  
  
G/TBT/N/EU/1032  
14 November 2023  
(23-7666) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addit ion, where applicable):   
• Plants obtained by certain new genomic techniques  
• Food and feed containing, consisting of, or produced from these plants  
• Other products containing or consisting of these plants  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Council on plants obtained by certain 
new genomic techniques and their food and feed, and amending Regulation (EU) 
2017/625 (COM(2023) 411 final); (70 page(s), in English), (5 page(s), in English)  
6. Description of content:  On 5 July 2023, the European Commission adopted a legislative 
proposal for a regulation on plants produced by certain new genomic techniques (NGTs) 
and their food and feed. The proposal is part of a package of proposals to ensure resilient 
and sustainable use of the EU's natural resources.  
The proposal sets out specific rules for the deliberate release into the environment for 
any other purpose than placing on the market of plants obtained by targeted  mutagenesis 
and cisgenesis (including intragenesis) and for the placing on the market of food and feed 
containing, consisting of or produced from such plants, and of products, other than food 
or feed, containing or consisting of such plants ('NGT plants a nd products').  
The main measures of the proposal include:  
1. The proposal (in Chapter I) makes the deliberate release and placing on the market of 
NGT plants and products subject to one of two procedures: verification procedure to G/TBT/N/EU/1032  
 
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  establish equivalence wit h conventional plants/products or authorisation in accordance 
with EU legislation on GMOs:  
2. Chapter II of the proposal provides for a verification procedure and criteria to verify 
whether NGT plants/products obtained by targeted mutagenesis or cisgenesis  could also 
have been obtained naturally or by conventional breeding techniques, based on the 
criteria laid down in Annex I ('category 1 NGT plants'). Category 1 NGT plants/products 
are exempted from the requirements of the GMO legislation, and subject to the rules on 
conventionally bred plants. Transparency is ensured in a public database, through 
labelling of the seeds and through the relevant registers on plant varieties.  
3. Chapter III of the proposal applies to NGT plants/products which do not meet the  
criteria to consider that they could also be obtained naturally or by conventional breeding 
('category 2 NGT plants'). They remain subject to the rules on GMOs with adaptations as 
regards risk assessment, detection method, monitoring and renewal requireme nts. They 
are made subject to traceability and labelling requirements of the GMO legislation, with 
the possibility of a voluntary label to indicate the purpose of the genetic modification. The 
proposal includes regulatory incentives for Category 2 NGT plan ts/products featuring 
traits that could contribute to the overall performance of varieties as regards sustainability 
(Annex III to the proposal).  
4. The proposal provides that NGT plants/products are prohibited in organic production.  
5. The proposal includ es provisions for the monitoring of economic, environmental and 
social impacts of NGT plants and products, supporting implementation reports and the 
future evaluation of the legislation.  
This Proposed Regulation was also notified under the SPS Agreement in  notice 
G/SPS/N/EU/687.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the proposal are to:  
1. Maintain a high level of protection of human and animal health and of the environment;  
2. Enable the development and placing on the market of plants and plant products 
contributing to the innovation and sustainability objectives of the European Green Deal 
and of the Farm to Fork and Biodiversity strategies;  
3. Ensure the effective functioning of the inter nal market and enhance the 
competitiveness of the Union agri -food sector at the Union and global levels; Protection 
of human health or safety; Protection of animal or plant life or health; Protection of the 
environment  
8. Relevant documents:   
• Impact assessment – executive summary (EN, FR, ES)  
EN: https://food.ec.europa.eu/system/files/2023 -09/gmo_biotech_ngt_ia_report_swd -
2023-413_en.pdf  
FR: https://food.ec.europa.eu/system/files/2023 -09/gmo_biotech_ngt_ia_report_swd -
2023-413_fr.pdf  
ES: https://food.ec.europa.eu/system/files/2023 -09/gmo_biotech_ngt_ia_report_swd -
2023-413_es.pdf  
• Impact assessment  
EN: https://food.ec .europa.eu/system/files/2023 -07/gmo_biotech_ngt_ia_report.pdf  
9. Proposed date of adoption:  2024: The proposal is currently under discussion by the 
EU legislative bodies following the ordinary legislative procedure.  
Proposed date of entry into force:  After its adoption, the proposal would enter into 
force on the 20th day following publication in the Official Journal of the European Union. 
It would apply two years after the entry into force.  G/TBT/N/EU/1032  
 
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  10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http:// ec.europa.eu/growth/tools -
databases/tbt/en/  
EN: https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:52023PC0411  FR: 
https://eur -lex.europa.eu/legal -content/FR/TXT/PDF/?uri=CELEX%3A52023PC0411  ES: 
https://eur -lex.europa.eu/legal -content/ES/TXT/PDF/?uri=CELEX:52023PC0411  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_13438_00_e.pdf  
https://members.wto.org/crnattachments/2023/ TBT/EEC/23_13438_01_e.pdf  
 