an ongoing public consultation to modify European regulations.
On July 25, 2018, a judgment of the European Court of Justice (CJEU) indicates that all products resulting from new genome modification techniques (NGT) after 2001 fall under the European regulations applied to GMOs. However, this court decision, based on administrative justification and not on scientific analysis, puts the EU at odds. Many countries in the Americas, Asia and the Pacific region have opened up, at different levels, to new genomic techniques (NGT) by adopting regulations adapted to their specificities.
European regulations on GMOs are based on Directive 2001/18. They are indeed very bulky. Moreover, they have hindered the development of agricultural GMOs in the European Union (EU). The costs of the long files to be compiled to request the MA, – whether for cultivation in the open field or import for processing for human and animal food, and also for the post-marketing of authorized GMOs which must be carried out for the duration of the granted authorization (usually 10 years)-, have restricted the process to large international consortia (such as Syngenta-ChemChina, Bayer, Corteva), with sufficient financial strength.
In this context, can the European Union stand out and position itself on the margins of the world market? As soon as the CJEU judgment was published, several European institutions and bodies in the scientific and academic sphere, as well as citizen movements, became concerned . They asked that a debate be opened on this subject because the obstacles to technological progress but also to development due to the attack on the free movement of goods in a globalized market seemed obvious.
Many calls to change the regulations
The Group of Principal Scientific Advisors to the European Commission (or Scientific Advice Mechanism SAM), a high-level committee of experts, created on June 9, 2015 inform the European Commission on scientific subjects in complete independence and transparency so that it can consciously adopting EU policies, issued a statement in November 2018 in which it underlined that “It is becoming clear that new scientific knowledge and recent technical developments have made the GMO Directive unsuitable”.
Then it was the turn of the European Union of Agricultural Academies (UEAA), supported by several academies of the Member States, to ask “new regulatory framework adapted to the most recent scientific advances” for “facilitate critical research in the European Union on gene editing”.
As far as citizens’ movements are concerned, a European citizens’ initiative called Cultivate scientific progress: cultures matter! was initiated in the summer of 2019 by a group of students of eight different nationalities from Wageningen University (Netherlands) (1). He called for a change in the current legislation”Focus on culture rather than technique. In this way, safety is ensured while the valuable benefits of new techniques are not lost through illogical regulatory hurdles..”
Various statements and forums by French and German political actors concerned about the consequences of the CJEU’s judgment have also been noted.
This context led the Council of the EU to invite the European Commission to adopt a new approach in November 2019: this new approach consisted of a study and an impact analysis in order to redefine the European status of TNGs.
The European Commission confirms the need to amend the Regulation
The European Commission published the results of this study at the end of April 2021. It was informed by two reports from the European Commission Joint Research Center (EU-JCR). The first report dealt with the state of the art of NGTs and the second with Research and Development and their commercial applications (2).
This study confirmed that GNTs have developed rapidly over the last decade on several continents. The flagship technique of NGT is CRISPR, published just 10 years ago, in 2012 in the magazine Science by American researcher Jennifer Doudna and European researcher Emmanuelle Charpentier, who received the 2020 Nobel Prize in Chemistry for this invention. More than 25,000 scientific publications have already been devoted to the applications of this technique. The European Commission emphasizes that NGTs have grown rapidly in many parts of the world and are expected to continue to do so. There is significant interest both in the EU and globally for plant applications of NGTs, and some of them their apps are already on the market outside the EU”. He noted “that plants obtained by NGT have the potential to contribute to the objectives of the European Green Deal and in particular to the farm-to-table and biodiversity strategies and the United Nations Sustainable Development Goals (SDGs) for a more sustainable agri-food system resilient and durable”.
A restricted perimeter
an initiative was therefore launched in autumn 2021 to reflect on the European legal framework that could apply to plants obtained by targeted mutagenesis and cisgenesis as well as to food and animal feed derived from these plants. The European Commission has narrowed the scope of the upcoming review. Only the regulations for plant applications are concerned. This decision is based on the conclusions of the European Food Safety Authority (EFSA) which underline “that plants obtained by targeted mutagenesis and cisgenesis may have the same risk profile as plants resulting from conventional breeding”; but like “EFSA has not yet assessed the safety of targeted mutagenesis and cisgenesis in microorganisms or animals, nor the safety of other techniques” the European Commission has decided to delay the review for these bodies (3).
Steps strewn with pitfalls
This initiative, classified under the theme “food safety”, intends to propose new European regulations. It is carried out in three stages. It started in September 2021 with the definition of a “roadmap”. This is followed by a public consultation, currently in progress until July 22, 2022. A third stage will take place in the 2nd quarter of 2023 and will lead to the adoption by the Commission of the revised regulations for DTT from power plants.
