The EU’s authorization process of GMOs involves two essential steps. The decision is based on the scientific advice of the European Food Safety Authority (EFSA), who conducts a scientific assessment of the potential risks and benefits of food and feed products containing GMOs. EFSA’s findings are then published online, and a public consultation is convened. These two steps allow for a close examination of the potential impact of GMOs on human and animal health and the environment. Furthermore, this process takes into consideration public perception on the matter. The final decision is then issued by the European Commission after consultation with the Standing Committee on Plants, Animals, Food and Feed.

With genome engineering techniques, we can intentionally introduce genetic modification to improve crop varieties by selecting desirable traits, such as resistance to pests and diseases or higher yields. In the past, these same traits could also occur spontaneously through genetic variations and/or they were selected through conventional breeding techniques.  

However, conventional breeding can take up a lot of time and make it difficult to create target-specific genetic alterations. When genetic engineering was introduced in the 90s, it revolutionized the technology landscape for plant breeding in several ways and resulted in clear benefits compared to conventional breeding techniques :

• More accurate outcomes through the introduction of specific genes that insert desirable traits into crops through direct and target-specific manipulation of the DNA.
• Faster results as there is no selective breeding and screening over many generations.
• Creating new crops which are unlikely to generate through conventional breeding.

Genetic engineering transformed the way we manipulate organisms’ genetic material, however, clarification is needed whether plants containing modified genetic material are subject to EU GMOs regulations and directives.

While EU legislation on GMOs was adopted in 2001, the first genome targeting techniques were already introduced in 1994. It might seem logical to assume that all organisms developed through genetic engineering techniques would fall under the EU legislation on GMOs, the EU regulator has taken a different approach.

New techniques introduced after Directive 2001/18/EC implementation are defined as “Novel Genomic Techniques” (NGTs) and they are currently subject to EU GMO legislation. Some techniques predating the directive, the Established Genome Techniques (EGTs), were included based on an assessment. The full outcome of this assessment is mentioned in Annex 1A part 1 and 2 of  Directive 2001/18/EC.

NGTs include different techniques which can be used in a variety of ways to obtain different results and products. For this reason, NGTs safety will be dependent on the technique, its use and the characteristics of the final products.  For certain NGTs, EFSA has concluded that no new hazard(s) were identified when compared to conventional breeding and EGTs. Furthermore,  while it is now easy to identify a mutation, the origin of a given modification (obtained via NGTs or via spontaneous mutation) might not be identified through currently available detection methods. This demonstrates that the current regulatory framework lacks a risk-based approach when determining which techniques should fall under the GMOs Directive and traceability criteria will need to be revised. As a response, the commission has prepared a proposal for the amendment of Regulation (EU) 2017/625.

NGTs have the potential to contribute to sustainable agri-food systems and leave a positive impact on the environment contributing to the objectives of the European Green Deal and Farm to Fork and Biodiversity strategies. However, stakeholders have contrasting views on these techniques and products developed through them. Hence, a common ground to address and solve their concerns still needs to be found.

The United States (US) widely uses GMOs for feed and food production. Genetic engineering has been applied to most major crops grown in the US such as corn, soybeans, canola, and cotton, among others. Moreover, the US Food and Drug Administration (FDA) has approved several genetically modified crops for animal (e.g. canola, soybean, and corn) and human consumption (e.g. potatoes, apples, and papayas).

The three federal agencies that are responsible for the regulation of GMOs in the US include the U.S. Food and Drug administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). These agencies monitor the human safety and environmental impact of GMOs and require developers and processors of genetically modified crops to submit extensive data on their safety and efficacy before they can be approved for commercial use.

While the use of GMOs is widespread in the US, there has been ongoing debate and controversy over their safety and potential long-term effects on human health and the environment. Many NGOs have called for stricter regulation on GMOs or even a ban on their use, while researchers argue that they can bring benefits and advantages to the industry. To address and monitor concerns, independent research is ongoing to study their effects on public health and the environment. This debate is likely to continue in the US and around the world, as new developments in biotechnology and genetic engineering continue to emerge.