COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the documents Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90 (Regulation on plant reproductive material) and Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of forest reproductive material in the Union, amending Regulations (EU) 2016/2031 and 2017/625 of the European Parliament and of the Council, and repealing Council Directive 1999/105/EC (Regulation on forest reproductive material)
Date: 2023-07-05
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: agricultural production, crop production, forest, forest conservation, marketing, plant health legislation, plantation, seed, seedling, silviculture

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 5.7.2023  SWD(2023) 410 final  COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the documents Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90 (Regulation on plant reproductive material) and    Proposal for a Regulation of the European Parliament and of the Council  on the production and marketing of forest reproductive material in the Union, amending Regulations (EU) 2016/2031 and 2017/625 of the European Parliament and of the Council, and repealing Council Directive 1999/105/EC (Regulation on forest reproductive material) {COM(2023) 414 final} - {SEC(2023) 414 final} - {SWD(2023) 414 final} - {SWD(2023) 415 final} - {COM(2023) 415 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  legal  basis  for  these  proposals  is  Article  43(2)  of  the  Treaty  of  the  Functioning  of  the 
European Union (TFEU). This provides the legal basis for adopting the provisions necessary 
for the pursuit of the objectives of the common agricultural policy.  

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

In the area of agriculture, the Union’s competence is shared with the Member States.  

Subsidiarity does not apply for policy areas where the Union has exclusive competence as defined in 
Article  3  TFEU1.  It  is  the  specific  legal  basis  which  determines  whether  the  proposal  falls  under  the 
subsidiarity  control  mechanism.  Article  4  TFEU2  sets  out  the  areas  where  competence  is  shared 
between the Union and the Member States. Article 6 TFEU3 sets out the areas for which the Unions 
has competence only to support the actions of the Member States. 

2.  Subsidiarity Principle: Why should the EU act? 

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 24: 

-  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? 

To  collect  all  relevant  views  and  engage  with  stakeholders  as  much  as  possible,  different 
consultation  methods  were  combined.  The  Commission  services  consulted  stakeholders by 
means of the publication of the inception impact assessment for feedback, the open public 
consultation,  targeted  surveys,  working  groups  with  national  competent  authorities  and 
stakeholders,  and  bilateral  meetings  with  stakeholder  organisations.  The  inception  impact 
assessment was open for feedback between 15 June and 13 July 2021 on the ‘Have your say’ 
portal5 and was addressed to any interested citizen or stakeholder. Feedback was provided 
in a free text format, while respondents also had the possibility to submit position papers. 
The  feedback  collected  was  taken  into  account  for  adjusting  the  problem  description  and 
options,  the  design  of further  consultation  activities,  as  well  as  for  the  impact  assessment. 
The Commission services also organised two targeted online consultations on EUSurvey, one 
addressed  to  national  competent  authorities  responsible  for  FRM,  held  from  5  April  to  30 

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E003&from=EN  
2 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E004&from=EN  
3 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12008E006:EN:HTML  
4 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  
5 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13083-Plant-and-forest-reproductive-
material-revised-rules-_en  

1 

 
 
                                                           
May 2022 and one addressed to SMEs, held from 2 May to 13 July 2022. Furthermore,  the 
Commission services held meetings of working groups (online due to Covid-19 restrictions) 
with the national competent authorities and with stakeholders to discuss specific aspects of 
the  revision.  At  the  request  of  a  number  of  stakeholders,  the  Commission  services  held 
bilateral  meetings  and  also  attended  relevant  events  of  stakeholders.  Finally,  some 
stakeholders  and  national  competent  authorities  submitted  opinions  to  the  Commission 
services on specific matters outside the framework of the inception impact assessment and 
the  open  public  consultation.  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 Staff working document (chapter 
3) contain a section on the principle of subsidiarity (see also question 2.2 below).  

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? 

