COMMISSION STAFF WORKING DOCUMENT 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

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 5.7.2023  SWD(2023) 414 final  COMMISSION STAFF WORKING DOCUMENT  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) 415 final} - {COM(2023) 415 final}  
 
 
Table of Contents 

1. 

2. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ............................................................... 6 

PROBLEM DEFINITION .................................................................................................................. 12 

2.1.  What are the problems? ................................................................................... 12 
2.1.1.  Problem  1:  Non-harmonised  internal  market  (divergent  conditions  for  the  operators 
across Member States) ............................................................................................................... 13 

2.1.2.  Problem 2: PRM/FRM legislation is not aligned with the objectives of the European 
Green Deal and related strategies .............................................................................................. 16 

2.2.  What are the problem drivers? ........................................................................ 19 
2.2.1.  Regulatory drivers ....................................................................................................... 19 

2.2.2.  New policy developments ........................................................................................... 20 

2.2.3.  New developments in science and technology ............................................................ 20 

2.3.  How likely is the problem to persist? .............................................................. 20 

3.  WHY SHOULD THE EU ACT? ........................................................................................................ 21 

3.1.  Legal basis ....................................................................................................... 21 
3.2.  Subsidiarity: Necessity of EU action ............................................................... 21 
3.3.  Subsidiarity: Added value of EU action .......................................................... 21 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................... 22 

4.1.  General objectives ........................................................................................... 22 
4.2.  Specific objectives ........................................................................................... 22 
Intervention logic ............................................................................................. 23 
4.3. 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? .................................................................... 24 

5.1.  What is the baseline from which options are assessed? .................................. 24 
5.2.  Description of the policy options .................................................................... 26 
5.2.1.  Measures common to all options ................................................................................. 28 

5.2.2.  Option 1 - Highest flexibility ...................................................................................... 29 

5.2.3.  Option 2 - Balancing flexibility and harmonisation .................................................... 30 

5.2.4.  Option 3 - Highest harmonisation ............................................................................... 32 

5.2.5.  Stakeholders’ views on policy options ........................................................................ 36 

5.3.  Options discarded at an early stage and alternative measures ......................... 39 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 39 

6.1.  Economic impacts ........................................................................................... 40 
6.1.1.  Common measures to policy options 1-3 .................................................................... 40 

6.1.2.  Strengthened sustainability requirements .................................................................... 41 

6.1.3.  Official controls ........................................................................................................... 45 

6.1.4.  Conservation and sustainable use of plant and forest genetic resources ..................... 47 

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6.1.5. 

Innovation and digitalisation ....................................................................................... 48 

6.1.6.  SMEs ........................................................................................................................... 49 

6.1.7.  Competitiveness .......................................................................................................... 49 

6.2.  Environmental impacts .................................................................................... 50 
6.2.1.  Strengthened sustainability requirements .................................................................... 50 

6.2.2.  Conservation and sustainable use of plant and forest genetic resources ..................... 53 

6.2.3.  Common measures for PRM to contribute to sustainability, biodiversity and climate-
related challenges ...................................................................................................................... 53 

6.3.  Social impacts .................................................................................................. 54 
6.4.  Sustainability ................................................................................................... 54 
6.5.  Global combined impact of the policy options ................................................ 55 
6.6.  Stakeholders’ views on impact of policy options ............................................ 58 

7.  HOW DO THE OPTIONS COMPARE? ............................................................................................ 59 

7.1.  Effectiveness .................................................................................................... 60 
7.2.  Efficiency ........................................................................................................ 62 
7.3.  Coherence ........................................................................................................ 63 
7.4.  Subsidiarity and proportionality ...................................................................... 65 

8. 

PREFERRED OPTION ...................................................................................................................... 66 

8.1.  REFIT (simplification and improved efficiency) ............................................ 67 
8.2.  Simplification  and  burden  reduction  for  businesses,  supporting  the  one-in  one-

out approach .................................................................................................... 69 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 69 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................................ 73 

1. 

LEAD DG, DECIDE PLANNING/CWP REFERENCES .................................................................. 73 

2.  ORGANISATION AND TIMING ...................................................................................................... 73 

3. 

4. 

CONSULTATION OF THE RSB....................................................................................................... 74 

EVIDENCE, SOURCES AND QUALITY ......................................................................................... 76 

ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ................................................ 78 

1. 

CONSULTATION STRATEGY ........................................................................................................ 78 

1.1.  Consultation activities undertaken by DG SANTE ......................................... 78 
1.2.  Consultation  activities  conducted  in  the  framework  of  the  study  supporting  the 

impact assessment ........................................................................................... 79 

2. 

3. 

4. 

STAKEHOLDER PARTICIPATION ................................................................................................. 79 

RESULTS OF STAKEHOLDER CONSULTATION ACTIVITIES ................................................. 81 

CONCLUSIONS ................................................................................................................................. 83 

ANNEX 3: WHO IS AFFECTED AND HOW? .......................................................................................... 84 

1. 

PRACTICAL IMPLICATIONS OF THE INITIATIVE..................................................................... 84 

1.1.  Operators ......................................................................................................... 84 

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1.2.  National competent authorities ........................................................................ 84 
1.3.  Users of PRM and FRM .................................................................................. 85 

2. 

SUMMARY OF COSTS AND BENEFITS ....................................................................................... 85 

ANNEX 4: ANALYTICAL METHODS / CALCULATIONS .................................................................... 90 

1.  GLOBAL VALUE OF PRM/FRM  AND  COST OF PRM  AS A SHARE OF TOTAL  INPUT COSTS 

OF AGRICULTURAL PRODUCTION ............................................................................................. 90 

2.  NUMBER OF NEW VARIETIES ...................................................................................................... 92 

3. 

PRM  CERTIFICATION  AREAS  /  CERTIFIED  QUANTITIES  AND  CERTIFICATION  UNDER 
OFFICIAL SUPERVISION ................................................................................................................ 93 

4.  VARIETY REGISTRATION COSTS ................................................................................................ 97 

5. 

6. 

IMPACT  OF  STRENGTHENED  SUSTAINABILITY  REQUIREMENTS 
REGISTRATION ................................................................................................................................ 99 

IN  VARIETY 

IMPACT OF ASSESSMENT OF SUSTAINABILITY CHARACTERISTICS OF BASIC MATERIAL
 .......................................................................................................................................................... 101 

7. 

INNOVATION AND DIGITALISATION ....................................................................................... 102 

8.  DETAILED PRESENTATION OF COSTS AND BENEFITS ........................................................ 103 

8.1.  Costs of common measures ........................................................................... 103 
8.2.  Benefits of common measures ....................................................................... 106 
8.3.  Costs per option ............................................................................................. 109 
8.4.  Benefits per option ........................................................................................ 113 
8.5.  Net benefit and cost benefit analysis ............................................................. 117 

9. 

REDUCTION  OF  ADMINISTRATIVE  BURDENS  DUE  TO  SIMPLIFICATION  OF 
ADMINISTRATIVE PROCEDURES .............................................................................................. 118 

ANNEX 5: BACKGROUND INFORMATION ........................................................................................ 120 

1. 

2. 

3. 

4. 

5. 

THE PRM LEGISLATION AND ITS DEVELOPMENT................................................................ 120 

PRINCIPLES OF THE PRM LEGISLATION ................................................................................. 121 

2.1.  Variety registration ........................................................................................ 121 
2.1.1.  Distinctness, uniformity and stability (DUS) ............................................................ 121 

2.1.2.  Value for cultivation and use (VCU)......................................................................... 122 

2.2.  Certification ................................................................................................... 124 
2.2.1.  Official certification .................................................................................................. 124 

2.2.2.  Certification under official supervision ..................................................................... 125 

2.3.  Activities of seed conservation networks and exchange in kind ................... 126 
2.4.  Marketing to amateur gardeners .................................................................... 127 
2.5.  Organic  varieties  suitable  for  organic  production  and  organic  heterogeneous 

material .......................................................................................................... 128 
2.6.  Conservation varieties ................................................................................... 128 

PRINCIPLES OF THE FRM LEGISLATION ................................................................................. 129 

INTERACTION WITH OTHER EU POLICIES AND INSTRUMENTS ....................................... 131 

INTERACTION BETWEEN FSFS, PRM/FRM AND NGTS ......................................................... 133 

3 

 
 
6. 

7. 

8. 

INTERPLAY  BETWEEN  PRM/FRM  AND  NGT  INITIATIVES  AS  REGARDS  SUSTAINABILITY 
PROVISIONS ................................................................................................................................... 133 

INTERPLAY BETWEEN PRM/FRM LEGISLATION AND PHL................................................. 134 

INNOVATION AND DIGITALISATION ....................................................................................... 137 

9.  OFFICIAL CONTROLS ................................................................................................................... 140 

9.1.  Legal analysis ................................................................................................ 140 
9.2. 
Information on official controls from consultation activities ........................ 164 
9.2.1.  Controls on operators carrying out certification under official supervision.............. 164 

9.2.2.  PRM import controls ................................................................................................. 164 

9.2.3.  Types of import controls: .......................................................................................... 165 

9.2.4.  Controls on operators at production stage of PRM/FRM .......................................... 165 

9.2.5.  PRM marketing controls............................................................................................ 167 

10.  FURTHER DETAILS ON OPTION 2 (PREFERRED OPTION) .................................................... 169 

10.1.  Current  and  potential  future  approach  for  variety  registration  and  PRM 

certification .................................................................................................... 169 

10.2.  Potential future approach for variety registration, activities of seed conservation 

networks and exchange in kind of seeds ....................................................... 170 
10.3.  Value for sustainable cultivation and use (VSCU) ........................................ 171 
10.4.  Certification under official supervision ......................................................... 172 
10.5.  Future regulation of RNQPs .......................................................................... 174 

ANNEX 6: BIBLIOGRAPHY.................................................................................................................... 176 

1.  GENERAL LITERATURE .............................................................................................................. 176 

2.  DOCUMENTS OF THE EUROPEAN COMMISSION................................................................... 179 

3. 

EU LEGISLATION (OTHER THAN THAT LISTED IN SECTION 1 OF ANNEX 5) ................. 180 

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Glossary 

Term or acronym 

BMT 

CPVO 

CPVR 

Meaning or definition 

Bio-molecular techniques 

Community plant variety office 

Community plant variety rights 

DG SANTE 

Directorate-General for Health and Food Safety 

DUS  

EGD 

EU 

F2F  

FRM  

FSFS 

GMO  

IMSOC 

MS 

NCA  

NGT 

OC 

OCR  

OECD  

PHL 

PRM  

QP 

RNQP 

SDG 

SME 

SUR 

TFEU 

UPOV 

VCU 

VSCU 

Distinctness, Uniformity and Stability 

European Green Deal 

European Union 

Farm to Fork Strategy 

Forest reproductive material 

Framework for sustainable food system 

Genetically modified organism 

Information management system for official controls 

Member State(s) 

National Competent Authority 

New genomic techniques 

Official control 

Official Controls Regulation 

Organization for Economic Co-operation and Development 

Plant health legislation 

Plant reproductive material 

Quarantine pest 

Regulated non-quarantine pest 

Sustainable Development Goal 

Small and medium-sized enterprise 

Proposal for a Regulation on the sustainable use of plant protection 
products 

Treaty on the Functioning of the European Union 

International union for the protection of new varieties of plants 

Value for cultivation and use 

Value for sustainable cultivation and use 

5 

 
 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

Plant  reproductive  material  (PRM)  is  any  plant  material  (for  example  seeds,  tubers,  cuttings, 
rootstocks,  seedlings,  young  plants,  fully  grown  trees)  that  is  used  for  the  reproduction  of  other 
plants.  Forest  reproductive  material  (FRM)  is  the  PRM  of  tree  species  that  is  used  for  the 
creation  of  new  forests,  the  reforestation  of  existing  ones  and  other  tree  planting  activities  (for 
example,  in  rural  areas  for  the  purpose  of  climate  adaptation).  Thus,  PRM  and  FRM  form  the 
starting  point  of  agricultural  and  food  production  and  forestry,  respectively.  In  particular,  the 
availability of, and access to, high-quality PRM are key contributors to food security. They link to 
the four main pillars on which food security is based: availability, access, utilisation and stability1. 
The actions taken under the Farm to Fork Strategy  (F2F) including those under this initiative will 
help enable and contribute to the transition to sustainability, which will strengthen resilience and in 
turn enhance short- and long-term food security. The availability of and access to high-quality and 
genetically diverse  FRM will contribute to more  sustainable afforestation and reforestation which 
will  in  turn  strengthen  the  resilience  of  forest  ecosystems  and  ensure  that  forests  can  adapt  to 
climate change. 

The EU legislation on PRM and FRM currently includes 12 basic Directives, collectively known as 
‘marketing  Directives’:  10  specific  for  each  type  of  crop  (seed  of  cereals,  seed  of  fodder  plants, 
seed  of  oil  and  fibre  plants,  seed  of  beet,  seed  potatoes,  vegetable  seed,  vegetable  reproductive 
material  other  than  seed,  fruit  plants,  vine,  ornamental  plants),  one  Directive  establishing  the 
Common Catalogue  of varieties of agricultural  species  and one on FRM (for a detailed overview 
see Annex 5, Section 1). The oldest of these Directives date back to 19662. The legislation applies 
to  the  economically  most  important  plant  species.  The  aim  of  this  legislation  is  to  ensure  the 
identity, quality and health of the marketed PRM and FRM for its users. 

The  PRM  legislation  has  two  main  pillars:  registration  of  varieties3  and  certification  of  PRM 
(Annex 5, Section 2). For the purposes of variety registration, the candidate varieties are tested in 
field  trials  for  their  distinctness,  uniformity  and  stability  (DUS)4  by  the  National  Competent 
Authority (NCA) of the MS where the application is submitted. DUS tests take two to three years in 
the case of varieties of agricultural plant species5 and vegetable species and five to six years in the 
case of varieties  of fruit plants and vine. For agricultural  plant species the candidate varieties are 
also  assessed  by  comparative  field  trials  carried  out  by  the  NCAs  for  their  value  for  cultivation 
and use (VCU), i.e. whether they offer a clear improvement in performance compared to reference 
varieties. Upon satisfactory completion of the DUS, and where applicable of the VCU examination, 
varieties  are  registered  in  the  national  catalogue  of  the  MS  and  subsequently  notified  to  the 

the 

legislation  can  be 

found  at  https://food.ec.europa.eu/plants/plant-reproductive-

1 FAO (2022). 
2  A  compilation  of 
material/legislation/specific-legislation_en. See also Section 1 of Annex 5. 
3  A  plant  variety  represents  a  group  of  plants  of  a  given  species  with  a  common  set  of  characteristics,  while  a  plant 
species  can  include  from  a  few  to  thousands  of  different  plant  varieties.  PRM  (seed,  cuttings  etc.)  is  marketed  with 
reference to a registered variety. 
4  New  varieties  need  to  be  different  from  other  known  (reference)  varieties  (distinctness  requirement).  The 
characteristics  of  different  plants  within  the  same  variety  should  be  similar  (uniformity  requirement).  The 
characteristics of the plants of a new variety should not change over time (stability requirement). 
5 The term ‘agricultural plant species’ is referring collectively to cereals, fodder plants, beet, potato, oil and fibre plants. 

6 

 
 
                                                 
corresponding  EU  Common  Catalogue  for  marketing  throughout  the  EU.  Each  registered  plant 
variety is designated a unique denomination, i.e. a name that serves to identify that variety. 

Certification of PRM consists of checks (both in the field where PRM is produced, by sampling 
and  testing  the  PRM  lots  produced  and  control  plot  testing  of  the  varietal  identity)  to  verify  its 
identity,  quality  and  health.  As  regards  identity,  it  is  verified  that  the  PRM  has  the  same 
characteristics  as  the  registered  plant  variety  to  which  that  PRM  belongs  (i.e.  it  is  true  to  variety 
description).  Different  marketing  categories  of  PRM  are  defined  depending  on  the  quality  and 
technical  requirements  (e.g.  analytical  purity,  germination  rate,  absence  of  weeds).  As  regards 
health, it is verified that the PRM does not contain any plant pests or diseases. Certain aspects of 
the  certification  procedures  can  be  carried  out  by  authorised  operators  under  the  official 
supervision  of  the  NCAs.  For  PRM  that  meets  the  certification  requirements  the  NCAs  issue  an 
official  label  with  which  the  PRM  can  be  marketed  throughout  the  EU6.  The  PRM  legislation 
furthermore  includes  rules  for  marketing  of  PRM  in  homogeneous  lots  with  reference  to  a  lot 
number to assure traceability, as well as rules for packaging, sealing, labelling and documentation. 
The PRM legislation also sets the rules for imports of PRM  into the EU. Such PRM can only be 
marketed in the Union if it satisfies the same requirements as the material produced and certified 
within the Union (EU equivalence regime). Exports are not covered by the legislation.  Finally, to 
ensure the quality of PRM marketed throughout  the EU,  NCAs should carry out official controls 
(OCs)  in  order  to  verify  compliance  with  the  rules  on  the  production,  marketing  and  imports  of 
PRM. 

The FRM legislation is based on principles quite different from those of the PRM legislation, as 
FRM  differs  significantly  from  PRM  (Annex  5, Section  3).  While  seeds of  agricultural  crops  are 
harvested  in  annual  cycles,  for  certain  forestry  species  it  takes  50-100  years  before  FRM  can  be 
harvested.  FRM  is  marketed  in  relation  to  basic  material  (i.e.  approved  trees  from  which  seed  is 
harvested)  and  provenance  (the  place  in  which  trees  are  growing).  NCAs  approve  basic  material 
through an official inspection following which basic material is registered in the national catalogue 
of the MS and subsequently in the EU Common Catalogue FOREMATIS7. Upon harvesting seeds 
and other FRM from basic material, NCAs issue a master certificate. FRM has to meet the relevant 
requirements  (age,  development,  health  and  resistance  of  trees  in  stands  to  adverse  climatic 
conditions) before the operator can issue a supplier’s document or supplier’s label. The registration 
of basic material, the master certificate and the supplier’s document/label are prerequisites for the 
marketing  of  FRM  throughout  the  EU.  Similar  to  the  PRM  legislation,  the  FRM  legislation  also 
includes  rules  for  marketing  of  FRM,  imports  (equivalence),  derogations  aiming  to  facilitate  the 
conservation and sustainable use of forest genetic resources, and OCs for verifying compliance with 
the rules on the production, marketing and imports of FRM. 

The  EU  PRM  and  FRM  market  has  an  estimated  annual  value  of  over  EUR  13  billion8.  As 
regards the seed sector in particular, the EU is in the top three of globally exporting regions. The 
EU seed market covers agricultural species (e.g. wheat, maize, rice), vegetable species (e.g. tomato, 
carrot, lettuce). It is the third largest seed market after the USA and China and accounts for around 

6 Ornamental plants are an exception to the general approach described above. There is no obligation for registration of 
varieties and the PRM is subject only to basic requirements as regards health, vigour and germination. 
7 Forest Reproductive Material Information system (http://ec.europa.eu/forematis).  
8 Eurostat, see Annex 4 Section 1. 

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20% of the global market, estimated at EUR 7-10 billion (revenues from commercial seed sales, not 
including farm-saved seeds). There is little information available on the structure of the seed sector 
in  the EU. The number  of companies in  the seed sector is  about  7 000.  They  are very  diverse in 
terms of size (turnover, employees), crops or geographical area covered. They may be active in one 
or several stages of the seed industry: plant breeding, seed production, seed conditioning, and seed 
marketing and distribution. The number of small and medium-sized enterprises (SMEs) is assumed 
to be high, but no information is available on their market share. Furthermore, it is not known how 
many are independent (a single company may own a large number of brands), while cross-licensing 
and cooperation agreements have created a network of relationships between seed companies that 
make  the  mapping  of  the  sector  extremely  difficult9.  The  EU  plant  breeding  sector  is  highly 
innovative and new varieties are constantly developed to meet the demands of farmers, industry and 
consumers.  It  spends  around  15%  of  its  annual  turnover  on  research  and  development10.  Farmers 
also play an important role in the seed sector as they multiply the seed of agricultural plant species 
in  their  fields  on  behalf  of  the  seed  companies.  In  2021  the  area  used  for  production  of  certified 
seed (vegetable and ornamental seeds not included) in EU amounted to slightly more than 2 million 
ha11. As regards PRM of fruit plants, there are over 20 000 suppliers in the EU, almost all of which 
are  SMEs12.  As  regards  FRM,  there  are  over  4  000  suppliers  in  the  EU,  almost  all  of  which  are 
SMEs13. The overwhelming majority of  FRM (tree seeds and plants) are marketed within the EU 
and only a minority is traded with non-EU countries14. 

Relationship with other EU policies and instruments 

The  PRM/FRM  legislation  interacts  with  a  number  of  EU  policies  and  instruments  (Annex  5, 
Section 4). There is a close link with the European Green Deal (EGD)15 and its related strategies: 

  F2F16  recognises  that  sustainable  food  systems  rely  on  seed  security  and  diversity  and  that 
farmers  need  to  have  access  to  a  range  of  quality  seeds  for  plant  varieties  adapted  to  the 
pressures of  climate change.  The initiative for the PRM/FRM revision will introduce relevant 
considerations in the criteria for acceptance of new varieties. It will also contribute to reaching 
the F2F objective of at least 25% of the EU’s agricultural land under organic farming by 2030 
by introducing rules on registration of organic varieties suitable for organic production adapted 
to the needs of organic production. 

  The initiative for the PRM/FRM revision will contribute to the objective of the EU Biodiversity 
Strategy for 203017 to reverse the decline of genetic diversity by facilitating the market access 

9 Ragonnaud G. (2013). 
10 Bakker T. et al. (2012). 
11  European  Seed  Certification  Agencies  Association  (ESCAA)  Seed  production  in  EU  -  2021 (escaa.org). This  area 
corresponds  to  about  1%  of  the  total  utilised  agricultural  area  in  EU.  The  number  of  farmers  involved  is  unknown, 
indicatively in France about 17 900 farmers are involved in seed multiplication (semae.fr). 
12 Data collected from the NCAs. The existence of in total 20 137 suppliers of PRM of fruit plants were reported by the 
NCAs from 10 MS. 
13 Data collected from the NCAs. The existence of in total 4 129 suppliers of FRM were reported by the NCAs from 8 
MS. 
14 Information from the NCAs.  
15 COM(2019) 640 final. 
16 COM(2020) 381 final. 
17 COM(2020) 380 final. 

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 

 

for  traditional  and  locally  adapted  varieties,  thus  contributing  to  the  conservation  and 
sustainable use of plant genetic resources. 
It will also contribute to the objective of the EU Strategy on Adaptation to Climate Change18 to 
help farmers and land managers tackle climate risks. Relevant criteria will be introduced in the 
rules for the registration of new varieties and of FRM with a view to facilitate the broadening of 
the  supply  of  suitable  high-quality  plant  reproductive  material  to  support  adaptation  in 
agriculture, forestry, and land ecosystem management. 
It will furthermore contribute to the objectives of the EU Forest Strategy19 for adapting forests 
to  climate  change  and  restoring  forests  following  climate  damages  by  introducing  measures 
promoting  the  production  of  FRM  suitable  for  future  climatic  conditions.  It  will  finally 
contribute to meeting the target of planting at least 3 billion additional trees in the EU by 2030, 
by revising the scope of the FRM legislation, in order to ensure that FRM of high quality will 
be used for this. 

There are also links and interplays with other EU legislation, notably the Plant Health Legislation 
(PHL)20, the Official Controls Regulation (OCR)21, the Organic Regulation22, the Community Plant 
Variety Rights (CPVR) legislation23 and the genetically modified organisms (GMO) legislation24 as 
well as the EU Digital Strategy25. The PRM/FRM legislation also has to be aligned or interrelates 
with a number of international standards or agreements26.  

Relationship with other ongoing initiatives 

The  initiative  for  the  revision  of  the  PRM/FRM  legislation  is  linked  to  the  following  ongoing 
initiatives (for details see Annex 5, Section 5): 

  The  Framework  for  Sustainable  Food  System  (FSFS)  initiative27  aims  to  introduce  an 
overarching,  horizontal  legal  framework  (‘lex  generalis’)  establishing  common  sustainability 
principles and objectives for all food system related policies. The initiative for the PRM/FRM 
revision, which is underpinned by sustainability as an objective, will include specific rules for 
the  PRM/FRM  sectors  (‘lex  specialis’).  FSFS  will  ensure  the  benefits  of  an  integrated  policy 
perspective and  approach, while  specific requirements introduced by the PRM/FRM initiative 
will accelerate the transition towards more sustainable practices in the PRM/FRM sectors. 

18 COM(2021) 82 final. 
19 COM(2021) 572 final. 
20 Regulation (EU) 2016/2031. OJ L 317, 23.11.2016, p.4. 
21 Regulation (EU) 2017/625. OJ L 95, 7.4.2017, p. 1. 
22 Regulation (EU) 2018/848. OJ L 150, 14.11.2020, p.1. 
23 Council Regulation (EC) No 2100/94. OJ L 227, 1.9.1994, p. 1. 
24 Directive 2001/18/EC. OJ L 106, 17.4.2001, p. 1. Regulation (EC) No 1829/2003. OJ L 268, 18.10.2003, p. 1. 
25  COM(2021)118  final  -  The  EU's  digital  strategy  aims  to  make  the  transformation  to  digital  technologies  work  for 
people  and  businesses,  while  helping  to  achieve  its  target  of  a  climate-neutral  Europe  by  2050.  Allowing  the  use  of 
digital technologies will help creating future proof PRM and FRM sectors. 
26  Notably  the  OECD  Seed  Schemes  for  the  Varietal  Certification  of  Seed  (https://www.oecd.org/agriculture/seeds/), 
OECD  Scheme  for  the  Certification  of  Forest  Reproductive  Material  (https://www.oecd.org/agriculture/forest/),  the 
International  Convention  for  the  Protection  of  New  Varieties  of  Plants  (UPOV),  the  International  Rules  for  Seed 
Testing of  the International Seed Testing  Association (ISTA), the United Nations Economic Commission  for Europe 
(UNECE)  Standard  for  Seed  Potatoes,  the  International  Treaty  on  plant  genetic  resources  for  Food  and  Agriculture 
(ITPGRFA). 
27 https://food.ec.europa.eu/horizontal-topics/farm-fork-strategy/legislative-framework_en  

9 

 
 
                                                 
  The  New  Genomic  Techniques  (NGT)  initiative28  concerns  plants  produced  by  genetic 
modification, in particular targeted mutagenesis29 and cisgenesis30. These plants may contribute 
to  the  innovation  and  sustainability  objectives  of  the  EGD  and  of  the  F2F  and  Biodiversity 
strategies.  The  initiative  aims  at  a  proportionate  regulatory  oversight  better  adapted  to  NGTs 
that  combines  high  levels  of  safety  with  clear  benefits  to  society  and  the  environment. 
Coherence will be ensured between the PRM/FRM and NGT initiatives, in particular as regards 
any sustainability aspects (see Annex 5, Section 6). The plant variety registration system of the 
PRM  legislation  applies  to  all  varieties  irrespective  of  the  breeding  technique.  A  variety 
obtained by genetic modification and subject to the provisions of the GMO legislation can only 
be registered and PRM of such variety can only be marketed if this variety complies with the 
requirements  of  the  GMO  legislation31.  The  same  applies  for  FRM  consisting  of  GMOs. 
Varieties  and  FRM  with  NGT  traits32  will  be  treated  under  PRM  and  FRM  legislation  in  the 
same way as all other varieties and FRM regardless of the breeding methodology (conventional 
breeding, NGTs, established genetic modification techniques). 

  The sustainable use of plant protection products (SUR)33 initiative aims to  reduce the use 
and  risk  of  chemical  pesticides.  Current  VCU  rules  (examination  for  resistance  to  plant  pests 
and diseases) and the envisaged measures to extend these (Section 5) contribute to this objective 
of the SUR, as new varieties with increased resistance to plant pests may require less pesticides. 

Legislative context 

The PRM and FRM legislation was first evaluated in 200834. In 2013, the Commission adopted a 
proposal  for  its  revision35  (‘2013  PRM  proposal’)  accompanied  by  an  impact  assessment36.  That 
proposal  was  rejected  by  the  European  Parliament  in  201437  as  according  to  the  European 
Parliament,  one  Regulation  could  not  address  the  requirements  of  the  broad  range  of  PRM  and 
cover  FRM.  The  European  Parliament  also  had  concerns  regarding  the  marketing  to  amateur 
gardeners, the unnecessary burden on operators and NCAs and insufficient biodiversity provisions. 
Subsequently, the proposal was withdrawn by the Commission in 201538. 

Following  a  request  by  the  Council39,  the  Commission  presented  in  2021  a  study  on  the  Union’s 
options  to  update  the  existing  legislation  on  the  production  and  marketing  of  plant  reproductive 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-produced-by-

28 
certain-new-genomic-techniques_en  
29 Targeted mutagenesis is an umbrella term used to describe newer techniques of mutagenesis that induce mutation(s) 
in selected target locations of the genome without insertion of foreign genetic material. 
30  Cisgenesis  means  the  insertion  of  genetic  material  (e.g.  a  gene)  into  a  recipient  organism  from  a  donor  that  is 
sexually compatible (crossable). 
31 Directive 2001/18/EC and Regulation (EC) No 1829/2003. 
32  In  genetics  a  trait  is  a  specific  characteristic.  NGT  traits  are  modified  traits  obtained  by  targeted  mutagenesis  and 
cisgenesis. 
33 COM(2022) 305 final. 
34 FCEC (2008). 
35 COM(2013) 262 final. 
36 SWD(2013)162 final. 
37  European  Parliament  legislative  resolution  of  11  March  2014  (COM(2013)0262  —  C7-0121/2013  — 
2013/0137(COD)). OJ C 378, 9.11.2017, p. 303–303. 
38 Withdrawal of Commission proposals (2015/C 80/08). OJ C 80, 7.3.2015, p. 17–23. 
39 Council Decision (EU) 2019/1905. 

10 

 
 
                                                 
material  (‘PRM  study’)40,  which  was  supported  by  an  external  data  gathering  study41.  In  2022 
another external study42 was undertaken in support of this impact assessment.  

All concerns expressed  by the European Parliament  on the 2013 PRM proposal  are addressed by 
this initiative (Table 1). The context has changed to the degree that the issues identified in 2013 are 
even more actual, e.g. need to modernise the legislation to allow for new technical developments, 
increasing demand for sustainability in agriculture, adaptation to climate change and conservation 
of agro-biodiversity. These issues are also relevant in view of the new political objectives. 

Concerns expressed by the European Parliament on the 
2013 PRM proposal 

Approach taken in this initiative 

“One  size  fits  all”  approach  does  not  meet  the  different 
requirements  of  different  PRM,  operators,  consumers  and 
authorities. 

Two  different  proposals  will  be  adopted,  one  on  PRM 
and  the  other  on  FRM.  The  PRM  proposal  addresses 
crop-specific issues  with separate sections and annexes 
for seeds and for other plant reproductive material. The 
PRM  of  ornamental  plants  will  remain  separately 
regulated by the current Directive 98/56/EC that will be 
kept in place. 

Significant  number  of  delegated  and  implementing  acts 
make it difficult to properly assess the future impact of the 
regulation. 

FRM is a specific sector that should not be covered by the 
same legislation as with other PRM. 

Concerns in relation to PRM for ornamental purposes. 

Concerns  in  relation  to  PRM  intended  for  sale  to  home 
gardeners. 

Empowerments  are  considered  only  where  there  is  the 
need  to  maintain  flexibility  to  adapt  the  technical 
technological 
scientific 
requirements 
developments. 

and 

to 

Measures  on  PRM  and  FRM  have  been  considered 
separately.  There  will  be  two  different  proposals,  one 
on PRM and one on FRM. 
The  PRM  of  ornamental  plants  will  remain  separately 
regulated by the current Directive 98/56/EC that will be 
kept in place. 
Lighter 
to  amateur 
gardeners  have  been  considered,  on  the  basis  on  the 
results  of  the  consultation  while  ensuring  quality  of 
PRM. 

for  marketing 

requirements 

Concerns regarding poor quality of the impact assessment.  The Better Regulation guidelines for the preparation of 

Concerns in relation to extended remit for the CPVO. 

Vague  definitions  and  unnecessary  administrative  burden 
placed on the Member States. 

the impact assessment have been respected. 
CPVO’s role is limited to the extent necessary (audits of 
NCAs on DUS and denomination checks). 
legal  drafting 
Improved 
procedures. 

simplification  of 

and 

40 SWD(2021)90 final. 
41 ICF (2021). 
42 ICF (2023). 

11 

 
 
                                                 
Need  to  facilitate  and  encourage  the  maintenance  of 
biodiversity in agriculture and horticulture. 

A  number  of  new  approaches  (lighter  rules  on 
conservation varieties, new locally adapted varieties and 
heterogeneous  material,  rules  for  organic  varieties 
adjusted  to  the  needs  of  organic  production)  will 
contribute  to  the  conservation  and  sustainable  use  of 
plant  genetic  resources  and  the  increase  of  the  genetic 
diversity of cultivated crops. 

Table 1. Overview of concerns expressed by the European Parliament in 2014 and  approach taken in this initiative to 
address them. 

2. 

 PROBLEM DEFINITION 

2.1.  What are the problems? 

The PRM/FRM legislation has gradually evolved over several decades since the introduction of the 
first  marketing  Directives  in  the  1960s.  The  long  history  of  amendments  has  led  to  a  complex, 
incoherent  and  fragmented  legal  framework  that  is  not  up  to  date  with  the  current  scientific  and 
technical developments. For certain aspects, such as the implementation of derogations and OCs, it 
leaves  too  much  room  for  interpretation,  resulting  in  divergent  implementation  across  MS,  thus 
hindering  the  internal  market.  Furthermore,  the  complexity  and  rigidity  of  the  procedures  puts  a 
high  burden  on  NCAs  and  operators  alike.  The  basic  legislation  includes  detailed  technical 
requirements,  making  it  difficult  to  adapt  the  system  to  new  policy  priorities,  as  well  as  to  new 
developments  in  science  and  technology  and  demands  for  more  sustainable  agri-food  production 
and forestry.  

Figure 1. Problem tree 

12 

 
 
 
 
Development of the problems since 2013: 

The  2008  evaluation  and  the  2013  impact  assessment  already  identified  most  of  these  problems. 
Although  no  full-fledged  evaluation  of  the  PRM  legislation  was  carried  out  after  2008,  two 
evaluative studies were carried out. In 2021, there was an external data gathering study43 supporting 
the PRM study that was requested by the Council and in 2022 another external study44 supporting 
this  impact  assessment.  The  analysis  and  evidence  of  the  existing  problems  was  considered 
comprehensive,  and  the  problems  remain  valid.  The  results  of  the  feedback  received  on  the 
inception impact assessment in 2021, and of extensive consultations activities have confirmed the 
problems and provided further elements to substantiate them.  

However, in comparison to 2008 and 2013 the overall context has changed significantly as the EGD 
and its related strategies have put a stronger focus on sustainability, climate change adaptation and 
biodiversity.  Other related legislation (PHL45, OCR, Organic Regulation46) has  evolved  and there 
have been new scientific and technological developments. Individual Directives have undergone a 
high number of targeted amendments in certain articles to address specific issues and to keep pace 
with  these  developments47.  Furthermore,  seven  out  of  11  Directives  have  been  recast  (Annex  5, 
Section 1). However, the majority of the provisions in the Directives have never been revised in a 
coherent and systematic way. Additionally, MS have adopted their own solutions in relation to new 
developments  not  covered  by  the  legislation48.  These  scattered  approaches  have  exacerbated  the 
problems  of  incoherence  between  the  different  Directives  and  further  increased  their  overall 
complexity. 

2.1.1. 

Problem  1:  Non-harmonised  internal  market  (divergent  conditions  for 
the operators across Member States) 

Implementation  of  various  aspects  of  the  legislation  and  therefore  conditions  for  operators  and 
marketed PRM and FRM differ between Member States (MS), either because the legislation is 
unclear and leaves room for interpretation, or MS tried to find practical solutions to overcome rigid 
provisions and provisions that have not followed in a timely manner new developments in science 
and technology. 

The  provisions  in  the  marketing  Directives  on  OCs49  for  verification  of  compliance  with  the 
requirements of the legislation are quite vague and do not specify minimum requirements50. PRM 

43 ICF (2021). 
44 ICF (2023). 
45  For  example,  under  the  new  PHL  the  plant  passport  covers  compliance  with  the  requirements  for  RNQPs.  It  is 
therefore  no  longer  possible  to  regulate  RNQPs  only  in  the  framework  of  the  PRM/FRM  certification,  a  solution 
considered in the 2013 IA. 
46  The  Organic  Regulation  has  introduced  new  categories  of  “organic  varieties  suitable  for  organic  production”  and 
“organic heterogeneous material” (Annex 5, Section 2.5). 
47 For  example, Commission Implementing Directive  (EU) 2021/971 introduced the use of BMTs in certification but 
only for agricultural plant species. Other uses (e.g. DUS, marketing controls) and other species are not covered by the 
legislation.  Commission  Implementing  Directive  (EU)  2022/1647  and  2022/1648  introduced  derogations  as  regards 
DUS for the acceptance of “organic varieties suitable for organic production” for a few vegetable and agricultural plant 
species but the PRM legislation does not include a comprehensive approach for such varieties 
48 For example, the use of BMTs. 
49 OCs are carried out during the production and marketing of PRM in the EU and the import of PRM/FRM from third 
countries. 

