Advances in biotechnology
Biotechnology refers to the use of technology in biology to develop new products, methods and organisms for a wide range of sectors.
The discipline has evolved rapidly in recent years and is used for example in medicines, industry, the food chain and for environmental purposes.
Advances in biotechnology have also been facilitated by the evolution of new analytical tools such as whole genome sequencing Visualisation of the entire genetic makeup of a particular organism, OMICs technologies for quantifying and characterising biological molecules, and alternatives to animal testing known as new approach methods (NAMs).
This topic page focusses on biotechnology approaches for application in food and agriculture and use in the environment.
Genetic engineering is a biotechnology approach that involves altering the genetic structure of plants, microorganisms or animals by modifying, removing or introducing DNA A complex chain-like molecule that carries the genetic material, present in living organisms and some viruses. DNA (deoxyribonucleic acid) is capable of copying itself and carries the instructions for all the proteins used to create and sustain life.
This approach is used to introduce new traits or to enhance or diminish existing characteristics of an organism.
New genomic techniques are a recent example that produce faster and more precise results than conventional breeding (of plants and animals), self-cloning (for microorganisms) and older genetic modification techniques.
Advances in molecular biology have delivered molecular and computational tools that allow scientists to design traits of interest, an approach referred to as synthetic biology.
Examples include simplified genomes in microorganisms, more nutritious or higher-yielding plants or the elimination of undesired traits in plants such as bitterness or allergenicity The ability to trigger an abnormal immune response that leads to an allergic reaction in a person.
Currently there are no applications of synthetic biology in animals envisaged for the EU market.
Gene drives is another approach that can spread genes of interest at a greater frequency than would otherwise be achieved by natural inheritance.
The approach can be used in insects such as mosquitoes for example to limit their population Community of humans, animals or plants from the same species or stop them spreading diseases.
Synthetic biology and gene drives can be achieved using old or new genomic techniques.
See also:
Latest
EFSA is working on a request from the European Commission for an evaluation of new developments in biotechnology applied to animals (including synthetic biology and new genomic techniques). We expect to launch a public consultation in early 2025.
Milestones
2022
July
EFSA publishes an evaluation of the adequacy of existing guidelines for the food and feed risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation of genetically modified (GM) plants obtained through synthetic biology.
June
EFSA’s experts evaluate existing guidelines for the food and feed risk assessment of GM plants and GM microorganisms obtained through synthetic biology.
2021
February
EFSA publishes an evaluation of the adequacy of existing guidelines for the molecular characterisation and environmental risk assessment of GM plants obtained through synthetic biology.
2020
November
EFSA assesses whether existing guidelines for the risk assessment of GM animals are adequate for the molecular characterisation and environmental risk assessment of gene drive modified insects.
October
EFSA publishes an evaluation of the adequacy of existing guidelines for the microbial characterisation and environmental risk assessment of microorganisms obtained through synthetic biology.
March
EFSA publishes a horizon scan of synthetic biology developments for microorganisms with application in the agri‐food sector.
EFSA publishes a mapping exercise of synthetic biology developments for plants in the agri‐food sector.
EFSA's role
EFSA is responsible for assessing the potential adverse effects of applications of biotechnology on humans, animals and the environment.
We provide scientific advice to support EU legislators – the European Commission and EU Member States - to ensure that food and animal feed produced using biotechnology is safe.
The European Commission and EU Member States are responsible for deciding on the authorisation of new products and the conditions for their use on the European market.
Our scientific advice also helps EU legislators decide on the regulation of new products resulting from advances in biotechnology.
Ethical considerations are not part of the scientific process of risk assessment. These aspects are considered by the European Commission and EU Member States as part of their discussions on new regulations and their approval process for new products.
Our scientists also assess whether our scientific guidelines are fit for purpose for the safety assessment of new applications of biotechnology.
EU framework
The EU has established a legal framework to ensure that the development of modern biotechnology is safe for human and animal health.
- Genetically Modified Organisms – European Commission
- New techniques in biotechnology – European Commission
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