Inception Impact Assessment on New Genomic Techniques

ENGA’s Input to the EU Commission’s Roadmap for Deregulating New GMOs

ENGA does not see any necessity to change the current EU GMO legislation for new GMOs. The EC should respect the ruling by the ECJ and implement the EU GMO legislation for NGTs, as interpreted by the ECJ.

All new GMOs have to remain subject to a comprehensive risk assessment

To our understanding the EC suggests that products derived from targeted mutagenesis and cisgenesis shall be excluded from the current GMO legislation. This would affect app. 95 % of all new GM plants currently in the pipeline, according to data from the JRC.

We do not see any justification for such a deregulation. An a priori conclusion on the general safety of whole groups of plants cannot be drawn without a comprehensive and compulsory risk assessment. In accordance with the precautionary principle, a thorough, process-based case-by-case risk assessment for each individual new GM plant must be guaranteed.

The European food sector (producers and retail) bears responsibility and liability for all its products (towards the full value chain and consumers) and depends on a comprehensive safety regime for all new GMOs.

Freedom to conduct business has to be ensured for the conventional and organic Non-GMO sector

New GMOs restrict and threaten the freedom to conduct business for conventional and organic Non-GMO economic sectors. This applies to both regulated and deregulated products.

Regulated new GMOs would have to be strictly barred from Non-GMO value chains (just like old GMOs). Since no polluter-pays principle exists in the EU, Non-GMO producers have to bear the costs for segregation, analysis and certification. The more new GMOs receive EU authorisation, the more complex and costly segregation measures become.

Deregulated new GMOs would contaminate Non-GMO value chains in an uncontrollable way, due to abolished traceability and labelling. Not being able to identify and exclude new GMOs the conventional Non-GMO sector would face serious financial losses, with threat of full collapse. The food and retail market in at least eight EU countries where Non-GMO labelling systems are in force would be heavily impacted. The same applies to organic products, as the ban on GMOs is an important selling point. The ambitious targets for organic production in the Green Deal would be jeopardized by deregulation.

To ensure freedom to conduct business for the Non-GMO sector

  • labelling and traceability for all new GMOs have to remain mandatory and implemented by EU and national authorities.
  • strict and comprehensive coexistence rules between agriculture and food production with and without GMOs have to be implemented, including clear liability rules in case of contamination.

Development and implementation of a thorough traceability and labelling system for new GMOs have to be top priority of the impact assessment

GMO-free agriculture and food are based on traceability and labelling of GMOs. The same applies to consumer’s rights to make informed choices - which includes a right to say “no” to GMOs in food.

The EC needs to assist EU member states in the enforcement of EU GMO law, provide budgets and research capacities and coordinate all relevant endeavors in an efficient manner. This includes detection methods for new GM plants already on the market. Research needs to focus on detection of the individual technology used to create a new GMO. The EC has to establish a transparency register for new GMOs, with a focus on GM plants derived from targeted mutagenesis. Countries exporting agricultural or food products to the EU need to mandatorily participate in the register.

In addition, the EC has to establish traceability systems for new GMOs. Traceability does not depend on the ability to distinguish GM products from Non-GM products using laboratory methods. Experience with EU labels for regional specialties and organic food shows that it is possible to build robust traceability systems even when the information displayed on the label cannot be verified in a laboratory.


The impact asssessment (IA) on New Genomic Techniques will focus on plants obtained by targeted mutagenesis and cisgenesis. New Genomic Techniques is a term invented by EU institutions, avoiding the legally correct term GMOs as confirmed by the European Court of Justice. Plants created by targeted mutagenesis and cisgenesis are GMOs without the integration of DNA from other species.

With the IA, the EU Commission (EC) determines which policy options are politically feasible. As a rule, the EC publishes the results of an IA together with a legislative proposal. This is expected in the second quarter of 2023.

Why is the Impact Assessment about Freedom to Conduct Business Against Freedom to Conduct Business?
The inception impact assessment, conducted in October 2021, made very clear that business interests in the field of GMOs are at least contradictory or even exclude each other.  Under the heading „Likely impacts on fundamental rights“ it states:
 „Adapting legal requirements for plants obtained by targeted mutagenesis and cisgenesis in accordance with their risk levels may bring new opportunities for agri-food system and biotechnology operators, as well as researchers, and SMEs, enhancing their freedom to conduct their business. Organic and GM-free operators have expressed concerns that their freedom to conduct business might be negatively affected“.
While an adaption of legal requirements (a lowering or abolishing of risk assessment and transparency standards, thus a deregulation) will expand the freedom to conduct business for agri-food system operators (such as commodity traders and some farmers) and biotechnology operators (such as Bayer and Corteva as the major patent holders for New Genomic Techniques), it will massively threaten the freedom to conduct business for the conventional and organic Non-GMO sectors.
This applies to both regulated and deregulated new GMOs. For regulated new GMOs costly and complex systems are needed to separate the flow of goods. Since it exists no polluter-pays principle in the EU, the Non-GMO producers bear the costs for product separation, analysis and monitoring.  
For deregulated new GMOs traceability and labelling requirements would be eliminated. To label „Non-GMO“ economic operators need to know which products are made with GMOs. Without this knowledge they run the risk to sell unwittingly and unintentionally new GMOs.

Deregulation of New GMOs: What is at Stake for the Conventional and Organic Non-GMO Sector?
•    Loss of control over all value chains due to lack of GMO labelling: new GMOs can be present everywhere, not only in Non-GMO and organic value chains.
•    Massive setbacks in the conventional Non-GMO sector, as a Non-GMO label reliably has to exclude old and new GMOs.
•    Severe setbacks for the organic Non-GMO sector: the obligatory exclusion of GMOs as a major selling point would be eliminated.
•    Loss of consumer trust: How to explain if a Non-GMO product is contaminated with a new GMO? How to explain that organic could be “with GMOs”?
•    Loss of investments: especially for the Non-GMO sector (changing formulations, developing quality assurance systems, marketing).