13 

 
 
                                                 
imported from third countries needs to fulfil the same requirements as PRM produced in the Union 
pursuant  to  Union rules,  but  there is  no  harmonised framework for  OCs  establishing  the place of 
those OCs (at the border control post51 or the final point of destination) and the approach (random 
or risk-based OCs). MS have implemented import controls in a different way and as a consequence 
it is easier to import PRM in some MS compared to others. There are also differences between MS 
as regards OCs and enforcement related to marketed PRM and FRM52. All operators are affected 
by those inconsistent and unsystematic controls and enforcement that undermine the functioning of 
a competitive market and increase the likelihood of lower quality PRM and FRM on the market. 

Differences  in  controls  and  enforcement  regarding  Union  regulated  non-quarantine  pests 
(RNQPs)53 have an impact on all operators54 producing and marketing PRM. Those difference arise 
because RNQPs are regulated both under the PHL55 and under the marketing Directives as part of 
the certification requirements (Annex 5, Section 7). Those two frameworks are not fully coherent, 
as  any  amendments  of  PHL  and  the  marketing  Directives  are  not  simultaneous.  Furthermore,  the 
PHL falls under the scope of the OCR56 while the marketing Directives do not. Where measures on 
RNQPs of fruit plants and vine are regulated under the marketing Directives57 while the RNQPs are 
listed  in  the  PHL58,  there  is  uncertainty  as  to  whether  RNQPs  fall  under  the  scope  of  the  OCR 
(Annex  5,  Section  7).  The  OCs  on  the  deliberate  release  into  the  environment  of  Genetically 
Modified Organisms (GMOs) for the purpose of food and feed production falls under the scope of 
OCR and includes the presence of GMOs in PRM. OCs on PRM containing GMOs fall under the 
scope  of  the  OCR  while  the  identity  and  quality  controls  on  that  PRM  in  the  frame  of  the  PRM 
legislation  are  not  under  the OCR. This  results in the doubling of OCs  on the same material  and 
subject to different approaches. This situation leads to uncertainty for all MS and operators about 
which legislation to adhere to59 and consequently to differences in implementation and conditions 
for the operators, that could eventually undermine enforcement and the quality of controls. 

50 See for example Article 19(1) of Council Directive 66/402/EEC. 
51 Border control posts are the places designated by MS for the performance of OCs at first arrival into the Union and 
on each consignment of certain categories of goods (i.e. in contrast to OCs performed at the place of destination). 
52  ICF  (2021)  Section  4.1.6  and  ICF  (2023)  Section  2.1.  For  example,  while  documentary  checks  form  the  largest 
proportion  of  OCs  in  all  MS,  there  is  a  huge  variation  between  MS  as  regards  the  proportion  of  the  inspected 
PRM/FRM  subjected  to  visual  inspections  and  to  sampling  and  testing  (ranging  from  0%  to  100%).  In  relation  to 
import controls there are big differences between MS in relation to the percentage of consignments subjected to official 
controls (ranging from less than 10% to more than 75%).  
53  RNQPs  are  defined  in  Article  36  to  Regulation  (EU)  2016/2031.  The  definition  of  RNQP  includes  the  following 
elements: It has a taxonomic identity. It is present in the Union territory. PRM/FRM is the main pathway for spreading 
of RNQPs. The presence of an RNQP on PRM/FRM has an unacceptable economic impact on the intended use of that 
PRM/FRM.  
54 About 7 000 operators in seed sector and over 20 000 suppliers of PRM of fruit plants across the EU. 
55 Commission Implementing Regulation (EU) 2019/2072. 
56 Article 2, point (g) of Regulation (EU) 2017/625. 
57 This is the case for fruit plants under Commission Implementing Directive 2014/98/EU and Implementing Directive 
2008/90/EC and for vines under Council Directive 68/193/EEC. 
58 Additionally, PHL includes requirements on Quarantine Pests (QPs). 
59 ICF (2021) Section 4.1.5 and targeted survey of NCAs in the context of ICF (2023). 

14 

 
 
                                                                                                                                                                  
The  VCU  examination  for  variety  registration  can  only  be  carried  out  officially,  but  in  order  to 
overcome the limitations in resources60 a few NCAs have introduced their own practices for taking 
into account breeders’ data61, leading to a divergence in the conditions for operators across MS62. 

Absence  of  common  rules  on  recent  scientific  and  technical  developments,  namely  innovative 
production  processes,  bio-molecular  techniques  (BMTs)63  and  digitalisation64,  has  resulted  in 
operators not being able to market certain PRM/FRM produced by innovative processes (e.g. true 
potato seed65, the fruit plants and vine marketing Directives do not include rules for the certification 
of  selected  clones).  For  FRM,  clones  produced  by  in  vitro  propagation  the  current  rules  do  not 
ensure traceability, because the legislation does not require reference to the production place of the 
clones.  As  regards  BMTs,  MS  increasingly  adopt  national  approaches  (Annex  5,  Section  8).  For 
example,  in  Spain  the  use  of  BMTs  is  allowed  as  a  self-standing  tool  for  the  identification  of 
varieties during marketing controls without the need for observing the phenotypic characteristics of 
the varieties during control plot testing66,67. This leads to divergent conditions for operators across 
MS as well as to missed opportunities to increase the efficiency of processes and competitiveness 
of  the  PRM/FRM  sectors68  Furthermore,  the  absence  of  such  rules  at  EU  level  leads  to  the 
divergence  of  the  EU  legislation  from  international  standards  where  such  advances  are  already 
catered  for  (e.g.  International  Union  for  the  Protection  of  New  Varieties  of  Plants  (UPOV)69, 
Organization for Economic Co-operation and Development (OECD) Seed Schemes). 

60  The  examination  for  variety  registration  (DUS  and  VCU  where  applicable,  with  DUS  and  VCU  done  in  parallel) 
depending on the species last at least two years. This period cannot be reduced as these examinations require growing 
the  plants  in  the  field.  Implementation  of  DUS  is  standardised  across  the  MS  (based  on  the  application  of  CPVO 
protocols for CPVR) while for VCU only four general characteristics are laid down. There are also differences between 
the  MS  as  regards  VCU  costs  (attributed  mostly  to  differences  in  wages)  and  duration  of  VCU  (for  a  given  species 
some NCAs may perform VCU 1 year longer than others, difference attributed mostly to the relative importance of the 
species in the given MS), FCEC(2010) and ICF (2021). 
61  Before  submitting  an  application  for  official  registration  of  a  new  variety,  breeders  already  test  that  variety  for  a 
number of desirable characteristics. 
62 Outcome of targeted survey of NCAs in the context of ICF (2023). 
63  BMTs  have  the  potential  to  increase  efficiency  by  shortening  variety  registration  (PRM)  and  provenance  trials 
(FRM). BMTs also have the potential to support marketing controls to check the identity of varieties, by supplementing 
visual inspection and control plot testing in the field. 
64 Currently the legislation implies that labels are physical. Digitalisation has the potential to improve the efficiency and 
integrity of the certification and labelling system and to address the increased risk of fraud in the seed sector caused by 
increasing volumes of seed lots being traded internationally. 
65  The  marketing  Directive  on  seed  potatoes  is  restricted  to  vegetative  propagation  with  potato  tubers  (=  asexual 
reproduction), therefore it does not cover the use of true potato seeds, i.e. botanical seed (= sexual reproduction). The 
legislation on fruit plants and FRM lacks specific provisions for the use of in vitro propagation (process whereby PRM 
and FRM are produced in the laboratory under sterile conditions). 
66  Article  30  to  Real  Decreto  929/1995,  de  9  de  junio,  por  el  que  se  aprueba  el  Reglamento  técnico  de  control  y 
certificación de plantas de vivero de frutales. «BOE» núm. 141, de 14/06/1995.  
67 PLAN NACIONAL DE CONTROL Y CERTIFICACIÓN DE PLANTAS DE VIVERO DE FRUTALES PARA EL 
AÑO 
2017.  MINISTERIO  DE  AGRICULTURA,  ALIMENTACIÓN  Y  MEDIO  AMBIENTE. 
https://www.mapa.gob.es/es/agricultura/temas/medios-de-
produccion/plannacionaldecontrolycertificaciondeplantasdevivero2017_tcm30-552931.pdf  
68 ICF (2021) Section 4.2. 
69 UPOV (2020). 

15 

 
 
                                                 
2.1.2. 

Problem 2: PRM/FRM legislation is  not  aligned with  the objectives of 
the European Green Deal and related strategies 

This  problem  concerns  restrictions  in  relation  to  genetic  diversity  of  PRM/FRM,  insufficient 
sustainability  considerations  and  incomplete  scope  of  the  FRM  legislation.  In  the  case  of  PRM, 
more genetically diverse varieties (e.g. conservation and organic varieties) cannot meet the existing 
legal  requirements  for  variety  registration.  The  activities  of  seed  conservation  networks  and 
exchange  in  kind  of  seed  are  subject  to  the  current  rules  on  variety  registration.  There  is  an 
insufficient supply of high-quality certified FRM due to the increasing demand for FRM for non-
forestry  purposes70.  The  increasing  occurrence  of  extreme  weather  and  disasters  in  combination 
with an insufficient assessment of sustainability  characteristics in the registration of new varieties 
and of FRM put pressure on the stability of yield in the PRM sector and on the supply of suitable 
FRM and thus on the resilience of agri-food production and forestry.  

First, the current variety registration system based on DUS limits the acceptance and therefore the 
access  to  the  market  of  less  uniform  and  more  genetically  diverse  varieties.  Such  varieties  are 
desirable for organic production71 and other low input agricultural systems. They could contribute 
to more diverse agri-food systems, in particular at local level and broaden the genetic reservoir of 
cultivated crops72 but are currently restricted due to the DUS requirements. The demand for organic 
seed in the EU vastly exceeds the supply (though with variations between the different regions and 
crops),  resulting  in  a  high  use  of  derogations  for  untreated  conventional  seeds  despite  that  these 
derogations  are  phased  out  by  2036  under  the  Organic  Regulation.  In  the  absence  of  sufficient 
quantities  of  certified  organic  seed,  the  use  of  untreated  conventional  seed  in  organic  farming 
ranges  between  18%  in  Central  Europe  and  48%  in  Eastern  Europe73.  The  problem  concerns  all 
breeders active in the breeding of organic varieties, since those varieties have difficulties to access 
the market74 as well as the organic farms across the EU. There are about 244 000 farms in the EU 
that  have  some  organic  area,  two-thirds  of  which  are  fully  organic.  In  2018  the  total  area  under 
organic production in the EU was 13 million hectares or 8% of the total utilised agricultural area75. 
The  problem  also  undermines  the  effort  to  reach  the  objective  under  F2F  of  at  least  25%  of  the 
EU’s agricultural land under organic farming by 2030. 

The  variety  registration  system  has  a  restrictive  impact  on  activities  that  are  important  for  the 
conservation  and  sustainable  use  of  plant  genetic  resources  and  help  in  addressing  the 
biodiversity  and  climate  change  challenges.  Seed  conservation  networks76  aim  to  conserve 

70  Non-forestry  purposes  comprise  agroforestry,  plantations  for  biomass  production  and  the  EU  target  of  planting  3 
billion additional trees by 2030. 
71  According  to  the  principles  of  the  Organic  Regulation,  for  the  production  of  organic  varieties  suitable  for  organic 
production, the organic breeding activities shall be conducted under organic conditions and shall focus on enhancement 
of genetic diversity, reliance on natural reproductive ability, as well as agronomic performance, disease resistance and 
adaptation  to  diverse  local  soil  and  climate  conditions.  However,  currently  the  biggest  share  of  PRM  for  organic 
varieties marketed in the EU are varieties accepted under the DUS rules (Euroseeds (2019)), i.e. they are characterised 
by high uniformity contrary to the abovementioned principles. 
72 FAO (1997). 
73 Solfanelli F. et al. (2022). 
74 The number of those breeders in EU is unknown. 
75 Eurostat (2020). 
76 There is no accurate information on the number of such networks in EU, nor on the number of varieties or accessions 
that  they  maintain.  Indicatively,  DIVERSIFOOD  (2017a)  collected  via  a  survey  information  on  80  such  initiatives 

16 

 
 
                                                 
 
threatened varieties77 and prevent genetic erosion78, while for addressing particular local needs new 
locally adapted varieties79 are bred80. However, most often conservation and new locally adapted 
varieties  either do not  meet  the  variety  registration requirements (DUS) or the  quantities of PRM 
are so low that it is unfeasible to benefit from the existing derogations for conservation varieties81. 
Due  to  these  restrictions  the  availability  of  such  varieties  in  the  public  domain  often  relies  on 
exchange in kind of seed82,83, which is currently not possible as it is covered by the definition of 
“marketing” within the Directives84 and therefore requires the fulfilment of variety registration and 
certification  requirements  (Annex  5,  Section  2.2).  Exchange  in  kind  of  seeds  between  farmers  is 
currently  also  restricted  by  these  requirements,  although  an  important  number  of  small  farmers 
across EU save and exchange seed from their harvest, because such seed is better adapted to their 
local  environment  conditions  following  ongoing  on-farm  selection  over  many  years.  Indicatively, 
one  of  the  organisations  advocating  for  a  framework  for  seed  exchange  between  farmers  counts 
over 80 000 members across EU. These restrictions also affect all operators marketing to amateur 
gardeners (Annex 5, Section 2.4) with the vast  majority of PRM  marketed to  amateur  gardeners 
belonging to registered varieties, leaving the demand for locally adapted varieties unsatisfied85. The 
derogations  to  the  rules  for  acceptance  of  varieties  and  certification  of  seeds  for  agricultural  and 
vegetable conservation varieties86 have had some results87 but the requirements are still considered 
too  burdensome88.  Furthermore,  these  derogations  do  not  cater  for  new  locally  adapted  varieties. 
MS currently have the possibility to accept conservation varieties on the basis of an official DUS 
examination, or an official DUS examination with increased tolerance for reduced uniformity or on 
the basis of other information such as historical  knowledge. This leads to different conditions for 
operators  between  the  MS.  For  example,  Czechia  carries  out  DUS,  Spain  carries  out  DUS  but 

across the EU. Most of them manage between 100 to 1 000 samples each. Number of members varies from a few to 
hundreds.  The  survey  also  identified  that  there  are  probably  many  more  initiatives  across  the  EU  than  those  that 
responded.  
77 Conservation can be done in situ at the existing location (i.e. in the farmed environment in the case of cultivated plant 
species and forest genetic resources in forests) or ex situ in gene banks. 
78 Genetic erosion is the loss of genetic diversity between and within populations or varieties of the same species over 
time, or reduction of the genetic basis of a species due to human intervention or environmental change (Article 2(b) of 
Commission Directive 2008/62/EC).  
79  Lack  of  improved  varieties  suitable  for  marginal  areas  led  to  breeding  of  such  varieties,  which  are  typically  quite 
heterogeneous  in  order  to  withstand  particular  conditions.  Usually  bred  under  participatory  plant  breeding,  whereby 
breeders, researchers, farmers and other stakeholders work together.  
80 This is reflected also in the eligible types of intervention in CAP Strategic Plans under Regulation (EU) 2021/2115 
81 Exemption from DUS and certification requirements under Directives 2008/62/EC and 2009/145/EC. See also Annex 
5, Section 2.6. 
82 DIVERSIFOOD (2017b). 
83 Exchange in kind of seed means the transfer of seed from one farmer to another farmer. See also Annex 10 of ICF 
(2023). 
84 Marketing is defined in the Directives as ‘the sale, holding with a view to sale, offer for sale and any disposal, supply 
or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.’ 
85 ICF (2021) Section 4.5. 
86 Conservation varieties according to Commission Directives 2008/62/EC and 2009/145/EC are landraces and varieties 
which  have  been  traditionally  grown  in  particular  localities  and  regions  and  threatened  by  genetic  erosion.  Landrace 
means a set of populations or clones of a plant species which are naturally adapted to the environmental conditions of 
their region.  
87 At the end of 2021, there were 396 conservation varieties of agricultural plant species and 177 of vegetable species 
registered in the Common Catalogues (representing around 1% of the total number of registered varieties).  
88 ICF (2021) Section 4.6. 

17 

 
 
                                                                                                                                                                  
accepts  uniformity  levels  of  90%,  Germany  accepts  a  variety  description  by  applicant  but  carries 
out a DUS examination in case of doubt89. 

Second, the current PRM/FRM rules have only a limited contribution to sustainable production. 
Those provisions are restricted to varieties of agricultural species (VCU)90 in the case of PRM and 
the  higher  FRM  categories91.  Similar  requirements  to  VCU  are  in  place  for  vine  under  the  DUS 
examination92. Currently no such provisions exist for vegetable species and fruit plants. The PRM 
legislation prescribes four broad criteria that must be examined in VCU testing leaving the degree 
to which sustainability is addressed at the discretion of the MS, thus implying that new varieties can 
be registered without improved performance regarding sustainability characteristics93. 

Likewise,  the  FRM  legislation  prescribes  two  broad  sustainability  characteristics  (adaptability  of 
basic  material  to  ecological  conditions,  and  health  and  resistance  of  basic  material  to  adverse 
climatic conditions), leaving room for manoeuvre to MS for their implementation94. Some MS (e.g. 
Estonia,  France,  Finland,  France  and  Germany)  have  invested  in  tree  breeding  programmes  to 
ultimately improve the sustainability of the resulting FRM. Others have paid little attention to this 
aspect95 despite forests being under pressure because of climate change. This situation is inadequate 
for rapidly changing conditions. 

Potentially all farmers and foresters in the EU (over 5 million specialist crop farms and over 500 
000 persons employed in the forestry and logging sector96) are at risk of not having PRM and FRM 
suitable  for  future  challenges  and  subsequently  of  facing  increased  losses  of  production.  The 
consequences  will  be  equally  detrimental  for  the  wider  society  in  terms  of  reduced  food  security 
and  other  indirect  impacts  on  sectors  relying  on  agriculture  and  forestry.  The  magnitude  of  the 
problem  is  already  very  significant.  Over  the  period  1981-2010,  the  average  annual  crop  losses 
caused by drought in the EU have been estimated at EUR 4.8 billion/year97. However, in 2018 and 
2019 in Germany alone extreme drought and heat events have caused losses in agriculture of EUR 
7.8 billion, including direct losses of EUR 4.4 billion across all crops (especially wheat and potato) 
and indirect losses of EUR 3.4 billion. Losses in forestry were EUR 17.8 billion, including losses of 
forestry  companies  of  EUR  8.5  billion,  indirect  costs  of  EUR  2.8  billion  from  CO2  release  from 

89 Information collected by the survey under ICF(2019). 
90 Some sustainability aspects are included in the VCU examination of candidate varieties of agricultural plant species. 
91 Qualified and tested material. 
92 For the purpose of simplicity, the field trials carried out to meet these VCU-like requirements for vine will also be 
referred to as VCU. 
93 Those criteria are currently defined as “1. Yield; 2. Resistance to harmful organisms; 3. Behaviour  with respect to 
factors in the physical environment; 4. Quality characteristics” without any further specification. France has elaborated 
multi-criteria indexes for each plant species with weighting factors for each of the criteria and therefore already cater 
for sustainability  in a holistic manner. Most MS (e.g. Germany and The Netherlands) have simpler systems in place, 
based on yield and pest resistance and include abiotic factors only for certain specific cases. 
94 The targeted survey undertaken by ICF (2023) could only collect indicative data due to a low response rate. About 
55% of forest nurseries assess basic material for sustainability characteristics and more than 55% out of those conduct 
this assessment on a voluntary basis. 
95 72% of basic material available in FOREMATIS is intended for the production of the lower quality FRM categories 
(source-identified and selected material) whereby a minimal effort is undertaken to demonstrate the superiority of the 
FRM in comparison with the efforts undertaken for the qualified and tested categories. 
96 EUROSTAT (2020) 
97 PESETA IV https://joint-research-centre.ec.europa.eu/peseta-projects/jrc-peseta-iv_en 

18 

 
 
                                                 
damaged wood (at EUR 201 per tonne of CO2) and additional indirect damages of EUR 6.5 billion 
along various value chains98. 

Third, the scope of the FRM legislation is incomplete as it is restricted to the production of FRM 
for  forestry  purposes  despite  an  increasing  demand  for  FRM  for  non-forestry  purposes  under  the 
EGD99. Moreover, temporary difficulties in the supply of FRM are increasing because of a higher 
incidence of adverse weather, drought and disasters caused by changing climatic conditions. This 
results in the need for reforestation of damaged parts of the forests. Because of the restricted scope 
of the legislation, the current FRM production levels are insufficient to address the higher demand 
for FRM. In addition, MS have interpreted in a different way the activities100 that are considered as 
forestry purposes101 causing a difference in scope between the national legislations.  This problem 
affects  all  operators  active  in  the  production  and  marketing  of  FRM  because  an  activity  that  is 
within the scope in one MS may be out of the scope of the legislation in another MS. Finally, the 
legislation does not contain clear rules on the information to be provided to users of FRM by the 
nurseries102,  while  such  information  is  necessary  for  sound  decision  making  in  relation  to  tree 
planting103.  Without  prior  access  to  this  information,  users  of  FRM  may  plant  trees  that  are  not 
suited for the regional climatic and ecological conditions in the worst-case scenario. This is likely 
to  result  in  forests  that  are  more  vulnerable  to  drought,  pest  attacks  and  other  disturbances  and 
could in turn have a huge environmental, economic and social impact104. 

2.2.  What are the problem drivers? 

2.2.1. 

Regulatory drivers 

The long history of amendments of the legislation has led to a complex, incoherent and fragmented 
legal  framework  that  is  not  up  to  date  with  the  current  scientific  and  technical  developments. 
Certain provisions, as on OCs, are vague, therefore leaving significant margin for interpretation to 
the MS and resulting in different conditions for operators. Furthermore, there are no legal means of 
ensuring  more  coherent  OCs  and  enforcement  of  the  rules  across  MS105.  The  PRM  and  FRM 
legislation  has  not  been  fully  adjusted  to  the  evolution  of  closely  related  policies  (PHL,  Organic 
Regulation, OCR and SUR). Overlaps between the different policies create uncertainty about how 
to implement the respective provisions, exacerbating the possibilities for different interpretations by 
the MS and subsequently different conditions for operators. 

98 Trenczec J. et al. (2022) 
99 FRM  production for non-forestry purposes  makes up about 10% of FRM  in  most Member States (Section 3.8.6 to 
Analytical summary report targeted survey by ICF (2023)). 
100 Certain MS consider restoration of ecosystems and biodiversity conservation to be forestry purposes while others do 
not. 
101 Position paper submitted by EUFORGEN in reply to public consultation. 
102 ICF (2021) Section 4.7.2. 
103 Mauri et al. (2023) 
104 Schuldt et al. (2020), Hlásny et al. (2021) 
105 With the exception of fruit plants and FRM, the marketing Directives do not contain any provisions for audits of the 
OC systems in MS. 

19 

 
 
                                                 
2.2.2. 

New policy developments 

At the time of its  introduction, the PRM legislation focussed on productivity  and good quality of 
the PRM in order to ensure food security106, while the FRM legislation prioritised the origin of the 
basic  material  and  its  characteristics  suitable  for  forestry  purposes.  The  legislation  however  has 
limited means to address the new challenges in relation to sustainability, climate change adaptation 
and  biodiversity.  This  alignment  is  inadequate,  as  it  does  not  provide  the  appropriate  tools  for 
meeting the commitments made under EGD strategies. Rules for variety registration are not adapted 
to  the  needs  for  less  uniform  varieties  (such  as  the  “organic  varieties  suitable  for  organic 
production” under the Organic Regulation) and new locally adapted varieties. The comprehensive 
scope of the current marketing rules restricts the activities related to conservation and sustainable 
use of plant and forest genetic resources. The scope of the FRM legislation is unfit for the increased 
demand  for  FRM  due  to  climate  change  and  the  objectives  of  the  Biodiversity  Strategy.  The 
PRM/FRM legislation has also diverged from  other related legislation (PHL, Organic Regulation, 
OCR) that has significantly evolved over the last years. 

2.2.3. New developments in science and technology 

Developments in technology and new scientific knowledge lead to new processes of production of 
PRM/FRM.  New solutions are being developed  with  the use of BMTs and digital  tools  that have 
the  potential  to  simplify  and  render  more  efficient  variety  registration,  certification  of  PRM  and 
FRM  and  marketing  controls.  The  PRM  and  FRM  legislation  has  not  kept  pace  with  these 
advances, therefore leading to non-harmonised application of such techniques as  MS increasingly 
adopt national approaches (Annex 5, Section 8).  

2.3.  How likely is the problem to persist? 

In  the  absence  of  EU  action,  the  differences  between  MS  as  regards  the  interpretation  and 
implementation of the existing marketing Directives will persist and are likely to further increase. 
The lack of coherence of the PRM/FRM legislation with the PHL and OCR and resulting burdens 
for  NCAs  and  stakeholders  will  remain,  such  as  the  duplication  of  RNQPs  in  the  marketing 
Directives and the PHL and the uncertainty as regards the OCs on RNQPs. MS will likely continue 
to deploy different solutions, further aggravating the differences of conditions for operators. 

Technical innovations such as digital technologies and BMTs are more likely to be taken up by big 
companies while there is a risk that SMEs would not invest in such technologies if there is no legal 
certainty  around  the  acceptance  of  their  use  (Annex  5,  Section  8)  thus  impacting  the 
competitiveness of the EU industry in relation to other major international players (US, China) and 
in lost opportunities in related innovation and marketing. 

Disproportionate  burdens  for  activities,  such  as  seed  conservation  networks  and  breeding  for 
organic production and locally adapted varieties are likely to be aggravated. Without clarifying the 
rules, such activities will depend on MS decisions to support them, leading to increased uncertainty 
for the stakeholders concerned and a non-level playing field for operators. This situation is likely to 
lead  to  further  loss  of  cultivated  diversity.  Differences  between  MS  related  to  sustainability 

106 See for example the recitals of Directive Council Directive 66/402/EEC. 

20 

 
 
                                                 
characteristics  in  the  examination  of  new  varieties  and  the  approach  for  registering  “organic 
varieties suitable for organic production” are also likely to further increase. 

Activities, such as agroforestry, plantations for biomass production and the EU target of planting 3 
billion additional trees by 2030 are gaining importance under the EGD. Those activities generate an 
increasing  demand  in  supply  of  FRM.  Problems  in  supply  of  appropriate  FRM  are  likely  if  the 
scope of the FRM legislation is not adjusted accordingly. 

Efforts  to  address  the  challenges  around  sustainability,  climate  change  and  biodiversity  will  be 
undermined.  In  the  medium  or  long  term  there  could  likely  be  insufficient  incentives  to  produce 
PRM  and  FRM  that  is  adapted  to  new  climatic  conditions  and  could  contribute  to  sustainable 
production. More frequent extreme weather events (e.g. drought, heavy winds, and flooding) may 
cause  more  regular  difficulties  in  supply  of  PRM  and  FRM.  This  may  in  turn  jeopardise  the 
availability of crops to ensure seed and food security as well as of tree seedlings for multifunctional 
forestry purposes. 

3.  WHY SHOULD THE EU ACT? 

3.1.  Legal basis 

The PRM legislative framework is based on Article 43(2) of the Treaty on the Functioning of the 
European  Union  (TFEU)  implementing  the  Common  Agricultural  Policy.  The  TFEU  qualifies 
agriculture as shared competence between the EU and its MS. All sectors of agricultural activity, as 
well as ancillary activities upstream and downstream, have been largely regulated at EU level. This 
means  that  in  accordance  with  Article  2(2)  TFEU,  legislation  in  the  area  of  agriculture  is 
predominantly a role for the institutions of the EU. The same legal basis should also be used for the 
new act(s) that might be adopted as a result of this initiative.  

3.2. 

Subsidiarity: Necessity of EU action 

The introduction of the EU Directives on the marketing of PRM/FRM has been a major contributor 
to  the  creation  of  the  internal  market.  The  EU  rules  on  marketing  of  PRM/FRM  have  had  a 
generally positive impact on free movement, availability and quality of PRM/FRM107. If there had 
been no action at EU level, 27 systems instead of one would be in place today  thus hindering the 
movement  within  the  internal  market,  distorting  competition  and  increasing  the  financial  burden 
associated  with  registration  of  varieties  and  the  necessary  controls  on  the  identity,  health  and 
quality of PRM/FRM. 

3.3. 

Subsidiarity: Added value of EU action 

Variety  registration  and  certification  and  marketing  of  PRM  and  FRM  rely  on  examinations, 
assessments and inspections performed by NCAs. Their results are valid in all 27 MS and follow 
the  'one  key,  several  doors'  principle.  This  ensures  the  quality  of  EU  PRM  and  FRM  while 
safeguarding open and fair competition on the single market. However, the different interpretation 
and implementation  of the EU rules at  national  level  has caused unequal conditions  for operators 
across MS. This requires a greater harmonisation of the legislation but at the same time  MS need 

107 FCEC(2008), ICF(2021). 

21 

 
 
                                                 
flexibility to adapt the production process and the examination of the characteristics of the plants to 
local agro-ecological conditions and in the case of FRM to environmental and climatic conditions. 

The unrestricted marketing of PRM and FRM throughout the EU territory is imperative to address 
transboundary issues such as the climate and biodiversity crises, the need for sustainable production 
to ensure food security and sustainable afforestation/reforestation to secure multi-functional forests 
for  future  generations.  The  current  geopolitical  situation  and  energy  crisis  have  elevated  the 
importance  of  securing  agricultural  and  food  production.  Under  the  F2F,  EU  Adaptation  and 
Biodiversity  Strategies  several  commitments  were  made  that  necessitate  the  amendment  of  the 
PRM and FRM legislation. Those commitments mirror the demand from society for increased food 
security,  more  sustainable  food  production,  locally  produced  food,  diversification  of  production 
methods  and  multi-functional  forests  (e.g.  timber  production,  biodiversity  conservation,  leisure 
activities). 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

4.1.  General objectives 

The general objective of this initiative is to ensure, for all types of users, PRM and FRM of high 
quality and diversity of choice, adapted to current and future projected climatic conditions that will 
in turn contribute to food security, protection of biodiversity and restoration of forest ecosystems. 
The  availability  and  access  to  varieties  and  basic  material  with  strengthened  sustainability 
characteristics  are  essential  to  improve  sustainability  by  ensuring  the  stability  of  yield  of 
agricultural production and of the productivity of forest ecosystems. 

  To ensure a level playing field for operators across the EU; 
  To support innovation and competitiveness of the EU PRM/FRM industry; 
  To contribute to addressing sustainability, biodiversity and climate-related challenges. 

4.2. 

Specific objectives 

  To increase clarity and coherence of the legal framework through simplified, clarified and 

harmonised basic rules on fundamental principles presented in a modern legal form; 

  To enable the uptake of new scientific and technical developments (in particular, innovative 

production processes, BMTs and digital solutions); 

  To ensure availability of PRM/FRM suitable for future challenges; 
  To support the conservation and sustainable use of plant and forest genetic resources. 
  To harmonise the framework for OCs on PRM/FRM; 
  To improve coherence of PRM/FRM legislation with the PHL. 

22 

 
 
4.3. 

Intervention logic 

Figure 2. Intervention logic 

23 

 
 
 
5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

5.1.  What is the baseline from which options are assessed?  

The  baseline  is  a  “no  policy  change”  scenario,  in  which  the  current  EU  legislation  on  PRM  and 
FRM remains in force as it currently stands, while other policy initiatives (SUR and NGTs) will be 
adopted. As regards PRM, the current VCU requirements provide a basic common framework for 
the sustainability assessment of new varieties of agricultural plant species. For species not subject 
to  VCU  assessment  for  variety  registration  (vegetables  and  fruit  plants),  the  breeding  of  new 
varieties depends only on the priorities set by the breeders and the degree to which they respond to 
market  demands.  Increased  yield,  tolerance  to  pests  and  abiotic  factors  and  other  desirable 
characteristics are in increasingly high demand by farmers, however present only to a certain extent 
in  the  breeding  efforts  of  new  varieties108.  As  regards  FRM,  some  elements  of  sustainability 
assessment are in place only for the highest categories of FRM. Political priorities set by the EGD 
Strategies  (i.e.  F2F,  Biodiversity,  Forest  and  Adaptation)  and  regulatory  developments  (e.g.  the 
initiative for a new regulation on the sustainable use of plant protection products, SUR) for reduced 
use of fertilisers and pesticides also provide an incentive for breeders to develop new varieties that 
are  less  dependent  on  such  inputs  and  are,  therefore,  contributing  to  sustainability  of  agri-food 
systems. The F2F, EU Forest Strategy109 and SUR110 recognise the necessity of introducing relevant 
measures  in  the  PRM/FRM  legislation.  Breeding  of  new  varieties  take  on  average  over  10  years 
depending  on  the  species,  while  the  timeframe  for  FRM  can  be  much  longer111.  Over  the  same 
timeframe,  challenges  as  climate  change  are  projected  to  have  significant  impacts  on  agriculture 
and forestry112.  

Efforts  are  made  to  compensate  impacts  of  climate  change  by  moving  from  south  to  north 
agronomic practices (e.g. introduction or increase of irrigation in areas where it was previously not 
necessary),  varieties  and  species  (e.g.  cultivation  of  sorghum  instead  of  maize  to  compensate  for 
reduced availability of water). However, these solutions are constrained by the new agro-ecological 
conditions  (e.g.  precipitation  rates,  daylight,  soil).  In  forestry  there  are  longer  cycles  (several 
decades) than in agriculture. It is therefore not likely that foresters will change the tree species used 
in  the mid-term  period.  Foresters could consider using the same tree species but  from a different 
provenance (origin). Moving of varieties and species from south to north is not a sufficient solution 
in itself as there will not be enough area as soils are not always suitable for agricultural production 
(e.g. tundra). Targeted breeding  efforts for new  varieties, new species  and selection  for  FRM are 
needed to overcome these constraints in order to be able to successfully move varieties and species 
from south to north, but also for developing new varieties adapted to new conditions in the south. 

The time frame assumed for the dynamic baseline is 10 years and assumes that other relevant EU 
policies  (SUR,  NGTs  and  FSFS)  would  be  implemented.  Even  if  other  initiatives  would  be 

108 For example, https://www.kws.com/corp/en/media-innovation/innovation/breeding-objectives/  
109  F2F  recognises  that  farmers  need  to  have  access  to  a  range  of  quality  seeds  for  plant  varieties  adapted  to  the 
pressures of climate change. The EU Forest Strategy recognises that adapting forests to climate change and restoring 
forests following climate damages will require large quantities of appropriate FRM. 
110 SUR identifies new varieties with increased resistance to pests as one of the means to achieve its objectives. 
111 Some tree species set seed only every decade. Trees can reach 100s of years depending on the species and as such 
are likely to face unpredictable conditions over their lifetime. 
112  Changes  in  temperature  and  precipitation  as  well  as  weather  and  climate  extremes  are  already  influencing  crop 
yields and forest productivity in Europe. The number of extreme events  negatively affecting agriculture in Europe is 
projected to increase. Other climate change effects are increase in plant pests, changing patterns in water availability for 
irrigation, changes in species range and forest composition. EEA (2016) and EEA (2019). 

24 

 
                                                 
successful  in  halting/limiting  greenhouse  gas  emissions,  the  impacts  of  climate  change  would 
persist. Adaptation of new varieties and species and of FRM to those impacts would still be needed. 
In  absence  of  regulatory  changes  for  steering  the  breeding  of  new  varieties  for  characteristics 
necessary to face those challenges, new varieties and FRM would gradually become unsuitable for 
the current and future challenges. A recent assessment suggests that current breeding programmes 
and variety selection practices do not sufficiently prepare for climatic uncertainty and variability113. 
The opportunity to mitigate the impacts of climate change that are already occurring would be lost 
(e.g. on average EUR 4.8 billion/year of crop losses caused by drought in the EU, 4.9% of canopy 
cover  loss  in  Germany  in  2018-2020114).  Similarly,  opportunities  would  be  missed  to  introduce 
varieties with improved disease resistance that could help reduce the use of pesticides. 

The  problems  resulting  from  the  limitation  of  activities  that  can  be  carried  out  under  official 
supervision,  incoherence  and/or  duplications  between  PRM/FRM  legislation  and  PHL,  OCR  and 
the  Organic  Regulation,  the  use  of  innovative  production  processes,  BMTs,  and  digital  solutions 
will  remain.  They  are  expected  to  persist  and  gradually  aggravate,  as  MS  will  continue  to  adopt 
divergent national practices.  

