COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the 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
Date: 2023-07-05
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal health, cultivation techniques, food inspection, food production, genetically modified organism, labelling, market approval, plant health legislation, public health

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  EN 

   EUROPEAN COMMISSION  Brussels, 5.7.2023  SWD(2023) 411 final  COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the 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} - {SEC(2023) 411 final} - {SWD(2023) 412 final} - {SWD(2023) 413 final}  
 
 
Subsidiarity Grid 

1.  Can the Union act? What is the legal basis and competence of the Unions’ intended action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy initiative? 

The proposal is based on Articles 43, 114 and 168(4)(b) of the Treaty on the Functioning of the 
European Union (TFEU). These articles provide the legal basis for the EU to adopt measures which 
have as their objective to implement the common agricultural policy (Article 43), and to ensure the 
good functioning of the internal market (Article 114(1)) while maintaining a high level of human 
health protection in the veterinary and phytosanitary fields (Article 168(4)(b)). 

1.2 Is the Union competence represented by this Treaty article exclusive, shared or supporting in 
nature? 

In this policy area, the Union’s competence is shared with the Member States. 

2.  Subsidiarity Principle: Why should the EU act? 

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 21: 

-  Has there been a wide consultation before proposing the act? 
- 

Is there a detailed statement with qualitative and, where possible, quantitative indicators 
allowing an appraisal of whether the action can best be achieved at Union level? 

The impact assessment takes into account the input from a range of stakeholder consultation 
activities. A public consultation2 was held between 29 April and 22 July 2022 (2300 contributions). It 
was complemented by a range of targeted consultation activities: 
  Stakeholder interviews (25) to receive input on the initiative and on the impacts of policy 

options, including on costs. 

  A targeted survey (from 28 June to 5 September 2022) to which 397 stakeholders and Member 

State authorities were invited. 123 responded and self-categorised as business associations (32), 
NGOs, environmental, consumer and other civil society organisations (28), public authority/body 
(23), large company/business (11), academic/research organisation (9), SMEs (8), other (12). 

  Two expert focus groups on sustainability and traceability on 22 and 23 September 2022. 
  Regulatory cost interviews (23) to map regulatory costs of operators developing and marketing 

NGT plants as well as to assess costs of risk assessment and enforcement authorities. 
Furthermore, DG SANTE held meetings of a working group with the GMO national competent 
authorities to discuss specific aspects of the initiative. At the request of a number of stakeholders, 
DG SANTE held bilateral meetings and also attended relevant events of stakeholders. Finally, some 
stakeholders and national competent authorities submitted to DG SANTE opinions on specific 
matters. 
A summary of all these activities and their outcomes is provided in the Annex 2 – Synopsis report, of 
the Impact Assessment Staff working document. 
The explanatory memorandum and the impact assessment (chapter 3) contain a section of the 
principle of subsidiarity.  

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  
2https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-
produced-by-certain-new-genomic-techniques/public-consultation_en  

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2.2 Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the conformity with the 
principle of subsidiarity? 

Plants  obtained  by  targeted  mutagenesis  and  cisgenesis  are  living  organisms  which,  as  any  other 
plant,  when  released  into  the  environment  for  experimental  purposes  or  as  commercial  products, 
may  reproduce  in  the  environment  and  cross-national  borders.  It  is  essential  to  achieve  a 
harmonised, high level of protection of human and animal health and the environment in relation to 
these  plants  and  of  food  and  feed  derived  from  them  so  that  they  may  circulate  freely  within  a 
smooth-functioning  internal  market.  In  addition,  the  EU  Farm  to  Fork  Strategy  recognises  the 
potential of NGTs as a possible tool to increase sustainability of the food system and bring benefits to 
society as a whole. 
The requirements for the deliberate release and the placing on the market of NGT plants and their 
derived  food  and  feed  are  already  harmonised  at  EU  level  under  the  existing  legal  framework 
applicable  to  GMOs  but  need  to  be  adapted  to  the  specificities  of  plants  obtained  by  these  new 
techniques. Carving out NGT plants from the current EU legal framework and leaving it to Member 
States  to  regulate  them  would  likely  lead  to  different  regulatory  requirements  and  levels  of 
protection  in  the  EU  Member  States.  Differing  national  requirements  for  NGT  plants  would  hinder 
the free movement of these products, fragment the internal market and lead to uneven competition 
between economic operators.  

