On 5 July 2023, a new step in the procedure for revising the European regulations that will apply to New Genomic Techniques (NGTs) was reached. This revision of the legislation is being carried out through a “European initiative”, a very complex process with several stages and is stretching over several years! How far is it now?
A very long process
The European Court of Justice (CJEU) on 25 July 2018 stated that all products modified by genetic engineering with New Genomic Techniques (NGTs) developed after 2001 must be regulated as GMOs without any exception. Considering the consequences of CJUE ruling for the EU economy within a worldwide market, the SAM (Scientific Advice Mechanism, the Principal Scientific Advisers to the European Commission group’s name) , intervened very quickly. It published as early as November 2018 a statement entitled “A scientific perspective on the regulatory status of products derived from gene editing and its implications for the GMO directive” in which was pointing out that “due to new scientific knowledge and recent technical progress, the GMO directive is now unsuitable” (1). Following this, the European Council called on the European Commission (EC) on 8 November 2019, asking for changing the legislation on NGT with news proposals.
The Commission therefore commissioned studies to the JRC (Joint Research Centre), precisely the state of the art and the developments in R&D research (2). The next stage of this revision took place in April 2021, when, on the strength of the conclusions of these studies, the EC sent an official letter to the country holding the rotating presidency of the European Union (at that time Portugal). It asked it to initiate the process of a European initiative in order to change the regulations regarding some NGTs.
The next step, known as the road map step, ended in October 2022 with the gathering of opinions from European citizens, economic players and various organisations on the proposals to be made. This stage was indeed the subject of a cyber-attack aimed at stopping the initiative. Backed by some Green MEPs, this anti-democratic manoeuvre was nevertheless foiled. The process therefore continued with a public consultation from 22 April to 22 July 2022. The results were indisputable: 80% of respondents said they were in for a change in regulation and 17% against (mainly NGOs well known for their anti-technological stance). As a consequence of these results, the EC published a regulatory proposal on 5 July 2023 which is now subject to comments from the public until 1st September 2023. The purpose of this consultation is to inform of citizens’ opinion the European Parliament and the European Council which will debate on this point in autumn/winter 2023-2024. The whole process will therefore take more than five years!
The European Commission’s regulatory proposals for NGTs
The European Commission is proposing to regulate two categories of products derived from NGT techniques: targeted mutagenesis (such as the CRISPR technique) and cisgenesis. The CRISPR technique makes it possible to cut cellular DNA with a high degree of precision (akin to molecular scissors) using a cellular protein (Cas) associated with a guide RNA. This cut can be repaired in several ways, with minor modifications such as the deletion or replacement of a small number of basic DNA units (nucleotides), which is accompanied by a genomic rearrangement, or with the insertion of more substantial genetic material. Cisgenesis is a genetic modification in which only genetic material from the same species or from species with a common origin is used, and which can also be conducted by conventional selection techniques.
The new European regulation proposal distinguishes between two cases:
– NGT-1 plants, which the new regulation classifies as equivalent to conventional plants. Will be exempt from GMO regulation minor genetic modifications produced in the laboratory using NGTs that could also have occurred spontaneously in nature or resulted from a conventional selection process without the addition of foreign DNA to the gene pool. They are not subject to sanitary and environmental risk assessment. If the products derived from these seeds are not specifically labelled, the seeds themselves are labelled in order to inform the farmer who grows them. Following submission of a dossier and after the opinion of the European Food Safety Agency (EFSA), the plants included in this category “Cat-NGT1” receive a positive notification from the authorities which registered them in a public database.
NGT-2 plants, which have also been modified using NGTs but whose modifications do not meet the criteria for the NGT-1 category. These NGT-2 plants are subject to appropriate “GMO-like” regulations which must be proportionate to the modified trait but include a safety and environmental risk assessment. The application file for authorisation of NGT-2 plants is much heavier than that for NGT-1 plants. In particular, it must include: (1) molecular traceability tools or, if traceability is impossible, an explanation of the reasons why; (2) labelling that may include positive mentions (e.g. tolerance to drought or disease, improved food quality, etc.); (3) environmental monitoring plans if necessary. The decisions notified by the authorities are recorded in the database mentioned above.