Under the baseline there are no provisions in the EU legislation for the use of innovative production 
processes,  BMTs  and  digital  solutions.  For  this  reason,  an  effort  to  resolve  these  issues  by  EU 
guidelines  would  be  impossible  without  any  revision  of  the  EU  legislation.  The  absence  of  a 
common  EU  framework  will  lead  to  further  divergence  of  conditions  for  operators  across  the 
Union.  In  turn,  the  burdens  for  NCAs  and  operators  are  expected  to  increase,  leading  to  reduced 
competitiveness of the EU PRM and FRM sectors.  Likewise, the clarification and streamlining of 
existing  administrative  procedures  cannot  be  resolved  without  changing  the  legislation.  That 
clarification in most cases concerns the streamlining and/or simplification of procedures across crop 
groups such as the decision-making procedure for regulation/deregulation of species. In Directive 
2008/90/EC on fruit plants, the decision to regulate/deregulate species is based on the Comitology 
procedure while in the Directives on agricultural species the co-decision procedure applies115.  

Experience gained by temporary experiments has shown that certain aspects of the legislation can 
be simplified. For example, the extension of the possibility for operators to carry out  certification 
activities for pre-basic and basic seed of agricultural species has been shown to be equally reliable 
as  official  certification  but  with  reduced  costs  for  the  operators.  However,  permanent 
implementation  of  such  changes  is  not  possible  under  the  baseline  without  a  revision  of  the 
legislation. The legislative framework will furthermore remain cumbersome for activities linked to 
the conservation and sustainable use of plant and forest genetic resources. Currently the Common 
Catalogues contain a small number of conservation varieties116 and no forest genetic resources117. 
The number of conservation varieties of agricultural plant species and  vegetable species added to 
the Common Catalogues every year is negligible. There is no indication that this trend will change 
over the next years under the baseline. 

113 Kahiluoto et al. (2019) 
114 Thonfeld et al. (2022) In the period 2018-2020 4.9% of canopy cover was lost in German forests because of extreme 
drought and tree species unsuitable for the environmental and climatic conditions. 
115  The  list  of  species  can  be  amended  by  comitology  but  at  the  same  time  the  technical  requirements  for  the  new 
species must be introduced in the basic act by co-decision. 
116 Conservation varieties constitute less than 1% of the varieties of agricultural and vegetable species. 
117 The FRM Common Catalogue (https://ec.europa.eu/forematis) does not contain any forest genetic resources due  to 
the cumbersome process for the registration of basic material fit for use as forest genetic resources. 

25 

 
                                                 
Breeding of varieties for  organic production and  low-input agriculture and of varieties adapted to 
local  agro-ecological  conditions  will  remain  under  the  baseline  marginal  activities  because  such 
varieties are often too heterogeneous to meet the uniformity requirements under DUS examination, 
while  they  are  not  covered  by  the  current  derogations  for  conservation  varieties.  Provisions  on 
organic  heterogeneous  material  recently  introduced  by  the  Organic  Regulation  offer  a  partial 
solution  as  the  production  of  this  type  of  material  is  restricted  to  certified  organic  production 
(Annex 5, Section 2.5). 

5.2.  Description of the policy options 

The  options  were  designed  based  on  the  PRM  study,  the  supporting  studies  and  by  reassessing 
elements  of  the  2013  impact  assessment.  The  options  constitute  the  best  options  to  address  the 
problems, albeit to a different extent. Alternative measures have been reviewed but discarded at an 
early stage due to lack of stakeholder support (Section 5.3). There was no reason to design options 
that deregulate the sector as no stakeholder supported it. 

The options share a common set of measures which are the same for all options (Figure 3). Some of 
those common measures are only for PRM and others are only for FRM. There is overall support in 
the  PRM/FRM  sector  for  maintaining  the  current  regulatory  system  and  its  two  basic  pillars  of 
registration  of  varieties/basic  material  and  PRM/FRM  certification.  The  policy  options  have 
therefore been designed from a spectrum of highest flexibility for MS and operators (option 1) to 
one of highest harmonisation with little to no room for individual flexibility (option 3) with option 
2 presenting a balanced approach. The current presentation of the 3 options graded as described in 
terms  of  flexibility/harmonisation  seemed  to  be  the  most  coherent  approach,  especially  given  the 
number of issues to be addressed and taking into account their actual feasibility in relation to the 
interaction with various stakeholders. The design of the policy options considered the priority of the 
F2F  to  address  sustainability  challenges.  Hence,  under  all  options  the  sustainability  requirements 
for the approval of new varieties are strengthened. 

The  flexibility  which  the  MS  need  relates  in  the  first  place  to  their  national  agro-ecological 
conditions. The MS will continue to be exempted from the scope of the legislation for certain crops 
(e.g.  vine  not  growing  in  Nordic  MS).  Variety  testing  including  relevant  variety  characteristics 
needs  to  be  adapted  to  the  climatic  conditions  (e.g.  cold  tolerance  in  the  North  and  drought 
tolerance in  the South)  or the  certification requirement to  combat noxious  weeds (Avena fatua in 
certain MS). 

Under  all  options,  a  transitional  period  will  be  foreseen  to  allow  the  reorientation  of  breeding 
efforts towards varieties with improved sustainability characteristics. The defining elements of the 
options for both PRM and FRM are: 

  Strengthened sustainability requirements; 
  Conservation and sustainable use of plant and forest genetic resources; 
  Official controls; 
  Enable uptake of BMTs, innovative production processes and digital solutions. 

26 

 
Figure 3. Design of options 

27 

 
 
 
5.2.1. 

Measures common to all options 

Apart from the no policy change scenario all 3 options share a core of several common measures 
aimed  at  simplifying  administrative  procedures  and  a  more  flexible  decision-making  process,  as 
this is a problem which affects the efficiency of processes. 

For PRM and FRM legislation: 

  All professional operators to be registered in a single register under the PHL118. 
  All  certification  tasks  are  permitted  under  official  supervision  except  the  issuing  of  the 

official label (PRM) and the Master certificate (FRM). 

  To avoid overlaps with PHL, PRM/FRM legislation will directly refer to PHL for the list of 
RNPQs  and  specific  measures.  Compliance  with  requirements  for  QPs  and  RNQPs  will 
remain a prerequisite for the certification of PRM/FRM. 

For PRM legislation: 

  Simplification of existing administrative procedures: 

-  Decisions for addition of new species in, or removal of species from, the scope of the 
PRM legislation and Decisions on the equivalence to EU rules for third countries will be 
taken by means of tertiary legislation119. 

-  The transfer/notification  of new varieties  from  national  to  the EU Plant Variety Portal 

will be managed by the MS without the need for a Commission Decision120. 

-  Allow  MS  to  decide  themselves  on  permitting  temporarily  the  marketing  of  seed  that 
does not satisfy the requirements in respect of minimum germination, if germination is 
not lower than 15 % than the required germination rate121. 

  The requirements for the registration of organic varieties suitable for organic production 
(Annex  5,  Section  2.5)  will  be  adapted  to  the  specific  needs  of  organic  production,  by 
providing the possibility to deviate from certain DUS requirements as regards uniformity. 
  The rules for conservation varieties are lighter and extended to cover new locally adapted 

varieties (Annex 5, Section 2.6.). 

118 Currently professional operators in the sectors of fruit plants and FRM are obliged to be registered both under the 
marketing Directives and the PHL. 
119  Currently  this  is  already  the  case  for  some  marketing  Directives  for  both  the  addition  of  new  species  and 
equivalence. However, some Directives require that for such decisions the ordinary legislative procedure is followed, 
which is cumbersome and disproportionate compared to the technical nature of the matter. 
120 On the basis of notifications received from MS, the Commission publishes in the Official Journal of the European 
Communities under the titles ‘Common Catalogue of Varieties of Agricultural Plant Species’ and ‘Common Catalogue 
of Varieties of Vegetables Species’ lists of all the varieties of which the seed and propagating material can be marketed 
throughout the EU. The publication of the supplements to the Common Catalogues requires a Commission  Decision. 
This procedure creates unnecessary waiting time until a variety is included in the Common Catalogues and gets access 
to the common market. 
121 Currently MS  wishing to use this derogation have to inform the Commission and the other MS who can make an 
offer to cover the missing supply. If no offers are received, the MS are authorised to allow the marketing of seed with 
lower  germination  rate  by  a  Commission  Decision.  The  procedure  is  disproportionate  as  most  often  there  are  no 
suitable offers. Over the last five years only 5 to 12% of the requested amounts could be covered by seed offered by 
other MS. Around 85% of the requests concern germination 15% or less below the minimum germination as laid down 
in the seed marketing Directives. 

28 

 
 
                                                 
  The  scope  for  heterogeneous  material  is  broadened  beyond  organic  production  (Annex  5, 

Section 2.5.). 

For FRM legislation: 

  The decisions on the equivalence to EU rules for third countries will be taken by means of 

tertiary legislation. 

  The  existing  empowerment  to  define  the  information  to  be  made  available  to 
users/buyers  of  FRM  is  extended  to  explicitly  cover  suitability  of  FRM  for  climatic  and 
ecological conditions. 

5.2.2.  Option 1 - Highest flexibility 

Option 1 gives the highest level of flexibility to MS in relation to enabling the uptake of innovative 
production  processes,  BMTs  and  digital  solutions,  the  sustainability  considerations  in  the 
assessment of new varieties/FRM, OCs and the activities of seed conservation networks, marketing 
to amateur gardeners and exchange in kind of PRM between farmers. 

Common elements for PRM and FRM: 

  The  uptake  of  innovative  production  processes,  BMTs  and  digital  solutions  will  be 
enabled  by  introducing  in  the  PRM/FRM  legal  framework  provisions  allowing  their  use. 
Under option 1, these new possibilities will be implemented by the adoption of guidelines 
based  on  existing  international  standards  but  adjusted  to  the  specificities  of  the  EU 
legislation (Annex 5, Section 8). 

-  The use of BMTs will be clarified by allowing the use in variety registration process to 
speed  up  DUS  testing  and  as  a  supplementary  test  in  PRM/FRM  certification  and 
marketing controls, in those cases where the field inspection and control plot testing are 
inconclusive about the identity of the variety under investigation. 

-  The PRM/FRM legal framework will allow the certification of PRM/FRM produced by 
innovative production processes such as in vitro propagation of clones, true potato seeds 
and seed for the production of PRM of fruit plants and vines. 

-  The PRM/FRM legal framework will  allow the use of digital technologies (e.g. digital 
certificates and digital labels) and digitalisation of the PRM/FRM certification system. 

  Option  1  lays  down  minimum  requirements  for  PRM/FRM  OCs.  Risk  based  OCs  aligned 
with  the  OCR  provisions  will  be  introduced  and  MS  will  be  required  to  prepare  a  multi-
annual  control  plan,  aligned  with  the  principles  of  the  OCR.  However,  all  rules  on  OCs 
remain  in  the  PRM/FRM  legislation.  More  specifically,  requirements  for  OCs  on 
production,  marketing  and  imports  of  PRM/FRM  are  introduced  in  the  PRM/FRM 
legislation (e.g. delegation of OC tasks and multi-annual national control plans) but without 
linking these to the OCR. 

For PRM legislation only: 

  Sustainability considerations in the examination of new varieties are strengthened.  

29 

 
 
 
-  The  current  VCU  examination  for  agricultural  plant  species  and  vine  is  extended  to 
include  characteristics  that  contribute  to  sustainable  production  in  order  to  better  steer 
breeding  efforts  in  this  direction.  The  new  examination  will  be  called  ‘Value  for 
sustainable  cultivation  and  use’  (‘VSCU’).  For  organic  varieties  suitable  for  organic 
production,  it  will  be  required  that  the  VSCU  examination  is  carried  out  under 
conditions adapted to the specific needs of organic production.  

-  A new voluntary approach is adopted for the assessment of new varieties of other crop 
groups (i.e. fruit plants and vegetables) for characteristics that contribute to sustainable 
production. Applicants may submit along with their application for the registration of a 
new  variety  the  results  of  trials  that  they  have  carried  out  themselves.  A  link  to  this 
information is published in the Common Catalogues122. Submission of any information 
is not linked to the acceptance of the varieties. 

  The  activities  of  seed  conservation  networks,  marketing  to  amateur  gardeners  and 
exchange in kind of seed between farmers are exempted from the scope of the legislation 
to stimulate the increase in genetic diversity of PRM. 

For FRM legislation only: 

  “Forestry”/“non-forestry”  purposes  are  defined  but  the  scope  of  the  legislation  remains 
limited to the production of FRM for “forestry” purposes. The FRM legislation only covers 
the  production  for  “forestry  purposes”  to  ensure  the  availability  of  high-quality  FRM  for 
afforestation/reforestation. 

  The  sustainability  requirements  are  extended  to  cover  lower  FRM  categories  (source-
identified and selected material) and guidelines are adopted on sustainability requirements 
for all FRM categories. 

  Empowerment  to authorise MS to  use  FRM  not  fulfilling all  requirements when there are 
temporary difficulties in supply is maintained and supplemented by adoption of guidelines 
on contingency planning in the MS to better prepare for major shortages in supply of FRM 
caused by extreme weather, disasters or any other event. 

  Adoption  of  guidelines  for  the  registration  of  basic  material  for  the  purposes  of 

conservation and sustainable use of forest genetic resources. 

5.2.3. 

Option 2 - Balancing flexibility and harmonisation 

Option 2 balances the need for flexibility with a higher degree of harmonisation to  overcome the 
problems stemming from differences in interpretation. 

Common elements for PRM and FRM: 

  The  uptake  of  innovative  production  processes,  BMTs  and  digital  solutions  will  be 
enabled  by  introducing  in  the  PRM/FRM  legal  framework  provisions  allowing  their  use. 
Under  option  2,  these  new  possibilities  will  be  implemented  by  the  introduction  of  basic 

122 As of beginning of 2023 the Common Catalogues are accessible through a new EU Plant Variety Portal. This will 
allow in the future to include links to MS’s sites where variety descriptions are published. 

30 

 
 
                                                 
principles for the use of innovative production processes, BMTs and digital solutions in 
the legislation (Annex 5, Section 8). 

-  The use of BMTs will be clarified by allowing the use in variety registration process to 
speed  up  DUS  testing  and  as  a  supplementary  test  in  PRM/FRM  certification  and 
marketing controls, in those cases where the field inspection and control plot testing are 
inconclusive about the identity of the variety under investigation. 

-  The PRM/FRM legal framework will allow the certification of PRM/FRM produced by 
innovative production processes such as in vitro propagation of clones, true potato seeds 
and seed for the production of PRM of fruit plants and vines. 

-  The  PRM/FRM  legal  framework  will  contain  rules  on  the  use  of  digital  technologies 
(e.g. digital certificates and digital labels) and foresee the possibility for digitalisation of 
the PRM/FRM certification system. 

  Risk  based  OCs  aligned  with  the  OCR  provisions  will  be  introduced  and  MS  will  be 
required  to  prepare  a  multi-annual  control  plan.  The  OCs  for  PRM/FRM  will  be  brought 
under the scope of the OCR, but with simplified import controls at appropriate places within 
the  EU  to  ensure  a  more  targeted  and  efficient  enforcement  of  existing  rules123.  Specific 
rules for production, marketing and imports will be established through tertiary legislation 
under the OCR. OCR will apply to all OCs in the sector. Article 44(1) to Regulation (EU) 
2017/625 will apply for PRM/FRM import controls, which will be performed at appropriate 
places  within  the  EU124.  The  operator  responsible  for  the  PRM/FRM  consignment  must 
provide the relevant information about that consignment (e.g. quantity of PRM/FRM, type 
of material, category of material,…). OCs in relation to PRM/FRM certification remain in 
the sectoral PRM/FRM legislation. 

For PRM legislation only: 

  Sustainability considerations in the examination of new varieties are strengthened. 

The current VCU examination for agricultural plant species and vine is extended to include 
additional  characteristics  that  contribute  to  sustainable  production  in  order  to  better  steer 
breeding efforts in this direction. The new examination will be called Value for sustainable 
cultivation  and  use  (VSCU).  It  will  also  be  extended  to  new  varieties  of  the  other  crop 
groups (fruit plants and vegetables). 

-  MS  will  have  the  flexibility  to  implement  VSCU  according  to  their  agro-ecological 

conditions. 

-  It  will  be  possible  for  operators  to  conduct  the  VSCU  examination  under  official 

supervision. 

-  MS will be able to collaborate and accept results from MS with similar agro-ecological 

conditions, and/or create shared testing networks. 

123 This approach is in line with Article 44(1) to Regulation (EU) 2017/625 for OCs on animals and goods other than 
those subject to OCs at border control posts. 
124 OJ L 95, 7.4.2017, p. 1 

31 

 
 
                                                 
-  An empowerment will be created to determine the minimum requirements for carrying 
out the VSCU examination and the accepted methodologies for assessing the individual 
VSCU characteristics. 

-  For organic varieties suitable for organic production, it will be required that the VSCU 
examination  is  carried  out  under  conditions  adapted  to  the  specific  needs  of  organic 
production. 

  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 retain  traceability and guarantee a minimum 
level of PRM quality. 

For FRM legislation only: 

  The “forestry” and “non-forestry” purposes are defined and the current scope of legislation 
is extended to increase the FRM quality beyond afforestation/reforestation uses and include 
the production of FRM for specific “non-forestry” purposes. 

  The  sustainability  requirements  are  extended  to  cover  lower  FRM  categories  (source-
identified  and  selected  material).  General  principles  on  the  sustainability  requirements  are 
introduced  in  the  legislation  for  all  FRM  categories,  with  flexibility  for  MS  to  implement 
according to their environmental conditions. 

  The existing empowerment to authorise MS to use FRM not fulfilling all requirements when 
there  are  temporary  difficulties  in  supply  is  supplemented  by  the  introduction  in  the 
legislation of a general requirement for contingency planning by the MS to better prepare 
for major shortages in the supply of FRM caused by extreme weather, disasters or any other 
event. 

  A  derogation  is  introduced  in  the  legislation  for  the  registration  of  basic  material  for  the 

purposes of conservation and sustainable use of forest genetic resources. 

5.2.4. 

Option 3 - Highest harmonisation 

Option  3  would  entail  the  highest  harmonisation  in  order  to  minimise  differences  in  the 
implementation of the legislation. 

Common elements for PRM and FRM: 

  The  uptake  of  innovative  production  processes,  BMTs  and  digital  solutions  will  be 
enabled  by  introducing  in  the  PRM/FRM  legal  framework  provisions  allowing  their  use. 
Under option 3, these new possibilities will be implemented by the introduction of detailed 
and  binding  rules  for  the  use  of  innovative  production  processes,  BMTs  and  digital 
solutions in the legislation (Annex 5, Section 8). 

-  The use of BMTs will be clarified by allowing the use in variety registration process to 
speed  up  DUS  testing  and  as  a  supplementary  test  in  PRM/FRM  certification  and 
marketing controls, in those cases where the field inspection and control plot testing are 
inconclusive about the identity of the variety under investigation. 

-  The PRM/FRM legal framework will allow the certification of PRM/FRM produced by 
innovative production processes such as in vitro propagation of clones, true potato seeds 
and seed for the production of PRM of fruit plants and vines. 

32 

 
 
-  The  PRM/FRM  legal  framework  will  contain  detailed  rules  on  the  use  of  digital 
technologies  (e.g.  digital  certificates  and  digital  labels)  and  the  conditions  for 
digitalisation of the PRM/FRM certification system. 

  Risk  based  OCs  aligned  with  the  OCR  provisions  will  be  introduced  and  MS  will  be 
required  to  prepare  a  multi-annual  control  plan.  The  OCs  for  PRM/FRM  will  be  brought 
under the scope of the OCR, with stricter import controls at border control posts requiring 
special import documentation pursuant to Article 47(1) to Regulation (EU) 2017/625125 to 
strengthen  and  fully  harmonise  enforcement.  Specific  rules  for  production,  marketing  and 
imports will be established through tertiary legislation under the OCR. OCR will  apply to 
all OCs in the sector. For each consignment of PRM/FRM subject to OCs at border control 
posts, the operator responsible for the consignment must complete the relevant part of the 
Common  Health  Entry  Document  (CHED),  providing  the  information  necessary  for  the 
immediate and complete identification of the consignment and its destination. Rules on fees 
will be laid down by MS pursuant to Article 79 of the OCR. 

For PRM legislation only: 

  Sustainability considerations in the examination of new varieties are strengthened. 

The current VCU examination for agricultural plant species and vine is extended to include 
additional  characteristics  that  contribute  to  sustainable  production  in  order  to  better  steer 
breeding efforts in this direction. The new examination will be called Value for sustainable 
cultivation  and  use  (VSCU).  It  will  also  apply  to  new  varieties  of  the  other  crop  groups 
(fruit plants and vegetables). 

In contrast to option 2: 

-  Implementation of the VSCU will be harmonised between the MS. 
-  Detailed  rules  on  accepted  methodologies  for  assessing  the  individual  VSCU 
characteristics  will  be  introduced  and  harmonised  across  MS.  The  VSCU  examination 
would still be conducted in different locations that reflect the different agro-ecological 
conditions  in  each  MS.  However,  this  could  result  in  a  MS  having  to  test  for 
tolerance/resistance  to  plant  pests  that  do  not  occur  in  their  territory.  This  on  the  one 
hand would lead to the highest assurance regarding the variety characteristics but would 
on the other hand also lead to unnecessary costs. 

As under option 2: 

-  It  will  be  possible  for  operators  to  conduct  the  VSCU  examination  under  official 

supervision. 

-  MS will be able to collaborate and accept results from MS with similar agro-ecological 

conditions, and/or create shared testing networks. 

125 OJ L 95, 7.4.2017, p. 1 

33 

 
 
 
                                                 
-  For organic varieties suitable for organic production, it will be required that the VSCU 
examination  is  carried  out  under  conditions  adapted  to  the  specific  needs  of  organic 
production. 

  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 
legislation (See Annex 5, Sections 2.3. and 2.4.) to achieve homogenous rules for all market 
segments. 

For FRM legislation only: 

  The “forestry” and “non-forestry” purposes are defined and the current scope of legislation 
is extended to increase the FRM quality beyond afforestation/reforestation uses and include 
the production of FRM for specific “non-forestry” purposes. 

  The  sustainability  requirements  are  extended  to  cover  lower  FRM  categories  (source-
identified  and  selected  material).  Detailed  and  harmonised  rules  on  sustainability 
requirements for all FRM categories are introduced in the legislation.  

  The existing empowerment to authorise MS to use FRM not fulfilling all requirements when 
there  are  temporary  difficulties  in  supply  is  supplemented  by  the  introduction  in  the 
legislation  of  common  rules  for  contingency  planning  by  the  MS  to  better  prepare  for 
major shortages in supply of FRM caused by extreme weather, disasters or any other event. 
A  derogation  is  introduced  in  the  legislation  for  the  registration  of  basic  material  for  the 
purposes of conservation and sustainable use of forest genetic resources. 

Policy issue 
addressed 

Simplification of 
procedures 

Innovative 
production 
processes, BMTs 
and digitalisation 

Official controls 

Option 1 

Option 2 

Option 3 

 

 

A number of existing 
administrative procedures are 
clarified and simplified 

Permit under official supervision 
all certification tasks except the 
issuing of the official label 
(PRM) and the issuing of the 
master certificate (FRM) 

 

 

A number of existing 
administrative procedures are 
clarified and simplified 

Permit  under  official  supervision 
all  certification  tasks  except  the 
issuing  of 
label 
(PRM)  and  the  issuing  of  the 
master certificate (FRM) 

the  official 

 

 

A number of existing 
administrative procedures are 
clarified and simplified 

Permit  under  official  supervision 
all  certification  tasks  except  the 
issuing  of 
label 
(PRM)  and  the  issuing  of  the 
master certificate (FRM) 

the  official 

[measures common to all options] 

[measures common to all options] 

[measures common to all options] 

 

 

 

The uptake on the use of 
innovative production processes, 
BMTs and digital solutions will 
be enabled by introducing in the 
PRM/FRM legal framework 
provisions allowing their use. 

Adoption of guidelines on 
innovative production processes, 
BMTs and digitalisation 

Harmonisation of OCs on 
production, marketing and 
imports of PRM/FRM without 
links to OCR 

 

 

 

 

The uptake on the use of 
innovative production processes, 
BMTs and digital solutions will 
be enabled by introducing in the 
PRM/FRM legal framework 
provisions allowing their use. 

Introduction of basic rules on 
innovative production processes, 
BMTs and digitalisation and 
creation of empowerments for 
detailing rules according to new 
developments 

Harmonisation of OCs on 
production, marketing and 
imports of PRM/FRM subject to 
the OCR  

Simplified import controls at 
appropriate places 

 

 

 

 

The uptake on the use of 
innovative production processes, 
BMTs and digital solutions will 
be enabled by introducing in the 
PRM/FRM legal framework 
provisions allowing their use. 

Introduction of detailed rules on 
innovative production processes, 
BMTs and digitalisation 

Harmonisation of OCs on 
production, marketing and 
imports of PRM/FRM subject to 
the OCR  

Stricter import controls at border 
control posts requiring special 
import documentation  

34 

 
 
 
 
 
 
 
Policy issue 
addressed 

Plant health 
requirements 

Option 1 

Option 2 

Option 3 

 

 

 

 

The lists of RNQPs and specific 
measures are moved to the PHL 
and PRM/FRM legislation refer 
to them instead of duplicating 
them 

Compliance with requirements 
for QPs and RNQPs remains a 
prerequisite for the certification 
of PRM/FRM through the 
continuation of the current robust 
certification regime 

 

 

The lists of RNQPs and specific 
measures are moved to the PHL 
and PRM/FRM legislation refer 
to them instead of duplicating 
them 

Compliance with requirements 
for QPs and RNQPs remains a 
prerequisite for the certification 
of PRM/FRM through the 
continuation of the current robust 
certification regime 

The lists of RNQPs and specific 
measures are moved to the PHL 
and PRM/FRM legislation refer 
to them instead of duplicating 
them 

Compliance with requirements 
for QPs and RNQPs remains a 
prerequisite for the certification 
of PRM/FRM through the 
continuation of the current robust 
certification regime 

[measures common to all options]  

[measures common to all options] 

[measures common to all options] 

 

 

 

 

 

 

 

Extension of the current VCU 
requirements for agricultural 
plant species and vine to better 
address sustainability 

For all other species, reliance on 
information that applicants 
voluntarily submit along with the 
application for registration of a 
new variety 

For the examination of organic 
varieties DUS and VCU 
requirements are adapted to the 
specific needs of organic 
production 

 

 

 

 

 

 

Extension of the current VCU 
requirements for agricultural 
plant species and vine to better 
address sustainability  

Introduction of these 
requirements for all other crop 
groups (vegetables and fruit 
plants) 

Flexibility for MS to implement 
these requirements according to 
their agro-ecological conditions 

Permit examination of these 
requirements under official 
supervision 

Creation of empowerment to 
adopt rules on accepted 
methodologies for assessing the 
different characteristics 

For the examination of organic 
varieties DUS and VCU 
requirements are adapted to the 
specific needs of organic 
production 

 

 

 

 

 

 

Extension of the current VCU 
requirements for agricultural 
plant species and vine to better 
address sustainability 

Introduction of these 
requirements for all other crop 
groups (vegetables and fruit 
plants) 

Harmonised implementation of 
these requirements. 

Permit examination of these 
requirements under official 
supervision 

Introduction  of  detailed  rules  on 
accepted  methodologies 
for 
assessing 
different 
characteristics  

the 

For the examination of organic 
varieties DUS and VCU 
requirements are adapted to the 
specific needs of organic 
production 

[measure common to all options] 

[measure common to all options] 

[measure common to all options] 

Exemption from the scope of the 
legislation of activities of seed 
conservation networks, marketing 
to amateur gardeners and 
exchange in kind of seed between 
farmers 

Simplification of current rules for 
conservation varieties and 
extension of those rules to cover 
new locally adapted varieties 

Broadened scope for 
heterogeneous material beyond 
organic production 

 

 

 

Subject activities of seed 
conservation networks, marketing 
to amateur gardeners and 
exchange in kind of seed between 
farmers to lighter rules 

Simplification of current rules for 
conservation varieties and 
extension of those rules to cover 
new locally adapted varieties 

Broadened scope for 
heterogeneous material beyond 
organic production 

[measure common to all options] 

[measure common to all options] 

Define  forestry  and  non-forestry 
purposes  but  maintain  current 
scope of FRM legislation 

 

Define forestry and non-forestry 
purposes and extend scope of 
FRM legislation to include the 
production of FRM for specific 
non-forestry purposes 

 

 

 

 

Subject activities of seed 
conservation networks, marketing 
to amateur gardeners and 
exchange in kind of seed between 
farmers to the general 
requirements of the legislation 

Simplification of current rules for 
conservation varieties extension 
of those rules to cover coverage 
by the same rules of new locally 
adapted varieties 

Broadened scope for 
heterogeneous material beyond 
organic production 

[measure common to all options] 

Define forestry and non-forestry 
purposes and extend scope of 
FRM legislation to include the 
production of FRM for specific 
non-forestry purposes 

 

Extend sustainability 
requirements to cover lower FRM 

 

Extend sustainability 
requirements to cover lower FRM 

 

Extend sustainability 
requirements to cover lower FRM 

Assessment of new 
varieties for 
characteristics 
contributing to 
sustainable 
production 

Organic 
production 

Conservation and 
sustainable use of 
plant genetic 
resources 

Scope of the FRM 
legislation 

Assessment of 

35 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Policy issue 
addressed 

FRM for 
characteristics 
contributing to 
sustainable 
production 

Address difficulties 
in supply of 
suitable FRM 

Information to 
FRM users/buyers 

Conservation and 
sustainable use of 
forest genetic 
resources 

 

 

 

Option 1 

Option 2 

Option 3 

categories 

categories  

categories  

 

Adopt guidelines on 
sustainability requirements for all 
FRM categories 

 

Introduce general principles on 
sustainability requirements for all 
FRM categories with flexibility 
for MS to implement according to 
their environmental conditions 

 

Introduce detailed and 
harmonised rules on 
sustainability requirements for all 
FRM categories 

  Maintain the existing 

  Maintain the existing 

empowerment to authorise MS to 
use FRM not fulfilling all 
requirements when there are 
difficulties in supply 

Adopt guidelines on contingency 
planning to ensure availability of 
FRM 

Extend existing empowerment to 
define the information to be made 
available to users/buyers of FRM 
to explicitly cover suitability of 
FRM for climatic and ecological 
conditions 

 

 

empowerment to authorise MS to 
use FRM not fulfilling all 
requirements when there are 
difficulties in supply 

Introduce a general requirement 
for contingency planning in the 
MS to ensure availability of FRM 

Extend existing empowerment to 
define the information to be made 
available to users/buyers of FRM 
to explicitly cover suitability of 
FRM for climatic and ecological 
conditions 

  Maintain 

existing 
the 
empowerment to authorise MS to 
fulfilling  all 
use  FRM  not 
requirements  when 
there  are 
difficulties in supply 

 

 

Introduce common rules on 
contingency planning in the MS 
to ensure availability of FRM 

Extend existing empowerment to 
define the information to be made 
available to users/buyers of FRM 
to explicitly cover suitability of 
FRM for climatic and ecological 
conditions 

[measure common to all options] 

[measure common to all options] 

[measure common to all options] 

Adoption of guidelines for the 
registration of basic material for 
the purposes of conservation of 
forest genetic resources 

 

Introduction of a derogation for 
the registration of basic material 
for the purposes of conservation 
of forest genetic resources 

 

Introduction  of  a  derogation  for 
the  registration  of  basic  material 
for  the  purposes  of  conservation 
of forest genetic resources 

Table 2. Overview of policy options 

5.2.5. 

Stakeholders’ views on policy options 

Stakeholder consultations showed that there is  overall support  in  the PRM sector  for maintaining 
the  current  regulatory  system  and  its  two  basic  pillars  of  variety  registration  (based  on  DUS  and 
where  applicable  VCU)  and  PRM  certification.  NCAs  and  stakeholders,  in  particular  the  seed 
industry,  highlighted  that  the  current  system  works  well  and  that  the  EU  PRM  industry  receives 
international  recognition  for  the  high  quality  of  the  certified  seed.  Likewise,  in  the  FRM  sector 
there is overall support for keeping the existing regulatory system of registration of basic material 
and FRM certification. The majority of NCAs, a business association and an EU trade union called 
for maintaining the current alignment of the EU FRM legislation with the Rules and Regulations of 
the OECD Forest Seed and Planting Scheme. All NCAs and stakeholders emphasised that the FRM 
legislation should remain separate from the PRM legislation. They argued that as forest trees often 
have a life span of over 100 years, some rules that apply to PRM might neither be needed for FRM, 
nor be reasonable to implement due to the difficulty of ensuring consistency over such long periods 
of time. 

As regards PRM, the majority of NCAs and stakeholders is in favour of option 2 with the exception 
of the extension of the assessment of sustainability characteristics to all crop groups including fruit 
plants and vegetables. A few NCAs and stakeholders express a preference for option 3. A number 
of  stakeholder  groups  is  in  favour  of  option  1  as  regards  e.g.  the  exemption  from  the  scope  of 
certain activities. As regards FRM, most NCAs and regional forest authorities, a regional union of 
forest nurseries and an NGO emphasised that MS should have the flexibility to decide which FRM 
is  best  adapted  to  their  regional  climatic  and  ecological  conditions.  For  this  reason,  several 
stakeholders  expressed  preference  for  maintaining  a  Directive  (option  1).  Some  business 
associations and a trade union expressed preference for a full harmonisation of the legislation. 

36 

 
 
 
 
 
NCAs and stakeholders strongly agree with the set of common measures proposed (Section 5.2.1.), 
with  the  exception  of  permitting  certification  tasks  to  be  carried  out  by  operators  under  official 
supervision instead of being carried out directly by the NCAs. Certain stakeholders are concerned 
that  this  will  be  disadvantageous  for  SMEs  that  do  not  have  sufficient  resources  to  carry  out 
certification  tasks  under  official  supervision.  The  new  legislation  will  however  oblige  MS  to 
maintain  official  certification  in  order  to  respond  to  the  needs  of  SMEs.  No  other  alternative 
solutions that would allow simplification of administrative procedures have been identified. 

One  main  objective  of  the  revision  is  to  extend  the  assessment  of  characteristics  contributing  to 
sustainable  agri-food  production.  With  the  exception  respondents  from  business  associations,  a 
majority of NCAs and stakeholders agreed with the need for a set of general sustainability criteria 
that  MS  can  apply  taking  into  account  their  agro-ecological  conditions.  Several  stakeholders 
highlighted  the  difficulties  of  harmonising  VCU  across  MS  (option  3),  the  need  for,  and 
implications  of,  new  sustainability  criteria  as  well  as  suggested  approaches  for  sustainability 
criteria. 

The seed sector’s position as regards agricultural plant species is that the sustainability assessment 
of  new  varieties  can  be  addressed  with  slight  modifications  of  the  current  VCU,  while  available 
information should be used before new obligations and costs are introduced for species other than 
agricultural  plant  species.  The  sector  argues  that  such  information  is  already  available  as  other 
legislation and targets (organic production, reduction of pesticides and fertilisers), climate change 
conditions  and  market  demand  have  been  steering  breeding  towards  the  examination  of  more 
sustainable characteristics. 

Some  stakeholders  call  to  abolish  the  current  VCU  requirement  (and  not  to  introduce  a 
sustainability assessment) for: 

  seed potatoes, using arguments similar to the vegetable sector mentioned above; 
  crops for which there are very few applications for registering new varieties and where the 
current VCU makes it even more difficult for those varieties to reach the market. Moreover, 
they state that NCAs are not in a position to organise the relevant examinations every year. 

The organic sector  calls  for  a specific VCU examination adapted to  organic varieties suitable for 
organic  production.  Moreover,  they  are  of  the  opinion  that  all  new  plant  varieties  should  be 
examined  under  organic  and/or  low  input  conditions.  This  opinion  is  shared  by  some  seed  saver 
organisations. 

Several NGOs and small farmers’ organisations overall reject the principle of VCU assessment of 
new varieties. In their view, this examination guarantees the adaptation of new varieties to certain 
local  and  regional  agro-ecological  conditions  but  not  the  adaptability  of  the  varieties  to  different 
agro-ecological  conditions.  In  their  view,  the  adaptability  of  varieties  is  key  for  the  resilience  of 
agriculture  to  climate  change.  This  approach  is  dealt  with  in  the  options  by  establishing  the 
conditions  for  heterogeneous  material,  organic  varieties  suitable  for  organic  conditions  and  the 
exchange in kind of seed between farmers. 

