Update on ongoing discussions on the regulatory proposal of the European Commission on New Genomic Techniques ("NGTs"): recommendations to reach the Trilogue

The Commission’s Proposal has been managed first under the Spanish Presidency (2nd semester 2023), then under the Belgian (1st semester 2024) and Hungarian (2nd semester 2024) presidencies, in the Council’s „Agriculture“ configuration (AGRIFISH). A first draft compromise was presented under the Spanish presidency on 11 December 2023⁴, but did not achieve a qualified majority (a minimum of 15 MS must vote in favor, and the MS in favor must represent at least 65% of the EU’s population).

Under the Belgian Presidency, a new compromise text was presented and agreed on 7 February 2024, at the COREPER meeting, by 17 States⁵, but still not representing a qualified majority. This text is not public, but we were able to access a copy.

In March 2024, the Belgian Presidency proposed to condition the regulatory status of NGT-1- plants on the absence of patent coverage. This proposal was not accepted.

A working group continues to meet under the Hungarian presidency (2nd semester 2024), which will be followed by the Polish (1st semester 2025) and Danish (2nd semester 2025) presidencies.

We comment below on the adjustments made by the EU Council in the text dated 7 February 2024, and other topics still under discussion:

A.    Exclusion of herbicide tolerant plants from Cat 1

This proposal seems neither necessary nor desirable. We understand that it aims to discourage the development of herbicide-tolerant (HT) varieties, or to strengthen their supervision.  It is important to keep in mind that HT plants and varieties can easily be obtained by spontaneous mutation, random mutagenesis, TILLING or other conventional breeding techniques.  A more logical and non-discriminatory solution would be to treat all HT varieties in the same way in the proposed regulation on plant reproductive material („PRM“)⁶ (uniform authorization, traceability and monitoring requirements), regardless of the techniques used to obtain them. 

B.     Consideration of ploidy for criteria Annex I

In the Council text of 7 February 2024 amending Annex I, it is specified⁵: 

„A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications per monoploid genome…“

The scientific community had already observed that if one wanted to cap the number of possible modifications for an NGT-1- plant, it was necessary to take into account ploidy for species with multiple genomes. The amendment proposed by the Council is consistent with recital 18 bis proposed by the EP⁷:

‚The maximum number of genetic modifications authorised for inclusion in Category 1 NGTs should be proportionate to the number of genomes they contain.‘

C.     Opt-out possible for Cat 2 (as for transgenic GMOs)

As Category 2 plants do not meet the conditions of Annex I because they have a more complex set of genetic modifications, the Commission has proposed to subject them to the same regulatory regime as GMOs, but with adjustments. The Commission did not want opt-outs to be possible for NGT-2 as in the case of GMOs. We agree with the Commission and consider this possibility to be undesirable and counterproductive. Indeed, if opt-outs were allowed, the possibility for breeders or farmers to use such plants in the EU would become unpredictable, as the Commission had pointed out, and would therefore discourage their development and use.

For example, the low-gluten wheat advocated by the Commission and JRC⁸ would probably not be able to see the light of day if it were to be classified as Cat 2 with an opt-out.

D.     Mention all traits resulting from genetic modification in the case of voluntary labelling of Cat 2 plants

Mentioning all the characteristics conferred seems reasonable for the sake of transparency.

E.     Addressing the question of Patents: delivery of the Commission’s study by the end of 2025

The Commission is expected to provide the study by the end of 2025. But the IP impacts of NGTs should not be addressed in the Commission’s NGT proposal (aimed at the regulatory status of these plants) — proposals for amendments to EU IP law should instead be dealt with by separate acts after stakeholder consultation and evaluation following an impact assessment, without limiting the scope to patents alone.

F.    Establishment of a group of experts appointed by Member States to monitor the consequences of patents

As the subject matter is different from the regulatory status, it is appropriate to deal with it outside the Proposal. If the creation of such a group of experts were to prove useful, it should only be set up after the Commission’s study has been received and should focus on two IP systems: patents for plants and PBRs for varieties.

