New advances in biotechnology
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. 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’s scientific experts have confirmed the conclusions of their 2012 scientific opinion on cisgenesis and intragenesis. In assessing different contributions to potential hazards in cisgenic/intragenic plants, they concluded that no new risks are identified in cisgenic and intragenic plants compared with plants obtained with conventional breeding or established genomic techniques (those from before 2001). The experts also confirmed that on a case-by-case basis lesser amounts of data may be needed for the risk assessment of cisgenic and intragenic plants developed by established or new genomic techniques. Therefore, they concluded that the current guidelines for assessing plants developed through cisgenesis and intragenesis are partially applicable and sufficient.
Summarising aspects of the above opinion and other recent assessments carried out since October 2020, EFSA’s experts have proposed six main criteria to assist the risk assessment of plants produced using the genomic techniques of targeted mutagenesis, cisgenesis and intragenesis. The European Commission asked for this scientific advice to support their ongoing policy initiative on new genomic techniques.
EFSA’s experts evaluate existing guidelines for the food and feed risk assessment of GM plants and GM microorganisms obtained through synthetic biology. They concluded that the existing guidelines are adequate and sufficient in some synthetic biology applications and in other cases are adequate but need future updating, for example, in the areas of new proteins safety assessment and comparative analysis.
Experts identify knowledge gaps on the prediction of allergenicity of proteins and identify development and research needs for improving the allergenicity risk assessment of products derived from biotechnology. Stakeholders such as patient groups, Member States, industry representatives and academia contributed to the shaping of this scientific opinion. This work will help prioritise research funding and enable the scientific community to prepare for the assessment of future biotechnology products.
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.
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.
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.
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.
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.
February and October
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.
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Experts in food and feed safety assessment, environmental sciences, molecular characterisation, and...