Stakeholders’  views  differ  regarding  the  measures  proposed  under  the  options  to  facilitate  the 
conservation  and  sustainable  use  of  plant  genetic  resources.  NCAs  and  most  stakeholders  agree 
with  the  common  measure  under  all  options  to  adapt  the  DUS  and  VCU  requirements  for  the 
examination of organic varieties to the specific needs of organic production. The seed sector on the 

37 

 
 
contrary states that organic varieties should comply with the current DUS requirements. NCAs and 
stakeholders  agree  with  lighter  rules  for  conservation  varieties  and  new  locally  adapted  varieties, 
but the seed sector would like to maintain the current restriction related to the local marketing of 
those varieties in their region of origin. Stakeholders’ views are mixed as regards the activities of 
seed  conservation  networks  and  exchange  in  kind  of  seed  between  farmers.  NGOs  and  certain 
academia  favour  an  exemption  of  these  activities  from  the  scope  of  the  legislation.  They  refer  to 
UNDROP  and  the  rights  of  peasants  to  freely  exchange,  multiply  and  sell  seed  In  relation  to 
exchange in kind of seed, the seed sector is concerned that a total exemption could be misused by 
farmers  and  calls  for  a  quantitative  restriction.  As  regards  the  activities  of  seed  conservation 
networks, the seed sector is of the opinion that PRM marketed for the purposes of conserving plant 
genetic resources should be subject to the same rules as organic heterogeneous material. All NCAs 
and stakeholders agree with the broadening of the scope of heterogeneous material beyond organic 
production. 

The  majority  of  NCAs  and  stakeholders  fear  an  increase  in  administrative  burden  upon  the 
inclusion  of  OCs  into  the  scope  of  the  OCR  (options  2  and  3).  Several  NCAs  and  businesses 
recognise  the  divergent  conditions  for  operators  and  marketed  PRM  and  FRM  across  MS.  They 
prefer  for  OCs  to  be  included  into  the  scope  of  the  OCR,  albeit  with  simplified  import  controls 
(option  2).  They  see  the  advantages  of  using  common  IT  applications  for  OCs  such  as  IMSOC. 
Only  a  few  stakeholders  are  in  favour  of  a  full  inclusion  into  the  scope  of  the  OCR  with  stricter 
import controls at border control posts (option 3). 

Most  NCAs  and  stakeholders  including  SMEs  want  to  have  the  possibility  of  using  BMTs  and 
digital  solutions. Some SMEs highlight  a lack of resources for being  able to  invest in  BMTs and 
digitalisation. As regards the use of BMTs some stakeholders agree if their use remains optional in 
addition  to  the  observation  of  the  phenotypic  characteristics.  Others  ask  for  the  use  of  BMTs  as 
self-standing tools for the characterisation of new plant varieties. Most NCAs call for allowing the 
use  of  innovative  production  processes  such  as  the  production  of  hybrid  seed  in  the  fruit  plant 
sector  and  the  use  of  in  vitro  propagation  methods  including  somatic  embryogenesis  to  produce 
PRM and FRM. 

As  regards  FRM,  stakeholders’  views  were  mixed  regarding  the  extension  of  the  scope  of  the 
legislation  to  include  certain  specific  non-forestry  purposes.  About  50%  of  stakeholders  from 
across stakeholder categories believed that the definition of FRM should be clarified in relation to 
the  purposes  for  which  it  is  produced.  Most  stakeholders  felt  that  FRM  production  should  cover 
wood production, afforestation, reforestation, and conservation and sustainable use of forest genetic 
resources. In contrast, 52% believed that tree planting in urban and peri-urban areas and plantations 
for protection purposes (shelter belts against the wind) should not be covered. 

Most  stakeholders  were  favourable  towards  the  assessment  of  sustainability  characteristics  with 
over half of the operators stating that they already assess, either on a voluntary or mandatory basis, 
basic  material  and  FRM  for  characteristics  that  contribute  to  sustainable  afforestation  and 
reforestation. In relation to difficulties in supply, about half of stakeholders from across stakeholder 
groups  recognise  the  need  for  more  long-term  planning  across  the  FRM  supply  chain.  They 
identified  potential  risks  in  the  form  of  using  lower  quality  FRM,  economic  losses  and  the 
increasing need of import. They expect that the demand for FRM will likely increase in the next 20 
years further underlying the importance of security of supply and climatic suitability of FRM. This 
justifies  the  proposed  measures  on  national  contingency  plans  and  better  informing  FRM 
users/buyers about the FRM characteristics. 

38 

 
 
Stakeholders active in the conservation and sustainable use of forest genetic resources declared that 
the  current  FRM  legislation  cannot  address  the  needs  of  this  type  of  FRM.  They  agree  with  the 
introduction of a derogation from the requirements for the registration of basic material (option 2). 

5.3.  Options discarded at an early stage and alternative measures 

No full policy options were discarded at an early stage. Some specific measures however have been 
considered and discarded as unfeasible. Total deregulation is not supported by any stakeholder. To 
a lesser or greater extent all agree that the current system is functional and relevant. Abolishing the 
legislation would lead to different regulatory approaches at MS level with the possibility to threaten 
the principle of the internal market and leading to a lack of transparency of the EU market. 

Different fees may cause different conditions for operators in different MS. An effort was made to 
harmonise fees for variety registration and PRM/FRM certification was proposed in the 2013 PRM 
proposal. It was based on the principle of cost recovery and the exemption of microenterprises but 
did  not  receive  any  support.  The  overall  opinion  was  that  the  PRM/FRM  legislation  should  not 
cover fees, even by the principle of cost recovery, because the cost structures differ between MS, 
the level of salaries being the main difference. 

In  relation  to  FRM,  the  creation  of  a  voluntary  coordination  group  for  collaborative  production, 
pooling and exchange of FRM was considered as an alternative measure to better address potential 
major  shortages  in  the  supply  of  FRM  caused  by  extreme  weather,  disasters  or  any  other  event. 
Stakeholder consultations revealed that the situation differs between MS with  some being largely 
self-sufficient and not yet having experienced any events that have led to shortages. A number of 
respondents from across stakeholder categories informed that difficulties in FRM supply may partly 
be due to a lack of planning and communication across the supply chain. It was therefore decided to 
require that MS prepare national contingency plans. 

Likewise, the creation of a voluntary inventory was considered an alternative measure for providing 
information  to  FRM  users/buyers  about  the  suitability  of  FRM  for  climatic  and  ecological 
conditions. Most respondents from across stakeholder categories were in favour of such a measure, 
but  opinions were  evenly  split  on whether this  voluntary inventory  should be organised  at  EU  or 
national  level.  As  most  stakeholders  fear  that  an  EU  inventory  would  increase  the  administrative 
burden for NCAs and operators, it was opted to make such information available through websites, 
planters’ guides and other appropriate means. 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

Due  to  the  complex  nature  of  the  options,  the  assessment  of  the  impacts  will  be  guided  by  the 
defining  elements  of  the  options126  and  a  further  distinction  between  PRM  and  FRM  before 
assessing the total combined impact of each policy option. The assessment is mainly based on the 
data which was collected for the PRM study127 and through two external supporting studies128. This 
was supplemented by feedback and consultation  with the stakeholders as well as further in-house 

126  Strengthened  sustainability  requirements,  OCs,  conservation  and  sustainable  use  of  plant  and  forest  genetic 
resources and innovation and digitalisation 
127 SWD(2021)90. 
128 ICF(2021) and ICF(2023). 

39 

 
 
                                                 
calculations. While the  outmost  effort was  undertaken to  collect  as much as possible quantitative 
data e.g. by targeted questionnaires, it must be noted that a quantitative assessment of the potential 
economic,  environmental  and  social  impacts  of  each  of  the  retained  options  was  not  always 
possible. This section summarises the main impacts. Details on the methodology, the limitations of 
the available data as well as a detailed assessment of all elements and their economic impacts  are 
available in Section 8 of Annex 4. 

6.1.  Economic impacts 

6.1.1. 

Common measures to policy options 1-3 

For  the  common  measures  of  policy  options  1-3,  the  simplification  of  existing  administrative 
procedures  will  result  in  a  reduction  of  administrative  burdens  for  NCAs  and  operators  (same 
impacts for options 1-3): 

  Professional operators will be required to be registered in a single register under the PHL. 
This measure will not result in new costs as currently professional operators are registered 
either under the marketing Directives, or PHL, or both. Over 20 000 duplicate registrations 
will  be  avoided  and  over  EUR  800  000  annual  savings  in  registration  costs  for  operators 
supplying PRM of fruit plants. Over 4 000 duplicate registrations will be avoided and there 
will be over EUR 237 000 annual savings in registration costs for operators supplying FRM. 
  Electronic  notification  by  MS  to  the  EU  Plant  Variety  Portal  of  on  average  4  000  new 
varieties per year will avoid the handling of those notifications (Commission Decision and 
publication in the Official Journal) and speed up access of those varieties to the EU market 
by  1  to  4  months129.  In  turn,  faster  market  access  will  have  a  positive  impact  on  the 
competitiveness of the EU PRM sector.  

  Allowing  MS  to  authorise  the  temporary  marketing  of  seed  that  does  not  satisfy  the 
requirements  as  regards  the  minimum  germination  rate,  will  avoid  the  handling  by  on 
average  30  notifications  per  year.  The  waiting  time  for  operators  to  use  this  seed  will  be 
reduced by at least 15 days. Such notifications concern 50 000 tonnes of seed or 0.01% of 
the quantity of seed certified annually. 

  Extending  the  possibilities  for  operators  to  carry  out  activities  under  official  supervision 
(PRM  and  FRM)  is  not  expected  to  have  significant  impacts  on  enforcement  costs  for 
NCAs130  (Annex  4,  Section  3).  There  will  be  no  effect  on  the  administrative  burdens  for 
operators as regards certification and variety registration, as the administrative steps remain 
the  same.  The  measure  is  already  applied  by  10  MS  under  temporary  experiments  since 
2012131.  A  permanent  implementation  would  bring  potential  annual  cost  savings  for 
operators of around EUR 1.7 million across the EU (Annex 4, Section 3). 

  The  possibility  to  deviate  from  certain  DUS  requirements  as  regards  uniformity  will  be 
provided for the DUS examination of organic varieties suitable for organic production. The 
breeding  period  of  varieties  compliant  with  reduced  uniformity  requirements  can  be  in 
average  2  years  shorter  than  for  varieties  fully  meeting  the  uniformity  requirements. 

129 There are no data allowing the monetisation of these benefits. 
130 This will require a reallocation of resources of NCAs from official examinations to official supervision and training 
activities. The overall impact is neutral. 
131 Commission Implementing Decisions 2012/340/EU and 2020/1106. 

40 

 
 
                                                 
Operators  making  use  of  this  possibility  will  therefore  access  the  market  faster,  with 
reduced  breeding  costs  and  with  varieties  that  up  to  now  were  restricted  from  the  market 
since  it  was  not  possible  to  register  varieties  not  meeting  the  DUS  requirements.  A  few 
dozen operators across EU are likely to use this option. The number of varieties registered 
under  these  rules  could  be  in  average  100  annually.  Assuming  EUR  50  000  savings  in 
breeding costs per variety, concerned operators may see savings of EUR 5 million annually. 
  The  scope  for  heterogeneous  material  is  broadened  beyond  organic  production.  This 
measure creates a new market segment. Potentially a large number of operators may benefit 
but  the  quantities  of  PRM  concerned  are  expected  to  be  very  limited  and  of  insignificant 
market value132. 

  The rules for conservation varieties  are lighter and extended to  cover new locally adapted 
varieties. This measure creates a new market segment. Operators would benefit from lighter 
procedures  for  access  to  market  (no  DUS/VSCU  requirements  for  variety  registration  and 
no  certification  of  PRM).  The  number  of  operators  concerned  could  be  in  the  range  of 
several  hundreds.  The  number  of  varieties  marketed  under  these  rules  could  be  a  few 
hundred  annually.  However,  the  quantities  of  PRM  concerned  are  expected  to  remain 
limited and below 2% of the market133. The potential market value could be up to EUR 13.3 
billion /year * 2%= EUR 266 million/year. 

6.1.2. 

Strengthened sustainability requirements 

This section examines the potential additional costs and benefits for operators, NCAs and users of 
PRM/FRM due to the inclusion of requirements  for assessment of sustainability characteristics in 
the registration of new plant varieties (PRM) and basic material (FRM).  

Operators 

For the PRM sector, the envisaged measures for strengthening sustainability requirements in VCU 
for  agricultural  plant  species  and  vine  and  for  introducing  sustainability  requirements  in  the 
examination  of  new  varieties  of  other  crops  (vegetables  and  fruit  plants)  will  result  in  additional 
testing costs for operators due to increased fees paid to NCAs for the examination of new varieties 
(Table 3). The additional possibilities under options 2 and 3 for conducting the VSCU examination 
under official supervision and for collaboration between NCAs on these will mitigate the additional 
testing  costs  for  operators.  It  is  assumed,  on  the  basis  of  a  trend  observed  for  certification  under 
official  supervision,  that  44%  of  all  VSCU  examinations  will  be  carried  out  under  official 
supervision. Costs for operators are assumed to be 12% less for carrying out activities under official 
supervision  in  comparison  to  the costs they have under official examinations134. The savings will 
partly  compensate  the  expected  increase  in  the  testing  costs  due  to  strengthened  sustainability 
requirements (Table 3). 

132 Based on the experience  gained by the implementation of the provisions on organic heterogeneous material under 
Regulation (EU) 2018/848. 
133 Based on the experience gained by the temporary experiment providing for certain derogations for the marketing of 
at 
populations 
https://food.ec.europa.eu/system/files/2022-04/prm_temp-exp_pop-exp_en.pdf  
134 Calculated by ICF (2023) on the basis of survey results. 

and  maize.  Final 

species  wheat, 

available 

barley, 

report 

plant 

oats 

the 

of 

41 

 
 
 
                                                 
Baseline  Option 1  Option 2  Option 3 

Increase in variety registration cost for operators 
Agricultural species 
Vegetable species 
Vine 
Fruit plants 
Total annual increase in variety registration costs for operators 
EU27 (million EUR) 
Total annual increase in variety registration costs for operators 
EU27 (million EUR) if 44% of VSCU examinations are carried 
out under official supervision 
Table  3.  Cost  increases  for  operators  for  registration  of  new  varieties  due  to  the  assessment  of  sustainability 
characteristics (for detailed calculations see Annex 4 Section 4).  

9% 
115% 
14% 
110% 
8.39 

6% 
92% 
9% 
101% 
6.75 

6% 
11% 
9% 
9% 
2.45 

0 
0 
0 
0 
0 

7.95 

6.40 

N/A 

0 

It  is  important  to  note that  these testing costs including strengthened sustainability  considerations 
are  negligible  as  they  represent  only  about  1%  of  the  total  cost  for  developing  a  new  plant 
variety135.  The  increased  requirements  for  characteristics  contributing  to  sustainable  production 
could however lead to a reduction of the number of varieties being accepted. For agricultural and 
vegetable species up to about 4 000 varieties less could be made available in the EU market over a 
period  of  10  years  because  of  the  strengthened  sustainability  requirements  (Table  4),  but  this 
system  will  be  necessary  to  avoid  that  varieties  without  improved  characteristics  contributing  to 
sustainable  production  will  enter  the  market.  The  position  of  SMEs  with  a  small  number  of 
applications for new varieties per year could nevertheless be negatively affected in the short term, 
with the need to re-orient investments in varieties with improved sustainability characteristics136. 

Average  number  of  new 
plant  varieties  registered 
per year 

Baseline 

Agricultural plant species 
Vegetable species 
Vine 
Fruit plants 

2 564 
1 384 
41 
39 

Option 1 
Additional 
withdrawal 
and/or 
rejection 
rate 3% 
2 487 
1 342 
40 
38 

Option 2 
Additional 
withdrawal 
and/or 
rejection 
rate 5% 
2 435 
1 315 
39 
37 

Option 3 
Additional 
withdrawal 
and/or 
rejection 
rate 10% 
2 308 
1 246 
37 
35 

Table 4. Average number of new plant varieties registered per year. The baseline is the average number of 
new  plant  varieties  registered  annually  over  the  period  2012-2021  as  retrieved  from  the  Common 
Catalogues.  Details  on  the  assumptions  on  which  the  calculations  are  based  can  be  found  in  Annex  4 
Section 2. 

In the FRM sector, the extension of the assessment of sustainability characteristics is expected to 
lead  to  a  negligible  increase  of  costs  for  operators  under  all  options  1-3  (Table  5)137.  New  basic 

135 Total testing costs in the range of EUR 10 000 and total costs for developing a new variety in the range of 1 000 000 
EUR. This value represents all costs (labour, infrastructure, land etc.) over the 10-12 years needed for the development 
of a new variety.   
136  There  is  no  data  available  on  allowing  estimating  the  magnitude  of  this  impact,  in  particular  because  several 
varieties are being registered without actually being made available on the market by the applicants. 
137  Increased  testing  (inspection)  costs  arise  because  of  the  need  to  assess  more  characteristics  under  all  categories. 
Inspection  of  the  lowest  FRM  category  currently  does  not  include  sustainability  characteristics.  More  characteristics 
will be included in the assessment of higher categories. For all categories it will also be required to indicate for which 
area the FRM is suited/adapted. 

42 

 
 
                                                 
material is on average registered every 5 years and the budget spent by operators on the registration 
of basic material is estimated to be less than 1% of their total revenue138. 

Baseline 

Option 1 

Option 2 

Option 3 

Total 
cost 
annual 
increase for operators 
registration  of 
for 
in 
basic  material 
EU27  

EUR 

0 

3 280 

6 560 

9 841 

Table  5.  Estimated  annual  cost  increase  in  EU27  for  the  registration  of  new  basic  material  due  to  the  extension  of 
assessment of sustainability characteristics of basic material to the lower FRM categories, based on an average of 44 
applications per year. Detailed calculations are available in Annex 4, Section 6. 

Under option 1 non-forestry purposes will be defined in the legislation, however these would not 
be  included  in  the  scope  of  the  legislation.  It  would  be  up  to  MS  which  non-forestry  purposes 
would be included, thus increasing or decreasing the FRM covered by the scope of the legislation 
with a potential increase of testing costs in some MS139. Under options 2 and 3 the extension of the 
scope  of  FRM  legislation  to  include  the  production  of  FRM  for  specific  non-forestry  purposes 
(common measure), will result in an increase in testing costs (for certification) for operators. This 
increase would be more pronounced in those MS where the non-forestry  purposes to be added in 
the  scope  of  the  FRM  legislation  are  currently  not  within  the  scope  of  the  current  national 
legislation140.  While  there  is  insufficient  data  and  evidence  to  allow  an  estimation,  it  is  expected 
that the impacts on all options will be limited141. 

The  measures  contributing  to  sustainable  production  will  not  have  an  impact  on  administrative 
burden for operators, as the administrative requirements for the registration of varieties under the 
PRM legislation and for registration of basic material under the FRM legislation remain the same 
under all options in relation to the baseline. 

NCAs 

The measures will result in additional enforcement costs for the NCAs. In options 1-3 due to the 
introduction of strengthened sustainability characteristics there will be additional costs for carrying 
out the examination of new varieties For agricultural species and vine, there will be no need for 
additional testing stations for VSCU examinations. It will only be necessary to increase the number 
of  characteristics  assessed  during  the  VSCU  examination  in  comparison  to  the  current  VCU 
examination142.  For  new  varieties  of  fruit  plants  and  vegetables,  under  options  2  and  3,  NCAs 

138 Based on the data provided by 2 respondents in the targeted survey by ICF (2023). 
139 By explicitly defining what is a non-forestry purpose, some MS may take out certain non-forestry purposes that are 
currently included in the scope of their legislation. This could even decrease costs but also risks reducing quality. 
140  Indicatively  in  7  out of  11 MS  that  provided data  non-forestry  purposes  are  currently  not  within  the  scope  of  the 
FRM legislation. 
141  Information  collected  by  the  targeted  survey  under  ICF  (2023)  indicates  that  only  10%  of  FRM  produced 
corresponds to non-forestry purposes. 
142 It has not been possible to collect an overview of the situation in all MS as regards the assessment of sustainability 
characteristics  under  the  current  VCU  provisions.  For  example,  France  has  already  included  several  sustainability 

43 

 
 
                                                 
 
will have to increase up to 50% their capacity in areas and staff, including the need for additional 
testing stations. The total annual cost for the NCAs would be in the range of EUR 43 to 98 million 
in options 2 and 3 depending on the percentage of operators that will opt for official supervision. 
The cost for NCAs under option 1 will be insignificant because it does not require an increase in the 
capacity of the existing VCU testing stations (Annex 4, Section 5). 

In the FRM sector, the extension of the assessment of sustainability characteristics is expected to 
lead  to  higher  enforcement  costs  for  NCAs.  These  will  however  be  negligible  for  options  1-3 
because the measure concerns on average only 44 applications per year in EU27 for the registration 
of basic material.  

The  extension  of  the  scope  of  the  FRM  legislation  to  cover  non-forestry  purposes  (not  included 
under option 1, but under options 2 and 3) may result in  some increase of costs for NCAs (up to 
10%-increase in number of applications for certification of FRM143).  

The requirement for MS to prepare national contingency plans aims to ensure the availability of 
FRM in case of major losses due to extreme weather or disasters. MS will have to set up such plan 
once and update it as appropriate in view of evolving conditions. The resulting costs are expected to 
be highest  under option  3, whereby there will be common requirements  on contingency planning 
for  all  MS,  therefore  risking  that  NCAs  will  also  have  to  address  issues  that  are  not  relevant  for 
their  MS.  The  additional  costs  would  be  lowest  under  option  1,  as  it  will  depend  on  the  MS 
decision to prepare a contingency plan (voluntary approach). The  costs in all options are however 
not considered significant as the MS already take similar measures144. 

Users of PRM and FRM 

The  increased  costs  for  operators  (breeders)  caused  by  extension  of  the  sustainability 
requirements in  variety registration (leading to  less varieties reaching the market)  is  expected to 
result in increased prices of PRM for their users (mainly farmers). This is assumed to result in an 
additional increase of the prices of PRM by 1% for option 1, 3% for option 2 and 5% for option 3. 
Assuming other factors influencing the costs of inputs do not change, these additional costs would 
correspond  to  an  increase  of  overall  costs  of  inputs  for  farmers145  below  0.3%  every  year  in  all 
options,  but  would  gradually  reduce  over  the  years  as  breeding  programmes  would  adjust  to  the 
new requirements. Therefore, cascading impacts on the competitiveness of farmers and food prices 
due to the above-mentioned increases in price of PRM are estimated to be marginal. Furthermore, 
the  resulting  varieties  with  improved  characteristics  should  result  in  a  more  stable  agricultural 
output under fluctuating conditions and thus contribute to food security and the competitiveness of 
farmers. The avoided losses of production would compensate for the increased costs of PRM, with 
option  2  resulting  in  a  net  benefit  for  farmers  ranging  between  EUR  221  million  and  2.1 

characteristics  in  the  VCU  examination.  Other  MS  (e.g.  Germany  and  The  Netherlands)  focus  on  yield  and  disease 
resistance/tolerance but are already working towards a more comprehensive assessment of sustainability characteristics. 
143  ICF(2023)  survey  data  showed  that  in  MS  producing  FRM  for  non-forestry  purposes  (e.g.  France,  Germany  and 
Poland) this covers on average up to 10% of all FRM produced. 
144  According  to  information  collected  through  the  interviews  by  ICF  (2023),  Finland  and  Sweden  already  have 
contingency plans in place, while Slovenia and Spain are undertaking efforts to improve contingency planning. 
145  Referred  to  in  Eurostat  as  ‘Intermediate  consumption  in  agriculture’.  It  includes  fertilisers,  pesticides,  seeds  and 
other inputs. 

44 

 
 
                                                                                                                                                                  
billion  annually, option 1 resulting in  a net  benefit  for farmers ranging  between  EUR  177 and 1 
110 million annually and option 3 resulting likely in benefits under an “optimistic” scenario (EUR 
1  198  million  annually)  and  in  negative  balance  (EUR  -201  million  annually)  under  a  more 
“conservative” scenario (Table 6 and Annex 4, Section 5).  

Table  6.  Costs  and  benefits  for  farmers  due  to  strengthened  sustainability  requirements  for  the  acceptance  of  new 
varieties of PRM. Detailed calculations are presented in Annex 4 Section 5. 

As the extension of the assessment of sustainability characteristics and the extension of the scope of 
FRM legislation to include the production of FRM for specific non-forestry purposes is expected to 
lead  to  a  marginal  increase  of  costs  for  operators  and  NCAs  in  the  FRM  sector,  the  impacts  on 
FRM users in terms of price will be negligible. FRM may however experience reduced economic 
losses by using more suitable FRM, but these benefits cannot be quantified146.  

6.1.3. 

Official controls 

Currently there are significant differences between MS as regards the total number and type of OCs 
carried out147. The impact of the harmonisation of OCs will differ between MS depending on their 
current implementation of OCs.  

Operators 

Under  options  1  and  2,  the  harmonisation  of  the  current  requirements148  will  not  introduce  new 
obligations for operators. 

Under options 1 to 3, passing from a combination of random checks and risk-based controls to risk-
based controls will allow OCs to be carried out in a more focussed and efficient way. This will be a 
fairer system in comparison to the baseline, because operators will be subject to OCs depending on 
their  risk  profile.  As  a  result,  individual  operators  could  either  be  subject  to  a  lower  or  higher 

146 ICF(2023). 
147 Described in section 2.1.1. 
148  Import  controls,  marketing  controls  and  production  controls  on  operators  carrying  out  certification  under  official 
supervision.  

45 

Million EUR                         (current 2021 price)Impact  on farms of strengthened sustainability requirements for the acceptance of new varieties of PRMOption 1Option 2Option 3INCREASE IN COSTS13,346Increase in total PRM cost in agriculture (%)1%3%5%(million EUR)133400667Total annual PRM cost in relation to cost of all inputs in agriculture260,168Increase in global cost of inputs in agriculture due to increase in PRM cost(%)0.05%0.15%0.26%BENEFITS248,657Avoided loss in crop output annually (%)0.50%1.00%0.75%(million EU)1,2432,4871,865Balance / optimistic scenariomillion EUR  1,1102,0861,198248,657Avoided loss in crop output annually (%)0.125%0.250%0.188%(million EU)311622466Balance / conservative scenario million EUR  177221-201Total annual PRM cost in agricultureTotal annual crop outputTotal annual crop output 
 
 
                                                 
number of OCs in comparison to the baseline situation, especially when currently OCs are carried 
out only randomly. Consequently, the overall impact on operators will be neutral. 

Under option 3, operators that are importing PRM/FRM into the Union will in addition be required 
to submit special import documentation and be subject to OCs at border control posts. NCAs will 
also  have  increased  costs  under  option  3  for  carrying  out  these  OCs,  which  most  likely  will  be 
transferred to operators in the form of fees. Therefore, those operators who import PRM/FRM into 
the Union will face increased administrative burden and costs (fees). These cannot be calculated as 
there  is  no  information  available  on  the  number  of  operators  and  transactions  concerned.  The 
overall impact under option 3 on operators is considered as moderate negative as not all operators 
are concerned by the OCs on imports. 

NCAs 

Depending  on  the  baseline  situation  per  MS,  under  options  1  to  3  the  harmonisation  of  the 
requirements for  OCs may lead to increased enforcement costs  and administrative burden  for 
NCAs.  Such  costs  will  be  due  to  the  obligations  to  draft  multi-annual  control  plans  and  report 
annually  on  OCs.  There  can  also  be  one-off  costs  linked  to  potential  need  for  reallocation  of 
resources in  order to  adjust to the new requirements  for risk-based OCs. NCAs may also  need to 
increase or decrease the frequencies of OCs. These impacts overall are considered to be neutral for 
the NCAs in total.  

Option 3 however entails additional costs for the NCAs in comparison to options 1 and 2 because 
under option 3 OCs on imports will be carried out at border control posts. This requirement would 
mean that NCAs would have to equip the border control posts with additional staff to carry out the 
sampling  of  imported  PRM/FRM.  There  are  about  500  border  control  posts  across  the  EU 
designated for phytosanitary controls under the PHL. Assuming that these would also be designated 
for  PRM/FRM,  they  would  need  to  be  equipped  by  staff  to  carry  out  sampling  of  imported 
PRM/FRM.  With  1  person  in  average  by  border  control  post  at  EUR  30  000  for  salary,  the  total 
annual  cost  under option 3 for NCAs amounts to EUR 15 million  (not occurring under options 1 
and 2). 

As regards benefits, under options 1 to 3, the introduction of the risk-based approach will lead to 
better focus the OC activities of the NCAs on where most needed, therefore  there will be overall 
efficiency gains. Moreover, options 2 and 3 will provide additional efficiency gains in comparison 
to option 1 due to the inclusion the OCs on PRM/FRM in the scope of the OCR. This will allow the 
use of common IT applications for reporting on  OC149 and for exchanging on fraud matters150, as 
well as opportunities for training (Better Training for Safer Food programme). It will also allow to 
align  the  OCs  on  PRM/FRM  with  those  under  other  legislative  frameworks  already  within  the 

149 IMSOC is the information management system for official controls under the OCR. In COM(2021)786 final on the 
experience  with  the  implementation  of  PHL,  it  is  reported  that  the  use  of  TRACES-NT  (part  of  IMSOC)  can  be 
considered  an  important  improvement  brought  by  the  OCR.  The  functionality  offered  to  notify  non-compliances  at 
import  was  declared  as  effective  by  80%  of  the  respondents.  The  interconnection  with  other  systems,  the  user-
friendliness and the availability of information was also rated positively. 
150 A secure IT system that would allow the exchange between MS of confidential information on fraud matters related 
to  PRM/FRM  is  currently  not  in  place.  Inclusion  in  the  scope  of  OCR  would  allow  for  these  purposes  the  use  of 
iRASSF, that allows secure exchanges on food and feed safety alerts. 

46 

 
 
                                                 
scope of the OCR which might be applicable also to PRM/FRM, as the case may be (PHL, Organic 
Regulation and GMOs)151. Such efficiency gains are not possible under option 1.  

Finally, measures aiming to increase the coherence between the PRM/FRM legislation and the 
PHL is expected to lead to a reduction of administrative burden for operators and enforcement 
costs for NCAs to carry out OCs (Annex 5, Section 7) depending on how the MS distribute the 
competences for PRM/FRM and PHL152. 

6.1.4. 

Conservation  and  sustainable  use  of  plant  and  forest  genetic 
resources 

To  contribute  to  biodiversity  and  increase  the  genetic  diversity  of  PRM  and  FRM,  there  will  be 
adapted rules for activities of seed conservation networks, exchange in kind of seed and marketing 
to amateur gardeners in the PRM sector and for the registration of basic material in the FRM sector.  

Operators and NCAs 

There will be a reduction of administrative burdens under options 1 and 2 for operators involved in 
seed conservation networks, marketing to amateur gardeners and exchange in kind of seed between 
farmers due to the exemption from the scope of the legislation, but given the limited volume of seed 
involved153,  the  absolute  magnitude  of  such  reduction  in  relation  to  the  whole  seed  sector  is  not 
significant. Under option 2 lighter rules still present a reduced administrative burden in comparison 
to  the  baseline.  Those  rules  ensure  a  minimum  level  of  quality  and  traceability  which  would  in 
particular  be  important  for  marketing  to  amateur  gardeners.  They  would  allow  for  the 
documentation and characterisation  of plant  genetic resources,  thus  maximising their contribution 
to more resilient agri-food systems. Under option 3 the administrative burden remains unchanged in 
comparison to the baseline. Finally, it is assumed that mostly SMEs and, in particular small-scale 
local operators, are involved in such activities. They benefit from the exemptions and derogations 
to  be  introduced  for  varieties  marketed  exclusively  to  amateur  gardeners,  conservation  varieties 

151 A report on the experience with the  implementation of PHL (COM(2021) 786 final) sought to collect data on the 
savings  caused  by  simultaneous  controls  on  QPs  and  RNQPs  upon  import  but  the  low  response  rate  did  not  allow 
monetising those savings.  
152 In 12 out of 27 MS the inspections for RNQPs have been delegated to the NCA responsible for PRM certification. 
153 Though the total numbers across the EU are not known, there is no indication that the volumes of PRM distributed 
by seed conservation networks and farmers engaged in exchange in kind of  seed or of PRM  marketed exclusively  to 
amateur gardeners have a significant share of the EU PRM market. Furthermore, most of the PRM marketed to amateur 
gardeners belongs to varieties that are also available for professional operators. Marketing to amateur gardeners can be 
ascertained  only  if  seed  is  marketed  in  small  packages,  which  are  relatively  too  expensive  in  comparison  to  larger 
packages and therefore not used by professional operators. Currently only “vegetable varieties developed for growing 
under particular conditions” are subject to such limitations to the size of packages and can be considered as marketed 
exclusively to amateur gardeners. Such varieties represent less than 5% of the varieties in the Common Catalogue for 
vegetables.  Operators  marketing  varieties  addressed  to  both  professional  users  and  amateur  gardeners  (i.e.  the  vast 
majority of varieties in the market) will not be able to benefit from the reduction of administrative burden under options 
1  and  2  as  regards  marketing  exclusively  to  amateur  gardeners.  It  is  considered  unrealistic  that  for  the  same  variety 
operators would start having separate production lines for PRM to be sold to amateur gardeners and for PRM to be sold 
to professional operators (ICF(2023) Section 5.1.2). 

47 

 
 
                                                 
 
including  locally  adapted  varieties,  organic  varieties  suitable  for  organic  production  and 
heterogeneous material. 

Exempting  the  marketing  of  PRM  to  amateur  gardeners  from  the  scope  of  the  legislation  could 
result  in  a  lower  PRM  quality  and  lead  to  an  increase  of  fraudulent  practices  if  that  PRM  is 
marketed to professional users (option 1). Even though exchange in kind of seed between farmers 
is  considered  to  be  a  marginal  activity  (see  above),  there  could  be  a  potential  negative  economic 
impact  on  seed  companies  if  this  activity  is  exempted  from  the  scope  of  the  PRM  legislation 
(option 1). Such exemption  would also  allow  in  particular  large farms and farmers’  cooperatives 
currently  operating  as  seed  multipliers  to  place  on  the  market  big  quantities  of  seed  without  the 
obligation  to  meet  the  certification  requirements  and  thus  have  an  unfair  competitive  advantage 
over  the  companies  marketing  seed.  There  would  be  a  negative  impact  on  those  companies,  and 
particularly  on  SMEs  that  are  most  likely  to  work  with  non-hybrid  varieties  that  can  be  easily 
multiplied. Under option 2, an overall positive economic impact is expected because  lighter rules 
will prevent fraudulent practices, enhance traceability and ensure a minimum PRM quality. Under 
option 3, benefits are minimal because activities of seed conservation networks, exchange in kind 
of  seed  and  marketing  to  amateur  gardeners  would  be  subject  to  variety  registration  and  PRM 
certification. 

In  the  FRM  sector  there  will  be  no  additional  costs  and  administrative  burden  for  operators 
and NCAs as regards the measures for the purposes of conservation and sustainable use of forest 
genetic  resources  under  option  1.  Options  2  and  3  will  reduce  the  administrative  burden  for 
operators and NCAs because there will be a notification for the purposes of the conservation of 
forest genetic resources instead of a fully-fledged registration process.  

6.1.5. 

Innovation and digitalisation 

Operators and NCAs 

BMTs can be used to speed up the characterisation of new varieties and facilitate identification in 
PRM placed on the market. Digitalisation will improve the efficiency, integrity and traceability of 
the PRM/FRM  certification  and labelling system, making the certification process  more efficient. 
Setting out a framework (implemented either by guidelines in option 1, or common rules in options 
2 and 3) on the use of innovative production processes, BMTs and digital solutions will create legal 
clarity  for  operators  and  NCAs.  It  is  expected  to  encourage  NCAs  and  operators  to  invest  in 
these154, with a positive impact on innovation and research (Annex 5, Section 8). The measures 
under options 1-3 will provide new opportunities but not new obligations. Therefore, there are no 
costs  imposed.  Use  of  these  new  options  however  may  require  investments  in  equipment  and/or 
staff.  Any  investment  is  expected  to  be  recovered  within  few  years  due  to  efficiency  gains  and 
lower costs of operations (Annex 4, Section 7). 

154  Absence  of  such  framework  has  been  evoked  in  replies  to  the  targeted  survey  by  ICF(2023)  as  creating  legal 
uncertainty  for  NCAs  that  prevents  them  from  using  BMTs.  Other  NCAs  reported  that  they  already  use  BMTs  for 
variety  identification  and  official  inspections.  Operators  reported  that  BMTs  are  already  used  for  plant  breeding 
purposes (though this aspect is out of the scope of the PRM legislation), while in the FRM sector some companies have 
specialised in innovative production processes. 

