EU gene editing rules: summary
- EU introduces two-tier system distinguishing simple and complex gene edits
- NGT-1 crops face fewer regulations and no longer treated as GMOs
- CRISPR (clustered regularly interspaced short palindromic repeats)-edited crops meeting criteria can reach market more easily
- NGT-2 crops remain under strict GMO rules including safety assessments
- Patentability remains controversial raising concerns about market concentration and access
The European Union is changing its rules on gene editing.
With the introduction of a two-tier system, it has freed certain types of gene-edited crops from the regulation that they would have previously been required to comply with.
The EU’s decision is part of an ongoing debate around gene editing, with many believing gene-edited crops to be unsafe.
This decision could make CRISPR-Cas-edited crops easier to get on the market.
What is CRISPR-Cas?
CRISPR-Cas is an innovative gene editing technique. It is highly precise, and can remove or edit DNA sequences in any organism.
CRISPR stands for clustered regularly interspaced short palindromic repeats. In the natural world, it is an immune system used by bacteria to recognise invading viruses and defend against them. Cas stands for CRISPR-associated protein. Using the Cas enzyme, bacteria can cut the DNA of bacterial viruses called phages.
CRISPR is highly programmable and able to recognise its target. It was developed into a gene-editing tool by biochemists Jennifer Doudna and Emmanuelle Charpentier (for which they won the 2020 Nobel Prize for Chemistry).
How have the regulations changed?
Gene-edited crops were not banned in the EU before the rule change. However, any genetically modified plants had to submit an extensive risk assessment to the EU, slowing down market authorisation, as required by the EU’s directive on Genetically Modified Organisms (GMOs). The regulation also includes strict labelling and traceability requirements.
A decision by the European Court of Justice in 2018 put newer gene-editing techniques within the scope of this regulation.
This is now, in part, changing. The EU has altered how new genomic techniques (NGTs), which are advanced precision-breeding tools, are regulated.
Instead of keeping them all under the old GMO regulation, it introduces a two-tier system for NGTs, reducing requirements for some but keeping them the same for others.
It splits gene-edited crops into two categories: NGT-1 and NGT-2.
NGT-1 crops are those which have a limited number and type of changes that could have occurred through conventional breeding. These crops must not contain any genetic material available outside the gene pool that were available through conventional breeding, explains Ben Tolley, European patent attorney at law firm Mewburn Ellis. Furthermore, plants must have 20 or fewer changes to be NGT-1s.
Plants that are engineered for herbicide-tolerance or to produce insecticidal substances cannot be NGT-1s, irrespective of the number of modifications.
Once it is verified that a plant in this category meets the criteria of an NGT-1, it will be regulated like a conventional plant.
NGT-2s, on the other hand, are those that have undergone more complex or extensive genetic modifications. These are covered by the existing GMO regulations.
How will this affect CRISPR-Cas?
For crops edited using CRISPR-Cas, a gene-editing technique, the change in the law could open up new opportunities.
Some CRISPR-edited crops will now face less burdensome regulation, Tolley points out. Provided that they meet the requirements of NGT-1s, they will not be regulated as GMOs, as they were previously.
The new regulation is “technology agnostic”, he says, meaning that it does not target any particular type of gene-editing technology.
With many crops impacted by changing weather patterns as a result of climate change, CRISPR-Cas is often used to develop drought and heat-resistant varieties of crops, in order to bolster food security.
CRISPR-Cas can also alter crops in other ways, changing the structure, nutritional content and even the colour of plants.
Why is gene editing controversial?
Gene editing is controversial because many believe that it is unsafe.
For example, gene drives, where the inheritance of certain traits are enhanced, has been discussed as dangerous. They are created using gene-editing techniques.
Gene drives have the potential to spread uncontrollably throughout the environment, perhaps even damaging an entire ecosystem, according to law firm DLA Piper.
Another controversy around gene editing is the potential of patenting to concentrate power in a few hands. The non-profit Corporate Europe Observatory suggests that deregulating gene-edited crops could “trap farmers and breeders” in a “patent minefield”.
Gene-edited plants, whether NGT-1 or NGT-2, are still patentable after recent regulatory changes, explains Tolley. This “preserves the investment incentive and the innovation incentive”.
Nevertheless, steps have been taken to increase transparency. For instance, when requesting NGT-1 verification, the requester must declare any patents or published applications covering the plant in question, both those held by themselves or by third parties. There’s also an option for the requester to declare a willingness to licence any patents covering the NGT plants to a third party.
New opportunities
With fewer crops facing stringent GMO regulations, there is an immense opportunity for biotechnology companies to expand innovation.
This could have a significant impact on food and beverage. Gene editing not only opens the doors for the creation of more heat and drought-resistant crop varieties, but it can also produce crops with a range of other attributes.
CRISPR-Cas alone has been used to create more nutritious tomatoes, non-browning avocados and seedless blackberries.
The new regulation, which will come into effect in two years, would give biotech companies the ability to get products to market more quickly, and therefore has the potential to speed up innovation.
