But nonetheless, the European Parliament (EP) agreed to the regulation on “Plants obtained by certain new genomic techniques and their food and feed”, the deregulation proposal for New GMOs (or NGTs), submitted by the EU Commission the 5th of July 2023. In its plenary session on the 7th of February 2024, it defined its position and paved the way for the inter-institutional negotiations, known as ‘trilogues’. In the final vote on the overall package 307 EP members voted in favour, 263 against, 41 abstained and 91 members were absent.
A New GMOs legislation in this legislature?
Whether the trilogue between the EU Commission, the European Parliament and the Council can start under the current legislative term or whether the further legislative process will be postponed after the EU elections in June, is still an open question. It was originally expected that the Belgian Council Presidency would put the Council's negotiating mandate, i.e. its common position, to a vote in the AGRIFISH Council on 26 February. The required qualified majority is 55% of the EU Member States in which 65% of the EU population live. But even if the Belgian Presidency succeeds it is unclear whether the trilogue can be finalized with a legislation accepted by all three institutions. According to the Council’s press unit the trilogue must be completed by the end of February, according to other sources negotiations can take place up until mid-April. Then the European Parliament can vote on a New GMOs legislation, at its last meeting in this legislature at the end of April.
What did the European Parliament vote for?
In line with the EU Commission’s proposal, the Parliament agreed that NGT plants should have their own regulation and be divided into two categories: those considered equivalent to conventional plants (category 1 NGT plants) and which, therefore, will be exempted from the EU’s GMO legislation, i.e. they are no longer subject to any risk assessment; and those which will continue to have to comply with the stricter rules the EU’s GMO legislation (category 2 NGT plants), including a risk assessment ‘light’. 94% of all NGTs are considered to be NGT1 plants.
Although the Parliament has agreed to far-reaching deregulation of New GMOs, it repeatedly and prominently refers to the precautionary principle (for example in recitals 10 and 43 and article 1). The precautionary principle, if taken seriously, requires a case-by-case risk assessment, foreseen only for NGTs 2 or about 6% of all NGTs.
Criteria for NGT 1 plants
For NGT 1 plants, the Parliament’s plenary followed the ENVI committee’s vote (24th January) on equivalence criteria. So-called equivalence criteria (as laid down in Annex 1) determine when NGTs are considered equivalent to conventional breeding and are thus classified as NGTs 1. They form the centerpiece of the planned deregulation. Originally the EU Commission proposed equivalence criteria which has been criticized as “unscientific”, last by the French authority ANSES .
The agreed equivalence criteria have not been scientifically verified by any authority. They were submitted to the ENVI committee at the last minute before its vote and presented at such short notice that neither the European Food Safety Agency (EFSA) nor national authorities had the opportunity to assess them. They re-define the original equivalence criteria submitted by the EU Commission 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 this new equivalence criteria. The plenary followed the Commission’s approach to exempt all NGTs 1 plants from any risk assessment regarding health and environmental impacts.
It is therefore even more astonishing that an amendment providing for the monitoring of environmental effects of NGT1 plants received majority support (article 7) as well as three amendments called “withdrawal of the decision” (articles 11a, 17 and 21). “Withdrawal” means that marketing of the NGT plant or the product (NGT1 and NGT2) “may” be prohibited by the competent authority “if the monitoring results show that there is a risk to health or the environment” or if “new scientific data supports this hypothesis.”
In addition, the Commission has been obliged to establish a detailed monitoring program and to report on “intended and unintended effects and systematic effects on the environment, biodiversity and ecosystems” (article 30); 24 months after entry into force of the new legislation at the latest.
Of course, post authorization or post marketing monitoring programs never replace a thorough case-by-case risk assessment as part of an authorization process – but it is positive that the Parliament’s plenary countered the ‘no risk at all will ever occur’ narrative from the Commission, AGRI and ENVI Committee and the biotech industry.
Classification as a NGT1 plant
To be classified as a category 1 NGT a plant must meet the equivalence criteria to conventional breeding laid down in Annex 1, according to both institutions, Commission and Parliament. But the Parliament raised the hurdles for the category 1 classification, adding another criterion: A NGT1 plant must contain at least one ‘sustainable’ trait, as laid down in Annex 3, such as tolerance/resistance to biotic or anti-biotic stresses, more efficient use of resources. In addition, the plenary clarified that an NGT plant cannot be classified as category 1 if it is herbicide tolerant (article 6).
Labelling for category 1 NGTs
Both the Commission and the AGRI and the ENVI Committees excluded NGT 1 plants from labelling throughout the whole value chain, and thus about 94% of all New GMOs. But the plenary didn’t: 317 members of the Parliament voted in favour versus 302 against, and 13 members abstained.
Article 10 reads: “Category 1 NGT plants, products containing or consisting of category 1 NGT plant(s) and plant reproductive material, including for breeding and plant reproductive material, including for breeding and scientific purposes that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘New Genomic Techniques’. In the case of plant reproductive material, it shall be followed by the identification number of the NGT plant(s) it has been derived from.”