48 

 
 
                                                 
It  is  likely  that  initially  not  all  SMEs  would  be  able  to  benefit  to  the  same  degree  as  larger 
companies from the new opportunities given for the use of innovative production processes, BMTs 
and digital solutions155. Gradual reduction in investment costs and increase in the use of BMTs156 
and  digital  technologies  is  expected  to  quickly  reduce  this  gap.  The  long-term  benefits  would 
anyway outweigh the initial investments. In turn, such investments are expected to reduce costs for 
both NCAs and operators for examinations for variety registration, PRM/FRM certification and 
marketing  controls.  Depending  on  the  activity  they  specialise  in  and  their  current  research  and 
development intensity, some SMEs could be able to benefit from the new options more easily.  

6.1.6. 

SMEs  

Most  of  the  7  000  enterprises  active  in  the  seed  sector  in  the  EU  are  assumed  to  be  SMEs.  As 
regards  PRM  of  fruit  plants,  there  are  over  20  000  suppliers  in  the  EU,  almost  all  of  which  are 
SMEs. As regards FRM, there are over 4 000 suppliers in the EU, almost all of which are SMEs. 
SMEs in the PRM/FRM sectors are very diverse in their activities and the degree of R&D intensity, 
but  there  is  no  comprehensive  information  available  on  the  breakdown  between  the  different 
activities. Some are highly specialised e.g. in  breeding vegetable hybrids for only  a few (or even 
one)  species,  in  organic  varieties,  or  in  rapidly  producing  FRM  clones  through  somatic 
embryogenesis. Others are just multiplying seed. The evidence available for the different activities 
of the SMEs is insufficient for a detailed assessment of the impact of the policy options on those 
SMEs. 

An SME survey was carried out as part of the consultation activities. This confirmed the diversity 
of SMEs’ activities and the variable impact that proposed measures may have on SMEs. The replies 
however  did  not  indicate  that  SMEs  could  be  disproportionately  affected  in  relation  to  larger 
companies by the envisaged measures under the different options. Depending on the activity they 
specialise in and their current R&D intensity, some SMEs could be able to adjust more easily to the 
new  obligations  and  benefit  from  the  new  opportunities.  It  would  be  however  mostly  SMEs  that 
would  benefit  from  the  exemptions  and  derogations  to  be  introduced  for  varieties  marketed 
exclusively to amateur gardeners, conservation varieties including locally adapted varieties, organic 
varieties suitable for organic production and heterogeneous material, as it is mostly SMEs that are 
involved  in  such  activities.  Therefore  option  3  that  is  most  restrictive  in  these  aspects  can  be 
assumed that it provides the least benefits for SMEs. 

6.1.7. 

Competitiveness 

All  options  are  expected  to  improve  the  functioning  of  the  internal  market  by  increasing 
harmonisation and therefore more uniform application of requirements for operators across the EU, 
for both the PRM and FRM sectors. The highest harmonisation would be achieved in option 3 but 
possibly to a counter-productive degree as in option 3 most flexibility for Member States to adjust 
implementation  to  specific  conditions  would  be  lost.  The  policy  options  considered  are  not 

155  Replies  to  the  SME  questionnaire  indicate  that  the  majority  of  SMEs  considers  that  digital  solutions  and  use  of 
BMTs  would  bring  advantages  for  them  but  would  require  additional  investments  in  terms  of  access  to  third-party 
services, additional staff, training and/or infrastructure. A quantification of these investments is not possible. 
156  Costs  are  diminishing  quickly  and  related  technology  becomes  more  accessible,  but  also  improves.  E.g.  cost  of 
genome sequencing from 1980s to today has diminished 1 000 fold, while the potential applications are multiple since 
then. 

49 

 
 
                                                 
expected to have any significant impact on imports and exports of PRM and FRM. PRM and FRM 
imported from third countries is treated in the same way as the material produced in the EU. The 
principle remains that equivalence with EU requirements is given to third countries and imports are 
allowed  if  PRM/FRM  produced  in  third  countries  meet  the  requirements  of  the  EU  legislation. 
Particularly  for  imported  seeds,  these  must  be  of  a  variety  already  accepted  in  the  EU  Common 
catalogues. To be accepted, the variety has to be examined successfully by a MS according to the 
EU variety registration requirements. FRM can be imported from member countries of the OECD 
Forest Seed and Plant Scheme if the seed and planting stock fulfil the conditions set out by the EU 
legislation. PRM and FRM intended for export to  third countries are not  subject  to  the EU rules, 
while  in  all  options  the EU  rules  remain  compatible  to  relevant  international  standards  as  OECD 
Seed  Schemes,  ISTA  and  WTO/SPS.  Overall,  efficiency  gains  from  the  various  measures 
(increased  coherence  with  PHL,  OCR,  a  clearer  framework  for  BMTs,  innovative  production 
processes, digitalisation) will have a positive impact on competitiveness of operators, that will be 
maximised under option 2. 

6.2.  Environmental impacts 

Environmental impacts  

Availability of PRM/FRM suitable to address 
sustainability, climate change and biodiversity 
objectives 

Baseline 

Policy Option 
1 

Policy Option 
2 

Policy Option 
3 

0 

+/- 

++ 

+ 

Conservation and sustainable use of plant and 
forest genetic resources 
Table 7. Environmental impact of PRM/FRM measures 
The  scale  corresponds  to  the  following  scheme:  ++  positive  impact,  +  moderately  positive  impact,  +/- 
inconclusive/uncertain impact, = no significant impact, - moderate negative impact, --significant negative impact. 

+/- 

++ 

+ 

0 

6.2.1. 

Strengthened sustainability requirements  

The  significant  impact  of  rapidly  changing  conditions  highlights  the  importance  of  varieties  with 
improved sustainability characteristics. The positive environmental impact of such varieties may 
also  contribute  to  the  objectives  of  other  policy  initiatives  (F2F,  Biodiversity  Strategy  and 
Adaptation Strategy). Over the period 1981-2010, the average annual crop losses caused by drought 
in the EU have been estimated at EUR 4.8 billion/year157. Drought projections show that the maize 
sector  may  collapse  at  2ºC  of  global  warming  if  there  would  not  be  enough  water  available  for 
irrigation.  In  Europe  grain  maize  is  projected  to  be  the  crop  that  is  most  affected  by  climate 
change158.  Agro-climatic  zones  are  moving  northward  and  it  is  expected  that  this  will  further 
accelerate  under  climate  change159.  As  a  consequence,  crops  may  no  longer  be  suitable  for  the 
changing  agro-climatic  conditions160.  Varieties  with  improved  sustainability  characteristics  (e.g. 
drought tolerance161) would contribute to a more sustainable yield that would in turn contribute to 

157 https://joint-research-centre.ec.europa.eu/peseta-projects/jrc-peseta-iv  
158 Hristov et al. (2020), Toreti et al. (2022). 
159 Ceglar et al. (2019). 
160 Ceglar et al. (2021). 
161 Luo et al. (2019). 

50 

 
 
                                                 
food  security.  Under  option  1,  the  voluntary  approach  for  the  assessment  of  sustainability 
characteristics in vegetables and fruit plants, may result in PRM that is not suited for the local agro-
ecological  conditions.  Under  options  2  and  3,  the  mandatory  assessment  of  sustainability 
characteristics  in  vegetables  and  fruit  plants  and  the  strengthened  sustainability  requirements  of 
agricultural  species  and  vine  will  have  a  positive  environmental  impact.  The  international 
organisation  for  vine  and  wine  recommends  the  development  of  a  specific  examination  of  vine 
varieties  present  in  different  geographic  zones  with  the  aim  to  improve  the  knowledge  about  the 
adaptation  potential  of  vine  varieties162.  They  recognise  the  importance  of  the  conservation  and 
recuperation of genetic resources to develop new vine varieties that may contribute to adaptation to 
climate change. 

Apart from the migration of climate zones, climate change also has an impact on the host range and 
geographical distribution of certain plant pests163. Certain pests may pose a danger for agricultural 
crop protection (e.g. Meloidogyne graminicola on rice) necessitating the EU to impose emergency 
measures164. Varieties with disease resistance / tolerance as a sustainability characteristic will have 
a positive environmental impact and may reduce the need for plant protection products. Varieties 
with strengthened sustainability characteristics may also contribute to the availability of PRM that 
is more suitable for the current and future projected climatic conditions. 

The environmental impact of the strengthened sustainability considerations for FRM is interlinked 
with  the  impacts  of  other  policy  initiatives  (Biodiversity  Strategy,  new  Forest  Strategy  and 
Adaptation Strategy). By the end of the century, climate change will substantially alter the current 
distribution of climatically suitable areas for the majority of European trees165. FRM with improved 
sustainability  characteristics  can  contribute  to  adaptation  and  mitigation  of  the  already  visible 
impact of climate change on forests such as drought, wildfires, increased vulnerability to climate-
driven disturbances166. Strengthened sustainability requirements under options 2 and 3 will increase 
to  the  availability  of  FRM  contributing  to  sustainable  forest  management  and  restoration  of 
healthy forest ecosystems.  

Option 2 overall performs very well in terms of the positive environmental impacts of strengthened 
sustainability requirements in the PRM and FRM sectors. Option 3 shows weaknesses because the 
creation  of  fully  harmonised  conditions  for  MS  will  limit  possibilities  for  adjustments  by  MS  to 
their  own  agro-ecological  and  environmental  conditions,  which  is  a  key  aspect  in  terms  of 
contribution to sustainable agri-food production and forestry. 

The extension of the scope of the FRM legislation to cover non-forestry purposes (options 2 and 
3) will have a positive environmental impact especially in those MS where non-forestry purposes 
are significant167 and currently not within the scope of the legislation. The long-term losses caused 

162 OIV (2021). 
163 IPPC Secretariat. 2021. 
164 Commission Implementing Regulation (EU) 2022/1372. 
165 Mauri et al. (2022). 
166 Schuldt et al. (2020), Büntgen et al. (2021), Müller et al. (2020), Choat B.  et al. (2012), Forzieri G. et al. (2020), 
Forzieri G. et al. (2021). 
167 Spain, Greece, France and Italy have a significant agroforestry cover. 

51 

 
 
                                                 
by  the  planting  of  lower  quality  FRM  would  be  reduced168.  Even  when  FRM  for  non-forestry 
purposes  is  planted  close  to  certified  FRM  there  will  no  longer  be  any  risk  that  it  will  lower  the 
quality  of  the  certified  FRM,  thus  resulting  long-run  impacts  on  the  resilience  of  forests  are 
avoided.  For  all  of  the  above,  evidence  is  insufficient  to  allow  a  quantification  of  the  described 
impacts.  

National  contingency  plans  (options  2  and  3)  should  address  difficulties  in  supply  of  FRM  in  a 
more comprehensive way. National contingency plans will reduce the need for authorising the use 
of  lower  quality  FRM,  which  would  in  turn  help  reduce  canopy  cover  loss  and  contribute  to  the 
creation of resilient forests supporting biodiversity and mitigating climate change. In the absence of 
a  requirement  for  contingency  planning  (option  1),  it  is  less likely  that  MS  will  develop  national 
contingency plans, but some MS have already done so or are in the process of doing so. Therefore, 
under  option  1  the  reduction  of  canopy  cover  loss  would  be  low,  while  under  options  2  and  3  it 
would  be  high.  Difficulties  in  supply  of  FRM  combined  with  the  use  of  lower  quality  FRM  can 
result  in  delayed  planting  and  have  a  negative  impact  on  the  resilience  of  forests  and  could 
ultimately result in a loss of 5% of the total canopy cover169.  

More  and  better  information  on  the  suitability  of  FRM  for  current  and  future  climatic  conditions 
under  all  policy  options  will  have  a  positive  environmental  impact  through  the  selection  of  the 
right tree for the right place and thus support the resilience of future forests. It would also benefit 
users  of  FRM.  Access  to  information  about  FRM  characteristics  would  allow  users  to  select  the 
most  appropriate  FRM  and  reduce  economic  damage  caused  by  the  use  of  unsuitable  FRM. 
Indicatively, incidences of entire forests disappearing due to bark beetle infestations caused by the 
planting of monocultures of unsuitable tree species susceptible to bark beetles could be reduced170. 

In  the  PRM  and  FRM  sectors  innovative  production  processes  also  offer  big  potential  for 
addressing  new  demands  as  regards  sustainability  and  environmental  objectives171.  Positive 
impacts  are  expected  to  be  maximised  in  option  2,  under  which  general  legal  provisions  will 
provide  a  common  framework  that  is  on  the  one  hand  reliable  and  on  the  other  hand  flexible 
enough.  Under  option  1  (guidelines)  there  is  a  risk  that  the  rules  will  be  fragmented  and 
requirements  for  operators  will  continue  to  differ  across  MS,  with  less  environmental  benefits. 
Under option 3 (more detailed rules) there is a risk that the legislation will be too prescriptive and 
become outdated very soon in  light  of new technical  and scientific developments, thus  nullifying 
initial benefits. 

168 In the 9 MS that provided data in the targeted survey, on average 10% of the FRM produced is used for non-forestry 
purposes. 
169 Thonfeld et al. (2022) In the period 2018-2020 4.9% of canopy cover was lost in German forests because of extreme 
drought and tree species unsuitable for the environmental and climatic conditions. 
170 Hlásny et al. (2021). 
171  For  example,  true  potato  seed  has  great  potential  for  genetic  gains  in  potato  breeding.  In  vitro  propagation  can 
contribute  to  increasing  the  production  capacity  and  therefore  meet  the  increasing  demand  for  FRM.  Some  MS  are 
exploring the use of new production processes to produce large quantities of FRM in a fast way. See for example Wu 
(2019) and Rosvall (2019).  

52 

 
 
                                                 
6.2.2. 

Conservation  and  sustainable  use  of  plant  and  forest  genetic 
resources 

Measures  to  conserve the genetic diversity of  plant  and forest  genetic resources will alleviate the 
pressure on agricultural production and forests caused by increased exposure to biotic and abiotic 
factors.  Genetically  diverse  PRM  and  FRM  will  have  a  positive  environmental  impact  on  the 
resilience against extreme weather conditions and disasters. 

For  PRM,  lighter  rules  for  the  activities  of  seed  conservation  networks,  marketing  to  amateur 
gardeners and exchange in kind of seed will also lead to increased genetic diversity of cultivated 
crops and contribute to the conservation and sustainable use of plant genetic resources. Genetic 
diversity of cultivated crops in turn can have benefits for resilience to a number of pressures (e.g. 
climate change, plant pests). Genetic diversity is also essential for future breeding efforts to develop 
new improved varieties172. A total exemption from the scope of the legislation (option 1) may cause 
loss of genetic diversity due to a lack of identification and traceability of the PRM concerned while 
the  procedures  in  option  3  would  be  too  cumbersome.  Option  2  offers  the  best  solution  for 
safeguarding genetic diversity as it introduces light rules ensuring the identification and traceability 
of the PRM concerned. 

In  the  FRM  sector  the  environmental  benefits  regarding  lighter  rules  for  the  registration  of  basic 
material  will  be  marginal  under  option  1  since  the  effect  of  guidelines  will  be  limited  without 
changes  in  the  requirements  for  the  registration.  By  enabling  the  diversity  of  forest  genetic 
resources, policy options 2 and 3 will have a positive environmental impact on biodiversity and 
adaptation  to  climate  change.  Policy  option  2  will  provide  the  strongest  incentive  as  it  allows 
operators  to  notify  basic  material  instead  of  going  through  the  official  registration  procedure 
requiring verification by the NCAs. EU forests are fragile because currently, 32.8% of EU forests 
have a single tree species, 49.5% have 2 to 3 tree species, 13.1% have 4-5 species and only 4.6% of 
forests  have  more  than  6  tree  species173.  The  measures  under  option  2  will  ensure  and  conserve 
greater genetic diversity  within a single tree species.  It  is  estimated that the loss of canopy cover 
caused by the planting of a single tree species could be reduced by 5%. 

6.2.3. 

Common  measures  for  PRM  to  contribute  to  sustainability, 
biodiversity and climate-related challenges 

A  number  of  common  measures  under  all  options  will  have  a  positive  environmental  impact. 
Adapted  rules  on  organic  varieties  suitable  for  organic  production  will  contribute  to  the  target  of 
having  25%  of  agricultural  production  under  organic  conditions  pursuant  to  the  goals  of  F2F, 
therefore indirectly contributing to reduced use of inputs in agriculture. Simplified requirements for 
marketing of conservation varieties, extension of these requirements to cover new locally adapted 
varieties and broadening the scope of heterogeneous material beyond organic production will also 
reduce the administrative burdens for the operators concerned, but again not significantly in relation 

172 Genetic diversity is crucial as it allows for the adaptability and resilience of the cultivated plants to climate change 
and  other  pressures.  It  is  also  necessary  for  breeding  new  varieties,  as  it  provides  for  a  pool  of  genes  out  of  which 
breeders select according to new needs and challenges. 
173 https://foresteurope.org/wp-content/uploads/2016/08/SoEF_2020.pdf  

53 

 
 
                                                 
to the whole sector174 . Finally, it would be mostly SMEs that would benefit from such derogations, 
as it is assumed that mostly SMEs and small local actors are involved in such activities. 

6.3. 

Social impacts 

Under all options, lighter rules for conservation varieties and their extension  to cover new locally 
adapted varieties have the potential to create a new market segment. Several hundreds of operators 
in rural areas could benefit from employment opportunities and a market that could reach an annual 
value of EUR 266 million annually. Also the exemption from the scope (option 1) or lighter rules 
(option 2) for activities of seed conservation networks, marketing exclusively to amateur gardeners 
and  exchange  in  kind  of  seed  between  farmers  are  expected  to  have  a  positive  impact  on 
employment in  rural  areas,  both  in  relation  to  SMEs in  the PRM  sector marketing these varieties 
and  to  the  development  of  local  value  chains175.  Under  all  options,  the  harmonisation  of  OCs, 
measures to improve the coherence with the PHL and extension of the activities that can be carried 
out  under  official  supervision  will  have  marginal/neutral  impacts  on  employment.  This  would  be 
restricted to reallocation of staff within the NCAs. 

6.4. 

Sustainability 

The  introduction  of  strengthened  sustainability  considerations  in  the  examination  of  new 
varieties will support food security176, since better adapted varieties – future proof varieties - will 
result  in  more  stable  yields.  Similar  contributions  are  expected  due  to  the  availability  of  organic 
varieties suitable for organic production and new locally adapted varieties. Availability of seed of 
such  varieties  will  result  in  more  stable  agricultural  production  and  ultimately  food  availability. 
Finally,  measures  to  support  the  conservation  and  sustainable  use  of  plant  genetic  resources  also 
contribute to sustainability by maintaining a broad genetic pool that is necessary for the breeding of 
improved varieties in the future. Currently food security in the short term is not an issue. However, 
the sustainability and resilience of the food system should be reinforced to ensure food security in 
the long term. The increasing frequency of extreme weather events will have a negative impact on 
agricultural production and risks increasing the number of pest outbreaks while all these events will 
potentially have an impact on food affordability177. 

Under option 1, the reinforcement of sustainability requirements would be restricted to agricultural 
crops and vine and would not contribute comprehensively to sustainability  of food systems. Even 
though  this  would  have  low  economic  costs  in  the  short  term,  there  will  be  a  potential  negative 
economic impact in the long term. The environmental benefits would be limited because other crop 
groups  (vegetable  species  and  fruit  plants)  would  not  be  addressed.  In  the  mid  to  long  term  this 
would  lead  to  increased  crop  losses  and  a  negative  impact  on  society  because  of  expected 
fluctuations  in  food  availability  and  food  prices.  Option  2  would  reinforce  sustainability 
requirements  also  in  vegetable  species  and  fruit  plants.  The  overall  benefits  in  terms  of 

174 Indicatively, in France locally adapted varieties of wheat represent 1% of volume.  
175 Conservation and locally adapted varieties are often linked to local food chains, e.g. wheat for local bakeries. See for 
example  the  final  report  on  the  Temporary  experiment  providing  for  certain  derogations  for  the  marketing  of 
populations 
2014/150/EU) 
barley, 
https://food.ec.europa.eu/system/files/2022-04/prm_temp-exp_pop-exp_en.pdf    
176 FAO recognises the role of improved varieties for food security globally. 
177 SWD(2023) 4 final. 

species  wheat, 

and  maize 

(Decision 

plant 

oats 

the 

of 

54 

 
 
                                                 
sustainability would be positive. In the mid to long term crop yields would remain more stable and 
have a positive impact on society because of more stable food availability  and food prices. Under 
option  3,  the  overall  benefits  in  terms  of  sustainability  would  still  be  positive  but  limited  by  the 
reduced possibilities to adapt to local agro-ecological conditions. 

The  impact  of  climate  change  is  already  visible  in  the  forest  sector.  Extreme  weather  events  and 
disasters  are  becoming  more  frequent.  Vegetation  zones  are  moving  fast  and  without  a  policy 
change, forests will not  be able to  cope with this178. As a result, forests will increasingly become 
poorly  adapted  to  the  changing  climatic  conditions.  Large  parts  of  forests  will  be  increasingly 
destroyed by drought, storms, floodings, forest fires and heat while insufficient and poorly adapted 
FRM will be available for reforestation of the damaged forests. In the FRM sector, the measures to 
assess  sustainability  characteristics  of  basic  material  and  the  establishment  of  national 
contingency plans (options 2 and 3) will contribute to sustainable afforestation and reforestation. 
This will in turn result in more resilient forest ecosystems and contribute to forests that are better 
adapted  to  climate  change.  Similar  positive  contributions  are  expected  from  the  obligation  to 
provide information on FRM to users/buyers. Extending the scope of the legislation to non-forestry 
purposes  will  have  a  long-term  positive  environmental  impact  by  avoiding  failure  of  forest 
ecosystems  (options  2  and  3).  Measures  on  forest  genetic  resources  will  increase  the  genetic 
diversity of FRM and therefore also contribute to more resilient forest ecosystems  (options 2 and 
3). Given the uncertainty  around the  future projected climatic conditions  and the time needed for 
the creation of new forests, it is important to ensure sustainable afforestation  and reforestation by 
planting  high-quality  climate-adapted  and  genetically  diverse  FRM.  This  will  ultimately  result  in 
resilient forest ecosystems that may withstand the pressures of climate change. 

Under option 1, voluntary guidelines on the assessment of sustainability characteristics may result 
in improperly assessed FRM reaching the market. If non-forestry purposes would not be included in 
the scope of the legislation low-quality FRM may be planted close to high-quality certified FRM. In 
spite  of  their  low  economic  impact  in  the  short  term,  there  would  be  a  significant  negative 
environmental  impact  in  the  long  term  (e.g.  forests  susceptible  to  pests  or  other  environmental 
pressures). Under options 2 and 3, measures on the assessment of sustainability characteristics and 
the  extension  of  the  legislation  to  cover  non-forestry  purposes  would  have  a  slightly  higher 
economic impact. Already in the mid-term the benefits would outweigh the initial costs by avoiding 
forest losses caused by the planting of low-quality and improperly assessed FRM. In the long-term 
forest ecosystems would become more resilient and less vulnerable to climate-driven disturbances. 
Under option 2 the benefit in terms of sustainability and contribution to genetic diversity would be 
positive  while  under  option  3  those  benefits,  while  still  positive,  would  be  more  limited  by  the 
reduced possibilities for MS to adapt to their specific environmental conditions. 

6.5.  Global combined impact of the policy options 

Option  1  presents  low  economic  costs  for  operators  and  NCAs  but  also  low  benefits  due  to 
strengthened  sustainability  requirements.  The  increase  in  costs  would  be  insignificant  as  few 
adjustments would be required both for operators and NCAs. However, the voluntary nature of the 
additional assessment of sustainability characteristics gives too much leeway, risking that varieties 
without  improved  sustainability  characteristics  enter  the  market.  This  would  in  turn  reduce  the 

178 Ceglar et al. (2019). 

55 

 
 
                                                 
contribution to more sustainable agri-food production and food security. Annual agricultural losses 
already reach up to EUR 4.8 billion because of drought only. Without additional effort for varieties 
better adapted to such extreme conditions this situation is expected to deteriorate even further.  In 
the FRM sector, the voluntary approach towards contingency plans may cause major shortages of 
FRM in case of extreme weather and disasters. Leaving non-forestry purposes out of the scope of 
the  FRM  legislation  may  result  in  the  planting  of  low-quality  FRM  in  proximity  of  high-quality 
FRM, and in  long-term impacts  on the resilience of forests. Finally, option 1 is  expected to  have 
positive  impacts  on  the  conservation  and  sustainable  use  of  plant  and  forest  genetic  resources 
though  limited  by  the  absence  of  tools  for  traceability  and  quality  assurance  for  plant  and  the 
voluntary nature of rules for forest genetic resources. 

Option  2  presents  considerable  economic  costs  for  operators  and  NCAs  due  to  the  need  for 
additional investments to conduct additional sustainability assessments. On the other hand, benefits 
due to strengthened sustainability requirements are high as the mandatory nature of the additional 
assessment is combined with flexibility to adapt to local agro-ecological conditions. This would in 
turn  increase  the  contribution  to  more  sustainable  agri-food  production  and  food  security.  In  the 
FRM  sector,  the  obligation  for  MS  to  establish  contingency  plans  is  expected  to  increase 
preparedness for major shortages of FRM in case of extreme weather and disasters. The inclusion 
of non-forestry purposes in the scope of the FRM legislation would reduce the risk of planting low-
quality PRM in proximity of high-quality FRM, and negative long-term impacts on the resilience of 
forests.  Finally,  option  2  is  expected  to  have  high  positive  impacts  on  the  conservation  and 
sustainable  use  of  plant  and  forest  genetic  resources  through  tools  for  traceability  and  quality 
assurance for plant and adapted rules for forest genetic resources. 

investments 

to  conduct  additional  sustainability  assessments.  Benefits  due 

Option  3  presents  considerable  economic  costs  for  operators  and  NCAs  due  to  the  need  for 
additional 
to 
strengthened  sustainability  requirements  are  positive  though  limited  by  the  lack  of  flexibility  to 
adapt  to  local  agro-ecological  conditions.  This  would  in  turn  limit  the  contribution  to  more 
sustainable  agri-food  production  and  food  security.  In  the  FRM  sector,  harmonised  contingency 
plans  with  lack  of  flexibility  to  adapt  to  local  climatic  and  ecological  conditions  will  limit  the 
benefits regarding increased preparedness for major shortages of FRM in case of extreme weather 
and  disasters.  The  inclusion  of  non-forestry  purposes  in  the  scope  of  the  FRM  legislation  would 
reduce the risk of planting low-quality PRM in proximity of high-quality FRM, and negative long-
term impacts on the resilience of forests. Finally, option 3 is expected to have negative impacts on 
the  conservation  and  sustainable  use  of  plant  genetic  resources  as  measures  concentrate  on 
increased  traceability  and  quality  assurance  without  fully  accommodating  the  specific  needs  of 
plant genetic resources. Harmonised rules adapted for forest genetic resources will have a positive 
impact on the conservation and sustainable use of forest genetic resources. 

The major cost and benefit elements of each option are summarised in Table 8. 

56 

 
 
 
 
Costs 

Policy Option 1 

Policy Option 2 

Policy Option 3 

Increased costs for PRM operators due to 
strengthened sustainability assessment  

Increased costs for NCAs due to strengthened 
sustainability assessment  

Increased costs of PRM for farmers due to 
strengthened sustainability assessment  

Increased costs for NCAs due to measures on 
official controls 

Increased costs for operators and NCAs due to 
measures for FRM (definition of purposes, 
assessment for sustainability characteristics, 
national contingency plans) 

2 

= 

6 

8 

43 to 98  

43 to 98 

133  

400  

667  

= 

= 

= 

= 

15 

= 

Benefits 

Policy Option 1 

Policy Option 2 

Policy Option 3 

Avoided loss in crop output due to increased 
sustainability requirements 

Reduction in costs of registration of operators 
due to single registration under plant health 
legislation 

Reduction in PRM certification costs due to 
extended scope of activities under official 
supervision 

Market opportunities due to lighter rules for 
conservation varieties and new locally adapted 
varieties 

Reduction of breeding costs due to adjusted 
uniformity requirements for organic varieties 

Efficiency gains due to measures on official 
controls 

Efficiency gains due to measures on 
innovation and digitalisation 

Sustainability of agri-food production, forestry 
and food security 

310 to 1 243 

621 to 2 486 

466 to 1 864 

1 

2 

1 

2 

1 

2 

266 

266 

266 

5 

+ 

+ 

+/- 

5 

++ 

++ 

++ 

5 

++ 

+ 

+ 

Benefits for the conservation and sustainable 
use of plant and forest genetic resources 
Table 8. Overview of major cost and benefit elements of each option 
The amounts are for EU27 in million EUR/year. For cost and benefit elements for which monetisation is not feasible, a 
qualitative  score  is  used.  The  scale  corresponds  to  the  following  scheme:  ++  positive  impact,  +  moderately  positive 
impact, +/- inconclusive/uncertain impact, = no significant impact,  - moderate negative impact, -- significant negative 
impact.   

+/- 

++ 

+ 

57 

 
 
 
 
6.6. 

Stakeholders’ views on impact of policy options 

Policy option 1 would be acceptable to a majority of stakeholders and MS as the impacts/additional 
costs  and  required  changes  would  be  minimal.  There  would  be  benefits  of  the  extension  of  the 
current  VCU  examination  for  agricultural  plant  species  and  vine  to  include  characteristics  that 
contribute  to  sustainable  production  (VSCU).  For  the  other  crop  groups  currently  not  subject  to 
VCU (vegetables  and  fruit plants),  the voluntary communication of  the information  coming  from 
the pre-registration trials (before application) could enable the farmers to choose the right varieties 
according to their needs.  

The majority of NCAs and stakeholders are of the opinion that the harmonisation of the framework 
for OCs outside the scope of the OCR (option 1) would have the lowest impact on the increase in 
cost  and  administrative  burden.  According  to  NGOs  and  certain  academia  the  total  exemption  of 
the  activities  of  seed  conservation  networks,  exchange  in  kind  of  seed  between  farmers  and 
marketing to amateur  gardeners from the scope of the legislation would have the biggest positive 
impact on the conservation and sustainable use of plant genetic resources. The seed sector and some 
NCAs are concerned that a total exemption could be misused by farmers multiplying seed under a 
service contract. As regards the possibility of using BMTs and digital solutions, some stakeholders 
prefer that the use of BMTs and digital solutions remain optional because of a lack of resources to 
invest in such technologies. 

Stakeholders  and  NCAs  are  concerned  about  the  increased  costs  and  the  reduced  number  of 
varieties coming to the market under policy option 2 extending the VSCU examination to all crop 
groups. NCAs state that the need for, and costs of, additional testing areas would be an important 
limiting factor, highlighting that even official supervision may not be an adequate solution. Smaller 
MS have reported that there would not be enough areas for field trials. MS have already identified 
the  lack  of  areas  for  field  trials  as  a  limiting  factor  for  carrying  out  the  VSCU  under  organic 
conditions.  Likewise,  the  seed  sector  is  concerned  that  the  VSCU  examination  under  option  2 
would  lead  to  disproportionate  costs  especially  for  SMEs  and  to  the  decrease  of  new  varieties 
entering  the  market.  While  the  main  farmers’  association  considers  it  important  to  assess  new 
varieties for those criteria and have the relevant information at hand, they are concerned about the 
increased  cost  and  the  reduced  availability  of  new  varieties  because  of  the  compulsory  VSCU 
assessment179. 

The  majority  of  NCAs  and  stakeholders  fear  an  increase  in  administrative  burden  upon  the 
inclusion of OCs into the scope of the OCR. Several NCAs and businesses are of the opinion that 
option 2 including OCs into the scope of the OCR with simplified import controls would contribute 
to more harmonised conditions for the operators and the marketing of PRM and FRM across MS. 
NGOs are of the opinion that the introduction of lighter rules for the activities of seed conservation 
networks,  exchange  in  kind  of  seed  between  farmers  and  marketing  to  amateur  gardeners  would 
hamper those activities and have a negative impact on the conservation and sustainable use of plant 
genetic  resources.  According  to  the  seed  sector,  the  introduction  of  at  least  lighter  rules  for  such 
activities would offer a minimum guarantee for compliance with the plant health requirements and 
for  the  traceability  of  such  activities.  Most  NCAs  and  stakeholders  including  SMEs  are  of  the 

179 This position however reflects a compromise between their different members. 

58 

 
 
                                                 
opinion that the introduction of basic rules on innovative production processes, BMTs and digital 
solutions would have a positive impact on the uptake and advancement of such technologies.  

Most stakeholders and MS are of the opinion that harmonisation of the VSCU examination under 
option 3 would be disproportionate and counterproductive. The majority of NCAs and stakeholders 
fear  an  increase  in  administrative  burden  upon  the  inclusion  of  OCs  into  the  scope  of  the  OCR. 
Only  a  few  stakeholders  are  of  the  opinion  that  a  full  inclusion  into  the  scope  of  the  OCR  with 
stricter import controls at border control posts (option 3) would have the highest positive impact on 
the creation of equal conditions for operators and marketed PRM and FRM across MS. NGOs and 
certain  academia  strongly  oppose  to  subjecting  the  activities  of  seed  conservation  networks, 
exchange in kind of seed between farmers and marketing to amateur gardeners to the requirements 
of the legislation.  In their  view, this  would undermine all efforts undertaken for the  conservation 
and sustainable use of plant genetic resources. Most stakeholders and NCAs in favour of the use of 
BMTs and digital solutions are of the opinion that the introduction of detailed rules  would have a 
negative  impact  on  the  use  of  such  technologies  and  restrict  scientific  and  technological 
developments. 

As  regards  FRM,  the  majority  of  NCAs  and  regional  forest  authorities  who  participated  in  the 
targeted survey on FRM believe that the inclusion of the purposes for which the FRM is produced 
will increase the administrative burdens for NCAs and operators, increase the costs for inspections 
and  require  and  additional  investment  by  the  operators.  Respondents  agreed  that  it  is  essential  to 
guarantee traceability of the genetic origin for the FRM users without increasing the administrative 
burden and the costs. 

7.  HOW DO THE OPTIONS COMPARE? 

This section compares the expected impacts of the policy options in relation to the baseline scenario 
in  terms  of  their  overall  effectiveness,  efficiency,  coherence,  subsidiarity  and  proportionality.  It 
considers the effects of no policy change in the long term.  

Criteria 

Effectiveness: contribution to achieving the policy specific objectives (SO) 

SO1: Simplified, clarified and harmonised basic rules 

SO2: Enabling the uptake of new scientific and technical developments 

SO3: Ensure availability of PRM/FRM suitable to address future challenges 

SO4: Support the conservation and sustainable use of plant and forest genetic resources 

SO5: Harmonisation of the framework for official controls 

SO6: Coherence with PHL 

Effectiveness: other economic, social and environmental impacts 

Economic impacts 

SMEs 

Competitiveness 

Innovation and research 

59 

No policy 
change 

Policy 
Option 
1 

Policy 
Option 
2 

Policy 
Option 
3 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

+ 

+ 

+/- 

+/- 

+ 

+ 

+ 

+/- 

++ 

+ 

+ 

++ 

+ 

++ 

++ 

++ 

++ 

+ 

++ 

++ 

+ 

++ 

+ 

+ 

+ 

+ 

+/- 

++ 

+ 

+ 

+ 

+ 

+ 

 
 
Criteria 

Environmental impacts 

Climate change resilience 

Sustainable use of resources 

Food security 

Employment 

Social impacts 

Efficiency  

Coherence 

Subsidiarity 

No policy 
change 

Policy 
Option 
1 

Policy 
Option 
2 

Policy 
Option 
3 

0 

0 

0 

0 

0 

0 

0 

+/- 

+/- 

+/- 

+ 

++ 

+ 

+ 

++ 

++ 

++ 

+ 

+ 

+ 

+ 

= 

+/++ 

+/- 

++ 

+ 

+ 

+ 

Proportionality 
Table  9:  Global  comparison  of  the  options.  The  scale  of  the  score  given  to  impacts  and  assessment  of  efficiency,  coherence,  subsidiarity  and 
proportionality  is  based  on  the  following  scheme:  ++  positive,  +  moderately  positive,  +/-  inconclusive/uncertain,  =  not  significant,  -  moderate 
negative, --significantly negative.   

++ 

+ 

0 

- 

7.1.  Effectiveness 

The  evaluation  of  effectiveness  looks  at  the  extent  to  which  the  option  would  achieve  the 
objectives. Option 2 overall outranks the other policy options. Option 3 ranks second, slightly better 
than option 1, which however performs better than the no policy change scenario.  

The common measures for simplification of administrative procedures are expected to accelerate 
market access of PRM/FRM produced within the EU and of imported PRM/FRM.  