The legislation on the marketing of PRM/FRM has, from the 1960s onwards, been the major 
contributor  for  the  creation  of  the  internal  market  of  PRM/FRM.  The  established  EU  rules 
have  had  a  positive  impact  on  the  free  movement,  the  availability  and  the  quality  of 
PRM/FRM. Without the EU legislation, 27 different systems at Member State level would be 
in place for PRM/FRM marketing causing fragmentation of the internal market. Despite the 
existence of EU legislation, divergent implementation in Member States has been observed 
over the years, whereby national approaches are more and more compensating for the  EU 
legislation not being up to date with the current scientific and technical developments (e.g. 
innovative  processes  for  the  production  of  PRM/FRM,  digitalisation  of  procedures  and 
documents).  Approaches  also  differ  between  Member  States  as  regards  sustainability 
considerations in the registration of new varieties (PRM) and of basic material (FRM) and on 
aspects  related  to  the  conservation  and  sustainable  use  of  plant  genetic  resources  (e.g. 
market  access  for  conservation  varieties).  EU  action  is  thus  required  to  modernise  that 
legislation, harmonise  its implementation, ensure a level playing field for the operators, as 
well as to help meet the objectives of transboundary EU policies in relation to the European 
Green Deal (Farm to Fork, EU Adaptation, EU Forest and Biodiversity Strategies) and the EU 
Digital Strategy.  

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)? 

in  place.  Similarly,  there  would  be  27  Member  State  systems 

Without  action  at  EU  level,  27  Member  State  systems  on  registration  of  varieties  and 
certification/control  of  PRM  and  related  technical  requirements  to  ensure  quality  of  PRM 
would  be 
for 
certification/control of FRM. Such situation would create barriers for the internal market and 
significant costs and administrative burden for both authorities and operators. Opportunities 
for  more  consistent  approaches  to  help  address  the  challenges  in  relation  to  sustainable 
agricultural and food production, climate change and biodiversity would be missed. 

2 

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

being tackled? Have these been quantified? 

While  common  EU  rules  on  PRM/FRM  have been  in place  since  the 1960s,  there has been 
margin for their interpretation by the Member States that resulted in different conditions for 
operators  between  Member  States.  Absence  of  common  rules  on  recent  scientific  and 
technical  developments  have  exacerbated  those  differences.  However,  the  unrestricted 
marketing of PRM and FRM throughout the EU territory is imperative for the functioning of 
the  common  market.  It  is  also  important  for  addressing  transboundary  issues  such  as  the 
climate  and  biodiversity  crises,  the  sustainability  of  agricultural  and  food  production,  food 
security  and  sustainable  afforestation/reforestation  to  secure  multi-functional  forests  for 
future generations. For example, on average EUR 4.8 billion/year of crop losses  are caused 
by drought  in the  EU.  These  losses  can  be  partly  mitigated  through the  use  of  PRM  better 
adapted to drought. The current geopolitical situation and energy crisis have  also elevated 
the importance of securing agricultural and food production.  

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

objectives of the Treaty6 or significantly damage the interests of other Member 
States? 

National  policies  alone  cannot  achieve  a  better  access  to,  and  availability  of,  high-quality 
PRM/FRM for its users in comparison to EU level action. Absence of EU level action would 
compromise, the functioning of the internal market, the integration of  the EU system with 
the global trade system, as well as the opportunities to help meet the objectives of the EU 
policies on sustainability, climate change and biodiversity. 

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

measures? 

Member States have in certain cases, and under certain conditions, the possibility to adopt 
more  stringent  national  technical  requirements  for  the  marketing  of  PRM/FRM,  so  as  to 
meet  national  agro-ecological  production  conditions.  In  certain  cases,  they  are  allowed  to 
derogate or to be exempted from Union rules. 

(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  problem  of  non-uniform  application  of  the  EU  legislation  and  divergence  of  national 
transposition has been noted in the majority of Member States. Further divergence between 
Member  States  arises  as  they  seek  solutions  for  aspects  where  the  legislation  is  not  up  to 
date  with  the  current  scientific  and  technical  developments.  This  has  an  impact  on  the 
internal  market  and  the  open  and  fair  competition  between  the  professional  operators 
concerned. Other spill-over effects are due to sustainability, climate change and biodiversity 
aspects  not  being  consistently  addressed.  These  include  increased  risks  of  losses  in 
agricultural production and forestry, as well as losses in genetic diversity of cultivated plants 
and  forestry  species.  The  impacts  vary  across  national,  regional  and  local  levels  due  to 
specific  agro-climatic  conditions.  The  proposals  provide  appropriate  flexibility  for  Member 

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

3 

 
 
                                                           
States to address these aspects. 