2.3 Based on the answers to the questions below, can the objectives of the proposed action be 

achieved sufficiently by the Member States acting alone (necessity for EU action)? 

Absence  of  EU  level  action  to  provide  for  specific  rules  on  NGT  plants  would leave  those  products 
under  the  current  GMO  rules,  which  are  not  fit  for  purpose  as  concluded  by  the  Commission  NGT 
Study of April 2021. Specific, EU-level rules are necessary in order to enable those plants and related 
products  to  deliver  and  contribute  to  the  sustainability  goals  of  the  Green  Deal  and  F2F  and 
Biodiversity strategies. 

(a)  Are there significant/appreciable transnational/cross-border aspects to the problems being 

tackled? Have these been quantified? 

The plants and products placed on the market would be authorised at EU level and allowed to be 
placed on the market in the EU The proposal ensures free movement of NGT products in the internal 
market while maintaining a high level of human health protection in the veterinary and phytosanitary 
fields throughout the EU. 

(b)  Would national action or the absence of the EU level action conflict with core objectives of 

the Treaty3 or significantly damage the interests of other Member States? 

The planned measure concerns the placing on the market of products containing or consisting of NGT 
plants and of food and feed produced from such plants. Therefore, the proposal directly affects the 
internal market as regards NGT products. Those products are GMOs and therefore they are already 
regulated at present under the GMO legislation. Therefore, national action regulating the placing on 
the market of such products would not be legally possible. Absence of EU level action to provide for 
specific  rules  on  NGT  plants  would  leave  those  products  under  the  current  GMO  rules,  which  the 
Commission NGT Study of April 2021 showed not to be fit-for-purpose and in need of modification in 
order to enable those plants and related products to deliver and contribute to the sustainability goals 
of the Green Deal and F2F and Biodiversity strategies. 

3 https://europa.eu/european-union/about-eu/eu-in-brief_en  

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(c)  To what extent do Member States have the ability or possibility to enact appropriate 

measures? 

NGT plants are GMOs. The rules on the deliberate release into the environment and placing on the 
market  of  GMOs  are  already  harmonised  at  EU  level  by  Directive  2001/18/EC,  Regulation  (EC)  No 
1829/2003 and Regulation (EC) No 1830/2003. Therefore,  Member States'  ability  to enact  national 
measures  in  those  areas  is  framed  within  the  limits  and  under  the  conditions  allowed  by  that 
legislation. 

(d)  How does the problem and its causes (e.g. negative externalities, spill-over effects) vary 

across the national, regional and local levels of the EU? 

The  problems  and  causes  are  the  same  across  the  national,  regional  and  local  levels  of  the  EU 
regarding  the  current  legislation  not  being  fit  for  purpose  and  raising  implementation  and 
enforcement  challenges.  However,  the  problem  of  current  legislation  not  being  conducive  to 
developing innovative beneficial products might have different intensity in different Member States 
and at regional and local level especially with regard the different impacts from climate change. 

(e)  Is the problem widespread across the EU or limited to a few Member States? 

The  planned  measure  aims  to  tackle  three  problems,  i.e.  the  inadequacy  of  the  current  risk 
assessment  and  authorisation  requirements  for  the  variety  of  potential  NGT  plant  products; 
implementation and enforcement challenges regarding NGT plants, in particular those for which an 
event-specific detection method cannot be provided; and the inability of the current GMO legislation 
to  support  the  development  of  innovative  beneficial  products.  All  these  problems  have  an  EU 
dimension as they are directly caused by shortcomings in the existing Union legislation and concern 
the breeding and placing on the market of NGT  plants,  which are activities that can be  carried out 
anywhere in the EU. 

(f)  Are Member States overstretched in achieving the objectives of the planned measure? 

The planned measure is aimed at making the current EU rules more fit-for-purpose for the diversity 
of NGT plants, facilitate their enforcement and enable the development of new plants and related 
products that can bring sustainable benefits to society. All the proposed rules will therefore make the 
implementation and enforcement tasks of Member States better adapted to the specificities of these 
plants and reduce rather than increase the demands on Member States’ resources. 

(g)  How do the views/preferred courses of action of national, regional and local authorities 

differ across the EU? 

