With this greenlight, the Parliament’s approval is scheduled during the 5-8 February 2024 plenary session. If adopted, the Parliament can start the inter-institutional negotiations, known as ‘trilogues’.
Council not ready for trilogue
However, the third trilogue member, the Council, is still struggling to find a common position. After the Spanish Presidency failed to achieve a “general approach” among member states, i.e. a common negotiating position, the Belgians are now attempting to do so. According to reports, the patent issue has still not been resolved. NGT plants - like all other GMOs - as well as the New Genomic Techniques such as CRISPR/Cas are subject to patents. Several member states, as well as EU parliamentarians, fear an increase in patent infringement proceedings because intellectual property rights attached to NGTs extend to genetic material and traits that can also be obtained by conventional breeding. Another concern: Only large seed companies will benefit from New GMOs because they already hold a large number of patents, including basic patents on the techniques. As patent holders, they can dictate access to and prices for genetic material and new genomic techniques. In addition, the French authority ANSES has presented a new analysis that calls into question the scientific basis of the equivalence criteria submitted by the Commission – criteria by which it will be determined when NGTs are considered equivalent to conventional breeding. These criteria form the centerpiece of the planned deregulation and would lead to an exclusion of all category 1 plants (or of 94% of all New GMOs) from any risk assessment and traceability and nearly all labelling.
Without the Council’s “general approach” the trilogue cannot start. But even if the Belgians succeed – due to the EU elections in June - it is uncertain whether the New GMOs legislation will be finalised during this legislature, especially as the EU Parliament will already be meeting for its last session at the end of April 2024. If there is no agreement in the trilogue on a new legislation by the end of April, the NGT legislative procedure will pass into the term of office of the next Parliament and the next Commission.
What did the ENVI Committee vote in favour of?
In line with the EU Commission’s proposal, the ENVI Committee agreed that NGT plants should be divided into two categories: those considered equivalent to conventional ones (NGT 1 plants) and which, therefore, will be exempted from the requirements of the EU’s GMO legislation; and those which will continue to have to comply with stricter rules (NGT 2 plants), including mandatory labelling of products.
Criteria for NGT 1 plants
For NGT 1 plants, MEPs agreed on new equivalence criteria laid down in Annex 1 which were submitted to the Parliament at the last minute and presented at such short notice that neither the European Food Safety Agency (EFSA) nor national authorities had the opportunity to assess them. Their amendment re-defines the original equivalence criteria proposed by the EU Commission (and criticised as unscientific by ANSES, see above) on the size and number of modifications needed for a NGT plant to be considered equivalent to conventional plants. According to initial estimates, even more than 94% of all NGTs would be deregulated under the ENVI Committee’s new equivalence criteria.
NGT 1 plants: Majority of MEPs against transparency and freedom of choice
MEPs only want NGT seeds to be labelled as “NGTs” but not feed and food, and to set up a public online register of all authorized NGT 1 plants. No labelling at consumer level is foreseen, nor is traceability for business operators. For most NGTs, feed and food producers, retailers and consumers will be left in the dark, whether they have New GMOs in their value chains or in their food.
Ironically – or cynically? MEPs want the Commission to report on how consumers and producers' perception of New GMOs is evolving, seven years after entry into force of the new legislation.
No coexistence measures, no opt out
The majority of ENVI MEPs voted down amendments for coexistence measures between an agriculture and food production with and without New GMOs. Particularly perfidious: To counter the foreseeable permanent contamination of organic products with NGT 1 plants, this is to be defined as “adventitious or technically unavoidable presence” that shall “not constitute a non-compliance of that Regulation.” This means: Contamination of organic products with NGT 1 plants is not considered to be economic damage, which neither must be compensated by the polluter nor leads to the withdrawal of organic certification. Simply letting the contamination continue … no matter what consumers and inspection bodies say about it.
Conventional Non-GMO production is not mentioned. Contamination will likely become the norm there too - and the Parliament’s lawmakers are simply ignoring the fact that conventional Non-GMO production must also be protected from contamination. A Non-GMO label has to guarantee the absence of old as well as New GMOs.
Both, the conventional and organic Non-GMO sectors need the necessary means to exclude New GMOs: labeling, traceability, detection methods, EU-wide, binding coexistence measures and a polluter-pays principle that puts the burden and costs on those who use New GMOs.
In accordance with the EU Commission, the majority of ENVI members refused “opt out”, the possibility for member states to ban or restrict New GMOs on their territory in whole or in part of it.
The compatibility of NGTs in organic products “requires further attention”, the ENVI Committee stated. The debate whether New GMOs shall be allowed in organic farming will emerge again.
Exclusion of NGT1 plants from patents: a “pseudo solution”
To exclude category 1 NGTs from patentability, the MEPs agreed to amend Directive 98/44/EC on the legal protection of biotechnological inventions; but the legal impact is questionable – this amendment will not exclude category 1 NGTs from patentability. It is the European Patent Convention that must also be amended. However, even if the European Union is a member, a respective amendment must be supported by all contracting states; the probability of this happening is close to zero. With this “pseudo-solution”, breeders, farmers and food companies cannot reliably exclude patented NGTs in their product flows - also because without mandatory traceability and labelling, they do not even know whether they use NGTs - and may therefore be subject to patent infringement proceedings.