G.    Romania’s concerns⁹ regarding the definitions of the Cartagena Protocol¹⁰ (under discussion)

We believe that NGT-1 plants should not be considered as LMOs (GMOs) under the Cartagena Protocol for the following reasons:

• if the modified sequence obtained by targeted mutagenesis or cisgenesis already exists in the breeders‘ gene pool, then it is not novel, and as such does not fall within the definition of an LMO which requires that the modification be a „novel combination“;
• if the modification is obtained by targeted mutagenesis, it can only be (1) a substitution or insertion of a maximum of 20 nucleotides or (2) a deletion (regardless of size), such modifications being able to be carried out in a natural way by recombination and, therefore, not overcoming „the natural barriers of reproductive or recombination physiology“, as required by the definition of the protocol.

In order to reassure Romania and other stakeholders, it would be desirable to insert in the Proposal a new explanatory recital (14b) after Recital 14, the text of which would reflect the above-mentioned argument:

‚It is understood that category 1 NGT plants are not considered to be living modified organisms within the meaning of the definition of the Cartagena Protocol, either because they reproduce genetic combinations already existing in the breeders‘ gene pool, or because the modifications made can be carried out naturally by recombination, and, therefore, do not overcome the natural barriers of reproductive physiology or recombination. »

H.   Equivalence criteria for Cat 1 (under discussion)

The clarifying changes made in the Council’s text are useful (they allow random cisgenic insertions and cap the total number of changes at 20 per haploid genome).

For example, if random insertions (not causing gene disruption) were not allowed under Annex 1, the disease-resistant potato or apple varieties advocated by the JRC¹¹ and the Commission, presented as obtained by NGT (cisgenesis), would be considered GMOs, subject to opt-outs, and therefore unlikely to be marketed in the EU.

I.     Risk assessment for Cat 1 (under discussion)

This subject should be closed following EFSA’s observations¹² in response to ANSES’s opinion:

“ The average number of spontaneous mutations per generation, according to the references cited by ANSES, is 10⁻⁸ and 10⁻¹⁰, which for a genome such as maize would lead to 20-30 mutations for every single progeny. This figure is 1,000-10,000 times higher when random mutagenesis is used, according to the references cited by ANSES. Therefore, it is scientifically justified to consider that a plant showing 20 modifications or less compared to its parental could be the result of spontaneous mutations.”

 „With regard to all equivalence criteria, EFSA’s GMO Panel (EFSA) considers that the available scientific literature shows that plants containing the types and number of genetic modifications used as criteria for the identification of category 1 NGT plants do indeed exist as the result of spontaneous mutations or random mutagenesis. It is therefore scientifically justified to consider these plants as equivalent to conventionally bred plants. »

„[W]ith respect to the potential risks from NGT plants, the EFSA GMO Panel did not identify any additional hazard associated with the use of NGTs compared to conventional breeding techniques, which include random mutagenesis using physical or chemical agents.”

J.    Traceability and labeling for Cat 1 (under discussion)

Conventional plants are not subject to traceability or labelling describing the breeding method; the Commission’s proposal to require labelling for all PRM (including those used in breeding and research) and a publicly available database for verified NGT-1 plants ensures transparency for consumers and non-use in organic farming.

K.    Opt-out, coexistence with organic (under discussion)

The opt-out possibilities make development and return on investment unpredictable.  There is no problem of coexistence with organic farming in the case of exempted GMOs (which are not subject to labelling for PRM and for which no comprehensive database is publicly available).

L.    Delegated acts (degree of freedom left to the Commission) (under discussion)

Articles 5 § 3 and 22 § 8 of the Proposal authorize the Commission by delegated acts to amend the equivalence criteria in Annex I and the list of NGT plant traits established in Annex III in order to adapt them to scientific and technological progress. These delegations are for five years, extendable, and can be revoked by the Council or the EP at any time – and therefore seem justified and reasonable.

M.    Intellectual Property (under discussion)

See our recommendations (Section 5 below) on the topic of IP for the Trilogue.