Should the Parliament’s position become law business operators (breeders, farmers, food and feed processors, retailers) and consumers will continue to have the right to know whether New GMOs are in their value chains and their food. The fact that NGTs are actually GMOs but with a different name will soon become common knowledge …
For category 2 NGTs labelling is mandatory.
Traceability for all NGTs
Traceability is a basis requirement for Non-GMO agriculture and food production – not provided for by the Commission nor the AGRI and ENVI Committees for New GMOs - but voted by the majority of the Parliament (314 votes in favour, 295 against and 16 abstentions).
The text agreed, like NGT 1 labelling in article 10, reads: “Appropriate document-based traceability for NGTs shall be provided by the transmission and holding of information that products contain or consist of NGT plants and product, and the unique codes for those NGTs, at each stage of their placing on the market.”
Recital 47 b underlines the meaning of traceability for New GMOs, especially with reference to Regulation (EC) No 1829/2003, originally established to regulate traceability for old GMOs: “Traceability requirements for food and feed produced from NGTs should be established to facilitate the accurate labelling of such products, in accordance with the requirements of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, so as to ensure that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner, as well as to enable control and verification of labelling claims. Requirements for food and feed produced from NGTs should be similar in order to avoid discontinuity of information in cases of change in end use.”
Further transparency requirements
All NGTs that received market authorization should be listed in a database, in an online format (article 9).
According to recitals 21 and 24, all NGT1 plants listed in that database should carry an ID number and information on the technique(s) used to obtain the trait or traits. Article 7 requires the disclosure of the sequence of genetic modification for NGT1 plants. This is better than nothing – however, applicants for an EU authorization of NGT1 plants don’t have to provide detection methods.
Applicants for the authorization of an NGT2 plant will have to. But they can claim that the development of a detection method is not feasible. If they do so the “Union reference laboratory shall carry out its own research and analyses to confirm the claimed unfeasibility. In that case, the decision of the Union reference laboratory shall be motivated and be made public” (article 20). This obligatory review should help to prevent false claims that it is not possible to provide detection methods for NGT2 plants.
Imports from third countries must meet the standards of the EU’s NGT regulation: “The implementation, enforcement and application of this Regulation shall not have the object or effect of preventing or impeding imports from third countries of NGT plants and products that meet the same standards as those laid down in this Regulation” (article 4).
No anti-GMO contamination measures
Unfortunately, amendments for coexistence measures between an agriculture and food production with and without New GMOs (in order to restrict the predictable permanent contamination of Non-GMO production with New GMOs) and for the right of Member States to prohibit or restrict cultivation on their territory did not gain a majority.
The plenary followed an ENVI committee’s amendment that defines the foreseeable permanent contamination of organic products with NGT 1 plants as “adventitious or technically unavoidable presence” that shall “not constitute a non-compliance of that Regulation” (article 5). 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. Due to the lack of coexistence measures contamination can become a permanent problem here too (depending on the number and area of cultivated New GMOs in the EU) - 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: besides labelling and traceability detection methods as well as EU-wide, binding coexistence measures and a polluter-pays principle that puts the burden and costs on those who use New GMOs.
Organic agriculture
NGTs remain banned in organic agriculture. But the wording in recital 23 leaves a loophole open to restart the debate on the compatibility of New GMOs with organic farming at an undefined point in time: “Currently, the compatibility of the use of new genomic techniques with the principles of organic production requires further consideration. The use of category 1 NGT plants should therefore be prohibited in organic production, until such further consideration takes place.”
Recital 47 appreciates organic agriculture and stresses the obvious contradiction of a deregulation of NGTs and the political aim of an expansion of organic farming in the EU – without offering a solution: “The European Green Deal, the ‘Farm to Fork’, and the EU Biodiversity Strategies put organic farming at the core of a transition to sustainable food systems, with a target to expand European agricultural land under organic production to 25 % by 2030. This is a clear recognition of the environmental benefits of organic farming, for less dependency on inputs for farmers, and a resilient food supply and food sovereignty. This Regulation must not adversely undermine the pathway to a transition of European food systems to organic farming to 25% by 2030.”
Exclusion of NGT1 plants from patents: a ‘pseudo solution’
To exclude category 1 NGTs from patentability, the plenary 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 will continue to 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. In addition, another concern is not resolved: Only large seed companies will benefit from New GMOs because they already hold a large number of patents, including basic patents on techniques like CRISPR/Cas. As patent holders, they can dictate access to and prices for genetic material and new genomic techniques – forcing the seed market concentration even further.
Plenary on the side of EU citizens and EU food sector
With its votes for labelling and traceability, the Parliament’s plenary has taken the side of EU citizens and the EU food sector. Farmers, food producers and retailers who want to exclude New GMOs from their value chains, and consumers who don't want to eat them, need transparency at product level - and they got it. Now it's about getting this result through the trilogue - and fighting for further measures to secure the EU’s Non-GMO production in the medium and long term: EU-wide binding coexistence measures, obligatory detection methods for all NGTs and the application of the pollute-pays-principle.