A step forward…. but a minimal revision
Several professional organisations, such as Euroseeds at European level, the Spanish Bioindustry Association (ASEBIO) in Spain, which has held the presidency of the European Union since 1 July 2023, and the Union Française des Semenciers (UFS) in France, have welcomed the creation of a category of NGT-1 plants subject to declaration but exempt from GMO regulations. However they insisted that there should be balanced regulations “to take account of scientific progress and to envisage the development of these varieties at European Union level without generating distortions of competition with the rest of the world” (3).
This decision certainly represents an opening for the use of some NGTs in the European Union, but what’s there to think of this new regulatory development?
The proposed regulatory revision is a minimum revision because of the restricted scope defined in its annex-1 of the authorised genetic modifications for the NGT-1 classification, and also because it excludes animal and microbiological applications. Let’s look at these two points.
Specific notification for plant NGTs, why not the sole inclusion in the Catalogue, a strong and tested procedure?
The proposed project is confined to deregulating the genomic modifications of plant products produced by NGTs which could also be obtained by natural mutation or conventional selection. But since number of NGT-1 products are indistinguishable from conventional products, why should they be subject to a special notification procedure, with a “NGT-1 category” entry in a specific database?
Remember that any new variety wishing to be marketed in France and Europe must pass the Distinctness-Homogeneity-Stability (DHS) and Agronomic, Technological and Environmental Value (VATE) tests under the responsibility of GEVES (Groupe d’Etude et de Contrôle des Variétés Et des Semences) before being registered in the Official Catalogue of Plant Species and Varieties Grown in France, which has existed since 1932. At European level, any variety registered in a national catalogue appears in the European Common Catalogue, enabling it to be marketed throughout the EU. By 2023, the French Official Catalogue will contain more than 9,000 varieties and the European Common Catalogue more than 23,000 (4). Each new plant variety is recognised and certified based on demanding assessments, through the characteristics of the finished product. This procedure is highly demanding since only 30% to 40% of varieties applying for this recognition obtain it. The method used to obtain the new variety (mutation, sexual cross) is not requested in the DHS-VATE dossier (5).
Why not apply to NGT products this single procedure that has been implemented for almost a century without any incident? In Canada, the regulations applied to new products are based on this approach: they assess the characteristics of the finished product and the quality of the product independently of the method of production: traditional crossbreeding, transgenesis (GMOs) or NGTs, through the Novel Foods regulation (6). This highly rational approach is marked by pragmatism and efficiency. It has been made possible because the precautionary principle does not have the same meaning in North America as it does in the European Union, where it has been holding back technological innovation for almost twenty years.
Regarding Organic Farming developed in France, it should be noted that a special committee named CISAB (Inter-Sectional Committee for the Evaluation of Varieties for Organic Farming) has been set up since 2017, within the CTPS (Permanent Technical Committee for the Selection of Cultivated Plants) to promote the inclusion in the Official Catalogue of varieties suitable for this farming. Why shouldn’t this committee manage the requirements of this special and so particular type of farming? Special because it has an obligation of means and not of results, and so particular because of its specifications rejecting technological progress! All in all, it is a highly ideological form of farming that struggles to recognise its shortcomings. It is encouraged by the intense lobbying of political parties (notably ecologists) who have convinced the EU authorities to increase the area under organic farming in the Union… even though, for some months now, more and more farmers and consumers have been turning away from this dogmatic approach to agricultural production.
A new regulation project with a limited scope
The proposed regulatory project does not therefore cover genetic modification techniques other than cisgenesis or targeted mutagenesis. This restriction takes account of the rise of certain genome-editing techniques that now dominate research in this field with the flagship CRISPR technique, whose authors, European Emmanuelle Charpentier and American Jennifer Doudna, were awarded the Nobel Prize for Chemistry in 2020. Let’s take note of this judicious choice, which is based on a very technological breakthrough that takes biotechnological innovation into a promising new dimension.
But the new regulations do not apply to micro-organisms or animals either. The reports commissioned from the JRC emphasised that over 80% of R&D agrifood projects are focused on plant and fungal organisms. Does this mean that animal and microbiological applications should be excluded from the scope of the new proposed regulation? At a time when the importance of soil health and the millions of telluric micro-organisms and organisms is being emphasised as a means of improving agriculture? At a time when research into gene editing of farm animals is helping to improve not only animal health but also animal welfare… elsewhere in the world!
