The European court of law ruled that genome editing technologies like CRISPR-Cas9 and TALEN are to be considered genetic modifications and therefore regulated under the European GMO Directive 2001/18/EC. It means that food or feed produced by genome editing technologies will need to be clearly labeled and will have to undergo a food/feed and environmental safety assessment. It also means that strict regulations apply for production, transport and traceability.
News agencies describe the ruling as “The European Court of Law prohibits genetic modification through the backdoor”.
What has happened?
French environmental and agricultural groups took to the French court over the countries’ practice to not consider products modified by genome editing technologies as GMOs. In France it was argued that CRISPR/Cas9 modified products would be created in the same manner as mutagenesis. And mutagenesis, a method where irradiation or chemicals are used to modify existing genomic materials, does not fall within the scope of the Directive 2001/18/EC.
On one hand, advocates of the technology argue that products produced with CRISPR/Cas would no longer be allowed to be called GMO-free, if the ruling places the technologies in the scope of the Directive 2001/18/EC. It was also argued that such ruling would prevent some research projects from taking pace and thereby prevent necessary progress.
On the other hand, opponents to the genome editing technology had argued that recent studies show that genome editing technologies cannot be controlled well enough and required therefore a safety assessment and labeling.
What are CRISPR/Cas and other editing technologies?
CRISPR/Cas9, in a nutshell, is a genome editing technology where a molecular scissor (an enzyme) is being used to precisely cut and insert DNA material into a genome. The discovery was made by Jennifer Doudna and Michelle Charpentier and published 2012 in the journal Science.
Besides CRISPR/Cas9, other gene and genome editing tools exists, including TALEN, ZFN and RNA interference (also called gene silencing). One recent food produced by gene silencing which is on the market is the non-browning, Arctic Apple. Key advantages, besides the precision, is the speed, with which this technology allows to produce organisms with modified properties. While it takes several years to produce genetically modified organisms with “older” GM technologies, genome editing tools can deliver the results in months at significantly lower cost.
Of course, these technologies cannot only be used to produce new plant and animal varieties, they can also be used to develop cures for certain diseases. CRISPR/Cas9 technology is also deployed in research which aims to eradicate Malaria, transmitted by the Anopheles mosquito.
European GMO Regulations and Directives
In the USA, genetically modified organisms are only regulated by the environmental protection agency (EPA) if they contain the so-called plant incorporated pesticides (PIPs): As example, CryIAb is such PIP. It is a protein toxic for insects and kills them when they feed on the plants expressing the protein. Well-known examples of transgenic varieties containing CryIAb are the Bt11 corn and MON810. All other genetic modifications are not regulated in the USA, including those produced with genome editing tools like CRISPR/Cas9.
In Europe, on the other hand, all genetic modifications are regulated. Also, those which make plants more resistant to pesticides (like the Monsanto Roundup Ready ® soya). The Regulation (EC) 1829/2003 requires strict controls, documentation, traceability and a system for detection of each GMO, in addition to labeling the food products as GMO.
The question the European Court of Law now had to answer is if also the new genome editing technologies fall into the scope of the GMO Directive 2001/18/EC (and subsequently Regulation EC 1829/2003) or if they are considered to be similar to mutagenesis, which is outside of the scope of the Directive. The court ruled that genome editing technologies are within the scope of Directive 2001/18/EC. That means that food, feed and environmental safety assessments are needed and labeling as GMO of any such product will be required.
The Ruling
Here is the original ruling from today (2018-07-25):
On those grounds, the Court (Grand Chamber) hereby rules (original text):
1. Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC must be interpreted as meaning that organisms obtained by means of techniques/methods of mutagenesis constitute genetically modified organisms within the meaning of that provision.
Article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex I B to that directive and in the light of recital 17 thereof, must be interpreted as meaning that only organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are excluded from the scope of that directive.
2. Article 4(4) of Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species, as amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003, must be interpreted as meaning that genetically modified varieties obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are exempt from the obligations laid down in that provision.
3. Article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex I B to that directive, in so far as it excludes from the scope of that directive organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record, must be interpreted as meaning that it does not have the effect of denying Member States the option of subjecting such organisms, in compliance with EU law, in particular with the rules on the free movement of goods set out in Articles 34 TFEU to 36 TFEU, to the obligations laid down in that directive or to other obligations.
Consumer Perception
What is interesting in this context is a recent survey, published by the German Federal Agency for Risk Assessment (BfR) in February this year (2018). In this survey, 50% of consumers were concerned about the presence of genetically modified foods on their plate. This concern was only topped by consumers’ concern about pesticide residues and antimicrobial resistance. However, only 3% of the consumers were concerned about genome editing (dropping 2% from 2017), the very technology ruled upon be the European Court of Law today.