For  innovative  production  processes,  BMTs  and  the  use  of  digital  solutions,  options  were 
assessed  in  relation  to  the  initial  investment  and  the  gradual  reduction  of  costs  for  NCAs  and 
operators. Option  2 performed the best  on these criteria while options  1 and 3 performed equally 
well.  Laying down  a reliable framework under option 2 will create legal  certainty and encourage 
operators  and  NCAs  to  invest  in  these  technologies  and  the  long-term  benefits  would  anyway 
outweigh the initial investments. With option 1 (implementation by guidelines) there is a risk that 
the rules will be fragmented and that operators may not be inclined to invest in such technologies 
due  to  the  absence  of  a  reliable  framework  that  will  give  them  a  perspective  of  a  return  on  their 
initial  investment.  More  consistent  rules  on  innovative  production  processes,  BMTs  and  digital 
solutions under option 3 come at the expense of the frequency for updating those rules due the rapid 
pace of new technical and scientific developments. 

To ensure availability of PRM suitable for future challenges, options were assessed in relation 
to the scope of the sustainability assessment of new varieties and the level of harmonisation of that 
assessment. The enlarged scope of the sustainability assessment under options 2 and 3 addresses the 
objective of PRM contributing to more sustainable agri-food production and increased resilience to 
climate  change  conditions  in  the  most  comprehensive  way.  With  the  voluntary  extension  of  the 
scope  of  the  sustainability  assessment  (option  1)  the  increase  in  varieties  with  improved 
sustainability  characteristics  of  non-regulated  crop  groups  may  be  lower.  An  approach  balancing 
harmonisation  of  the  sustainability  assessment  with  flexibility  (option  2)  allows  for  adaptation  to 
local agro-ecological conditions. For example, the relevance of pests and climatic conditions (e.g. 
drought,  frost)  differs  per  region.  Such  adaptation  would  not  be  possible  under  a  harmonised 
sustainability assessment (option 3). The risk of option 1 (most flexible approach for sustainability 

60 

 
 
assessment) is that MS will diverge in relation to the approach for this sustainability assessment and 
that varieties without improved sustainability characteristics will reach the market. 

Common measures creating a legal framework to ensure the availability of PRM suitable for the 
needs  of  organic  agriculture  will  ensure  a  consistent  approach  for  variety  registration  and 
certification  of  ‘organic  varieties  suitable  for  organic  production’  and  contribute  to  the  target  of 
having 25% of agricultural production under organic conditions (F2F). 

To ensure availability of FRM suitable for future challenges, options were assessed in relation 
to the sustainability assessment of basic material, inclusion of non-forestry purposes into the scope 
of  the  legislation  and  contingency  planning.  The  enlarged  scope  of  the  sustainability  assessment 
under  options  2  and  3  addresses  the  objective  of  FRM  contributing  to  more  sustainable  forest 
management and restoration of healthy forest ecosystems and increased resilience to climate change 
conditions in the most comprehensive way. It cannot be guaranteed that the voluntary guidelines on 
the assessment of sustainability characteristics under option 1 will be taken up to the same degree 
as  mandatory  principles  under  options  2  and  3.  Under  option  1,  there  is  the  possibility  that 
improperly  assessed  FRM  would  reach  the  market  and  this  could  have  a  significant  negative 
environmental  impact  in  the  long  term  (e.g.  forests  susceptible  to  pests  or  other  environmental 
pressures).  An  approach  balancing  harmonisation  of  the  sustainability  assessment  with  flexibility 
(option  2)  allows  MS  to  adapt  to  environmental  and  climatic  conditions  which  may  show  quite 
substantial  regional  differences.  Option  3  would  not  allow  such  adaptation.  The  inclusion  of 
specific non-forestry purposes in the scope of the legislation (options 2 and 3) will avoid long-run 
negative  impacts  on  the  resilience  of  forests  and  perform  better  than  keeping  the  current  scope 
(option  1).  In  addressing  temporary  difficulties  in  supply  of  suitable  FRM  through  contingency 
planning, option 2 is expected to be the most effective. Under option 2 the requirement to establish 
national contingency plans is coupled with the flexibility for MS to adapt contingency plans to their 
environmental and climatic conditions. The voluntary approach under option 1 risks that MS will 
ignore  the  need  for  such  plans,  while  the  highly  harmonised  approach  under  option  3  can  prove 
counterproductive  as  needs  and  priorities  can  differ  significantly  across  the  EU.  A  common 
measure providing more and better information by nurseries to FRM users/buyers on the suitability 
of FRM for current and future climatic conditions will allow FRM users/buyers to buy the right tree 
for the right place and thus support the resilience of future forests. Overall option 2 would be more 
effective in securing the availability of FRM suitable for future challenges. 

To  support  the  conservation  and  sustainable  use  of  plant  genetic  resources,  options  were 
assessed in relation to the approach towards seed conservation networks, exchange in kind of seed, 
and  marketing  exclusively  to  amateur  gardeners.  A  total  exemption  of  these  activities  from  the 
scope of the legislation (option 1) will not fully meet the objective due to a lack of identification 
and  traceability  of  the  PRM  concerned.  The  procedures  in  option  3  (general  requirements  of  the 
legislation  for  variety  registration  and  PRM  certification)  would  be  too  cumbersome  and 
counterproductive towards meeting the objective. Option 2 offers the best solution for safeguarding 
genetic  diversity  as  it  introduces  lighter  rules  ensuring  the  identification  and  traceability  of  the 
PRM  concerned.  To  support  the  conservation  and  sustainable  use  of  forest  genetic  resources, 
dedicated measures under options 2 and 3 would be most effective in comparison to the adoption of 
guidelines that risk not to be followed by the MS (option 1). Overall, in supporting the conservation 
and  sustainable  use  of  plant  and  forest  genetic  resources,  option  2  would  be  most  effective, 
followed by option 1. Option 3 would have uncertain results as the highest harmonisation foreseen 
under  option  3  would  be  effective  for  securing  the  quality  of  the  PRM/FRM  concerned  but  not 
suitable for its specific needs due to its higher genetic diversity. 

61 

 
 
For  the  harmonisation  of  the  framework  for  OCs,  common  measures  on  OCs  across  MS  and 
minimum requirements as regards the frequency and scope of OCs will provide a clear regulatory 
framework and  contribute to  a level  playing field  for operators. Options 2 and 3 perform  equally 
well and better than option 1. Alignment of the OC rules outside the scope of the OCR (option 1) 
would have the drawback of not making use of the advantages of the OCR (existing IT applications 
and  training).  Options  2  and  3  will  make  use  of the  existing  IT  applications  for  OCs  such  as  the 
Information Management System for Official Controls (IMSOC). Moreover, it will be possible  to 
report  suspected  cases  of  PRM/FRM  fraud  through  a  secure  IT  portal.  Training  activities  will  be 
organised to train MS official inspectors. As under option 1 the PRM/FRM legislation is outside the 
scope  of  the  OCR  as  regards  risk-based  OCs,  it  will  not  be  possible  for  MS  to  use  the 
aforementioned IT applications and follow training courses.  

Common measures for coherence between the  PRM/FRM legislation and the PHL will create 
clarity  for  NCAs  and  operators  as  regards  the  legal  framework  for  OCs  on  PHL  through  the 
removal of the duplication of RNQP requirements in both legal frameworks and the regulation of 
all plant pests (QPs and RNQPs) only under the PHL.  

7.2.  Efficiency 

The evaluation of efficiency considers the extent to which the options result in costs and benefits 
for  NCAs,  operators  and  other  stakeholders  (in  the  case  of  this  initiative  the  users  of  PRM  and 
FRM).  The  net  benefit  as  well  as  the  Benefit  Cost  Ratio  of  each  option  have  been  calculated 
(detailed  presentation  in  Annex  4).  Due  to  high  uncertainty,  calculations  have  been  done  for  an 
optimistic  scenario  (under  which  the  highest  benefits  and  the  lowest  costs  are  realised)  and  for  a 
conservative scenario (under which the lowest benefits and the highest costs are realised).  

Global costs and benefits per option (excluding common measures) 

Option 1 

Option 2 

Option 3 

PRM/FRM 
users 

Operators 

NCAs 

PRM/FRM 
users 

Operators 

NCAs 

PRM/FRM 
users 

Operators 

NCAs 

133 

2 

0 

400 

6 

from 43 to 
98 

667 

8 

from 58 
to 113 

135 

from 449 to 504 

from 733 to 788 

from  310  to 
1 243 

0 

0 

from 
2 486  

621 

to  

0 

0 

from  466  to 
1 864 

0 

0 

from 310 to 1 243 

from 621 to 2 486 

from 466 to 1 864 

Costs per stakeholder 
category (million 
EUR/year) 

Global costs (million 
EUR/year) 

Benefits per 
stakeholder category 
(million EUR/year) 

Global benefits 
(million EUR/year) 

Cost benefit analysis of options under an optimistic scenario (highest benefits and lowest costs) 

Net benefit (million 
EUR/year)  

1 243 – 135 = 1 108 

2 486 – 449 = 2 037 

1 864 - 733= 1 131 

Benefit Cost Ratio  

1 243 / 135 = 9.20 

2 486 / 449 = 5.53 

1 864 / 733 = 2.54 

Cost benefit analysis of options under a conservative scenario (lowest benefits and highest costs) 

Net benefit (million 
EUR / year)  

310 – 135 = 175 

621 – 504 = 117 

466 - 788 = - 322 

Benefit Cost Ratio  

310 / 135 = 2.29 

621 / 504 = 1.23 

466 / 788 = 0.59 

Table 10: Net benefit and Benefit Cost Ratio of the options 

62 

 
 
 
 
In terms of net benefits, under the optimistic scenario option 2 ranks first, followed by option 3 that 
only marginally outranks option 1. Under the  conservative scenario option 1 ranks first, followed 
by  option  2,  while  option  3  presents  higher  costs  than  benefits.  In  terms  of  Benefit  Cost  Ratio, 
under both scenarios option 1 ranks better than option 2, while option 3 is always the worst option.  

These calculations cannot capture a number of non-monetised benefits described in section 6. For 
these,  option  2  is  performing  better  than  options  1  and  3,  especially  as  regards  long-term 
environmental and sustainability benefits (see an overview in Table 8). As a result, the comparison 
of the options in terms of net benefit and benefit cost ratio is distorted in favour of option 1 against 
option 2.   

7.3.  Coherence 

The  initiative  relates  to  several  EU  policy  objectives,  policy  initiatives  and  instruments.  The 
evaluation of coherence looks at how consistent each option is with these and identifies the extent 
to which they promote horizontal objectives and facilitate delivery of relevant key targets.  

EU initiatives / 
regulatory 
framework 

PHL 

OCR 

CPVR system 

NGTs 

Key considerations 

Under  all  options  (same  measure)  coherence  with  PHL  is  maximised.  All 
requirements  for PRM/FRM  as  regards plant health  will be moved to  PHL. 
The PRM/FRM certification rules will require compliance with PHL. 

Option 1 does not introduce any links between the PRM/FRM legislation and 
the  OCR.  Options  2  and  3  harmonise  OCs  for  PRM/FRM  under  the  OCR 
thus allowing alignment with OCs for other legislative frameworks under the 
OCR (PHL, Organic Regulation and GMOs). 

The  DUS  protocols  used  for  granting  CPVR  (intellectual  protection)  are 
applied  also  for  the  purposes  of  variety  registration  (authorisation  for 
marketing). While the two systems are independent, that is a variety can be 
registered regardless of CPVR protection, the use of common DUS protocols 
results  in  significant  efficiency  gains.  Measures  to  facilitate  organic 
production  and  to  support  the  conservation  and  sustainable  use  of  plant 
genetic  resources  will  result  in  varieties  (conservation,  new  locally  adapted 
and organic varieties) and heterogeneous material becoming available to the 
market without meeting the DUS requirements, therefore also not eligible for 
CPVR.  However,  this  trade-off  is  considered  necessary  to  achieve  the 
respective objectives for organic production and plant genetic resources. 

The  variety  registration  system  of  the  PRM  legislation  (including  the 
assessment for characteristics contributing to sustainable production) applies 
to  all  varieties  irrespective  of  the  breeding  technique.  The  same  applies  for 
acceptance of basic material under the FRM legislation. Varieties and FRM 
with  NGT  traits  will  be  treated  in  the  same  way  as  all  other  varieties 
independently  of  the  breeding  methodology  (conventional  breeding,  GM 
technology,  NGT  technology).  This  initiative  and  the  NGT  initiative  in 

63 

 
 
 
F2F 

The  initiative  for  a 
new  regulation  on 
the  sustainable  use 
of  plant  protection 
products (SUR) 

FSFS 

Biodiversity 
Strategy 

preparation contribute to the goals of the EFD and F2F. 

The  increased  efficiency  and  efficacy  of  the  variety  registration  and 
certification systems will support innovation in plant breeding and thus seed 
and  food  security.  The  envisaged  measures  for  organic  production, 
conservation  varieties,  new  locally  adapted  varieties  and  heterogeneous 
material will increase coherence with F2F as regards the genetic diversity of 
PRM/FRM. Option 2 would be most coherent with the sustainability targets 
of  F2F  through  a  sustainability  assessment  covering  all  crop  groups 
(improved varieties can help reduce use of fertilisers and pesticides) with an 
implementation adjusted to the agro-ecological conditions of the MS. 

In comparison to option 1, options 2 and 3 present increased coherence with 
the SUR targets on reduced pesticide use through the extension of the current 
VCU  requirements  for  agricultural  species  and 
introduction  of 
sustainability  characteristics  for  the  other  crop  groups  which  include 
examination  for  resistance  to  plant  pests.  New  varieties  with  increased 
resistance  to  plant  pests  may  require  less  pesticides.  As  option  2  is 
considered more effective in this aspect than option 3, coherence with SUR 
would be highest under option 2.  

the 

The PRM/FRM initiative includes specific sustainability considerations (‘lex 
specialis’),  while  respecting  the  general  sustainability  principles  and 
objectives of FSFS (‘lex generalis’). 

Measures supporting the conservation and sustainable use of plant and forest 
genetic resources contribute to the Biodiversity Strategy objective to reverse 
the decline of genetic diversity. Highest coherence is achieved under option 
2,  whereby  lighter  rules  will  enable  the  characterisation  and  documentation 
of  plant  and  forest  genetic  resources  (in  contrast  to  the  absence  of  any 
traceability  under  option  1)  and  provide  more  flexibility  to  operators  (in 
contrast  to  being  subject  to  the  general  rules  on  variety  registration  and 
certification under option 3). 

EU Forest Strategy  Option  2  offers  more  coherence  with  the  EU  Forest  Strategy  target  of 
ensuring  resilient  and  multifunctional  forest  ecosystems  as  it  will  be  most 
effective in enabling availability of climate-adapted FRM, by the inclusion in 
the  scope  of  the  legislation  of  non-forestry  purposes  such  as  biodiversity 
conservation and the requirement for national contingency plans.  

Climate adaptation  The  initiative  will  facilitate  the  broadening  of  the  supply  of  suitable  high-
quality PRM/FRM to support adaptation in agriculture and forestry  through 
the requirements for more information to end users of FRM on the suitability 
of  FRM  for  future  climatic  and  ecological  conditions;  the  establishment  of 
national  contingency  plans  and  strengthened  sustainability  requirements  for 
FRM; a strengthened assessment of new plant varieties (including as regards 
abiotic factors such  as drought); enabling the registration of locally adapted 
varieties.  Highest  coherence  is  achieved  under  option  2  that  provides  for 
flexibility  to  MS  for  implementation  according  to  their  agro-ecological  and 
environmental conditions). 

Digital Strategy 

All  options  improve  coherence  with  the  general  requirement  for  digital 

64 

 
 
SDGs 

transformation by enabling digitalisation to improve the efficiency, integrity 
and  traceability  of  the  certification  and  labelling  system.  Options  2  and  3 
support  digitalisation  of  OCs  through  IMSOC  and  on-line  applications  for 
notifying non-compliances and combatting fraud. 

By strengthened sustainability requirements for all crop groups, measures for 
organic  production,  plant  and  forest  genetic  resources,  FRM  national 
contingency plans  the initiative contributes  to SDG 2 on zero hunger, SDG 
12 as regards responsible production, SDG 13 on climate action and SDG 15 
on life on land. As described above, the most coherent approach is provided 
by option 2.   

Table 11. Key considerations on coherence 

7.4. 

Subsidiarity and proportionality 

All three options are consistent with the EU’s right to act under the Treaty of the Functioning of the 
EU (agricultural production, the single market and the free movement of products within the EU).  

In  line  with  the  principle  of  subsidiarity,  the  initiative  is  limited  to  aspects  that  can  be  better 
achieved at Union level than if they were addressed individually by MS. Without common rules for 
PRM (variety registration and certification), FRM (approval of basic material and certification) and 
OCs, there would be 27 different  systems  instead of one common system in  place. This  situation 
would result in obstacles to the movement of PRM/FRM in the internal market and increased costs 
for controls to ensure equivalence between the different systems. A common EU framework is also 
most appropriate in order to implement in a harmonised way the various international standards in 
relation to PRM/FRM quality and plant health180. 

In  line  with  the  principle  of  proportionality,  the  envisaged  measures  do  not  exceed  what  is 
necessary  for  achieving  the  set  objectives.  A  number  of  existing  administrative  procedures  and 
requirements  will  be  simplified.  The  options  reflect  a  trade-off  between  flexibility  and 
harmonisation. Their comparison shows that a fully harmonised system (option 3) does not perform 
better and that the most proportionate solution is to retain some flexibility for MS (option 2). The 
latter balances the need for harmonised rules for variety registration and PRM certification with the 
flexibility  for  MS  to  implement  those  rules  to  adapt  to  their  local  agro-ecological  conditions  and 
measures to strengthen sustainability (F2F) and respond to the call for adaptation to climate change 
(EU Strategy on Adaptation to Climate Change) and restoring biodiversity (Biodiversity Strategy). 
Likewise,  in  the  FRM  sector  option  2  creates  a  balance  between  the  general  principles  of 
registration and FRM certification with flexibility for MS to respond to the biodiversity and climate 
challenges. To achieve these needs and take account of the important differences between the PRM 
and FRM sectors, the current 11 basic Directives181 will be replaced by a Regulation on PRM and a 
Regulation on FRM. 

180  OECD,  International  Seed  Testing  Association  (ISTA),  United  Nations  Economic  Commission  for  Europe 
(UNECE),  International  Plant  Protection  Convention  (IPPC),  World  Trade  Organization/Sanitary  and  phytosanitary 
measures (WTO/SPS). 
181 Council Directive 98/56/EC on the marketing of propagating material of ornamental plants will remain in place. 

65 

 
 
                                                 
8.  PREFERRED OPTION 

The assessment indicates that policy option 2 is  the strongest option to effectively address  all the 
objectives of the revision of the PRM and FRM legislation in an efficient and consistent manner. 
Option 1 presents the best Benefit Cost Ratio as it presents the lowest costs, but it is not the most 
effective option in terms of achieving the objectives. Actually, option 1 presents the risk that it will 
lead in the long term to increased losses due to its reduced ambition in addressing comprehensively 
the sustainability and climate adaptation challenges. 

Stakeholder  consultations  showed  that  preferences  were  split  between  option  1  (most  flexible 
system  but  also  with  lowest  costs)  and  option  2  (balancing  harmonisation  with  flexibility).  A 
majority of stakeholders highlighted the need for some degree of flexibility for MS to adapt to their 
local agro-ecological (PRM) and climatic and ecological conditions (FRM). All stakeholders were 
in favour of a separate legal framework for FRM. 

There  are  different  stakeholders  in  the  sector.  Most  stakeholders  produce  PRM  and  FRM  for 
commercial purposes while a segment does so for non-profit purposes. Although these stakeholders 
have  different  activities  and  objectives,  they  all  recognise  the  need  to  preserve  and  increase  the 
genetic  diversity  of  PRM  and  FRM.  In  fact,  the  work  done  by  seed  conservation  networks  as 
regards  the  conservation  of  plant  genetic  resources  is  invaluable  as  it  gives  the  seed  industry  a 
wider choice of PRM from which they can develop new varieties. Currently, the activities of actors 
involved in conservation and sustainable use of plant and forest genetic resources, such as activities 
of  seed  conservation  networks  and  exchange  in  kind  of  seed  are  restricted.  A  future  regulatory 
framework  needs  to  respond  to  the  needs  of  the  different  stakeholders.  The  impact  assessment 
investigated what would be the best approach to do so. NCAs and the seed industry value the well-
functioning certification system and its importance at global level with the EU in the top three of 
globally  exporting  regions.  However,  they  recognise  that  the  current  system  has  its  flaws,  in 
particular as regards the non-level playing field for operators, marketed PRM and FRM, OCs and 
enforcement.  Concerned  operators  and  NGOs  have  highlighted  that  the  existing  derogations  for 
conservation  varieties  have  not  been  successful.  The  organic  sector  has  expressed  the  need  for 
adapted rules for organic varieties intended for organic production. Moreover, the existing system 
is currently quite restrictive as regards the activities that can be carried out by operators under the 
official  supervision  of  the  authorities.  Since  2013,  scientific  and  technical  developments  have 
swiftly  moved  forward  while  the  legislation  does  not  have  adequate  provisions  on  innovative 
production processes, BMTs and digitalisation. 

The  current  legislation  does  not  have  sufficient  means  to  respond  to  sustainability  and  climate-
related challenges addressed by the EGD and its strategies. For agricultural species sustainability 
characteristics  have been incorporated by  certain  MS in the VCU examination while there are no 
sustainability  characteristics  for  the  other  crop  groups.  The  current  experience  with  agricultural 
species  shows  that  a  voluntary  approach  towards  extending  the  sustainability  assessment  to  other 
crop  groups  will  not  work.  The  preferred  option  will  extend  and  strengthen  sustainability 
requirements. This will come with a cost for businesses in terms of increased breeding costs while 
NCAs may need to increase their capacity in areas and staff. Mitigating measures can be taken such 
as a transition period in the application of the new legislation, reduction of the adjustment cost by 
permitting  VSCU  examination  under  official  supervision  and  promote  collaboration  between  MS 
by  creating  shared  testing  networks  and  allowing  delegation  of  activities  to  other  MS.  Therefore, 
strengthened  sustainability  requirements  applicable  to  all  crop  groups  show  the  highest 

66 

 
 
effectiveness in contributing to the increase in sustainable agri-food production under F2F and the 
availability of climate-adapted and more resilient PRM.  

The  regulatory  framework  should  leave  room  for  flexibility  for  MS  to  adapt  to  their  local  agro-
ecological  conditions.  Furthermore,  it  should  proportionally  regulate  activities  related  to 
conservation  and  sustainable  use  of  plant  and  forest  genetic  resources.  The  choice  of  legal 
instrument,  2  Regulations  (PRM  and  FRM)  replacing  11  Directives,  will  reduce  divergent 
implementation across MS caused by national transpositions.  

Under  option  2,  the  introduction  of  lighter  rules  for  registration  of  conservation  and  locally 
adapted varieties and for conservation activities will introduce a proportionate approach for a small 
market segment. This will most likely have a positive impact on employment in rural areas, both on 
small  operators  marketing  these  varieties  and  on  the  development  of  local  value  chains.  The 
preferred option will also result in increased genetic diversity and contribute to the objectives of the 
Biodiversity  Strategy.  Likewise,  the  introduction  of  variety  registration  rules  adjusted  to  the 
principles  of  organic  production  will  contribute  to  the  target  of  having  25%  of  agricultural 
production under organic conditions pursuant to the goals of F2F. 

As  regards  FRM  stakeholder  consultations  also  showed  a  split  between  options  1  (most  flexible 
approach)  and  2  (balancing  flexibility  with  harmonisation).  Stakeholders  were  very  strong  on 
separating the FRM legislation from the PRM legislation. In fact, the inclusion of FRM in the PRM 
proposal was one of the reasons for rejecting the PRM proposal. FRM stakeholders recognise the 
challenges brought  about  by climate  change. They  are confronted with  increasing  forest  damages 
caused  by  insects,  storms  and  drought.  Furthermore,  there  is  an  increased  demand  for  FRM  for 
plantations for biomass production and for responding to the target of planting 3 billion additional 
trees by 2030. To respond to these challenges and the higher demand in FRM there is a need for a 
legal  framework  that  includes  a  sustainability  assessment  of  basic  material,  increasing  the 
resilience of FRM by taking measures on the conservation and sustainable use of forest genetic 
resources and responds to the increased demand for FRM by extending to scope of the legislation 
to non-forestry purposes. The FRM proposal will contain updated rules for FRM and ensure that 
more information about the suitability of FRM for future climatic conditions is provided by the 
nurseries  to  FRM  users/buyers.  National  contingency  plans  will  prepare  MS  for  difficulties  in 
supply of suitable FRM. Altogether these measures will result in the planting of high-quality FRM 
in  suitable  areas  and  contribute  to  the  creation  of  resilient  forests  and  the  restoration  of  forest 
ecosystems. The impact assessment showed that option 2 combining flexibility with harmonisation 
was the best approach to address the problems identified in the current legislation. Option 3  does 
not  allow  taking  into  account  the  differences  between  MS  as  regards  the  type  of  forests  and  the 
activities carried out. 

In the PRM and FRM proposals, the measures on the harmonisation of OCs, the coherence with 
the  PHL,  innovative  production  processes,  BMTs  and  digital  solutions  serve  to  increase  the 
efficacy  and  efficiency  of  the  procedures  and  reduce  the  administrative  burden  for  MS  and 
businesses, overall contributing to the competitiveness of the PRM/FRM sectors. 

8.1.  REFIT (simplification and improved efficiency) 

The revision of the PRM and FRM legislation offers the opportunity of savings for businesses as 
regards variety registration, certification and OCs. There will be lighter rules for the registration of 
conservation  and  locally  adapted  varieties  as  well  as  for  the  activities  of  seed  conservation 

67 

 
 
networks,  the  possibility  of  VSCU  examination  under  official  supervision  (PRM),  extension  of 
certification activities possible under official supervision (PRM/FRM), increased efficiency of the 
registration and certification system (innovative production processes, BMTs and digital solutions) 
and  more  efficient  OCs.  The  table  below  gives  an  overview  of  the  main  opportunities  under  the 
preferred option. Some of these serve to mitigate the increased burden caused by the extension of 
sustainability requirements in the PRM and FRM sectors. 

REFIT cost savings – preferred option 

Description 

Replacing  11  Directives  by  2 
Regulations 

registration 
requirements 

and 
Simplified 
labelling 
for 
conservation  varieties  and  new 
locally adapted varieties 

registration 
variety 
Adapted 
requirements for organic varieties 

Notification  of  heterogeneous 
material/OHM (PRM) 

Notification  of  basic  material  for 
the  purposes  of  conservation  and 
sustainable  use  of  forest  genetic 
resoures (FRM) 

Extension 
certification 
of 
activities  that  are  possible  under 
official supervision 

Digitalisation  for  more  efficient 
processes in NCAs and businesses 

Qualitative 
assessment 

+/- 

Comments 

Regulation  is  directly  applicable  and 
creates  more  harmonised  approach  for 
businesses. 

in 

administrative 

Reduction 
and 
compliance  costs  because  there  will  be 
no  official  variety  examination  and 
certification  requirements,  and  labelling 
requirements will be simplified. 

Savings  in  compliance  costs  because 
variety registration will be adapted. 

in 

administrative 

and 
Reduction 
compliance  costs  because  marketing  of 
heterogeneous  material  will  be  subject 
to  notification  and  simple 
labelling 
requirements. 

in 

administrative 

Reduction 
and 
compliance costs because basic material 
will be notified  without the  need for an 
official registration requiring  an official 
inspection. 

for 

one-off 

investment 

Reduction in compliance costs. Possible 
in 
need 
equipment  and  official 
training  of 
inspectors  by  certification  NCAs,  but 
rather  limited  for  those  operators  that 
already  carry  out  certification  activities 
under official supervision. 

The  EU  Plant  Variety  Portal  will 
facilitate 
administration  of  variety 
accelerate  market 
registration 
access  of  new  varieties  by  up  to  4 
months. 

and 

Digital certification labels  will decrease 
administrative burden. 

Exchanges  between  MS  through  digital 

+ 

+ 

+ 

+ 

+ 

+ 

68 

 
 
 
Innovative  production  processes 
and BMTs 

+ 

Inclusion in the scope of the OCR 

+ 

systems  will  decrease  administrative 
burden. 

Innovative  production  processes  and 
BMTs  will 
speed  up  PRM/FRM 
production. 

BMTs  will  render  variety  registration, 
PRM/FRM  certification  and  OCs  more 
efficient. 

Harmonised  OCs  for  operators  across 
MS. 

Increased efficiency of OCs. 

Use  of  common  IT  platforms  for 
notifying  information  about  PRM/FRM 
imports,  reporting  non-compliances  and 
combatting fraud. 

Table 12: Refit cost savings – preferred option 

8.2. 

Simplification  and  burden  reduction  for  businesses,  supporting  the  one-in 
one-out approach 

The activities that imply significant administrative costs for businesses are the following: 

  Application for acceptance of new varieties (PRM); 
  Application for registration of basic material (FRM); 
  Certification of PRM; 
  Certification of FRM; 
  OCs. 

For implementing the one-in-one-out requirement, for each of these activities all cost drivers were 
mapped  but  the  analysis  showed  that  these  would  undergo  only  marginal  changes.  There  are  no 
administrative costs for the citizens. 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

Indicators for the preferred option, in relation to the core objectives of the PRM/FRM revision, with 
suggested data sources are presented in table below.  

General 
objectives 

ensure 

a 
To 
playing 
level 
field 
for 
operators across 
the EU 

Specific objectives 

Measures of success and monitoring indicators 

the 
Harmonise 
framework  for  OCs 
on PRM/FRM 

Comparable level of OCs across MS 

-  Number of controls in proportion to risk from analysis of multi-
annual  national  control  plans  (NCAs)  and  annual  reporting  on 
the number and outcome of OCs (NCAs) 

-  Number  of  controls  in  proportion  to  risk  from  harmonised 

checking and reporting of PRM/FRM imports (IMSOC) 

69 

 
 
General 
objectives 

Specific objectives 

Measures of success and monitoring indicators 

To improve coherence 
PRM/FRM 
of 
legislation with PHL 

support 
To 
innovation  and 
competitiveness 
of the EU 

uptake 

of 
Enable 
innovative  production 
processes,  BMTs  and 
digital solutions  

to 

Contribute 
sustainability, 
biodiversity and 
climate-related 
challenges 

Ensure  availability  of 
PRM/FRM 
suitable 
(identity,  quality  and 
health) 
future 
for 
challenges 

- 

Findings of EU audits (Commission) 

Implementation of RNQP rules under PHL 

-  Number  of  reporting  and  checking  of  RNQP-related  non-

compliances (IMSOC) and from findings of EU audits 

Uptake of innovative production processes, BMTs and digital solutions 

-  Number  of  new  certification  schemes  for  PRM  produced  by 

innovative production processes 

-  Number of BMTs accepted for registration and certification 
-  Number of MS setting up a digital system 
-  Number of FRM entries obtained through innovative production 

processes (FOREMATIS) 

Availability of PRM/FRM 

Rules on FRM contingency planning  

-  Number of new varieties per crop group accepted following the 
general  rules  on  DUS  and  sustainability  assessment  (Common 
Catalogues) 

-  Number of FRM entries containing information on suitability of 
FRM for climatic and ecological conditions (FOREMATIS) 

-  Quantities of certified PRM/FRM (reporting by NCAs) 
-  Number  of  MS  requests  to  apply  for  derogations  to  address 

temporary difficulties in supply of seed (Commission) 

-  Number  of  national  contingency  plans  to  address  FRM  supply 

difficulties (notification by NCAs at adoption) 
Findings of EU audits (Commission) 

- 

Ensure  availability  of 
PRM/FRM suitable to 
address 
future 
challenges 

Increased  availability  of  PRM  suitable  for  the  needs  of  organic 
agriculture 

-  Number  of  accepted  “organic  varieties  suitable  for  organic 

production” (Common Catalogues)  

-  Quantities  of  certified  PRM  of  “organic  varieties  suitable  for 

organic production” marketed within the EU (NCAs) 

the 
Support 
conservation 
and 
sustainable  use  of 
plant 
forest 
and 
genetic resources 

Increased  availability  of  PRM  of  conservation  and  locally  adapted 
varieties 

Increased  availability  of  FRM  for  purposes  of  conservation  of  forest 
genetic resources 

-  Number  of  conservation  and  new  locally  adapted  varieties  per 

crop group (Common Catalogues)  

-  Quantities  of  PRM  of  conservation  and  new  locally  adapted 
varieties  marketed  (notifications  by  operators  to  NCAs  and 
reporting by NCAs) 

-  Number of notifications of heterogeneous material (notifications 

by operators to NCAs and reporting by NCAs) 

70 

 
 
  
General 
objectives 

Specific objectives 

Measures of success and monitoring indicators 

-  Quantities  of  marketed  PRM  of  heterogeneous  material 
(notifications by operators to NCAs and reporting by NCAs) 
-  Number  of  SCNs  (notifications  by  operators  to  NCAs  and 

reporting by NCAs) 

-  Number of FRM notifications for the purposes of forest genetic 

resources’ conservation (FOREMATIS) 

Table 13. Measures of success and monitoring indicators 

The  legislation  will  be  considered  successful  if  there  are  sufficient  quantities  PRM  and  FRM 
available  that  are  suitable  to  address  future  challenges  and  respond  to  the  needs  of  the  different 
types of PRM and FRM users. The design of indicators that are Specific, Measurable, Achievable, 
Realistic  and  anchored  within  a  Time  Frame  (SMART)  is  not  fully  possible  because  the  number 
and  types  of  varieties  available  in  the  Common  Catalogues  is  demand  driven.  Farmers  will  plant 
PRM  of  those  varieties  for  which  there  is  a  demand.  Moreover,  there  is  no  simple  relationship 
between  the  number  of  varieties  and  the  quantities  of  certified  PRM.  For  example,  a  few  wheat 
varieties could cover the demand for wheat if planted in a large agricultural area, while it would be 
required to plant 100 varieties of tomatoes to cover diverse consumer demands. 

The  PRM  and  FRM  legislation  regulates  the  access  to  the  market  and  the  revision  addresses  the 
identified bottlenecks. For example, current variety registration rules are too restrictive for organic 
and  conservation  varieties.  Rules  that  are  adjusted  to  the  characteristics  of  such  varieties  will  be 
introduced  in  order  to  enable  their  access  to  the  market.  Accordingly,  success  would  mean  that 
within 10 years more organic and conservation varieties are registered and their seed/PRM is made 
available in the market in sufficient quantities. It cannot be anticipated how many new varieties and 
which  quantities  of  PRM/seed  will  be  marketed,  as  this  depends  on  the  uptake  of  the  new 
opportunities by the operators and the farmers presenting a sustained demand for such varieties. 

Another example is that the current rules for examination of new varieties, PRM certification and 
OCs  do  not  provide  for  the  use  of  new  methods  (BMTs)  that  have  the  potential  to  increase  the 
efficiency  of  these  procedures.  The  revision  will  remove  this  obstacle.  Success  would  mean  that 
within  10  years  BMTs  are  widely  used  and  lead  to  a  reduction  of  costs  of  examination  of  new 
varieties.  The  revision  is  expected  to  stimulate  their  development  and  use.  Genetic  markers  are 
specific to each species and variety. It cannot be anticipated if suitable markers will be available for 
all. 

The success of the legislation will therefore be measured through the number of varieties and basic 
material which are successfully registered in the Common Catalogues and the quantities of certified 
PRM and FRM produced thereof. The Common Catalogues (as of 2023 accessed through the new 
EU Plant Variety Portal) will be a key source for the indicators for monitoring progress as regards 
the type of plant varieties (accepted under general  rules on DUS and sustainability  assessment or 
under  rules  for  conservation/locally  adapted  varieties  or  organic  varieties  suitable  for  organic 
production).  Other  sources  will  be  notifications  and  reports  from  MS  as  well  as  audits  by  the 
Commission.  

Moreover,  this  approach  has  been  chosen  because  it  is  difficult  to  assess  the  individual 
contributions of the PRM and FRM legislation to sustainable agri-food production and restoration 

71 

 
 
of forest ecosystems, respectively. The impact of using improved varieties will be a combination of 
selecting  the  appropriate  variety  for  the  regional  agro-ecological  conditions  and  applying  good 
agricultural practices.  It  will also depend on the weather conditions.  Likewise, in the FRM sector 
the  improvement  is  assessed  through  the  indirect  impact  of  using  improved  tree  seeds  on  the  per 
unit  area  productivity  of  regenerated  forests.  Improved  tree  seeds  may  better  survive  in  a  harsh 
climate or show better tolerance against damages through abiotic or biotic factors. 

The number and quantities of PRM of conservation and locally adapted varieties, organic varieties 
suitable for organic production, heterogeneous material and FRM notifications for the purposes of 
forest  genetic  resources  conservation  will  offer  an  indirect  measure  of  contribution  to  increased 
genetic diversity. 