There is a general agreement between Member States that clarification on the legal status of NGT 
products is needed (Council Decision (EU) 2019/1904). The views vary on the level of regulatory 
oversight required (e.g. whether a full risk assessment is needed for all NGT products, level of 
requirements for traceability and labelling). 

2.4 Based on the answer to the questions below, can the objectives of the proposed action be 

better achieved at Union level by reason of scale or effects of that action (EU added value)? 

The  proposed  legislation  replaces  existing  Union  legislation  and  thereby  provides  legal  clarity  for 
NGTs. This provides a certain, uniform regulatory framework allowing developers of NGTs in the EU 
to harness the potential benefits of NGTs. Economies of scale provided by the large EU market allow 
NGT developers and producers to benefit from cost advantages through efficient production. 

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(a)  Are there clear benefits from EU level action?  

A large market with a uniform regulatory regime is the best possible way support the achievement of 
the potential benefits of NGTs. It also ensures the same level of human health protection in the 
veterinary and phytosanitary fields throughout the EU. 

(b)  Are there economies of scale? Can the objectives be met more efficiently at EU level (larger 

benefits per unit cost)? Will the functioning of the internal market be improved? 

Development of new traits and of new varieties is costly, leading to large sunk costs and to 
economies of scale, where costs can be spread over a larger production volume of the same product 
for a larger market with a uniform regulatory regime. The objectives can best be achieved with action 
at EU level.  

(c)  What are the benefits in replacing different national policies and rules with a more 

homogenous policy approach? 

The planned measure will replace existing Union legislation.  

(d)  Do the benefits of EU-level action outweigh the loss of competence of the Member States 
and the local and regional authorities (beyond the costs and benefits of acting at national, 
regional and local levels)? 

The  planned  measure  will  replace  existing  Union  legislation.  Member  States  will  keep  the  same 
competences as today as regards the implementation of the planned measure (e.g. carrying out the 
environmental  risk  assessment  of  NGT  plants,  deciding  on  whether  to  authorise  experimental 
releases). 

(e)  Will there be improved legal clarity for those having to implement the legislation? 

The proposal addresses specific implementation challenges related to NGTs. These were raised in the 
Council Decision  (EU)  2019/1904  that  asked the  Commission  to carry  out  a  study  on  regarding the 
status of novel genomic techniques under Union law, and a make proposal, if appropriate in view of 
the  outcomes  of  the  study.  The  EU  GMO  legislation  currently  requires  applicants  to  provide  an 
analytical laboratory method that is specific to the product for which they seek authorisation, i.e. it 
can both detect it and differentiate it from other products. If, however, the genetic alteration is not 
unique  for  the  relevant  product,  a  specific  detection  method  cannot  be  provided.  When  the  same 
alteration can be introduced by NGTs or conventional breeding methods, the detection method may 
be  able  to  detect  it,  but  will  not  allow  determining  whether  the  product  is  a  GMO  subject  to  the 
GMO  legislation  or  not.  In  such  cases,  applicants  will  be  unable  to  comply  with  an  authorisation 
requirement,  and  other  food  chain  operators  and  authorities  will  not  be  able  to  implement  or 
enforce the legislation. Furthermore, plants produced by targeted mutagenesis and cisgenesis, which 
could  also  occur  naturally  or  be  produced  by  conventional  breeding,  need  to  comply  with  the 
traceability  and  labelling  requirements  of  the  EU  GMO  legislation.  Consequently,  in  certain  cases, 
plant  products  with  similar  genetic  modifications  might  be  subjected  to  different  labelling  and 
traceability requirements, depending on the breeding technique that was used to obtain them. 
The proposal addresses these challenges with requirements tailored to the specific characteristic of 
targeted mutagenesis and cisgenesis. 

3.  Proportionality: How the EU should act 

3.1  Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the proportionality of the 

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proposal and a statement allowing appraisal of the compliance of the proposal with the 
principle of proportionality? 

As discussed in Chapter 7.4 of the impact assessment accompanying this proposal, the measures 
proposed are limited to actions that need to be taken at EU level in order to achieve the objectives. 
The adapted risk assessment will be proportionate as it is intended that the criteria (and subsequent 
data requirements based on them) for the risk assessment of different NGT plants and derived food 
and feed are not stricter than necessary to ensure that the potential risks are properly identified and 
evaluated. This approach of adapted risk assessment would ensure proportionality for all NGT plants 
except those that could have been obtained naturally or by conventional breeding, where a 
verification regime is provided for. The verification regime is designed to reflect the equivalence of 
the NGT plant with plants that could occur naturally or be obtained by conventional breeding 
methods, and (complemented by data requirements linked to those criteria) is adequate to ensure 
proportionality.  

