EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 5.7.2023  
COM(2023) 411 final  
ANNEXES 1 to 3  
 
ANNEXES  
to the  
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  
{SEC(2023)  411 final}  - {SWD(2023)  411 final}  - {SWD(2023)  412 final}  -
 {SWD(2023)  413 final}    
EN 1  EN ANNEX I 
Criteria of equivalence  of NGT plants to conventional plants  
A NGT plant is considered equivalent  to conventional plants when it differs from the 
recipient/parental plant by no more than 20 genetic modifications  of the types referred to in 
points 1 to 5, in any DNA sequence sharing  sequence similarity with the targeted site  that can 
be predicted by bioinformatic tools .  
(1) substitution or insertion of no more than 20 nucleotides ; 
(2) deletion of any number of nucleotides ;  
(3) on the condition that the genetic modification does not interrupt an endogenous gene : 
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s  gene 
pool;  
(b) targeted  substitution of an endogenous DNA sequence with a contiguous DNA 
sequence existing in the breeder’s gene pool ; 
(4) targeted  inversion of a sequence of any number of nucleotides ; 
(5) any other targeted  modification of any size, on the conditio n that the resulting DNA 
sequences already occur (possibly with modifications as accepted under points (1) 
and/or (2)) in a species from the breeders’ gene pool.   
EN 2  EN ANNEX II 
Risk assessment of category 2 NGT plants and category 2 NGT food and feed   
Part 1 of this Annex describes the general principles to be followed to perform the 
environmental risk assessment of category 2 NGT plants  referred to in Article 13, points (c) 
and (d), Article 14(1),  point (e) , and Article 19(3), point (a) , and the safety  assessment of 
category 2 NGT food and feed referred to in Article 19(1), point (b) . Part 2 describes specific 
information for the environmental risk assessment of category 2 NGT  plants and Part 3 
describes s pecific information for the safety  assessment of category 2  NGT food and feed. 
 
Part 1- General principles and information  
The environmental risk assessment shall be carried out in accordance with the principles set 
out in Annex II  to Directive 2001/18/EC.  
The type and amount of information necessary for the  environmental  risk assessment of 
category 2 NGT plants  laid down in Annex III of Directive 2001/18/EC  and for the food and 
feed safety assessment of category 2 NGT  food and fee d shall be adapted to their risk profile . 
Factors to be considered  include :  
(a) the characteristics of the NGT plant, in particular the trait(s) introduced , the function 
of the modified or inserted genome sequence(s)  and the function of any gene 
disrupted by the insertion of a cisgene or parts thereof ; 
(b) prior experience with the consumption of similar plants or their products ;  
(c) prior experience with the cultivation of the same plant species or plant species 
exhibiting similar traits or in which similar genome s equences have been modified, 
inserted or disrupted ; 
(d) the scale and cond itions of the release;  
(e) the intended conditions of use of the NGT plant.  
The environmental risk assessment of category 2  NGT plants and the risk assessment  of 
category 2  NGT food and NGT feed shall consist of the following:  
(a) hazard identification and characterisation ; 
(b) exposure assessment ; 
(c) risk characterisation . 
The following information shall always be required :  
(a) hazard identification and characterisation   
(i) information relating to the recipient plant or, where appropriate, to the parental 
plants ;  
(ii) molecular characterisation .  
The information shall be provided by collating already available data from scientific 
literature or from other sources or generating scientific data where  necessary by 
performing appropriate experimental or bioinformatic studies . 
(b) exposure assessment  
Information shall be provided on the likelihood of each identified potential adverse 
effect . This shall be evaluated taking into consideration , as relevant,  the  
EN 3  EN characteristics of the receiving environment(s) , the intended function, the dietary 
role, the expected level of use of the food and feed in the EU and the scope of the 
application  for authorisation . 
(c) risk characterisation  
The applicant shall base its risk characterisation of NGT  plants and foods and feed 
on information  from hazard identification, hazard characterisation and exposure  
assessment.  The risk shall be characterised by combining, for each potential adverse 
effect,  the magnitude with the likelihood of that adverse effect occurring to provide a 
quantitative or semi quantitative estimation of the risk. Where relevant, the 
uncertainty for each identified risk shall be described.  
Any information on hazard  identification  and characterisation  specified under Part s 2 and 3 
shall only be required if the specific characteristics  and the intended use  of the category 2 
NGT plant  or category 2 NGT food or feed give rise to a plausible risk hypothesis that can be 
addressed utilising the specified information.  
 
Part 2 - Specific information for  the environmental risk assessment of category 2 NGT 
plants concerning  hazard identification and characterisation  
(1) Analysis of agronomic, phenotypic and compositional characteristics  
(2) Persistence and invasiveness  
(3) Potential gene transfer  
(4) Interactions of the NGT plant with target organisms  
(5) Interactions of the NGT plant with non -target organisms  
(6) Impacts of the specific cultivation, manage ment and harvesting techniques  
(7) Effec ts on biogeochemical processes  
(8) Effects on human and animal health  
 
Part 3–Specific information for the safety  assessment of category 2 NGT food and feed  
concerning hazard identification and characterisation  
(1) Analysis of agronomic, phenotypic and compositional characteristics  
(2) Toxicology  
(3) Allergenicity  
(4) Nutritional assessment  
  
EN 4  EN ANNEX III 
Traits  referred to in Article 22 
 
Part 1  
Traits  justifying the incentives referred to in Article 22: 
(1) yield, including yield stability and yield under low -input conditions;  
(2) tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, 
fungi, bacteria, viruses and other pests;  
(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by 
climate change;  
(4) more efficient use of resources, such as water and nutrients;  
(5) characteristics that enhance the sustainability of storage, processing and distri bution;  
(6) improve d quality or nutritional  characteristics;  
(7) reduced need for external inputs, such as plant protection products and fertilisers.  
 
Part 2  
Traits  excluding the application of the incentives referred to in Article 22: tolerance to 
herbicides .