Genetic engineering, a process that alters the genetic structure of an organism by modifying, removing or introducing DNA, is a rapidly developing scientific field.
For example, new genome editing techniques may allow for much faster and more precise results than conventional breeding techniques. And advances in molecular biology have delivered molecular and computational tools that allow scientists to design traits of interest, an approach termed synthetic biology. One outcome of synthetic biology is the engineering of so-called gene drives, which spread genes of interest at a frequency greater than would otherwise be achieved by natural inheritance.
Before genetically modified organisms engineered in this way are released on the market, their risks need to be assessed. Scientific bodies like EFSA assesses their potential adverse effects on humans, animals and the environment.
EFSA experts are working on a scientific opinion that will evaluate the adequacy of existing guidelines for the risk assessment of food and feed from genetically modified microorganisms obtained through synthetic biology.
They are also working on a second opinion about the food and feed risk assessment of genetically modified plants obtained through synthetic biology. Both will be delivered in summer 2022.
EFSA has recently produced scientific opinions on synthetic biology, genome editing and gene drives.
Synthetic biology is a field that involves the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic material in living organisms.
Genome editing allows DNA to be inserted, modified or deleted in the genome of a living organism with very high precision compared to conventional breeding techniques or classical GM techniques.
A gene drive refers to a technology used in genetic engineering which is designed to bias – and therefore speed up – the transmission of certain genetic elements in a target population.
See the Milestones section of this page to learn more about completed work in this area.
April 2021 EFSA provides an overview on the risk assessment of plants developed through new genomic techniques (NGTs). NGTs are techniques capable of altering the genetic material of an organism that have emerged or been developed over the past two decades. The report is part of a study that the Council of the European Union requested from the European Commission. To compile the report, EFSA considered its previous scientific opinions on the topic as well as opinions published by competent authorities and national institutions since 2012.
February 2021 EFSA assesses whether existing guidelines for the molecular characterisation and environmental risk assessment of GM plants are adequate and sufficient for risk assessment of plants obtained through synthetic biology (SynBio) that are intended to be cultivated or used for food and feed purposes.
The GMO panel concluded that the EFSA guidelines are adequate and sufficient for the risk assessment of SynBio products to be developed in the next ten years, although specific requirements may not apply to all products. Experts acknowledged that as SynBio developments evolve, there might be a need to update the guidelines to ensure they are adequate and sufficient for the risk assessment of plants engineered with SynBio.
November 2020 Experts assess whether the conclusions of the 2012 scientific opinion on the safety assessment of plants developed using Zinc Finger 3 and other site-directed nucleases with a similar function may be applicable to plants developed with type 1 and type 2 site-directed nucleases and with oligonucleotide-directed mutagenesis (genome editing techniques that modify a specific region of the genome without introducing new DNA).
Experts conclude that the existing guidance is applicable for the evaluation of the three new techniques. However, fewer data for the risk assessment might be needed due to the absence of new DNA.
November 2020 EFSA assesses whether existing guidelines for the risk assessment of genetically modified animals are adequate for the molecular characterisation and environmental risk assessment of gene drive modified insects. EFSA’s experts conclude that the guidelines are adequate. However, further guidance is needed for some areas, such as molecular characterisation, environmental risk assessment and post-market environmental monitoring.
October 2020 EFSA publishes a scientific opinion on the adequacy of existing guidance for risk assessment in light of developments in synthetic biology (SynBio) for microorganisms. Experts conclude that the existing guidance – for the microbial characterisation and environmental risk assessment of genetically modified (GM) microorganisms – is useful as a basis for major parts of the risk assessment. However, they recommended further guidance in certain areas, such as methodologies for aspects of molecular characterisation of microalgae and fungi, and approaches to address all specific areas of risk as per Directive 2001/18/EC on the deliberate release into the environment of GMOs.
2012 EFSA issues two opinions on cisgenesis/intragenesis and zinc finger nuclease 3 and other site-directed nucleases, assessing the potential risks of these techniques and the applicability of the existing EFSA guidance documents on GM plants for their risk assessment. Experts conclude that the existing guidance documents are applicable for the evaluation of food and feed products derived from plants modified with these techniques and for performing an environmental risk assessment and do not need to be developed further.
EFSA assesses the safety of GMOs in relation to human and animal health, and the environment in Europe. Its scientific advice is used by risk managers such as the European Commission and EU Member States to decide on their possible authorisation.
Policy makers and risk managers in the EU want to be ready for the possible marketing of products that could enter the market because of the new advances in biotechnology. To be better prepared for the future and possible emerging risks, EFSA is assessing if its guidelines are fit for purpose for the safety assessment of such products.
The European Union has established a legal framework to ensure that the development of modern biotechnology, and more specifically of GMOs, takes place in safe conditions. The framework applies to new organisms developed through synthetic biology.
In July 2018, the Court of Justice of the European Union (CJEU) clarified that organisms from new mutagenesis techniques fall within the scope of the EU GMO legislation.