission's "have your say" procedure. The aim of GMO-Free Europe is not to collect as many signatures as possible, but to respectfully express personal, environmental, scientific, economic and other concerns. You are of course welcome to use parts of our text. If you wish to express your opinion anonymously, please use the form provided by the EU Commission.

Feedback period: 24 September 2021 - 22 October 2021  (midnight Brussels time)