COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT 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

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  EN 

   EUROPEAN COMMISSION  Brussels, 5.7.2023  SWD(2023) 415 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT     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) 410 final} - {SWD(2023) 414 final} - {COM(2023) 415 final}  
 
 
1.  Need for action 

What is the problem and why is it a problem at EU level? 

The  EU  legislation  on  the  marketing  of  plant  and  forest  reproductive  material  (PRM/FRM) 
has  been  in  place  since  1966.  Subsequent  amendments  have  led  to  a  complex  legal 
framework,  not  fully  aligned  to  closely  related  policies  (plant  health,  official  controls  and 
organic  production).  Implementation  and  therefore  conditions  for  operators  differ  between 
Member States, as aspects of the legislation leave room for interpretation. National practices 
have  been  adopted  where  the  legislation  has  not  followed  in  a  timely  manner  new 
developments  in  science  and  technology  (innovative  production  processes,  bio-molecular 
techniques, digital solutions).  

Due to the initial focus of the legislation on productivity, there are limited means to address 
the sustainability,  climate change  adaptation  and biodiversity  challenges. The  assessment of 
new  varieties  for  characteristics  that  can  contribute  to  sustainable  production  is  limited. 
Market  access  rules  are  restrictive  for  organic  and  conservation  varieties  and  activities  that 
can contribute to the genetic diversity of cultivated crops and cover specific local needs (e.g. 
short  supply  chains).  The  FRM  legislation  defines  FRM  in  relation  to  its  importance  for 
forestry purposes in all or part of the Union, but it remains vague about the forestry purposes 
covered by the scope of the legislation. Increasing difficulties in the supply of FRM because 
of changing climatic conditions are not addressed and rules on the information to be provided 
to users of FRM are unclear, with the risk that inappropriate FRM is used in afforestation and 
reforestation. 

What should be achieved? 

The initiative should ensure, for all types of users, PRM/FRM of high quality and diversity of 
choice  and  should  ensure  a  level  playing  field  for  operators  across  the  EU.  It  should 
contribute  to  the  stability  of  yield  of  agricultural  production  and  productivity  of  forest 
ecosystems  under  current  and  future  projected  climatic  conditions.  The  initiative  should 
harmonise the official controls, improve coherence with the plant health legislation and enable 
the  uptake  of  new  scientific  and  technical  developments.  Finally,  it  should  facilitate  the 
registration of organic varieties and support the conservation and sustainable use of plant and 
forest genetic resources. 

What is the added value of action at EU level (subsidiarity)? 

The  unrestricted  marketing  of  PRM/FRM  throughout  the  EU  is  imperative  to  address 
transboundary issues such as the need for sustainable production to ensure food security and 
sustainable forest management and restoration of forest ecosystems. The current geopolitical 
situation  and  energy  crisis  have  elevated  the  importance  of  this.  Access  to  market  of 
PRM/FRM  relies  on  examinations  and  inspections  by  the  national  competent  authorities. 
Common EU rules ensure the quality of PRM/FRM and the open and fair competition on the 
single market. Without them, 27 systems instead of one would be in place, thus hindering the 
movement,  distorting  competition  and  increasing  the  financial  burden  for  operators  and 
authorities.  

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2.  Solutions 

What are the various options to achieve the objectives? Is there a preferred option or not? 

Three  options  were  assessed,  from  one  of  highest  flexibility  (option  1)  to  one  of  highest 
harmonisation  to  minimise  differences  in  the  implementation  of  the  legislation  (option  3), 
with  option  2  balancing  the  need  for  flexibility  with  a  higher  degree  of  harmonisation  to 
overcome the problems stemming from differences in interpretation.  

Horizontal  elements  for  all  options:  1)  Simplification  of  administrative  procedures  and  a 
more  flexible  decision-making  process  2)  Streamlined  rules  for  organic  and  conservation 
varieties 3) Harmonisation with the plant health legislation. 