The  EU  Plant  Variety  Portal  will  allow  MS  to  fulfil  their  reporting  obligations  through  online 
submission of the relevant data (in the long term, machine to machine). MS’ reporting obligations 
under the OCR as well as EU audits will be important mechanisms to check the implementation of 
the new PRM/FRM legislation in MS. As regards the coherence with the PHL, the use of already 
existing  IT  applications  for  reporting  RNQP  non-compliances  and  the  submission  of  PRM/FRM 
import documents (IMSOC) will lead to efficiency gains. 

The  Commission  will  review  the  indicators  periodically.  The  implementation  of  the  national 
contingency plans ensuring  FRM supply will  be  regularly monitored  and  compared  with  the data 
obtained from the Forest Information System for Europe182 as regards the forest areas lost because 
of extreme weather, forest fires and disasters. 

The proposed reference period for the monitoring framework of the new PRM and FRM legislation 
is  10  years  as  it  takes  10-12  years  to  develop  a  new  plant  variety.  Based  on  the  time  needed  to 
obtain meaningful data through annual monitoring, it is considered appropriate to supplement this 
monitoring with a formal evaluation of the initiative at the earliest 10 years after the planned legal 
proposal becomes applicable. It should be avoided that the evaluation takes place before the impact 
of  the  new  requirements  for  variety  acceptance,  lighter  system  for  registration  of  conservation 
varieties and new locally adapted varieties and the notification of heterogeneous material and basic 
material for the purposes of forest genetic resources conservation becomes visible. The same holds 
true  for  the  other  actions  that  need  sufficient  data  and  monitoring  information  on  the 
implementation, application and enforcement of the expected legal provisions. 

182 Forest Information System for Europe https://forest.eea.europa.eu/  

72 

 
 
 
 
                                                 
ANNEX 1: PROCEDURAL INFORMATION 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

The Directorate-General for Health and Food Safety (DG SANTE) is the lead DG on the initiative 
on  Revision  of  the  plant  and  forest  reproductive  material  legislation.  This  initiative  is  in  the 
European  Commission's  Work  Programme  for  2022,  in  Annex  II:  REFIT  initiatives,  under  the 
heading  “A  European  Green  Deal”.  The  initiative  has  received  the  validation  in  the  Agenda 
Planning  on  25  September  2020  (reference  PLAN/2020/7576)  and  the  Inception  Impact 
Assessment was published on 15 June 2021. 

2.  ORGANISATION AND TIMING 

An Inter-Service Steering Group (ISSG) was set up. The following Commission services were its 
members: SG (Secretariat-General), SJ (Legal Service), AGRI (Directorate-General for Agriculture 
and  Rural  Development),  CLIMA  (Directorate-General  for  Climate  Action),  ENV  (Directorate-
General  for  Environment),  JRC  (Joint  Research  Centre)  and  TRADE  (Directorate-General  for 
Trade).  GROW  (Directorate-General  for  Internal  Market,  Industry,  Entrepreneurship  and  SMEs) 
and RTD (Directorate-General for Research and Innovation) were also invited but did not join the 
ISSG. The ISSG met on the following dates: 

Dates 

Topics discussed 

17 June 2021 

  Consultation strategy 
  Terms  of  reference  of  the  study  supporting  the  impact 

6 October 2021 

19 May 2022 

14 December 2022 

assessment for the revision 
  State of play of the revision 
  Kick-off  meeting  with 

the  contractor  for 

the  study 

supporting the impact assessment for the revision 

  State of play of the revision 
  Draft policy options 
  Outcome of consultations 
  Draft  interim  report  of  the  study  supporting  the  impact 

assessment for the revision  

  Final  report  of  the  study  supporting  the  impact  assessment 

for the revision 

12 January 2023 

  Draft Commission impact assessment report  
  Finalisation of the Commission impact assessment report 

18 April 2023 

  Presentation of revisions following the RSB opinion 
  Presentation of the legal proposals 

Table 14. Meetings of the ISSG. 

In  addition  to  the  above  meetings,  the  members  of  the  ISSG  were  regularly  informed  on  the 
progress  of  the  initiative  and  consulted  in  written  on  the  questionnaire  of  the  open  public 
consultation  and  the  draft  final  report  of  the  study  supporting  the  impact  assessment  for  the 

73 

 
 
revision.  In  addition,  DG  SANTE  consulted  the  Community  Plant  Variety  Office  (CPVO)  on 
aspects of this initiative relevant to CPVO’s mandate. 

3.  CONSULTATION OF THE RSB 

An upstream meeting with the Regulatory Scrutiny Board was held on 6 May 2022. A first version 
of this Impact Assessment Report was submitted to the RSB on 18 January 2023, the meeting took 
place on  15 February 2023 and the RSB written opinion was received on  17 February  2023. The 
Board  concluded  that  the  DG  had  to  revise  the  report  in  accordance  with  the  Board’s  findings 
before launching the interservice consultation. 

RSB main findings 

Modification of the IA report 

The Board noted the additional information 
provided and commitments to make changes to 
the report. 

However, the report still contained significant 
shortcomings. The Board gave a positive 
opinion with reservations because it expected 
the DG to rectify the following aspects: 

(1) The report did not present a comprehensive 
analysis of costs and benefits. The analysis of 
impact on competitiveness of EU operators, 
including on SMEs, was not sufficiently 
developed. 

The  recommendations  of  the  Board  have  been 
implemented. 

(1)  A  comprehensive  analysis  of  costs  and 
benefits has been added in Section 8 of Annex 4. 
Aspects  related  to  SMEs  and  competitiveness 
have  been  further  detailed  across  Section  6  of 
the  IA  report  and  they  are  also  summarised  in 
the new Sections 6.1.6 and 6.1.7. 

(2) The comparison of the options in terms 
efficiency was flawed. 

(2)  The  Section  7.2  on  the  comparison  of  the 
options in terms of efficiency has been revised.  

RSB adjustment requests 

Modification of the IA report 

(1) The report should explain how the concerns 
raised  by  the  European  Parliament  in  rejecting 
the  Commission’s  ‘2013  PRM  proposal’  have 
been addressed by this initiative.  

The  description  of  the  dynamic  baseline  should 
be  supplemented  with  quantitative  assessment 
where feasible. 

(1)  In  Section  1  of  the  IA  report  Table  1  has 
been added, giving an overview of the concerns 
expressed  by  the  European  Parliament  in  2014 
and  the  measures  addressing  those  concerns  in 
this initiative. 

No  additional  information  has  been  found  to 
allow adding further quantitative elements in the 
description  of  the  baseline.  The  relevance  of 
moving  from  south  to  north  of  agronomic  and 
forestry  practices  in  order  to  compensate  for 
climate change is described in Section 5.1 of the 
IA report.  

74 

 
 
 
 
 
 
 
 
 
(2)  The  intervention  logic  should  be  more 
clearly  presented.  The  report  should  better  link 
the  specific  objectives  with 
identified 
problems.  The  specific  objectives  should  be 
expressed in more SMART terms. 

the 

(3)  Based  on  a  clearer  intervention  logic,  the 
report  should  explain  in  more  detail  how  the 
policy options were designed. 

including  on 

(4)  The  report  should  assess  the  impact  on  the 
EU  operators,  seed  producers,  foresters,  and 
international 
farmers, 
competitiveness. The report should elaborate on 
Member  States’  and  other  stakeholders’  groups 
views  on  the  impacts  of  the  options  under 
consideration. 

their 

(5)  The  report  should  present  a  clear  and 
comprehensive  overview  of 
the  costs  and 
benefits  of  each  of  the  three  options.  It  should 
present the net benefit of each option, as well as 
the Benefit Cost Ratio. 

(6) Throughout the report and in all comparison 
tables the scores of the baseline should be set at 
zero. 

(7) The report should systematically refer to the 
views  of  different  stakeholder  categories, 
including  diverging  views, 
the 
report. 

throughout 

(2)  In  Section  4.3  of  the  IA  report    the 
intervention  logic  has  been  added,  linking  the 
identified  problems, 
the  general  objectives, 
specific  objectives  and  the  policy  options.  In 
Section  9  of  the  IA  report,  the  measures  of 
success  and  monitoring  indicators  have  been 
revised  and  certain  limitations  in  applying  the 
SMART approach are explained. 

(3)  The  Section  5.2  of  the  IA  report  has  been 
redrafted in order to explain in more details the 
design  of  the  policy  options.  The  previous 
Annex  6  has  been  integrated  in  Section  5.2  of 
the IA report, so that the main report presents in 
more  details  the  content  of  each  option.  In 
Sections 5.1 and 5.2 the differences between the 
baseline and Option 1 are further clarified.  

(4)  More  details  have  been  added  on  these 
aspects  across  Section  6.  Aspects  related  to 
SMEs  and  competitiveness  from  across  Section 
6 are also collated in the new Sections 6.1.6 and 
6.1.7. The different views on the impacts of the 
options under consideration are presented in the 
new Section 6.6. 

(5)  A  comprehensive  analysis  of  costs  and 
benefits has been added in Section 8 of Annex 4. 
The  major  costs  and  benefits  elements  of  each 
option are summarised in Section 6.5 of the  IA 
report.  The  net  benefit  as  well  as  the  Benefit 
Cost Ratio of each option is presented in Section 
7.2  of 
the  IA  report.  Further  details  on 
underlying  assumptions  and  uncertainties  have 
been added in Annex 4. 

(6)  The  scores  of  the  baseline  have  been  set  to 
zero throughout the report. 

categories  have  been 

(7)  Further  details  on  the  views  of  different 
added 
stakeholder 
throughout  the  report.  Sections  5.2.5  and  6.6 
have been added, elaborating respectively on the 
views  on  policy  options  and  on  views  on 
impacts  of  the  options,  including  diverging 
views on these.  

75 

 
 
 
 
 
 
 
 
 
 
Table 15. Modifications of the IA report following the comments by the RSB. 

4.  EVIDENCE, SOURCES AND QUALITY 

The  current  PRM  and  FRM  legislation  comprises  1  Directive  on  the  Common  Catalogue  and  11 
marketing Directives and covers diverse crop groups from annual crops in the case of agricultural 
species to perennial crops in the case of fruit trees. Each crop group has its specificities in relation 
to  the  two  pillars  variety  registration  (DUS  examination)  and  PRM/FRM  certification.  The 
consultation  activities  have  focussed  on  gathering  quantitative  and  qualitative  data  in  relation  to 
those two pillars and on OCs. It must be highlighted that most of the available information concerns 
agricultural  species  as  this  is  the  most  important  market  segment.  A  lot  of  effort  was  put  in  the 
collection of information on the activities of seed conservation networks, exchange in kind of seed 
between farmers and the reasons for the limited implementation of the Directives on conservation 
varieties and landraces. In general, it is to be noted that because of the diversity of crop groups and 
the multitude of technical aspects and some marginal activities, it was not feasible to  assess each 
aspect of the envisaged amendment of the legislation in detail. 

Evidence for this Impact Assessment has been collected by two external studies and a number of 
other sources. 

A  first  study183  aimed  to  update  the  state  of  play  since  the  last  evaluation  of  the  PRM/FRM 
legislation in 2008184 and the 2013 impact assessment185, as well as to fill key knowledge gaps, in 
order to support the Commission to prepare the study on the Union’s options to update the existing 
legislation  on  the  production  and  marketing  of  PRM186  following  a  request  by  the  Council187. 
Evidence  was  collected  by  literature  review,  40  interviews  (with  academics,  civil  society 
organisations, public authorities, industry representatives and farmers’ organisations), a workshop 
with 6 FRM experts, and four targeted surveys.  The targeted  surveys were addressed to 1) NCAs 
(authorities  from  25  MS  responded),  2)  amateur  gardeners  (with  6089  participants  from  29 
countries),  3)  maintainers  of  registered  varieties  for  the  amateur  market  (81  participants)  and  4) 
FRM  stakeholders  (80  participants,  including  both  FRM  users  and  NCAs).  The  limited  publicly 
available information and the fact that it is rarely broken down per group of agricultural species (i.e. 
cereal seed, beet seed, etc.), the small sample size and self-selection bias (interviews and targeted 
surveys) were identified by the contractor as limitations to the quality of the evidence collected by 
this study.  

A second study188 aimed to support the Commission in the preparation of this impact assessment. 
This  study  collected  evidence  by  literature  review,  a  targeted  survey  addressing  NCAs,  operators 
and other stakeholders in the PRM and FRM sectors (99 respondents in total), 43 interviews (30 on 
PRM and 13 on FRM), a focus group on the topic of marketing to amateur gardeners, a focus group 
on  FRM  topics,  a  case  study  on  exchange  in  kind  of  seed  (based  on  literature  review  and 
interviews) and an analysis of MS experiences on conservation varieties and varieties for amateurs 

183 ICF (2021). 
184 FCEC (2008). 
185 SWD (2013) 162 final. 
186 SWD (2021) 90 final. 
187 Council Decision (EU) 2019/1905 of 8 November 2019. OJ L 293, 14.11.2019, p. 105-106. 
188 ICF (2023). 

76 

 
 
                                                 
of  fruit  plants  and  vine  (based  on  a  targeted  survey  to  17  NCAs).  The  low  response  rates  to 
questions  aiming  to  collect  quantitative  information  to  fill-in  knowledge  gaps  as  regards  market 
size and costs for NCAs and operators were identified by the contractor as limitations to the quality 
of the evidence collected by this study. 

Despite  the  aforementioned  limitations,  the  data  collected  by  these  studies  allows  to  make 
assumptions (e.g. range of minimum to maximum values) and even allows for higher certainty on 
certain aspects where the dataset is rather complete, as NCAs from most MS have responded to the 
relevant  questions.  DG  SANTE  has  used  this  data  for  in-house  calculations  additional  to  those 
carried out  by the  external  studies, as appropriate in  combination with  quantitative data extracted 
from  the  Common  Catalogues189  on  the  numbers  of  registered  varieties,  Eurostat190  and  the  farm 
accountancy data network (FADN)191 on the cost of PRM and its share of the total cost of inputs in 
agricultural production, and the portal of the European Seed Certification Agencies Association192 
on production of certified seed (see Annex 4 for details). These sources offer the best available data 
for  the  respective  topics.  DG  SANTE  also  extracted  evidence  from  published  position  papers  of 
stakeholder organisations (either published online or submitted in the context of the consultations), 
online documents of NCAs, articles published in scientific journals and reports of EU co-financed 
research  projects.  In  particular  information  from  official  sites  and  articles  in  scientific  journals 
(having been subject to peer review) is considered to be evidence of higher quality. Remaining data 
gaps  have  been  addressed  by  using  assumptions  and  calculations  done  in  older  studies193  but  in 
such cases the uncertainty is higher. Finally, additional evidence on views and  opinions of NCAs 
and stakeholders were collected by extensive consultation activities undertaken by DG SANTE in 
the  form  of  online  questionnaires  and  meetings  with  NCAs  and  stakeholders  (see  Annex  2  for 
details).  

https://food.ec.europa.eu/plants/plant-reproductive-material/plant-variety-catalogues-databases-information-

189 
systems_en. 
190 Economic accounts for agriculture: https://ec.europa.eu/eurostat/web/agriculture/data/database. 
191 https://agriculture.ec.europa.eu/data-and-analysis/farm-structures-and-economics/fadn_en. 
192 http://escaa.org/. 
193 FCEC (2008) and FCEC (2011). 

77 

 
 
 
 
                                                 
ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) 

1.  CONSULTATION STRATEGY 

The objectives of the consultation activities were: 

 

 

 

to ensure that all relevant stakeholders are identified and given the opportunity to participate 
in the consultation; 
to  provide the opportunity for stakeholders to  inform  the impact  assessment, in  particular, 
offering an opportunity for them to inform the development of policy options addressing the 
problems identified; 
to  gather  stakeholders’  opinions  on  the  potential  policy  options  together  with  data  and 
qualitative  evidence  concerning  the  relevant  impacts  of  the  policy  options  considered. 

The consultation strategy combined different consultation methods in order to engage as much as 
possible all stakeholders identified: 

  NCAs  for  variety  registration,  PRM  certification  (agriculture,  horticulture,  vine),  FRM 

certification, plant and forest genetic resources 

  The CPVO 
  Plant breeding companies, seed and PRM multipliers and suppliers, seed and plant trading 
companies,  nurseries,  from  the  organic  and  non-organic  sectors,  both  large  and  small 
operators, and their associations 

  Professional farmers including organic farmers 
  Amateur gardeners 
  Foresters and forestry associations 
  Scientific networks on plant and forest genetic resources 
  Seed conservation networks. 

1.1.  Consultation activities undertaken by DG SANTE 

DG SANTE consulted stakeholders by means of the publication of the inception impact assessment 
(IIA)  for  feedback,  the  open  public  consultation  (OPC),  targeted  surveys,  working  groups  with 
NCAs and stakeholders and bilateral meetings with stakeholder organisations. 

The IIA was open for feedback between 15 June and 13 July 2021 on the ‘Have your say’ portal194 
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 this impact assessment. 

194 
material-revised-rules-_en  

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13083-Plant-and-forest-reproductive-

78 

 
 
 
                                                 
The OPC was carried out between 21 December 2021 and 27 March 2022 on the ‘Have your say’ 
portal195 and was addressed to any interested citizen or stakeholder. It included two sets of closed 
multiple  choice  questions,  one  for  PRM  and  one  for  FRM.  Respondents  could  also  provide 
additional  information  either  by  a  short  free  text  or  by  uploading  a  position  paper.  The  feedback 
collected was taken into account for this impact assessment. 

DG  SANTE  also  organised  two  targeted  online  consultations  on  EUSurvey196,  one  addressed  to 
NCAs responsible for FRM, held from 5 April to 30 May 2022 and one addressed to SMEs, held 
from  2  May  to  13  July  2022.  The  SME  survey  was  anonymous.  Furthermore,  DG  SANTE  held 
meetings  of  working  groups  (online  due  to  Covid-19  restrictions)  with  the  NCAs  and  with 
stakeholders  to  discuss  specific  aspects  of  the  revision.  Summary  reports  of  these  meetings  were 
published  on  the  webpages  of  DG  SANTE197.  At  the  request  of  a  number  of  stakeholders,  DG 
SANTE  held  bilateral  meetings  with  them  and  also  attended  relevant  events  of  stakeholders. 
Finally,  some  stakeholders  and  NCAs  submitted  to  DG  SANTE  opinions  on  specific  matters 
outside the framework of the IIA and the OPC. All relevant information was taken into account for 
this impact assessment. 

1.2.  Consultation activities conducted in the framework of the study supporting 

the impact assessment 

In the framework of the study a targeted survey, interviews and two focus groups were carried out. 
The  targeted  survey  was  held  online  between  9  March  and  1  April  2022.  It  was  open  to  NCAs, 
operators and other stakeholders in  the PRM  and FRM sectors, but  those interested to  participate 
had  to  pre-register.  The  interviews  aimed  to  obtain  more  detailed  and  contextualised  views.  The 
first  focus  group  addressed  the  topic  of  marketing  to  amateur  gardeners  and  the  second  one  the 
definitions of “forestry” and “non-forestry” purposes in relation to the scope of the FRM legislation 
and the potential measures to address temporary difficulties in supply of FRM. 

2.  STAKEHOLDER PARTICIPATION 

The  feedback  to  IIA  received  66  responses  from  16  countries  (15  MS  and  a  third  country). 
Geographic distribution was uneven, as 47 responses came from 5 MS (5 to 15 responses by each 
of them) and 18 responses from 10 MS (1 to 4 responses per MS). As regards type of stakeholder, 
the  submissions  were  from  business  associations  (20),  NGOs  (13),  companies/businesses  (10), 
public authorities (5), EU citizens (4), academic/research institutions (3), trade unions (3) and other 
(8). The over-representation of one MS (15 respondents from Belgium) is explained by the fact that 
these  respondents  are  EU-wide  associations  or  NGOs  based  in  Brussels.  With  the  exception  of 
public authorities, the most relevant types of activities, plant breeders (conventional and organic), 
marketing  of  PRM,  nurseries  (FRM,  ornamental),  seed  conservation  networks  and  farmers,  are 
represented in a balanced way. 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13083-Revision-of-the-plant-and-forest-

195 
reproductive-material-legislation/public-consultation_en  
196 https://ec.europa.eu/eusurvey/home/welcome  
197 
reproductive-material_en 
platforms/advisory-group-fcaph/wg-2022_en   

https://food.ec.europa.eu/plants/plant-reproductive-material/expert-groups-and-working-groups-legislation-plant-
https://food.ec.europa.eu/horizontal-topics/expert-groups/advisory-groups-action-

and 

79 

 
 
                                                 
The  OPC  received  2449  responses  from  29  countries  (24  MS  and  5  third  countries).    Number  of 
responses  ranged  from  1  to  1684  per  MS  when  citizens  are  included  and  from  1  to  184  per  MS 
when citizens are not included. There were no responses from Lithuania, Malta and Romania. All 
relevant  types  of  activities  as  well  as  public  authorities  are  represented  in  a  balanced  way. 
Furthermore, there were in total 15 responses from third countries. The majority of responses (78%, 
1908 of 2449) were from EU Citizens. Of the 541 respondents who were not citizens, 37% (202 of 
541)  were  from  company/business  organisations.  By  size,  a  majority  of  company/business 
organisations (59%, 120 of 202) were from ‘Micro (1 to 9 employees)’ enterprises. Over half of all 
public  authority  responses  (54%,  29  of  54)  were  from  national  authorities.  Amongst  Public 
authorities, Germany had the highest number of responses (18 of 54), with responses from national, 
regional and local authorities. The first question of the OPC was targeted at the general public and 
was responded to by the whole sample. Subsequent questions were addressed to stakeholders with 
expert knowledge of the legislation and only 10% of citizen participants respond to these. In total, 
488 participants responded only to expert questions on PRM, 61 only to expert questions on FRM, 
and  210  to  expert  questions  on  both  PRM  and  FRM.  Over  three  quarters  (79%)  of  citizen 
respondents,  and  half  (50%)  of  company/business  organisation  respondents  were  from  Sweden. 
National press articles concerning the PRM legislation revision and public consultation may have 
stimulated the higher-than-average level of response from Sweden. However, these have not been 
identified  as  a  campaign  as  there  was  a  high  level  of  variation  in  the  replies  to  closed  question 
responses. For Swedish citizens, only a small number of open question responses are identical (less 
than  five  in  any  one  case)  but  they  have  a  high  tendency  to  focus  on  a  few  specific  issues,  in 
particular  asking  to  facilitate  the  preservation  of  local  and  traditional  varieties  and  not  to  impose 
any rules on the exchange of seed between hobby growers. In both categories “company/business 
organisations”  and  “public  authorities”  there  were  cases  of  submissions  of  identical  additional 
documents,  although  less  than  10  in  each  case.  A  campaign  has  been  identified  where  32 
respondents,  mostly  citizens  from  Germany,  submitted  identical  additional  documents  supporting 
that  DUS  criteria  should  not  be  a  prerequisite  for  variety  registration,  calling  for  extended 
exemptions for conservation purposes and for the implementation of the farmers’ rights defined in 
the  International  Treaty  on  Plant  Genetic  Resources  for  Food  and  Agriculture  and  the  United 
Nations Declaration on the Rights of Peasants. As regards FRM 12 German stakeholders composed 
of regional authorities, citizens and a business association stated that; the legislation should not be 
substantially  changed,  an  extension  of  the  number  of  EU-regulated  species  is  necessary,  forestry 
and non-forestry purposes should be clearly defined, the origin of the FRM must be guaranteed in 
order for forests derived from that FRM to fulfil the various forest functions for the next decades 
and  centuries,  a  stable  and  sustainable  funding  to  minimise  potential  supply  shortages  should  be 
prioritised through an EU regulation and that the financial impact on all forest stakeholders affected 
by the implementation of the legislation must be restricted to a minimum. There were 25 responses 
to the targeted survey addressed to NCAs responsible for FRM from 19 different MS. There were 
251  responses  to  the  targeted  survey  addressed  to  SMEs  from  22  different  MS  (from  1  to  33 
responses per MS). 

themselves  as  academic/research 

The  targeted  survey  conducted  in  the  framework  of  the  external  study  supporting  the  impact 
assessment received 99 responses from 27 countries (23 MS and 4 third countries). 8 respondents 
identified 
institute,  26  as  business  association,  21  as 
company/business,  4 as NGO, 31 as a public or  NCA and 8 as “other”. There were no responses 
from Latvia, Lithuania, Malta and Romania. 74 respondents contributed only in relation to PRM, 18 
only in relation to FRM  and 7 in relation to both PRM and FRM aspects. Distribution as regards 
origin and type of activities is considered satisfactory. 

80 

 
 
3.  RESULTS OF STAKEHOLDER CONSULTATION ACTIVITIES 

As  regards  PRM,  there  is  overall  support  for  maintaining  the  current  regulatory  system  and  its 
two  basic  pillars  of  variety  registration  (based  on  DUS  and  where  applicable  VCU)  and  PRM 
certification.  Some  respondents  called  for  maintaining  the  current  “one-key  one-door”  approach 
(i.e. same DUS rules for the plant variety rights  regime and the market access of varieties) while 
most  NGOs  called  to  maintain  DUS  only  for  plant  variety  rights,  allowing  the  breeder  to  choose 
whether  to  use  DUS  or  not  for  variety  registration.  Potato  breeders  in  particular  called  for  the 
abolishment  of  VCU  for  potato  varieties  and  vegetable  breeders  called  not  to  introduce  VCU  for 
vegetable  varieties.  The  various  actors  involved  in  conservation  activities,  small-scale  farmers 
interested  in  exchange  in  kind,  the  organic  sector  and  most  citizens,  also  called  for  derogations 
from this basic system in order to enable the availability of PRM belonging to varieties that cannot 
meet the DUS requirements and/or to heterogeneous material. The necessity of such derogations is 
agreed  by  all  stakeholders  for  meeting  objectives  relevant  to  conservation  and  sustainable  use  of 
plant  genetic  resources,  organic  production  and  production  in  marginal  areas.  There  is  however 
important divergence of views in relation to the degree of such derogations, ranging from calls for a 
total  exception  of  exchange  in  kind,  conservation  activities  and  marketing  to  amateur 
gardeners to the opinion that existing derogations are sufficient and do not need to be extended. In 
particular,  several  NGOs  called  for  the  new  legislation  to  explicitly  implement  farmers’  rights  as 
defined  in  the  International  Treaty  on  Plant  Genetic  Resources  for  Food  and  Agriculture  and  the 
United Nations Declaration on the Rights of Peasants. Main arguments against total exemption are 
the  concerns  about  plant  health  i.e.  spreading  of  diseases  by  PRM  exempted  from  the  legislation 
(opinion  shared  by  conventional  breeders,  farmers  other  than  small-scale  ones  and  NCAs),  the 
respect of plant variety rights and the avoidance of unequal competition (opinion mostly supported 
by  conventional  breeders),  as  well  as  the  need  to  guarantee  a  minimum  quality  and  traceability 
(opinion shared by farmers other than small-scale ones and most NCAs, also important for 50% of 
the citizens responded to the various consultations). As regards marketing to amateur gardeners, 
several  stakeholders were of the view that it is  not  possible to  separate marketing to  professional 
users from marketing to amateur gardeners. Many operators market PRM to both professional users 
and amateur gardeners whereas others market exclusively to amateur gardeners. As regards organic 
varieties,  organic  breeders  stressed  the  need  for  variety  examination  (DUS  and  VCU  where 
applicable) adjusted to the needs and the principles of organic production. In contrast, conventional 
breeders questioned the need for such derogations for organic varieties, as currently in their view 
DUS  varieties  multiplied  under  organic  conditions  cover  most  of  the  needs  of  the  organic  sector 
with very good results. 

In relation to sustainability, there is overall recognition of the importance of PRM as the starting 
point of agri-food production for achieving the relevant objectives. Conventional breeders and most 
NCAs supported that the current VCU requirements for agricultural plant species already contribute 
to these objectives, as they allow for the acceptance of varieties with characteristics that contribute 
to  a  more  sustainable  production  as  disease  resistance,  nutrient  efficiency,  drought  tolerance  and 
increased  yield.  Introduction  of  requirements  of  examination  of  new  varieties  of  fruit  plants  and 
vegetables for such characteristics was supported, though not  in  the form of the current  VCU for 
agricultural  plant  species,  as  the  uses  especially  for  vegetables  are  very  diverse.  The  need  for 
flexibility to address the different conditions across Europe was stressed by almost all respondents. 
Actors involved in conservation activities and organic production stressed that the contribution to 
sustainability  of  material  not  meeting  the  DUS  requirements  is  equally  important,  especially  for 
production under low-input  and organic conditions  and in relation to  short supply  chains  (locally 
adapted  varieties  for  local  markets).  Some  of  these  actors  also  put  in  question  the  usefulness  of 

81 

 
 
examination  of  varieties  for  specific  characteristics,  arguing  that  one  should  rather  look  into  the 
sustainability of agricultural production practices.  

In  relation  to  links  to  plant  health  requirements,  the  need  to  remove  duplications  on  RNQPs 
between  PHL  and  PRM  was  recognised  by  most  NCAs  and  operators.  For  the  purposes  of 
conservation  and  sustainable  use  of  genetic  resources  some  stakeholders  called  for  exempting 
operators and PRM from all plant health requirements. On the contrary, the majority of NCAs and 
other  operators  explicitly  opposed  to  exemptions  from  plant  health  requirements,  even  if 
exemptions would be granted from the PRM rules for variety registration and PRM certification. 

As  regards  OCs,  most  operators  agreed  that  a  harmonisation  of  requirements  is  desirable,  noting 
that  this  however  should  not  lead  to  increased  administrative  burdens  for  them.  Views  were  also 
split  as  regards  the  inclusion  of  the  PRM  and  FRM  legislation  in  the  scope  of  the  OCR,  due  to 
concerns for potential increase in administrative burdens. In particular for PRM, almost all NCAs 
and operators were against including the certification system as such under the OCR. The majority 
saw  benefits  as  regards  more  efficient  marketing  and  import  controls.  As  regards  FRM,  most 
respondents opposed to the inclusion of the FRM legislation into the scope of the OCR because of 
the specificity of OCs in this sector and called for OCs to remain under the control of the respective 
forest  competent  authority.  Most  stakeholders  of  all  categories  called  for  maintaining  some 
flexibility in the organisation of OCs and keeping the costs as low as possible. 

In relation to the use of BMTs and digital solutions, most PRM and FRM stakeholders agreed that 
these could bring benefits and called for the legal framework to allow the latest technologies to be 
applied, in line also with developments of international standards. There is overall agreement that 
the  phenotype-based  system  of  registration  of  varieties  should  be  maintained.  Some  stakeholders 
even  called  to  limit  BMTs  use  only  when  these  are  linked  to  phenotypic  expression.  Almost  all 
however  could  agree  to  introduce  the  options  for  use  of  BMTs  and  digital  solutions,  without 
making these an obligation.  

There  is  overall  support  for  extending  PRM  certification  activities  under  official  supervision. 
Above  50%  of  FRM  stakeholders  were  favourable  of  allowing  certain  certification  tasks  to  be 
conducted under official supervision except for the issuing of the master certificate. Some PRM and 
FRM stakeholders declared that SMEs might not have sufficient human and financial resources for 
carrying out certification under official supervision. They stressed that it should always be possible 
for  the  operators  to  opt  for  certification  by  the  NCAs.  However,  views  on  whether  VCU  should 
become  possible  under  official  examination  were  split,  as  fears  were  expressed  by  different 
stakeholders that the reliability of results would be undermined and/or that it could be difficult to 
have  comparable  results.  The  majority  of  forest  NCAs  and  regional  authorities  opposed  to  the 
assessment for the approval of basic material intended to produce FRM of the source-identified and 
tested categories by operators under the official supervision of the NCAs. 

All  respondents  that  provided  comments  in  relation  to  ornamental  propagating  material 
emphasised that there is no need to change the current simple rules. There should not be any DUS 
tests  for  variety  registration  of  ornamental  crops  as  such  tests  would  seriously  increase  costs  and 
decrease the number of  varieties on the market  without having  any benefits.  In their opinion, the 
market regulates itself with a private registration system for determining the identity of varieties. 

As  regards  FRM,  there  is  overall  support  for  keeping  the  FRM  legislation  separated  from  the 
legislation on other PRM. All respondents called for keeping the existing pillars of registration of 

82 

 
 
basic  material  and  FRM  certification.  The  majority  of  respondents  highlighted  the  necessity  to 
retain flexibility  allowing MS to  decide which  FRM is  adapted to  the local  and  regional  climatic 
and ecological conditions. Respondents expressed mixed views on the extension of the scope of the 
FRM legislation to the production and marketing of FRM for certain non-forestry purposes.  

4.  CONCLUSIONS 

The different consultation activities complemented each other to achieve a balanced evidence base 
covering different stakeholder categories. From all the stakeholder consultation activities organised, 
it emerges that option 2 would best address the concerns of all actors. 

83 

 
 
 
 
ANNEX 3: WHO IS AFFECTED AND HOW? 

1.  PRACTICAL IMPLICATIONS OF THE INITIATIVE 

This  proposal  will  have  practical  implications  for  all  those  in  the  private,  public  and  non-
governmental sectors who are active in the marketing of PRM and FRM. This includes operators 
(breeders  of  new  varieties,  seed  multipliers,  companies  marketing  PRM  and  FRM,  organisations 
engaged  in  conservation  and  sustainable  use  of  plant  and  forest  genetic  resources),  NCAs 
responsible  for  the  acceptance  of  new  varieties  and  the  certification  of  PRM  and  FRM  and  the 
relevant OCs. 

1.1.  Operators 

Breeders and/or applicants for the registration of new varieties of the regulated species will have to 
meet  more  elaborated  criteria  as  regards  the  contribution  of  these  varieties  to  a  more  sustainable 
agri-food  production.  This  may  result  in  increased  breeding  costs  and  lower  numbers  of  new 
varieties being authorised for marketing, at least in the first years after entry into force of the new 
requirements until breeding programmes can be adjusted to the new requirements.  

Producers  of  FRM  will  have  to  assess  FRM  for  characteristics  contributing  to  sustainable 
production and make available to buyers/users of FRM information on the suitability of FRM for 
climatic and ecological conditions. Producers of FRM for specific non-forestry purposes will have 
to meet the requirements of the FRM legislation (approval of basic material, rules on provenance, 
certification of FRM). 

All  other  measures  do  not  result  into  new  obligations  for  operators  but  provide  them  with  new 
options (additional certification tasks possible under official supervision, VSCU examination under 
official  supervision,  digitalisation  of  documents,  use  of  BMTs,  use  of  innovative  production 
methods). In order to make use of some of these new options, operators may have to reallocate their 
resources and/or carry out some investment. The extent of such investments will largely depend on 
the current situation, e.g. using the option for additional certification tasks will be much easier and 
will  probably  require  no  significant  investments  for  operators  already  carrying  out  certification 
tasks  under  official  supervision.  Other  measures  will  provide  lighter  conditions  for  accessing  the 
market  (organic  varieties  suitable  for  organic  production,  conservation  and  locally  adapted 
varieties, heterogeneous material), without resulting into new obligations. 

1.2.  National competent authorities 

Extension of the certification tasks that may be carried out under official supervision is expected to 
require that NCAs will have to reallocate staff from official  certification activities to training and 
supervision  activities.  The  impact  of  this  will  depend  on  the  demand  by  operators  to  carry  out 
additional tasks under official supervision.  

Extension of the current VCU requirements for agricultural plant species and vine to better address 
sustainability and introduction of sustainability requirements for all other crop groups (vegetables 
and  fruit  plants)  in  the  procedure  of  acceptance  of  new  varieties  will  require  that  NCAs  increase 
their  capacity  in  terms  of  staff  and  testing  stations.  This  impact  will  be  mitigated  by  a  transition 

84 

 
 
period before these requirements enter into force, permitting these examinations to take place under 
official supervision at the premises of the operators and allowing the cooperation between the MS. 

Harmonisation of OCs on production, marketing and imports of PRM/FRM and subjecting them to 
the OCR, as well as moving the lists of RNQPs and specific measures to the PHL with PRM/FRM 
legislation referring to them instead of duplicating them, will also require NCAs to reallocate some 
of their resources  (depending on current  allocation between PHL  and PRM/FRM certification) or 
increase their resources in case they don’t already meet the minimum rates of OCs to be introduced. 
OCs subject to OCR will also mean that NCAs will have to include OCs on PRM and FRM in the 
multi-annual national control plan and to publish an annual report on the number of OCs carried out 
and  the  outcome  of  those  controls,  but  several  NCAs  already  follow  these  practices  despite  not 
being an obligation currently.  

Adapted DUS and VCU requirements for the examination of organic varieties suitable for organic 
production will require that NCAs allocate staff and testing stations to test these.  

Lighter rules for seed conservation networks, marketing to amateur gardeners and exchange in kind 
of  seed,  simplification  of  current  rules  for  conservation  varieties  and  extension  of  those  rules  to 
cover  new  locally  adapted  varieties  and  broadened  scope  for  heterogeneous  material  beyond 
organic  production  on  the  one  hand  will  require  dedicated  staff  for  their  implementation.  On  the 
other  hand,  removal  of  some  of  the  current  requirements  (variety  registration  and  PRM 
certification) will mitigate this impact. 

