New genomic techniques
New genomic techniques (NGTs) Molecular breeding techniques that can alter the genetic material of an organism and that have been developed since the adoption of the EU’s GMO legislation in 2001. are breeding techniques that alter the genetic material of plants, animals or microorganisms.
They are used to design new traits of interest or enhance or diminish existing characteristics of an organism.
NGTs, also called precision breeding, refer to the techniques developed since the adoption of the EU’s legislation on genetically modified organisms ( GMO A genetically modified organism (GMO) is an organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection.) in 2001.
They allow 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. to be altered in a more precise and faster way than conventional breeding methods or established genomic techniques (EGTs), developed before 2001.
NGTs, like EGTs, can be used to produce traits of interest such as improving the nutritional content of plants or making crops or animals resistant to disease or climatic conditions such as drought or flooding.
NGTs introduce changes in organisms - ranging from subtle to complex - by adding, removing or rearranging sections of DNA.
They include the techniques of targeted mutagenesis Technique that induces specific mutation(s) in targeted locations of the genome without inserting new genetic material. (e.g. genome The entire amount of genetic material found in the cells of living organisms. editing), and can be used in targeted cisgenesis An approach that modifies the genetic material of an organism with a sequence from a donor from the same species or one closely related. and intragenesis An approach that modifies the genetic material of an organism with a combination of different sequences from a donor that belongs to the same species or one closely related..
Some applications of targeted mutagenesis and cisgenesis result in genetic modifications that could also be produced by conventional breeding techniques including random mutagenesis.
EU rules require risks posed by plants, animals or microorganisms produced using genetic technology to be assessed before they can be marketed in the EU.
In July 2023, the European Commission proposed new rules that would treat some NGT plants similarly to conventional plants on the basis that they could also occur naturally or be produced by conventional breeding techniques. Our scientists provided scientific advice to inform their ongoing policy initiative.
EFSA is also responsible for assessing potential risks to humans, animals and the environment to inform the authorisation decisions taken by the European Commission and EU Member States.
Currently there are no crops or animals resulting exclusively from NGTs authorised for sale as food or animal feed in the EU.
Latest
Our experts are evaluating the suitability of our guidance and approaches for assessing future developments in biotechnology applied to animals, and possible risks compared to established genomic techniques.
We are also assessing new developments in biotechnology applied to microorganisms and the adequacy of our 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. guidelines.
The work is part of a series of EFSA evaluations, following requests from the European Commission, aiming to ensure the EU’s safety assessment framework is prepared for possible future applications related to new genomic techniques (NGTs).
Milestone
2024
July
EFSA publishes an evaluation of an analysis by the French agency for Food, Environmental and Occupational Health & Safety (ANSES) of criteria proposed by the European Commission to categorise plants developed by NGTs.
2023
December
EFSA publishes an external horizon scanning study of microorganisms and derived products obtained by new developments in biotechnology.
September
EFSA publishes an external review of the commercial and pre-commercial stage applications of new genomic technologies (NGT) applied to farm animals and derived food and feed products.
2022
December
EFSA holds an open meeting with interested stakeholders on the safety of plants derived from NGTs.
October
EFSA publishes an updated scientific opinion on the safety and risk assessment of plants developed through cisgenesis and intragenesis.
EFSA publishes a statement proposing six main criteria to assist the risk assessment of plants produced using the genomic techniques of targeted mutagenesis, cisgenesis and intragenesis.
June
EFSA’s experts evaluate existing guidelines for the food and feed risk assessment of GM plants. The evaluation includes two NGT case studies.
2021
April
February
EFSA assesses whether 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) Field of science that combines engineering and biology with the aim of developing new biological systems and attributing new features to living cells. that are intended to be cultivated or used for food and feed purposes. The evaluation included a genome editing case study for a low gluten protein found in wheat, barley and rye. The symptoms of coeliac disease are triggered by the ingestion of gluten. wheat.
2020
November
EFSA’s experts assess whether the conclusions of their 2012 scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. 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 Processes that change the genetic material of animals, plants and microorganisms with precision in subtle or more extensive ways. that modify a specific region of the genome without introducing new DNA).
EFSA assesses whether guidelines for the risk assessment of genetically modified animals are adequate for the molecular characterisation and environmental risk assessment of gene drive Genetic engineering technology designed to speed up the transmission of specific genetic elements of interest in a target population. modified insects.
2012
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 guidance for the risk assessment of GM plants.