Option  1  -  Highest  flexibility:  Option  1  lays  down  minimum  requirements  for  PRM/FRM 
official controls, but without linking it to the Official Controls Regulation. Guidelines on the 
use  of  innovative  production  processes,  bio-molecular  techniques  and  digital  solutions  are 
adopted.  The  existing  assessment  of  new  varieties  of  agricultural  plant  species  for 
characteristics  contributing 
to  sustainable  production  are  strengthened.  A  voluntary 
assessment  is  introduced  for  vegetables  and  fruit  plants.  The  activities  of  seed  conservation 
networks, marketing to amateur gardeners and exchange in kind of seed between farmers are 
exempted from the legislation’s scope to stimulate the increase in genetic diversity of PRM. 
The FRM legislation only covers production for “forestry purposes” to ensure the availability 
of high-quality FRM for afforestation/reforestation. Sustainability requirements  are extended 
to the lower FRM categories. Guidelines on contingency planning for major FRM shortages 
in case of extreme weather and disasters are introduced.  

Option 2 - Balancing flexibility and harmonisation (preferred option): Option 2 brings the 
official controls on PRM/FRM under the scope of the Official Controls Regulation, but with 
simplified import controls at appropriate places within the EU to ensure a more targeted and 
efficient enforcement of existing rules.  Basic principles for the use of innovative production 
processes, bio-molecular techniques and digital solutions are included in the legislation. The 
assessment of new varieties for characteristics contributing to sustainable production becomes 
a  requirement  for  all  crops  groups,  but  with  flexibility  for  Member  States  to  implement 
according  to  their  own  agro-ecological  conditions.  The  activities  of  seed  conservation 
networks, marketing to amateur gardeners and exchange in kind of seed between farmers are 
subject to lighter rules to stimulate the increase in genetic diversity of PRM but also guarantee 
a minimum quality. The FRM legislation covers production for “forestry” and “non-forestry” 
purposes  to  increase  FRM  quality  beyond  afforestation/reforestation  uses.  Sustainability 
requirements  are  extended  to  the  lower  FRM  categories.  General  legal  requirements  for 
contingency planning for major FRM shortages in case of extreme weather and disasters are 
introduced.  

Option 3 - Highest harmonisation: Option 3 brings the official controls on PRM/FRM under 
the scope of the Official Controls Regulation, with stricter import controls at border control 
posts requiring special import documentation to strengthen and fully harmonise enforcement. 
Detailed  and  binding  rules  for  the  use  of  innovative  production  processes,  bio-molecular 
techniques  and  digital  solutions  are  included  in  the  legislation.  The  assessment  of  new 
varieties for characteristics contributing to sustainable production becomes a requirement for 
all  crops,  with  detailed  and  harmonised  requirements  and  methodologies  for  all  Member 
States.  The  activities  of  seed  conservation  networks,  marketing  to  amateur  gardeners  and 
exchange in kind of seed between farmers are subject to the general requirements of the PRM 

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legislation to achieve homogenous rules for all market segments. The FRM legislation covers 
production  for  “forestry”  and  “non-forestry”  purposes  to  increase  FRM  quality  beyond 
afforestation/reforestation  uses.  Sustainability  requirements  are  extended  to  the  lower  FRM 
categories  and  are  subject  to  harmonised  rules.  Common  rules  for  contingency  planning  to 
prepare for major FRM shortages in case of extreme weather and disasters are introduced. 

What are the different stakeholders’ views? Who supports which option? 

There is overall support for maintaining the current regulatory system for PRM/FRM and its 
two  basic  pillars  of  registration  of  varieties/basic  material  and  PRM/FRM  certification 
(system to ensure the identity, quality and health of PRM/FRM). There is also broad support 
for derogations, deemed necessary for meeting the objectives relevant to the conservation and 
sustainable  use  of  plant  genetic  resources  and  organic  production.  Views  in  relation  to  the 
extent of the derogations vary. Citizens and civil society organisation seek a total exception of 
activities relevant to the conservation and sustainable use of plant genetic resources from the 
scope of the legislation. Most industry stakeholders and national competent authorities agree 
with derogations but ask that quality and health are ensured, while a minority considers that 
any  derogations  should  be limited. There is support  for an increased focus on sustainability 
but  subject  to  maintaining  flexibility  to  address  the  different  conditions  across  the  EU. 
However,  stakeholders  and  national  competent  authorities  are  concerned  about  the  resulting 
costs  in  relation  to  the  introduction  of  sustainability  assessments  for  fruit  plants  and 
vegetables.  Civil  society  organisations  stress  the  contribution  of  conservation  activities  and 
organic  production  to  the  sustainability  objectives.  There  is  overall  agreement  that: 
harmonisation  of  official  controls  is  necessary,  but  it  should  not  lead  to  increased 
administrative  burdens;  the  use  of  bio-molecular  techniques  and  digital  solutions  will  have 
benefits, but should be optional; and the FRM legislation must remain separate from the PRM 
legislation.  Stakeholders  expressed  diverging  views  regarding  the  purposes  that  are  covered 
by  the  scope  of  the  current  FRM  legislation.  Option  2  responds  best  to  the  different 
stakeholders’ views. 