The French Veterinary Academy has stressed on several occasions that because animal research is conducted in a highly controlled environment, it is incomprehensible that researches in this field cannot be encouraged by appropriate European regulations (7). This position is fully shared by the Union of European Academies of Agriculture (UEAA), which is concerned that, at a time of zoonoses (monkeypox, leptospirosis), European animal research is being hampered by this exclusion (8).
Repeal Directive 2001/18/EC
Research over the last twenty years has shown that genomic modifications by genetic engineering, previously considered to be artificial, i.e. the result of human manipulation, occur spontaneously in nature at a time not chosen by man. It has been identified that in nature there are not only genetic mutations but also completely spontaneous transgenic flows. Genetic engineering, on the other hand, makes it possible to choose the modification we want to make at a time when it is useful, freeing us from the vagaries of nature.
As knowledge has progressed, research has shown that Directive 2001/18/EC has become obsolete. Published in 2001, at a time when there was still a great deal of uncertainty, and because it is imbued with the precautionary principle (enshrined both in the French Constitution for almost 20 years and in Article 191 of the 2016 Treaty on the Functioning of the European Union), the European Directive on GMOs needs to be updated.
One might have thought that the new regulation rules called for in 2019 by the Council of Europe and initiated by the European Commission (EC) would be an opportunity to reconsider legislation on genomic modifications in the EU. Many countries in North and South America, and also in Asia, have taken this route. The recent EC proposal published on 5 July 2023 shows that this is not the case. Following the example of French President Emmanuel Macron, has the European Commission decided to practice the ambiguity of a “simultaneously” approach in order to avoid taking a clear-cut position? Is this cautious attitude equal to the biotechnological, economic and agrifood sovereignty challenges (7) facing the European Union in a globalised world?
- Group of Chief Scientific Advisors (2018) A Scientific Perspective on the Regulatory Status of Products Derived from Gene Editing and the Implications for the GMO Directive Statement by the Group of Chief Scientific Advisors November 13, 2018, https://op.europa.eu/en/publication-detail/-/publication/ a9100d3c-4930-11e9-a8ed-01aa75ed71a1/language-en.
(2) ) Broothaerts W, Jacchia S, Angers A,Petrillo M, Querci M, Savini C, Van den Eede G, Emons H. New Genomic Techniques: State-of-the-Art Review, Publications Office of the European Union Luxembourg. 2021. & Parisi C, Rodríguez-Cerezo E. Current and future market applications of new genomic techniques, Publications Office of the European Union, Luxembourg. 2021.
(3) CP – Nouvelles techniques d’amélioration des plantes (NGT) 5/07/2023 https://www.ufs-semenciers.org/a-la-une/cp-le-collectif-en-faveur-de-linnovation-varietale-salue-une-premiere-etape-vers-une-reglementation-europeenne-adaptee/
(4) https://www.semae.fr/catalogue-varietes/ (en ligne le 10/07/23)
(5) The author thanks Pierre Devaux and Daniel Segonds, members of French Academy of agriculture, for useful information on this topic
(7) Académie vétérinaire de France. Avis relatif à la production de modifications ciblées dans le génome des animaux domestiques. 2019. https://academie-veterinaire-defrance.org/publications/avis-rapports-prises-de-position/genome-des-animaux-domestiques-modifications-ciblees Académie vétérinaire de France. Lettre de Monsieur le Président de l’Académie Vétérinaire de France à Madame la Présidente de la Commission de l’Union Européenne, Madame Ursula von der Leyen. 2021. https://academie-veterinaire-defrance.org/actualites/lettre-a-madame-presidente-de-la-commission-de-lunion-europeenne-importance-strategique-pour-lunion-europeenne-de-la-recherche-sur-ledition-genomique-pour-lutter-contre-les-panzooties-de-maladies-infectieuses-chez-les-animaux-de-production
(8) Union of European Academies of Agriculture (UEAA). Recommendations for an EU regulation frame concerning Genome Editing Research and Development for Crop Plants and Farm Animals. 2022. https://ueaa.info/2022/01/03/the-ueaa-recommendations
(9) Regnault-Roger C. Enjeux biotechnologiques, des OGM à l’édition du génome, Presses des Mines, Paris, 2022, 204 pages
This post is also available in: FR (FR)