According to the European Commission, a genetically modified organism (GMO) is “an organism whose genetic material has been altered by means of genetic engineering to include genes that it would not normally contain”.
Under Regulation (EC) No 1829/2003 on genetically modified food and feed, GMOs must receive approval from the EC following a safety assessment by the European Food Safety Authority and evaluation by the Standing Committee on the Food Chain and Animal Health before they can be cultivated.
Europe also requires products containing GMO ingredients above a 0.9% threshold to be “clearly” labelled. The European Parliament established that packaging must state: “This product contains genetically modified organisms" or “this product contains genetically modified [name of organism(s)]" directly on the label. All non-packaged products that contain GMOs must include the statement within the product display.
In a legal opinion published this week, EJC Advocate General Michal Bobek said genetic engineering processes, known as New Plant Breeding Techniques (NPBTs), should be exempt from the rules provided no foreign DNA is inserted into the genetic sequence.
"Mutagenesis techniques are exempt from the obligations of the GMO Directive provided that they do not involve the use of recombinant nucleic acid molecules or GMOs," the opinion read.
The opinion was issued after France requested clarification on the status of NPBTs in 2016. It suggested that Member States are free to introduce national regulations, provided they do not conflict with European legislation.
How are NPBTs different from GMOs?
Developments in genetic coding techniques open the doorway to crops that produce higher yields or have positive characteristics, such as drought or pest resistance. The EU regulates the cultivation and use of GMOs in food but debate rages over how to treat new genetic engineering biotechnologies such as CRISPR.
CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats, the hallmarks of the bacterial defence system, which forms the basis of CRISPR-Cas genome editing technology.
CRISPR-Cas can be used as an advanced plant-breeding tool that facilitates crop breeding by making cuts at specific locations in a plant genome. Subsequent repair of the cut by the cell’s endogenous repair mechanism can introduce precise changes.
The system works with the native characteristics in the crop and does not introduce new genes. Proponents argue that this means that the new biotechnology poses fewer risk factors than GMOs and the process is frequently compared to traditional crop breeding techniques.
Ignoring the ‘precautionary principle’?
The European organic food sector has been a chief opponent of the unregulated use of NPBTs.
Organic trade body IFOAM EU, which represents more than 190 organic organisations, insisted that the decision ignores the principle of the “precautionary principle”.
“There are no legal or scientific reasons to exempt from risk assessment, traceability and labelling, recently developed genetic engineering,” Eric Gall, IFOAM EU policy manager, insisted. “Exempting these new genetic engineering from a risk assessment would be a blatant denial of the precautionary principle and of the citizens’ right to know how their food is produced.”
An EJC Advocate Opinion is non-binding and advisory for the panel of judges who will decide the case.
When the EJC does rule on the case, IFOAM EU called on the judges to consider the “intentions of the legislator” when the EU’s GMO regulations were first conceived in 1990. “The intention of the legislator back in 1990… was to only exempt from risk assessment techniques which were used since the 1960s and which had a long safety record," Gall argued.
The EJC's final decision is expected later this year.