3.2 Based on the answers to the questions below and information available from any impact 
assessment, the explanatory memorandum or other sources, is the proposed action an 
appropriate way to achieve the intended objectives? 

Based on the impact assessment, it is expected that the proposal will provide uniform, predictable 
and efficient rules, in the form of a Regulation, for the development and placing on the market of 
NGT plants and their products, creating a level playing field for operators and ensuring the 
availability to farmers, food operators and consumers in the entire EU of plant varieties that can cope 
with challenges of a global nature such as climate change and biodiversity loss. The initiative is 
furthermore expected to create significant cost reductions for operators, in particular breeders.  

(a)  Is the initiative limited to those aspects that Member States cannot achieve satisfactorily on 

their own, and where the Union can do better? 

Compared to individual action by  Member States, EU intervention would provide  uniform rules for 
the  development  and  placing  on  the  market  of  NGT  plants  and  their  food  and  feed  products. 
Harmonised EU-wide rules on the marketing of such products would ensure a level-playing field for 
operators  within  the  single  market  and  a  more  predictable  and  efficient  regulatory  oversight. 
Furthermore,  there  is  an  urgent  need  to  ensure  availability  to  farmers,  food  operators  and 
consumers of plant varieties that can cope with challenges of a global nature such as climate change 
and  biodiversity  loss,  which  have  been  further  aggravated  by  the  present  geopolitical  and  energy 
crisis in Europe, and to secure food security in the future. 

(b)  Is the form of Union action (choice of instrument) justified, as simple as possible, and 

coherent with the satisfactory achievement of, and ensuring compliance with the objectives 
pursued (e.g. choice between regulation, (framework) directive, recommendation, or 
alternative regulatory methods such as co-legislation, etc.)? 

The  instrument  chosen  is  a  Regulation.  The  planned  measure  consists  of  fully  harmonised  criteria, 
requirements and procedures that will  lead to  decisions valid  for the whole EU, ensuring the same 
level  of  protection  of  health  and  the  environment  and  the  availability  of  the  products  concerned 
across  the  EU.  A  Regulation  appears  to  be  the  most  appropriate  legal  instrument  to  embody  such 
procedures, as well as to achieve a uniform implementation of the  planned measure, which has an 
important internal market component.  

(c)  Does the Union action leave as much scope for national decision as possible while achieving 
satisfactorily the objectives set? (e.g. is it possible to limit the European action to minimum 

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standards or use a less stringent policy instrument or approach?) 

The planned measure has an internal market  component, and therefore  it leaves  limited scope for 
national action in order to ensure the smooth functioning of the internal market. Scope of national 
action is warranted, as in the current GMO framework, in deciding on the deliberate release of NGT 
plants for any purposes other than their placing on the market (e.g. field trials) and in the carrying 
out  of  the  environmental  risk  assessment  of  such  plants.  As  regards  NGT  products  to  which  GMO 
authorisation,  labelling  and  traceability  requirements  will  not  apply  any  more  as  a  result  of  the 
proposed verification regime for certain NGT plants, Member States cannot adopt national rules on 
such products, as this would obstruct their free circulation in the internal market. 

(d)  Does the initiative create financial or administrative cost for the Union, national 

governments, regional or local authorities, economic operators or citizens? Are these costs 
commensurate with the objective to be achieved? 

The initiative  is expected to  create significant  cost  reductions for operators, in particular breeders. 
Total  savings  for  notified  plants  are  estimated  to  range  from  EUR  99  520  000  to  111  710  000  per 
year. Total savings for authorisations are estimated to range from EUR 0 to 51 825 000 per year. 

(e)  While respecting the Union law, have special circumstances applying in individual Member 

States been taken into account? 

The  proposal  and  the  accompanying  impact  assessment  take  organic  agriculture  into  account  and 
take  into  consideration  that  the  share  of  organic  area  differs  between  Member  States.  The 
mandatory coexistence measures thus remain on a general level to allow Member States to take into 
account  the  diversity  of  farm  structures  and  farming  systems,  and  the  economic  and  natural 
conditions under which farmers operate in the Member States. 

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