3.  Impacts of the preferred option 

What are the benefits of the preferred option? 

The  preferred  option  will  bring  efficiency  gains  for  operators  and  national  competent 
authorities  through  extended  possibilities  for  operators  to  undertake  activities  under  official 
supervision,  harmonisation  with  the  plant  health  legislation,  the  introduction  of  risk-based 
official controls and the possibility to use bio-molecular techniques and digital solutions in the 
registration  and  certification  systems.  Mandatory  strengthened  sustainability  requirements 
combined with flexibility to adapt to local agro-ecological conditions will contribute to more 
sustainable agri-food production and food security, as varieties more suitable for the changing 
agro-climatic  conditions  will  have  a  more  stable  yield.  Varieties  with  disease  resistance  / 
tolerance  will  have  a  positive  environmental  impact  as  they  may  reduce  the  need  for  plant 
protection  products.  FRM  with  improved  sustainability  characteristics  can  contribute  to 
adaptation and mitigation of the already visible impact of climate change on forests, therefore 
delivering  important  environmental  benefits.  Preparedness  for  major  shortages  of  FRM  in 
case of extreme weather and disasters will be improved and the risk of planting of low-quality 
FRM will be reduced. Finally, benefits are expected for the conservation and sustainable use 
of  plant  and  forest  genetic  resources  through  specific  derogations  coupled  with  tools  for 
traceability and quality assurance. 

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What are the costs of the preferred option? 

The  preferred  option  presents  considerable  economic  costs  for  operators  and  national 
competent  authorities  due  to  the  need  for  additional  investments  to  conduct  additional 
sustainability  assessments.  These  are  however  proportional  to  the  objectives  and  will  in  the 
mid-term be compensated by the benefits to be realised in terms of sustainability of the agri-
food production and the forestry sectors. Other measures do not result in new obligations for 
operators but provide them with new options or lighter conditions for accessing the market. 

What are the impacts on small and medium-sized enterprises (SMEs)? 

SMEs  are  expected  to  benefit  as  all  other  enterprises  from  the  systemic  improvements  and 
resulting  efficiency  gains.  While  no  specific  breakdown  is  available,  SMEs  present  a  great 
diversity  of  crops  covered  (highly  specialised  in  a  few  crops  or  a  broader  portfolio)  and 
geographical coverage (national, EU or international markets). They may be active in one or 
several  stages  of  the  seed  industry:  plant  breeding,  seed  production,  seed  conditioning  and 
seed marketing. Depending on their specific activities and degree of innovation some SMEs 
might not be able to take up new possibilities to be introduced (e.g. use of digital technologies 
and bio-molecular techniques)  or these possibilities might  not  be relevant to  their activities. 
SMEs with a small number of new varieties per year could be negatively affected in the short 
term  by  the  increased  sustainability  requirements,  with  the  need  to  re-orient  investments  to 
varieties with improved sustainability characteristics. Finally, it would be mostly SMEs that 
would benefit from the measures for organic and conservation varieties, as mostly SMEs are 
involved in such activities. 

Will there be significant impacts on national budgets and administrations? 

National  competent  authorities  will  most  likely  have  to  increase  their  capacity  in  order  to 
enforce  the  increased  requirements  for  sustainability  assessments.  Adjustment  of  existing 
practices  and  rearrangement  of  resources  in  relation  to  official  controls  and  plant  health 
requirements  will  also  be  required,  depending  however  on  the  current  allocation  of 
competencies. 

Will there be other significant impacts? 

There will be no other significant impacts. 

Proportionality 

The initiative does not go beyond what is necessary to achieve the objectives of the revision. 
It  does  so  in  a  way  that  is  conducive  to  national  action,  which  would  otherwise  not  be 
sufficient to achieve those objectives in a satisfactory way. 

4.  Follow up 

When will the policy be reviewed? 

An appropriate review period would be 10 years after entry into application. This is consistent 
with  the  average  time  needed  for  the  breeding  of  a  new  variety  as  well  as  with  the  time 
needed to obtain meaningful data through annual monitoring.  

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