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.
The European Union has a low adoption rate for modified foods, with the only authorised GM crop—an insect-resistant corn—currently grown on 150,000 hectares spread over five member states. That is less than 1.5% of the total EU maize surface and compares to global GM cultivation of 175m hectares.
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.
While research has not currently indicated any heightened risk from GMOs, restrictions reflect the strong anti-GM public opinion among European consumers.
A different approach needed for 'new plant breeding techniques'?
Many in the scientific community are frustrated by Europe’s resistance to GMOs, arguing that they could be an important tool in boosting food security and improving sustainability.
Factsheet: GMOs worldwide
- Globally approximately 7.5% of farmland is planted with GMOs
- Four countries grow almost 90% of the total GM crops: the US, Canada, Argentina and Brazil
- Four crops account for the vast majority of of GMOs sold: soya, maize, cotton and oil-seed rape (canola)
“The whole GMO issue has been tackled in the wrong way, both because of the technology and the role of science but also because of the role of policy,” Louise Frisco, president of research at Wageningen University, told the Food2030 summit on harnessing R&D last week.
Frisco stressed that a different approach is required with the development of new gene-editing technologies, such as CRISPR-Cas, which have come to be referred to as new plant breeding techniques (NPBTs).
“We should not make that mistake with CRISPR-Cas again. We should not make that mistake with some of the big data issues that we are talking about here. We should train people who are broad enough to understand both the technical side and the socioeconomic side and the policy side. We should have room to do things that maybe look dangerous but we have enough checks and balances in Europe to do them. I am very worried if we limit agriculture research and food research we are going to miss out, not because others are doing it but because we are not attracting the greatest minds,” she argued.
“Science has to be inside our system, inside our heads. I am really worried that in some ways if science does not grow in a free academic environment we are going to miss the boat… What we need is real room for breakthroughs, and breakthroughs are not more of the same.”
CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats, which are the hallmarks of the bacterial defence system, which forms the basis of CRISPR-Cas genome editing technology.
“CRISPR-Cas is a new set of genetic techniques which allows us to do precision breeding. They came out of completely esoteric work on viral resistance in bacteria, having nothing to do with food,” Frisco explained.
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.
According to a recent report from Science Advice Mechanism (SAM), an advisory body for the EU Commission, gene-editing techniques provoke fewer so-called “unintended effects” - accidental changes in the genome - than the current biotechnologies like transgenesis or random mutagenesis.
SAM concluded that this biotechnology is cheaper, quicker to use and less risky than the current techniques. The process is also nearly impossible to trace, the advisory body noted.
However, the report also suggested that conclusions cannot be drawn about the “absolute or comparative” safety of techniques based on the predicted occurrence of unintended effects. “An assessment of safety can only realistically be made on a case-by-case basis and depends on features of the end product.”
A recent study on the use of CRISPR-Cas in mice, however, casts some doubt over whether the technique does indeed produce fewer “unintended effects”.
Research led by Kellie Schaefer and published in journal Nature Methods concluded that the process does indeed result in unintended effects in modified mice. Moreover, these were not random and always occur at the same places in the genome.
Call for 'legal certainty'
Industry body European Plant Science Organisation called for "urgent action to promote progress in plant science and commercial breeding in Europe to meet challenges for agriculture" and stressed the need to provide "legal certainty" for the sector.
The Dutch government has suggested that it wants to begin authorising NBTs outside the GMO framework. Two years ago, the Commission requested Memeber States hold fire on approving gene editing while it considers its options. The EC has, however, delayed its proposal for a regulatory framework pending a ruling from the European Court of Justice on a related topic.
The EJC has been asked by France to decide whether mutagenesis was included in the bloc's GMO regulations.
EPSO urged the EC to "provide legal certainty for science and industry regarding application and exploration of New Plant Breeding Techniques (NPBTs) to allow the plant sector addressing the grand challenges facing our planet".
GMOs by the back door?
The possibility of CRISPR-Cas gene-editing techniques being excluded from the EC's GMO regulation has met political resistance in the European Parliament. A spokesperson for The Greens in the European Parliament told FoodNavigator that the party is “deeply sceptical about the new breeding techniques”.
In particular, The Greens believe that the technology is too new and untested to be judged safe.
“These techniques are so new that the experts’ understanding is too incomplete to be able to make judgements on their safety. Each new study is changing, sometimes spectacularly, the state of the debate.
“We believe there are very good reasons to be prudent and to follow the precautionary principle. There is no good reason to deregulate these techniques when there is very well suited EU GMO regulation already in place.”
Campaign group's such as Greenpeace have also been vocal in opposition to what they term "new GMOs". A spokesperson for Greenpeace argued: "Gene-edited plants and animals are GMOs - both from a scientific and regulatory perspective. They are covered by EU GMO law. The European Commission and EU governments should acknowledge that."
The spokesperson suggested that "some companies nad researchers" are seeking to "circumvent" the EU's GMO legislation. "They claim that gene-edited plants and animals fall outside the scope of EU GMO regulations. This is wrong. These techniques should be regulated at least as tightly as old-style GMOs."
This conclusion is supported by the European Network of Scientists for Social and Environmental Responsibility (ENSSER).
"We contend that NGMTs are indeed genetic modification techniques (as they do modify genetic material or gene function regulation via epigenetic or other changes) and that organisms produced by these methods are therefore, logically, genetically modified organisms (GMOs)."
ENSSER suggests that the application of these techniques allows for outcomes that may be "unprecedented" in human experience. "All products of NGMTs must therefore be regulated at the level of strictest GMO regulations, and new, technique-specific regulations may be necessary," the organisation argued.