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

The problems are affecting all Member States, but to different degrees.  

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

measure? 

The  proposed  measures  are  based  on  an  assessment  of  different  policy  options  and  their 
respective impacts. Most measures do not result in significant costs for the Member States. 
Costs for the Member States mainly result from the new requirements necessary to achieve 
the  sustainability  objectives  of  the  proposals.  These  are  nevertheless  proportionate  to  the 
expected  benefits,  while  the  cost  of  inaction  would  be  even  higher,  especially  in  terms  of 
increased losses in agricultural production and forestry.  

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

authorities differ across the EU? 

The Council requested in 20197 the Commission to submit a study on the options to update 
the  existing  legislation, as  it  considered  that  the  concerns  which the  Commission  aimed to 
address  in  2013  through  a  legal  proposal  on  the  production  and  marketing  of  plant 
reproductive  material  were  still  relevant.  Furthermore,  the  Council  requested  the 
Commission to submit a proposal, if appropriate in view of the outcomes of the requested 
study.  National  competent  authorities  of  most  Member  States  also  contributed  to  the 
consultations in preparation of the current proposals. Overall, Member States are supportive 
of the objectives of the proposals but ask to avoid additional administrative burden and to 
maintain  a  sufficient  level  of  flexibility for  implementation  adjusted to national  conditions. 
Only very few regional and local authorities have expressed their views. 

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 key added value of action at EU level is the common  legal framework on production and 
marketing of PRM/FRM and related technical requirements instead of 27 different systems 
at  Member  State  level.  The  common  legal  framework  establishes  a  level  playing  field  for 
operators  and  a  more  consistent  approach for addressing  the transboundary  challenges of 
sustainability, climate change and loss of biodiversity.  

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

Establishing  an  EU  system  and  minimum  standards  of  PRM/FRM  quality  brings  significant 
efficiencies for Member States and operators by avoiding the multiplication of systems and 
potential  barriers  to  the  internal  market.  By  providing  a  framework  and  related  technical 
requirements, the EU-level measures are best placed to effectively ensure minimum quality 

7 Council Decision (EU) 2019/1905 of 8 November 2019 requesting the Commission to submit a study on the 
Union’s options to update the existing legislation on the production and marketing of plant reproductive 
material, and a proposal, if appropriate in view of the outcomes of the study (OJ L293, 14.11.2019, p.105). 

4 

 
 
                                                           
of  PRM/FRM  for  its  users,  a  functioning  internal  market  and  a  level  playing  field  for 
operators  while  contributing  to  open  and  fair  competition.  Moreover,  temporary  supply 
difficulties in Member States can be overcome by action at EU level. Furthermore, common 
requirements for sustainability and the conservation and sustainable use of plant and forest 
genetic  resources  ensure  a  more  consistent  approach.  Action  at  EU  level  also  brings 
efficiency  by  common 
import  rules  and  consistency  with  relevant  agreements  at 
international level.  

(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? 

Common  EU  rules  on  the  production  and  marketing  of  PRM/FRM  are  in  place  since  the 
1960s. These have contributed to the development of world-wide competitive PRM and FRM 
sectors in the EU. The EU market has an annual value of about 15 billion EUR, accounting for 
about  20%  of  the  global  market,  while  the  EU  is  one  of  the  top  three  exporting  regions 
globally.  The  proposals  will  further  improve  the  functioning  of  the  internal  market  by 
increasing the clarity and coherence of the legal framework. 

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

homogenous policy approach? 

The proposals do not replace different national policies, since EU common rules are in place 
since the 1960s, but address the shortcomings identified in these common rules. 

(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)? 

Member  States  will  not  lose  competences  as  the  proposals  keep  the  main  aspects  of  the 
current framework in place, as already set out by Directives since the 1960s.  

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

Yes,  the  proposed  Regulations  will  resolve  the  ambiguities  of  the  existing  Directives  that 
have led to differences between the national transposition by Member States. 11 Directives 
will  be  replaced  by  two  Regulations  (one  on  PRM  and  another  one  on  FRM)  that  will  be 
directly applicable in all Member States. 

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

The measures proposed are limited to actions that need to be taken at an EU level in order 

5 

 
 
 
 
 
to achieve the intended objectives. They balance the need for harmonised rules on certain 
aspects (e.g. variety registration and certification of PRM) and for flexibility on other aspects 
(e.g.  implementation  of  sustainability  requirements  according  to  local  agro-ecological 
conditions). 

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? 

The  proposed  action  takes  the  form  of  2  new  Regulations  repealing  11  existing  Directives. 
This type of  instrument is  considered  most  suitable,  considering that  a  key  element  of  the 
proposal  is  to  establish  harmonised  rules  for  the  production  and  marketing  of  PRM/FRM. 
Uniform requirements  for  PRM/FRM  are the  only  way  to  ensure  a high level  of  quality  for 
users,  the  proper  functioning  of  the  internal  market  and  a  level  playing  field  for  the 
operators as well as to consistently contribute to the sustainability of agricultural and food 
production and forestry.  

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

satisfactorily on their own, and where the Union can do better? 

Yes, in all aspects where Member States could achieve better or equal results, on the basis 
of  their  own  national  legislation,  the  initiative  allows  them  to  do  so.  This  concerns,  for 
instance,  PRM  excluded  from  the  scope  of  the  legislation  or  aspects  for  which  Member 
States  are  allowed  to apply  more  or  less  stringent  national  standards,  if  they  consider this 
appropriate.  Member  States  are  also  given  the  necessary  flexibility  to  implement  the 
sustainability requirements in a way adapted to their local agro-ecological conditions. 

(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 that of a Regulation, one Regulation on PRM replacing 10 existing 
Directives  and  one  Regulation  on  FRM  replacing  one  existing  Directive.  This  choice  is 
coherent  with  the  objectives  pursued,  in  particular  to  ensure  a  level  playing  field  for 
operators across the EU and to increase the clarity and coherence in relation to the current 
legal framework. Differences in the transposition of the current Directives have contributed 
to divergent conditions for operators across Member States. 

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

Yes,  the  proposed  action  sets  minimum  technical  requirements  for  marketing  of  PRM  and 
FRM.  It  also  allows,  in  certain  cases  and  under certain  conditions,  Member  States  to  apply 
stricter  national  technical  requirements.  To  increase  transparency,  Member  States  are 
required  to  notify  these  requirements  to  the  Commission  and  the  other  Member  States. 

6 

 
 
 
 
Moreover, in order to meet temporary supply difficulties of seed Member States may apply 
lower  requirements  subject  to  certain  conditions.  Member  States  are  also  given  the 
necessary flexibility to implement the sustainability requirements in a way adapted to their 
local agro-ecological conditions. 

(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? 

Most of the proposed measures entail marginal changes in administrative costs, as existing 
administrative procedures remain in place (e.g. application for registration of a new variety) 
and no financial costs, as new possibilities are introduced without imposing new obligations 
(e.g. option to use digital solutions). The main costs resulting from these proposals relate to 
the strengthened sustainability requirements for the examination of new varieties. Member 
States will have to increase their capacity for such examinations, with total costs in the range 
of 43 to 98 million EUR per year. Plant breeders will face increased costs for registration of 
new varieties (estimated at 6 million EUR annually). They will also have increased breeding 
costs that are expected to be transferred to farmers in terms of increased price of PRM, in 
total  estimated  at  400  million  EUR  per  year.  This  amount  however  corresponds  to  an 
increase  of  costs  of  inputs  for  farmers  by  only  0.15%.  These  costs  are  considered 
commensurate  with  the  objective  of  ensuring  availability  of  PRM  suitable  for  future 
challenges.  The  strengthened  sustainability  requirements  for  the  examination  of  new 
varieties  are  expected  to  result  in  improved  varieties  (e.g.  more  tolerant  to  plant  pests  or 
drought)  that  is  expected  to  reduce  crop  losses  by  622  to  2487  million  EUR  annually  and 
more broadly can help achieve increased food security. 

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

Member States been taken into account? 

No special circumstances in individual Member States were identified that  would require a 
particular territorial variation in the measures to be applied. However, and in certain policy 
areas, Member States will have the possibility to derogate from EU standards, if so justified 
by the national circumstances and if authorised by the Commission to do so. 

7