The public was consulted on the Roadmap for one month, from September 24, 2021 to October 22, 2021 and 70,879 responses were received. A large majority of these responses came from citizens of the Union (more than 96% or 68,183 contributions), followed by universities and research institutes (113 contributions), professional organizations and associations (190 contributions ), and 93 contributions received from trade unions, NGOs, and environmental and consumer associations. Most responses came from German (46%) and French (36%) citizens, together reaching a total of 92%, followed by Belgian, Dutch and Austrian citizens (3%) and Italian ‘2%) (the other countries having contributed less than 1% each).
Due to the very high number of responses received, the European Commission has been alerted to a possible ruse. And in fact, this stage of the consultation gave rise to a manipulation campaign by the Greens/EFA (European Free Alliance) political group in the European Parliament, which flooded it with more than 69,000 spam messages, with the help of a communication agency based in Estonia.
The German Federal Minister of Agriculture, Julia Klöckner, described this action in November 2021 as sabotage of the legislative process (4). This manipulation was supported by a small handful of MEPs (seven of them) (5) who aimed to block the revision of the regulation as part of the campaign “Let’s keep GMOs off our fields and our platesthey led (6).
The objective of today’s public consultation is to carry out a survey to assess
- the interest of the new regulations in focusing on the assessment of risks for products resulting from targeted mutagenesis or cisgenesis. This question is relevant because the products obtained by these techniques cannot be distinguished, for the most part, from a product harvested in the wild or obtained by conventional farming techniques.
- taking into account the durability of these products.
- the information to be communicated to operators and consumers in complete transparency
- the technological access that this regulation would give to European SMEs.
July 17e, 1503 opinions were validated, of which three quarters were expressed by EU citizens. The Germans surveyed come first (31%), followed closely by the Italians (26%), and further behind the French and the Spaniards (12 and 9%), with other EU nationalities accounting for around 14%. There is one week left to talk.
I hope that this process will lead to new European regulations facilitating the use of NGT in all sectors where they can bring essential innovations for the competitiveness and sovereignty of European agriculture (7).
(1) European citizens’ initiative: sign the Green Biotech petition, C.Regnault-Roger, European https://www.europeanscientist.com/en/agriculture/european-citizens-initiative-sign-the-green-biotech-petition/
(2) Broothaerts W, Jacchia S, Angers A, Petrillo M, Querci M, Savini C, Van den Eede G, Emons H (2021) New Genomic Techniques: State-of-the-Art Review EUR 30430 EN, Publications Office of the European Union, Luxembourg ISBN 978-92-76-24696-1 doi:10.2760/710056 JRC121847; (2) Parisi C, Rodríguez-Cerezo E (2021) Current and future market applications of new genomic techniques EUR 30589 EN, Publications Office of the European Union, Luxembourg ISBN 978-92-76-30206-3 doi:10.2760/02472 JRC123830.
(3) Legislation for plants produced by certain new genomic techniques https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-applicable-aux-vegetaux-produits-a-laide-de-certaines-nouvelles-techniques- genomics/F_en
(4) A scandalous procedure” About Spamming of the European Commission consultation on “GMOs” and “NGT” Schillipaeppa https://seppi.over-blog.com/2021/11/un-procede-scandaleux. html
(5) Martin Hausling (🇩🇪), Benoit Biteau (🇫🇷), Eleonora Evi (🇮🇹), Tilly Metz (🇱🇺), Michèle Rivasi (🇫🇷), Thomas Waitz (🇦🇹), Sarah Wiener (🇦🇹) //act.greens-efa.eu/en/keep-gmo-off-our-plates
(6) Check the news. Has the Greens group in the European Parliament organized a “spam” campaign against a consultation on GMOs? https://www.liberation.fr/checknews/le-groupe-des-verts-au-parlement-europeen-at-il-organise-une-campagne-de-spams-contre-une-consultation-sur-les- gmo 20211103_J66AB4FP7BBVLPCJ3EA732B6NM/
(seven) Biotechnological challenges from GMOs to genome editing, Catherine Regnault-Roger, preface Jean-Yves Le Déaut, collection Académie d’agriculture de France, 203 pages, 2021
Europe’s alternative reality for reducing agricultural greenhouse gas emissions
Sri Lanka’s adoption of organic farming was a debacle. (For others, take note.)
Why COP26 is the time to double investment in agricultural research
This position is also available in: