G/SPS/GEN/1931  
 
12 July 2021 
(21-5479) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
THE EUROPEAN COMMISSION STUDY ON THE STATUS  OF 
NEW GENOMIC TECHNIQUES IN THE EUROPEAN UNION  
COMMUNICATION FROM THE EUROPEAN UNION  
The following document , received on 12 July 2021, is being circulated at the request of the 
Delegation of the European Union . 
 
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1.  On 29 April 2021, the European Commission published a study on the status of New Genomic 
Techniques (NGTs) under European Union law. The New Genomic Techniques (NGTs) term is used 
to refer to techniques of genetic modification that have emerged or have been developed since 2001, 
when the current EU legislation on genetically modified organisms (GMOs) was adopted.  
2.  The study found that NGTs and their pro ducts have been rapidly developing in the last 20 years 
in many parts of the world, with some applications already on the market of some EU trade partners. 
More applications in various sectors are expected in the years to come; while there is considerable 
interest for NGT -related research in the European Union , the large majority of applications are being 
developed outside the European Union . 
3.  The study also observed that NGT products have the potential to contribute to sustainable 
agri-food systems in line with the objectives of the European Green Deal and Farm to Fork Strategy. 
In the pharmaceutical sector, these techniques would allow faster, more affordable development of 
medicines, with potential to tackle unmet medical needs. NGTs can be used for the pr oduction of 
useful substances from microorganisms, with applications in cosmetics, biofuels, food ingredients 
and pharmaceutical substances.  
4.  The main concerns raised in the consultation are related to possible safety and environmental 
impact of NGTs, among  other s, on biodiversity, coexistence with organic and GM -free agriculture, 
as well as labelling and consumers ' right to information and freedom of choice.  
5.  Based on the available scientific evidence, the European Food Safety Authority (EFSA) concluded 
that plant products with similar risk profiles can be obtained with conventional breeding techniques, 
targeted mutagenesis and cisgenesis. For these techniques, EFSA did not identify new hazards 
compared with conventional breeding methods. EFSA a lso concluded that these techniques can 
induce off -target mutations (i.e. modifications in other genomic locations than the intended target) 
but these would be of the same type and fewer than those occurring with conventional breeding 
techniques. For other  NGTs or for applications in animals and microorganisms, the necessary 
scientific knowledge is still limited or lacking, especially on safety aspects.  
6.  The study concluded that the current GMO legislation, adopted in 2001, is not fit for purpose for 
certain  NGTs and their products, and that it needs to be adapted to scientific and technological 
progress.  
7.  The European Commission believes that new genomic techniques can contribute to the 
Green  Deal and Farm to Fork objectives of innovation and sustainability o f the food systems, as well 
as to a more competitive economy, which are at the centre of current priorities of the 
European  Union.  G/SPS/GEN/1931  
 
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  8.  Based on the information available and the outcome of the study, the European Commission has 
concluded that there is sufficie nt evidence and scientific basis to initiate a targeted policy action on 
plants derived from targeted mutagenesis and cisgenesis.  
9.  For other organisms (animals and microorganisms) and other new genomic techniques, the 
Commission intends to continue to build  up the required scientific knowledge, in view of possible 
further policy actions.  
10.  Considerations related to the use of NGTs in medicinal products will be addressed separately, 
in the context of the Commission 's Pharmaceutical Strategy.  
11.  The policy action o n plants will aim at a proportionate regulatory oversight, which would 
maintain a high level of protection of human and animal health and the environment and allow 
reaping benefits from innovation, in particular to achieve the goals of the European Green D eal and 
Farm to Fork Strategy.  
12.  In 2022, an impact assessment, including a public consultation, will be carried out in accordance 
with the EU Better Regulation rules, to examine potential policy options. The impact assessment will 
also examine the concerns expressed about NGTs during the consultation on the study, and how 
they can be addressed.  
13.  More information:  
a. Documents:  
• EC study on new genomic techniques:  
https://ec.europa.eu/food/plants/genetically -modified -organisms/new -techniques -
biotechnology/ec -study -new-genomic -techniques_en  
b. Website:  
• New techniques in biotechnology:  
https://ec.europa.eu/food/plants/genetically -modified -organisms/new -techniques -
biotechnology_en  
 
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