In the European Union (EU), all products derived from biotechnology must receive approval by the EU authorities and those in the Member States (MS) before they are allowed to be used in food and feed or sold as seed for cultivation. Approval implies that the products are safe and are neither harmful to human or animal health nor to the environment.
Only one biotech crop, Monsanto’s MON 810 corn, a Bacillus thuringiensis (Bt) corn resistant to the corn borer, is approved for cultivation in the EU. The variety is however banned in all or parts of nineteen MS which, since 2015, under Directive (EU) 2015/412, have “opted out” of GE crop cultivation for all or part of their territories. This regulation, also called the “opt-out” Directive, allows any MS to “opt out” of cultivating an approved GE crop for socio-economic as opposed to scientific reasons.
As a result, since 2017 the area planted in MON 810 in the EU decreased by 31 percent from 130,000 to about 70,000 hectares in 2022 and is in fact limited to less than one percent of the EU’s total corn area. Spain represents 97 percent of this area and Portugal the remaining 3 percent. The Czech Republic and Slovakia no longer cultivate Bt corn since 2017 while Romania stopped in 2016. The threat of destruction by activists and difficult marketing conditions also discourages the cultivation of GE crops in general.
For more than two decades, lack of appeal of GE foods over traditional ones combined with consistent fear mongering campaigns from anti-biotech groups, resulted in overall negative attitudes of European consumers toward GE products. The EU’s food industry and retailers adapt their product offerings to meet consumer perceptions. There are increasingly more initiatives to differentiate non-GE food products at the retail level by using voluntary GE-free labels. Several major supermarkets promote themselves as carrying only non-GE products.
The EU imports large amounts of genetically engineered (GE) feed to sustain its livestock sector. Despite efforts at the EU and Member State (MS) levels to grow protein crops in the EU and gain feed self-sufficiency, farmers in the EU will continue to need imports of safe, reliable, and affordable feedstuffs. The stakeholders that defend agricultural biotechnology at the EU level are scientists and professionals in the agricultural sector, including farmers, seed companies, and representatives of the feed supply chain.
The EU approval process for GE products consists of a scientific risk assessment phase and a more politically influenced risk management phase. The first is carried out by the European Food Safety Authority (EFSA). The latter is the responsibility of the European Commission (EC), with determining input from the MS. In 2022, the EU issued 6 approvals and 1 renewal for GE crops, compared to 12 approvals and 6 renewals in 2021.
In September 2019, the European Union adopted a Regulation amending the General Food Law Regulation, with the intention to increase: the transparency of the risk analysis processes; the reliability, objectivity, and independence of studies used in this process; and the governance and resources of EFSA – the agency responsible for executing the risk assessment process. The Transparency Regulation entered into force on March 27, 2021.
The EU is primarily active in basic medical research regarding animal biotechnology. Some MS also conduct research for agricultural purposes, focusing their efforts on improving livestock breeding. No foods are produced from animal clones or GE animals because consumer acceptance is low and, to date, no application has been submitted to EFSA for the release into the environment or placing on the market of GE animals.
Genome Editing or “New Genomic Techniques” (NGTs)
Currently, GE organisms regulated by the EU are primarily produced through transgenic breeding techniques, where genes are moved from one non-closely related species to another. Plant breeders around the world are increasingly using genome editing or “new genomic techniques” (NGTs), which refer to new breeding techniques and modification techniques that allow the introduction of sequence-specific changes in the plant genome.
On July 25, 2018, the European Court of Justice (ECJ) ruled that organisms produced with newer genetic technologies (i.e., genome editing) are subject to the regulatory obligations of the Directive for genetically modified organisms (GMOs). These newer methods are subject to the same risk assessment and review requirements, labeling, and monitoring obligations, as well as traceability laws, currently applied to genetically engineered products.
The court also found that EU Member States have the authority to regulate organisms produced by conventional mutagenesis (chemical and radiation) that are exempt from the “GMO” Directive, as long as the actions follow the overarching obligations of EU law, particularly the free movement of goods.
In May, 2020, the Commission also announced both the Farm to Fork (F2F) Strategy and the EU Biodiversity Strategy for 2030 as roadmaps for enhancing food and agricultural sustainability by 2030 under the EU Green Deal. On page 10 of the F2F Strategy, the Commission specifically notes:
New innovative techniques, including biotechnology and the development of bio-based products, may play a role in increasing sustainability, provided they are safe for consumers and the environment while bringing benefits for society as a whole. […] Farmers need to have access to a range of quality seeds for plant varieties adapted to the pressures of climate change.
The Council of the EU requested that the EC submit a study on the status of new genomic techniques in the EU. On April 29, 2021, the European Commission published a report titled, “Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16.” While the Court of Justice ruling stated that products of genome editing fall under Directive 2001/18/EC, the Commission’s study concluded that this Directive is not “fit for purpose” for these newer products and a targeted policy action was needed. The study says that genome editing can contribute to the objectives of the European Green Deal’s Farm to Fork and Biodiversity Strategies.
As a consequence, on September 24, 2021, the European Commission launched a policy initiative and roadmap on “Legislation for plants produced by certain new genomic techniques.” The initial feedback period lasted four weeks and received more than 70,000 comments. In early 2022, Russia invaded Ukraine. Shortly after, the European Commission released a communication on “Safeguarding food security and reinforcing the resilience of food systems” noting the potential for “new genomic techniques.” In April 2022, the Commission launched the 12-week public consultation period to seek additional views from stakeholders, and dialogues continued throughout the year on these newer techniques. The proposed legislation is scheduled to be published in June 2023.