EFSA's role
We provide scientific advice to support EU legislators – the European Commission, EU Member States and the European Parliament - to ensure that food and animal feed produced using biotechnology is safe for humans, animals and the environment.
Our scientific advice helps EU legislators decide on the regulation of new products resulting from advances in biotechnology.
EU legislators are responsible for deciding on the authorisation of NGTs and the conditions for their possible future use on the European market.
FAQs
Some plants produced with new genomic techniques (NGTs) may have small changes that might also occur in nature or through conventional breeding. Others may have multiple and extensive modifications that may be similar to those in plants produced by established techniques of genetic modification used in the last two decades.
Targeted mutagenesis is an umbrella term used to describe techniques that induce specific mutation A permanent, typically negative, change in the genetic material in a cell which, in most cases, can be passed onto any offspring.(s) in selected target locations of the genome. The changes occur without inserting genetic material.
Cisgenesis refers to modifying the genetic material of an organism with a sequence from the same species A subdivision of the genus, a species is a group of closely related and similar-looking organisms; for example, in the case of Homo sapiens (humans), the second part of the name (sapiens) represents the species. or one closely related. The new sequence contains an exact copy of the sequence already present in the breeders’ gene pool, which is the set of all genetic information for a given species that is available for use by plant breeders.
Intragenesis refers to modifying the genetic material of an organism with a combination of different sequences from the same species or one closely related. The new sequence contains a re-arranged copy of sequences already present in the breeders’ gene pool.
Our experts proposed relevant criteria to be considered for the risk assessment of plants produced using new genomic techniques.
The work was a first step in establishing a robust science-based framework for assessing risks from these techniques in food and feed and for the environment, on a case-by-case basis.
This included listing where existing risk assessment methodologies can be applied and also highlighting gaps in the current approaches and data requirements.
We describe our criteria in our statement. The first four of the six criteria relate to the molecular characterisation of the genetic modification introduced in the recipient plant. They evaluate:
- If a foreign (“ exogenous Describes substances within the human body which have arisen from an external source in the diet or environment; for example, veterinary medicine residues.”) DNA sequence The exact order of units in a DNA chain. is present
- If yes, whether the sequence is from the breeders’ gene pool
- How the sequence is integrated, for example is it random or targeted?
- If any host plant A plant on which a pest lives or by which it is nourished. gene was “interrupted” (split) by the newly introduced sequence
Criteria 1-4 are designed to establish if cisgenic and intragenic sequences have altered the host plant’s genes. If they haven’t, or if no risk is identified when a endogenous Describes substances which naturally occur within the body; for example, cholesterol. gene has been affected, two further criteria apply:
- Does it have a history of use?
- If not, the structure and function of the modified versions of the DNA sequence (“allele”) should be carefully assessed.
These last two criteria apply also to plants produced by targeted mutagenesis.
Evaluating the history of use should be an important part of the proportionate risk assessment of cisgenic, intragenic and targeted mutagenesis plants as the newly modified DNA versions (“allele”) may already be present in nature.
The concept is well established in the assessment of GMOs developed before 2001. The demonstration of a history of use is based on evidence that some or all of a plant has been consumed in the diet (food and/or feed and derived products) for a considerable time with no evidence of harmful effects for the consumer, and that exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. from a new use will be within the range of that of the ‘historic’ use.
Similar approaches are used in assessing risks to the environment. When the history of use of the newly modified DNA sequence (allele) cannot be sufficiently demonstrated, its structure and function should be carefully assessed (step 6 of the proposed criteria).
Off-target effects are unintended mutations that are introduced in locations of the genomes other than the intended one. For plants in which the newly modified DNA sequence is successfully targeted there will be cases where the potential for unintended effects, such as off-target effects, is significantly reduced compared to random insertions or conventional breeding. When that happens, the data requirements for the risk assessment may be reduced on a case-by-case basis.
Two recent EFSA surveys – a 2021 flash poll and the 2022 Eurobarometer on food safety – revealed low awareness of new genomic techniques among EU citizens.
The Eurobarometer indicated that use of new biotechnology in food production was not a frequently mentioned concern of citizens, with only 8% of those aware of the issue also indicating it as one of their five main food safety concerns.
However, the flash poll revealed “What the possible risks are” as an important information gap for citizens, with around two-thirds (69%) wishing to know more about it.
EU framework
Currently, the EU regulatory framework on GMO applies also to new genomic techniques.