Extension  of  the  scope  of  FRM  legislation  to  include  the  production  of  FRM  for  specific  non-
forestry  purposes,  extension  of  sustainability  requirements  to  cover  lower  FRM  categories,  and 
introduction  of  a  requirement  for  contingency  planning  to  ensure  availability  of  FRM  may  also 
require an increase in the resources of the NCAs. 

1.3.  Users of PRM and FRM 

There  are no new obligations for  the users of PRM and FRM  resulting  from  this  initiative as the 
scope  of  the  legislation  does  not  cover  the  use  and  the  users  of  PRM  and  FRM.  However,  the 
increased  sustainability  assessment  may  lead  to  a  marginal  increase  of  price  of  inputs  (seed  and 
other PRM) for farmers, but the initiative is expected to lead to increased availability of PRM and 
FRM  for  all  types  of  users,  and  to  PRM  and  FRM  being  more  suitable  for  meeting  future 
challenges.  Consequently,  users  of  PRM  and  FRM  will  benefit  from  a  higher  stability  of  their 
income under adverse conditions. 

2.  SUMMARY OF COSTS AND BENEFITS 

The estimates of costs and benefits refer to the preferred option in relation to the baseline. The main 
recipient of the benefit is indicated in the comments’ column. 

85 

 
 
 
 
I. Overview of Benefits (total for all provisions) – Preferred Option 

Description 

Amount 

Comments 

All  certification  tasks  are  permitted 
under  official  supervision  except  the 
issuing of the official label. 

Strengthened sustainability 
requirements 

Direct and indirect benefits 

  EUR  1.7  million  per  year 

in  reduced 

  Operators 

certification costs198 (direct benefit) 

  Efficiency  gains 

and 

flexibility,  not 

monetised (indirect benefits) 

  Avoided  loss  in  crop  output  ranging  from 
EUR 621 to 2 486 million annually (indirect 
benefit) 

  Farmers 

  Reduced  losses  in  forestry  (indirect  benefit, 

  Foresters 

not monetised) 

Harmonisation  of  official  controls 
subject to OCR 

  Efficiency  gains 
monetised)  

(direct  benefit,  not 

  NCAs 

Decisions for addition of new species 
in  (or  removal  of  species  from)  the 
scope  of  the  PRM  legislation  and  on 
the equivalence to EU rules  for third 
countries  will  be  taken  by  means  of 
tertiary legislation. 

  Shorter time to reach such decisions but the 
benefits  are  rather  limited  as  only  a  small 
number  of  decisions  every  year  (0-4)  are 
concerned. Not monetised. 

  Commission 
  NCAs 
  Operators 

Lighter  rules  for  seed  conservation 
networks,  marketing 
to  amateur 
gardeners  and  exchange  in  kind  of 
seed,  simplification  of  current  rules 
and 
for 
extension of those rules to cover new 
locally 
and 
broadened  scope  for  heterogeneous 
material. 

conservation 

varieties 

varieties 

adapted 

  Operators  would  benefit 

from 

lighter 
procedures for access to market. Number of 
operators  and  quantities  of  PRM  concerned 
are  unknown.  Though  number  of  operators 
could  be  in  the  range  of  several  thousands, 
the  quantities  of  PRM  concerned  are 
considered 
limited.  New  market 
opportunities  could  have  a  value  of  up  to 
EUR 266 million annually. 

to  be 

Several 

  Operators: 
hundred  
varieties 
heterogeneous 
material  to  be  brought  in  the 
market over the next ten years.  

or 

to  deviate 

The  possibility 
from 
certain  DUS  requirements  as  regards 
uniformity  will  be  provided  for  the 
DUS examination of organic varieties 
suitable for organic production. 

  Operators 

The  breeding  period  of  varieties  compliant  with 
reduced  uniformity  requirements  can  be 
in 
average  2  years  shorter  than  for  varieties  fully 
meeting those requirements. 
Operators  making  use  of  this  possibility  will 
therefore  access  the  market  faster,  with  reduced 
breeding costs and  with varieties that up to now 
were restricted  from the  market since it  was  not 
possible  to  register  varieties  not  meeting  the 
DUS requirements. 
A  few  dozen  operators  across  EU  are  likely  to 
use 
this  option.  The  number  of  varieties 
registered  under  these  rules  could  be  in  average 
100 annually. Assuming EUR 50 000 savings in 
breeding  costs  per  variety,  concerned  operators 
may see savings of EUR 5 000 000/year. 

The 
transfer/notification  of  new 
varieties  from  national  to  Common 

Administrative cost savings related to the ‘one in, one out’ approach 
The  period  between  acceptance  in  a  national 
catalogue and access to the common market will 

  Commission: need for adoption of 
24  Decisions  every  year  and 

198 The certification costs are considered as testing costs and not as administrative costs. 

86 

 
 
 
 
                                                 
Catalogues  will  be  managed  by  the 
MS  without 
a 
Commission Decision. 

the  need 

for 

Allow  MS  to  decide  themselves  on 
permitting  temporarily  the  marketing 
of  seed  that  does  not  satisfy  the 
requirements  in  respect  of  minimum 
germination,  if  germination  is  not 
lower  than  15  %  than  the  required 
germination rate. 

to  be 
All  professional  operators 
registered  in  a  single  register  under 
the PHL. 

be  shortened  by  1  to  4  months  for  about  4  000 
new varieties every year. Not monetised. 

In  average  30  notifications  annually  (for  a  total 
of 50 000 tonnes of seed, or about 0.01% of the 
quantities  of  seed  certified  annually)  become 
redundant. Not monetised. 

Over  20  000  duplicate  registrations  will  be 
avoided and over EUR 800 000 annual savings in 
registration  costs  for  operators  supplying  PRM 
of fruit plants. Over 4 000 duplicate registrations 
will be avoided and there will be over EUR 237 
000  annual  savings  in  registration  costs  for 
operators supplying FRM 

publication  of 
the  Common 
Catalogues in the Official Journal 
is removed 
  Operators: 

avoidance 
unnecessary waiting time 

of 

  Commission and NCAs: avoiding 
the  handling  of  on  average  30 
notifications 
and 
per 
adoption 
corresponding 
Commission Decisions. 

year 

of 

  Operators:  Reduced  waiting  time 
by  at  least  15  days  for  each 
notification avoided. 

  Operators 

II. Overview of costs – Preferred option 

Citizens/Consumers 

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Direct adjustment 
costs 

Direct administrative 
costs 

N/A 

N/A 

Direct regulatory fees 
and charges 

N/A 

Strengthened 
sustainability 
requirements    

Direct enforcement 
costs 

Indirect costs 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

EUR  400  million 
in 
annually 
increased 
PRM 
costs  for  farmers, 
corresponding 
to 
3%  increase  in  cost 
of  PRM  or  0.15% 
increase  in  cost  of 
global inputs 

Direct adjustment 
costs 

N/A 

N/A 

Harmonisatio
n  of  OCs 
subject 
to 
OCR 

Direct administrative 
costs 

N/A 

N/A 

Increased 
registration 
costs:  EUR  6.4  million 
annually (PRM) 

Up to 200 varieties less 
(or  5%  less)  registered 
every year (PRM) 

EUR  43 
million annually 

to  98 

on 

Reallocation  of 
resources, 
depending 
current 
organisation  
Globally  neutral 
impact. 

Modified  rate  of  OCs 
(increase  or  decrease) 
depending  on  current 

  Multi-annual 
national 
control plan 

87 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
situation 
Globally 
impact. 

per  MS.  
neutral 

 

Annual  report 
on OCs 

on 

Depending 
current 
implementation  (not 
quantifiable). 
Globally 
impact. 

neutral 

Direct regulatory fees 
and charges 

N/A 

N/A 

Direct enforcement 
costs 

N/A 

N/A 

Indirect costs 

N/A 

N/A 

Costs related to the ‘one in, one out’ approach 

N/A 

N/A 

N/A 

N/A 

Direct adjustment 
costs  

Total   

Indirect adjustment 
costs 

Administrative costs 
(for offsetting) 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

88 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RELEVANT SUSTAINABLE DEVELOPMENT GOALS 

III. Overview of relevant Sustainable Development Goals – Preferred Option(s) 
Relevant SDG 

Expected progress towards the Goal 

Comments 

SDG  2  –  End  hunger, 
achieve  food  security  and 
improved nutrition and 
promote 
agriculture 

sustainable 

– 

12 

Ensure 
SDG 
sustainable consumption and 
production patterns 

SDG  13  –  Take  urgent 
action 
to  combat  climate 
change and its impacts 

SDG  15  –  Protect,  restore 
and  promote  sustainable  use 
of terrestrial 
sustainably 
ecosystems, 
manage 
combat 
forests, 
desertification,  and  halt  and 
reverse land degradation and 
halt biodiversity loss 

The  simplification  of  the  legal  framework  and  its  adjustment  to 
recent  scientific  and  technical  developments  will  increase  the 
efficiency  of  the  system  and  support  the  competitiveness  of  the 
EU  PRM  sector.  In  turn,  this  will  contribute  in  securing  the 
availability  and  affordability  of  PRM  in  the  EU.  As  PRM  is  the 
starting point and critical input for the agri-food production, this is 
also  a  direct  contribution  towards  achievement  of  food  security 
(SDG 2). 

The  assessment  of  new  varieties  for  sustainability  characteristics 
will steer breeding efforts towards improved varieties with higher 
and  more  stable  yields  (SDG  2),  improved  water  and  nutrients 
efficiency  and  increased  resistance  to  plant  pests,  contributing  to 
reduced  reliance  of  agri-food  production  on  inputs  like  water, 
fertilisers  and  plant  protection  products  (SDG  12),  better 
performing under the climate change conditions, contributing to a 
strengthened  resilience  and  adaptive  capacity  of  agri-food 
production  to  climate-related  hazards  and  natural  disasters  (SDG 
13). 

Measures  for  facilitating  the  registration  of  organic  varieties 
suitable  for  organic  production  will  contribute  to  the  further 
expansion  of  organic  farming,  which  produces  high  quality  food 
with low environmental impact (SDGs 2 and 12). 

Measures for facilitating the availability of conservation varieties 
and other locally adapted varieties, exchange in kind of seed and 
the 
the  use  of  heterogeneous  material  will  contribute 
sustainability  of  agricultural  production  in  marginal  areas  (SDGs 
2  and  12).  Furthermore,  these  measures  will  contribute  to 
increased  genetic  diversity  of  cultivated  plants  (SDG  15),  which 
again  is  a  contribution  to  SDG  2,  as  the  breeding  of  improved 
varieties relies on this genetic diversity. 

to 

Measures  for  assessing  FRM  for  characteristics  contributing  to 
sustainable production (resistance to pests, suitability for climatic 
conditions), making available information to users/buyers of FRM 
on  the  suitability  of  FRM  for  climatic  and  ecological  conditions, 
contingency planning ensuring the availability of FRM will enable 
the  availability  and  use  of  the  most  appropriate  FRM  for  each 
location,  therefore  contributing  to  a  more  sustainable  forest 
management and afforestation (SDGs 12, 13 and 15). Facilitation 
of  the  registration  of  basic  material  for  the  purposes  of 
conservation of forest genetic resources will also contribute to the 
achievement of SDG 15.  

89 

 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 4: ANALYTICAL METHODS / CALCULATIONS 

1.  GLOBAL  VALUE  OF  PRM/FRM  AND  COST  OF PRM  AS  A  SHARE  OF  TOTAL  INPUT  COSTS  OF 

AGRICULTURAL PRODUCTION 

According  to  information  retrieved  from  Eurostat  economic  accounts  for  agriculture199,  the  total 
value in EU27 of seeds and planting stock used in agriculture as input in the production200 in 
2021  was  13.3  billion  EUR.  This  value  covers  the  total  consumption  of  bought-in  domestic  and 
imported  seeds  and  planting  stock  for  current  production  and  maintaining  stocks  in  vineyards, 
orchards,  and  Christmas  tree  plantations.  It  includes  in  particular  direct  purchases  of  seeds  and 
planting  stock  from  other  farmers.  However,  it  does  not  include  seed  produced  and  consumed 
within the same unit201. It also does not include seeds and planting stock sold to amateur gardeners. 
It includes PRM of species not subject to the PRM legislation and therefore provides the upper limit 
of the value of PRM covered by the PRM legislation. The overestimate is not considered excessive, 
as the PRM legislation covers the economically most important species. 

The amount of EUR 13.3 billion represents in comparison to 2010 an increase of 24.77% (values at 
constant prices, 2010 = 100) and an increase of 27.84% in current values. The evolution in current 
prices is comparable to that of the total value of all inputs (total intermediate consumption) and to 
that of plant protection products. The cost of seeds and planting stocks as a percentage of the total 
intermediate consumption has remained stable at around 5.2% but this is only an indicative average, 
as  seeds  and  planting  stock  are  input  mainly  for  crop  production,  while  the  total  intermediate 
consumption includes all input for all sectors including the livestock sector. 

199 https://ec.europa.eu/eurostat/web/agriculture/data/database  
200  See  point  2.089  of  Annex  I  of  Regulation  (EC)  No  138/2004  on  the  economic  accounts  for  agriculture  in  the 
Community. 
201  See  point  2.097  of  Annex  I  of  Regulation  (EC)  No  138/2004  on  the  economic  accounts  for  agriculture  in  the 
Community. 

90 

 
 
 
 
                                                 
Year 

2005 

2006 

2007 

2008 

2009 

2010 

2011 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

Constant prices (2010 = 100) in million EUR 

Total intermediate 
consumption 

Seeds and planting stock 

Fertilisers and 
improvers 

Plant protection 
products 

200.843,86 

200.340,25 

202.561,99 

202.725,39 

201.365,51 

201.771,43 

205.928,91 

202.797,05 

205.244,50 

208.589,48 

209.352,92 

210.845,06 

212.882,43 

215.706,45 

215.873,54 

218.111,87 

220.084,44 

9.267,60 

9.537,09 

9.622,62 

9.973,34 

9.609,87 

10.439,09 

10.463,09 

10.071,73 

10.187,92 

10.491,53 

10.724,34 

10.872,46 

11.105,58 

11.342,27 

11.465,32 

11.442,48 

11.563,71 

16.372,26 

16.004,65 

16.199,51 

14.484,88 

12.991,40 

13.751,84 

14.122,28 

13.905,10 

14.777,15 

15.177,37 

15.077,51 

15.289,65 

15.310,92 

15.535,67 

15.333,82 

15.405,23 

15.340,85 

9.132,67 

8.939,98 

9.087,47 

9.790,25 

9.518,42 

9.200,33 

9.465,13 

9.664,09 

10.123,11 

10.531,11 

10.593,68 

10.682,33 

10.611,95 

10.584,32 

10.593,60 

10.538,50 

10.980,05 

Evolution between 2010-
2021  
(constant prices, 2010 = 
100) 

9.08% 

24.77% 

-6.29% 

19.34% 

Current prices in million EUR 

Year 

2010 

2021 

Total intermediate 
consumption 

201.771,43 
Share of total intermediate 
consumption 

260.167,89 
Share of total intermediate 
consumption 

Seeds and planting stocks 

Fertilisers and 
improvers 

Plant protection 
products 

10.439,09 

5.17% 

13.345,85 

13.751,84 

6.82% 

19.599,82 

5.12% 

7.53% 

9.200,33 

4.56% 

11.828,69 

4.54% 

Evolution between 2010-
2021  
(current prices) 

28.56% 
Table 16. Value of PRM as input to agricultural production and its evolution (calculations based on data retrieved from 
Eurostat). 

28.94% 

27.84% 

42.52% 

Data retrieved from the farm accountancy data network (FADN)202 was used to estimate203 the cost 
of seeds and plants (PRM) as a share of total intermediate consumption (total input costs) for the 

202 
http://agridata.ec.europa.eu/extensions/FADNPublicDatabase/FADNPublicDatabase.htmlhttps://agridata.ec.europa.eu/e
xtensions/FADNPublicDatabase/FADNPublicDatabase.html  
203 DG SANTE in-house calculations. 

91 

 
 
 
 
 
                                                 
eight different types of farming defined in FADN. This is compared to the share of fertilisers and 
plant protection products. These estimates are considered indicative as they express only the FADN 
surveyed farm populations204. Furthermore, the FADN data structure does not allow calculating by 
extrapolation  total  values205.  Nevertheless,  the  FADN  data  indicates  that  the  cost  of  seeds  and 
plants  as  share  of  the  total  intermediate  consumption  is  more  important  in  horticulture  (largely 
corresponding  to  the  vegetable  species)  and  double  than  the  share  for  field  crops  (largely 
corresponding to the agricultural plant species). 

Cost of main input categories as share of the total intermediate consumption for the different types of farming 
Average for the period 2018-2020 for EU27 

Type of farming 

Seeds and plants 

Fertilisers 

Plant protection products 

Field crops 
Horticulture 
Wine 
Other permanent crops 
Milk 
Other grazing livestock 
Granivores 
Mixed farms 

13.61% 
26.97% 
1.52% 
2.39% 
2.65% 
2.40% 
1.24% 
4.53% 

16.37% 
6.36% 
6.53% 
16.15% 
4.40% 
4.37% 
1.37% 
6.36% 

12.04% 
5.15% 
11.49% 
14.19% 
1.45% 
7.04% 
1.22% 
4.08% 

Global average 
9.83% 
Table 17. Cost of main input categories as share of the total intermediate consumption for the different types of farming 
(average for the period 2018-2020 for EU27), calculations based on data retrieved from FADN. 

6.73% 

7.75% 

The global average share of seeds and plants to the total intermediate consumption derived from the 
two datasets is comparable, therefore it is assumed that the share of “seeds and planting stocks” to 
“total intermediate consumption” according to Eurostat data can be used for further calculations. 

No similar data are available in relation to FRM in Eurostat and FADN. 

2.  NUMBER OF NEW VARIETIES 

The  Common  Catalogues  were  used  to  calculate  the  average  number  of  new  varieties  registered 
annually over the period 2012-2021. It is assumed that due to the envisaged measures for increased 
sustainability requirements in the examination of candidate varieties, it will become more difficult 
to register new varieties. A number of varieties that would have been registered under the baseline 
will  be  either  withdrawn  by  the  applicants  or  rejected.  This  impact  is  expected  to  be  lowest  for 
agricultural plant species, where the VCU is already in place. For the other crop groups, the impact 
of  sustainability  assessment  would  be  lowest  in  option  1  (reliance  on  information  that  applicants 
voluntarily submit along with the application for registration of a new variety). For all crop groups, 
the  impact  would  be  highest  in  option  3  as  highly  harmonised  rules  would  be  most  difficult  to 
comply with. 

204  The  FADN  survey  does  not  cover  all  the  agricultural  holdings  in  the  Union,  but  only  those  which  are  of  a  size 
allowing  them  to  rank  as  commercial  holdings.  The  FADN  weighting  system  has  been  optimised  with  a  view  to 
providing  good  averages  for  groups  rather  than  good  total  values  for  groups.  Taken  from  the  document  “FADN 
definitions of variables in FADN standard rules”.  
205 The FADN used a weighting system optimised for providing good averages for groups rather than good total values 
for groups. Taken from the document “FADN definitions of variables in FADN standard rules”. 

92 

 
 
 
 
                                                 
Average  number  of  new 
plant varieties per year 

Baseline1 

Agricultural plant species 
Vegetable species 
Vine 
Fruit plants 

2 564 
1 384 
41 
39 

Option 1 
Additional 
withdrawal 
and/or 
rejection 
rate 3% 
2 487 
1 342 
40 
38 

Option 2 
Additional 
withdrawal 
and/or 
rejection 
rate 5% 
2 435 
1 315 
39 
37 

Option 3 
Additional 
withdrawal 
and/or 
rejection 
rate 10% 
2 308 
1 246 
37 
35 

Table 18. Average number of new plant varieties per year. 

3.  PRM CERTIFICATION AREAS / CERTIFIED QUANTITIES AND CERTIFICATION UNDER OFFICIAL 

SUPERVISION 

ESCAA category 
Cereals 

Potatoes 

Maize and sorghum 

Forage and turfgrass 

Oil crops 

Pulses 

Beets and chicory 

Fibre crops 

Vegetables 

TOTAL 

Certified seed quantities 
(in tons) in 2020 (EU27) 
3 988 386.90 

2 443 652.30 

572 810.70 

397 890.91 

198 757.00 

191 373.30 

179 725.80 

17 239.20 

8 594.96 

7 998 431.07 

Table  19. Certified seed quantities per ESCAA crop categories (in tons) in 2020 (EU27)  (calculated on basis of data 
retrieved from escaa.org). 

CERTIFIED SEED QUANTITIES in EU in 2020 (tonnes) 

Common name 
Seed potatoes 

Wheat 

Barley 

Maize (except popcorn and sweet corn) 

Forage and turfgrass 

Durum wheat 

Triticale (hybrid of wheat and rye) 

Oat 

Rye 

Sugar beet 

Soja bean 

Rice 

Latin name 
Solanum tuberosum L.   

Triticum aestivum L.  

Hordeum vulgare L. 

Zea mays L. 

Various species 

Triticum durum desf.  

Triticosecale wittm.  

Avena sativa L.  

Secale cereale L. 

Beta vulgaris L. 

Glycine max (L.) 

Oryza sativa L. 

93 

Total 

2.443.652,30 

2.095.709,00 

1.029.853,70 

568.833,20 

397.890,91 

297.390,40 

251.942,20 

175.221,10 

151.386,40 

99.347,20 

92.943,20 

60.607,80 

 
 
 
 
 
Sunflower 

Spelt wheat 

Flax for fibres 

Bristle oat 

Cotton 

Flax for oil 

Sorghum 

Hemp 

Fodder beet 

Sudan grass 

Groundnut (peanut) 

Poppy 

Safflower 

Canary grass 

Caraway 

Helianthus annuus L. 

Triticum spelta L.  

Linum usitatissimum L.  

Avena strigosa L. Schreb. 

Gossypium spp. 

Linum usitatissimum L. 
Sorghum bicolor (L.) Moench 
subsp. bicolor 

Cannabis sativa L. 

Beta vulgaris L. 

Sorghum x drummondii 

Arachis hypogaea L. 

Papaver somniferum L. 

Carthamus tinctorius L. 

Phalaris canariensis L. 

Carum carvil L.  

50.743,30 

25.690,20 

15.054,90 

13.794,00 

8.280,40 

6.086,50 

2.572,60 

2.184,30 

1.150,40 

317,50 

226,40 

211,70 

159,20 

113,30 

50,40 

Table  20.  Certified  seed  quantities  per  species  (in  tons)  in  2020  (EU27)  (calculated  on  basis  of  data  retrieved  from 
escaa.org). 

EU area for seed production (1000 ha, excluding vegetables) 

Member State 
France 

Italy 

Germany 

Spain 

Poland 

Denmark 

Romania 

Hungary 

Czech Republic 

Sweden 

Rest of the MS (incl. UK for 2018 and 2019) 

EU total 
Top 10 MS share 

2018 
355 

2019 
357 

2020 
363 

2021 
372 

201 

177 

187 

146 

152 

140 

113 

100 

63 

339 

191 

195 

185 

147 

162 

138 

114 

102 

60 

361 

199 

198 

179 

166 

163 

161 

118 

103 

65 

367 

205 

195 

183 

173 

164 

139 

118 

111 

67 

368 

1973 

2095 
82.82%  82.06%  82.37%  82.43% 

2082 

2012 

Table 21. EU area for seed production per MS (1000 ha, excluding vegetables)  (calculated on basis of data retrieved 
from escaa.org). 

Species 
Soft wheat 

Forage and turf 

Barley 

Durum wheat 

Corn 

Area for seed production by species (1000 ha) 

% of 
total 
area 

23% 

25% 

13% 

6% 

7% 

2018 
457 

485 

248 

109 

140 

2019 
470 

482 

259 

96 

152 

% of 
total 
area 

23% 

24% 

13% 

5% 

8% 

94 

% of 
total 
area 

22% 

24% 

13% 

4% 

8% 

2020 
468 

508 

263 

90 

174 

2021 
440 

546 

250 

101 

190 

% of 
total 
area 

Average 
2018-
2021 

21% 

26% 

12% 

5% 

9% 

459 

505 

255 

99 

164 

 
 
Certification 
activity 
Field 
inspections 
for  bred  seed  of 
generations  prior  to 
(pre-
seed 
basic 
basic seed) 
Field 
for basic seed 

inspections 

Potatoes 
Sunflower, soja and 
rapeseed 

102 

113 

5% 

106 

5% 

109 

5% 

109 

6% 

112 

6% 

108 

5% 

106 

5% 

5% 

107 

110 

Table 22. Species with highest areas for seed production in EU 2018-2021 (calculated on basis of data retrieved from 
escaa.org). 

The  possibility  will  be  introduced  to  carry  out  under  official  supervision  for  the  certification 
activities for which it is currently not possible: 

Agricultural  plant  species 
(except from seed potatoes) 
Possibility  to  carry  out  under 
official  supervision  will  be 
introduced 

Vegetable species 

Seed potatoes 

Possibility  to  carry  out 
under official supervision 
will be introduced 

Possibility 
to  carry  out 
under  official  supervision 
will be introduced 

under 

possible 

inspections 

Field 
for certified seed 

Possibility  to  carry  out 
under official supervision 
will be introduced 
Currently  possible  under 
official supervision 

Possibility  to  carry  out  under 
official  supervision  will  be 
introduced 
Currently 
official supervision 

Possibility 
to  carry  out 
under  official  supervision 
will be introduced 
Possibility 
to  carry  out 
under  official  supervision 
will be introduced 
Possibility 
to  carry  out 
under  official  supervision 
will be introduced 
Possibility 
to  carry  out 
under  official  supervision 
will be introduced 
Table 23. Scope of the measure of extension of certification activities permitted under official supervision. 

Currently  possible  under 
official supervision 

Currently  possible  under 
official supervision 

Currently 
official supervision 

Currently 
official supervision 

Seed sampling 

Seed testing 

possible 

possible 

under 

under 

The generations of pre-basic and basic seed constitute up to 2% of the quantities of certified seed 
and the areas of production206. 

In  EU  every  year  about  2  million  hectares207  are  used  in  average  for  the  production  of  certified 
seed, of which 1.9 million hectares for agricultural plant species other than seed potatoes and 0.1 
million hectares are for seed potatoes. The areas used for the production of certified vegetable seed 
are in comparison insignificant (about 2 500 hectares). 

Furthermore, in EU every year about 8 million tons of seed in average are certified, of which 5.54 
million tons of agricultural plant species other than seed potatoes, 2.44 million tons of seed potatoes 
and 0.01 million tons of vegetable seed. 

The measures therefore concern: 

  For agricultural plant species (except from seed potatoes) the certification of up to 2% * 1.9 
=  0.04  million  hectares  and  of  2%  *  5.54  =  0.11  million  tons  of  pre-basic  and  basic  seed 
annually. 

206  Own  estimation  in  absence  of  more  accurate  data,  based  on  an  average  multiplication  rate  of  100  between 
subsequent generations. 
207 Average for the years 2018-2021, source: escaa.org.  

95 

 
 
                                                 
  For  seed  potatoes,  the  certification  of  up  to  0.1  million  hectares  and  2.44  million  tons  of 

seed potatoes.  

  Small areas and quantities as regards vegetable seed. 

Potential annual savings for operators by extension of certification activities possible under official supervision 

a)  Area becoming eligible for certification under official supervision (ha) 
b)  Average annual cost for official certification (EUR/ha) 
c)  Total annual cost for official certification (EUR) (a*b) 
d) 
e) 
f)  Average annual cost for under official supervision (EUR/ton) 
g)  Total annual cost for official certification (EUR) (e*f) 
h) 

Potential annual savings for operators by switching to certification under official supervision (EUR) (c*12%) 
Seed quantities becoming eligible for certification under official supervision (tons) 

140 000 
10 
1 400 000 
180 000 
2 550 000 
5 
12 750 000 
1 530 000 

Potential annual savings for operators by switching to certification under official supervision (EUR) (g*12%) 

Total potential annual savings for operators by switching to certification under official supervision (EUR) (d+h) 
Table 24. Calculation of the potential annual savings for operators by extension of certification activities possible under 
official supervision. 

1 710 000 

Extending  the  possibilities  for  operators  to  carry  out  certification  activities  under  official 
supervision  is  not  expected  to  have  significant  impacts  on  enforcement  costs  for  NCAs.  On  the 
basis of experience gained by a temporary experiment208, it is expected that if there is high demand 
by  operators,  NCAs  rather  risk  a  reduction  of  the  competence  and  the  jobs  for  their  official 
inspectors209. NCAs will also need to reallocate resources from carrying out official inspections to 
training,  licensing  and  supervising  the  operators’  inspectors.  Overall,  the  impact  on  NCAs  will 
largely  depend  on  the  demand  by  the  operators  but  it  is  considered  to  be  neutral  and/or 
insignificant,  as  already  certification  under  official  supervision  is  possible  for  the  certified 
categories (except seed potatoes) that are assumed to constitute 98% of areas and of quantities. 

The demand by operators is expected to depend largely on the quantities to be certified, with lower 
willingness to invest in own inspectors when quantities are lower. The size of the company (small, 
medium  or  big)  does  not  seem  to  affect  the  ability  to  use  the  option  for  official  supervision. 
Operators  opting  for  official  supervision  are  likely  to  bear  one-off  (upfront)  costs  for  setting  up 
laboratories and recurrent costs for hiring and training staff in order to use this option, however the 
responses to  the related survey did  not  provide data allowing to  calculate the scale of such costs. 
However, survey results210 indicate that around 50% of operators (valid also for SMEs) already use 
the  existing  options  for  official  supervision  and  would  make  use  of  certification  conducted  by 
operators under official supervision for all steps of the seed certification process if this was made 
available.  Survey  data  also  indicate  that  obtaining  a  certification  under  official  supervision  is 
estimated  to  be  around  12%  less  costly  to  operators  than  certification  performed  by  MS 
authorities211. If all operators opt to carry out certification activities under official supervision under 
the  new  possibilities  introduced,  the  potential  annual  cost  saving  for  operators  would  be  around 
EUR 1.7 million  (Table 24). These savings are rather insignificant, but  survey responses indicate 

208 Temporary experiment on field inspection under official supervision for pre-basic and basic seed 2012-2019 - final 
report, available at https://food.ec.europa.eu/system/files/2022-04/prm_temp-exp_field-inspec_en.pdf  
209 The impact assessment of 2013 (SWD(2013) 162 final) estimated that up to 700 public sector jobs might be lost if 
all fields and seed lots of pre-basic and basic seed were inspected by operators under official supervision. Part of this 
staff would be recruited in the private sector. 
210 ICF (2023) and SME targeted survey. 
211 ICF (2023) Section 6.1.1.1. 

96 

 
 
                                                 
that operators appreciate the efficiency gains and flexibility resulting from carrying out certification 
under  official  supervision,  expecting  that  in  the  long  term  there  will  be  more  significant  savings. 
These  impacts  are  most  relevant  for  agricultural  plant  species,  as  95%  of  the  seed  of  vegetable 
species  is  not  certified  but  marketed  as  standard  seed.  There  are  no  data  available  to  allow  an 
estimation of cost and benefits from introducing the option to carry out certification under official 
supervision of PRM for fruit plants and of FRM. 

4.  VARIETY REGISTRATION COSTS 

The costs for operators for variety registration currently consist of administrative costs (submission 
of an application), the cost of DUS examination and for the agricultural plant species the cost of the 
VCU examination. In the case of vine, there is an examination similar to the VCU examination, but 
this is carried out in the frame of the DUS examination. Under all options there will be no changes 
in  the  component  of  administrative  costs  and  DUS  examination.  The  envisaged  measures  for 
strengthening  sustainability  requirements  in  the  VCU  examination  of  agricultural  plant  species 
and vine and the introduction of an obligation for assessment for characteristics that contribute to 
sustainable agri-food production of new varieties of the other crop groups (i.e. vegetables and fruit 
plants) will result in additional testing costs for operators (increased fees paid to NCAs for the 
examination of new varieties).  

The  current  average  cost  for  VCU  for  agricultural  plant  species  is  EUR  3  200  per  year  and  on 
average  VCU  examination  is  carried  over  two  years.  The  assessment  for  characteristics  that 
contribute to sustainable agri-food production of new varieties of the other crop groups is assumed 
that  will  last  for  2  years  on  average  for  vegetables,  and  for  4  years  for  fruit  plants  and  vine

97 

 
 
Table 25. Calculation of the total increase of variety registration costs for operators due to increased sustainability requirements (VSCU). 

98 

Assumption on additional costs for operatorsIncrease per variety in relation to baseline (EUR)Total increase in variety registration costs in relation to baseline (EUR)Assumption on additional costs for operatorsIncrease per variety in relation to baseline (EUR)Total increase in variety registration costs in relation to baseline (EUR)Assumption on additional costs for operatorsIncrease per variety in relation to baseline (EUR)Total increase in variety registration costs in relation to baseline (EUR)10% of current VCU * 2 years [2.364 varieties]10% of current VCU * 2 years [1.859 varieties]15% of current VCU * 2 years [1.795 varieties]EUR6401.512.960EUR6401.189.760EUR9601.723.200%6%%6%%9%10% of current VCU * 2 years [1.314 varieties]80% of current VCU * 2 years [1.003 varieties]100% of current VCU * 2 years [969 varieties]EUR640840.960EUR5.1205.135.360EUR6.4006.201.600%11%%92%%115%10% of current VCU * 4 years [39 varieties]10% of current VCU * 4 years [30 varieties]15% of current VCU * 4 years [29 varieties]EUR1.28049.920EUR1.28038.400EUR1.92055.680%9%%9%%14%10% of current VCU * 4 years [37 varieties]110% of current VCU * 4 years [28 varieties]120% of current VCU * 4 years [27 varieties]EUR1.28047.360EUR14.080394.240EUR15.360414.720%9%%101%%110%EUR2.451.2006.757.7608.395.200EUR2.321.7776.400.9507.951.933Grand total of increase in variety registration costs (lower limit) for operators in EU27, assuming 44% of VCU and sustainability assessments under official supervision with 12% reduced costsoption 1option 2option 3 10.9155.58013.840Agricultural plant speciesVegetable speciesVineFruit plantsGrand total of increase in variety registration costs (upper limit) for operators in EU27 Baseline: Average registration cost (administrative fee + DUS + VCU where applicable) for operatorsper variety (EUR)14.000 
 
 
The increase in variety registration costs relative to the baseline due to the new VSCU can reach to 
EUR 2.45 million in option 1, EUR 6.75 million in option 2 and EUR 8.39 million in option 3 in 
total for all operators in EU27 every year. This can be reduced to EUR 6.40 million and EUR 7.95 
million under options 2 and 3 respectively following the application of mitigating measures (VSCU 
examination  under  official  supervision  and  collaboration  between  NCAs).  These  savings  are 
calculated  by  assuming  that  up  to  44%  operators  will  opt  for  official  supervision  and  have  12% 
savings  in  their  costs  (i.e.  assuming  the  same  percentage  and  savings  recorded  for  certification 
under official supervision). 

5. 

IMPACT OF STRENGTHENED SUSTAINABILITY REQUIREMENTS IN VARIETY REGISTRATION 

It is expected that the measures for strengthened sustainability requirements for the acceptance of 
new varieties (VSCU) will result in increase of cost of seeds and other PRM for farmers. The main 
driver of the increase of the costs is the reduced number of varieties that can be put on the market 
that  will  increase  the  cost  of  breeding  of  new  varieties.  The  return  of  the  costs  of  breeding 
programmes will depend on a smaller number of varieties. The assumed loss of new varieties will 
be highest in option 3 and lowest in option 1 (Table 18). A secondary driver is the increase of cost 
of examination of new varieties due to  the strengthened sustainability requirements. The increase 
will  be  highest  in  option  3  and  lowest  in  option  1  (Table  25).  In  absence  of  data  allowing  more 
accurate calculations, it is assumed that the total cost of PRM used in agriculture annually in EU27 
will  increase  on  average  1%,  3%  and  5%  under  options  1,  2  and  3  respectively.  This  assumed 
increase in prices  is  lower than the reduced number of varieties coming to the market (additional 
rejection  or  withdrawal  rate  of  varieties  is  assumed  at  3%,  5%,  10%  under  options  1,  2  and  3 
respectively) because it is observed that the returns on breeding investments come from only a part 
of  the  varieties  marketed,  while  some  varieties  are  registered  without  being  actually  put  in  the 
market. 

On  the  other  hand,  farmers  will  benefit  from  the  improved  characteristics  of  the  new  varieties  in 
terms  of  improved  use  of  inputs,  reduction  of  loss  of  yield  due  to  extreme  conditions  etc.  Such 
gains are being realised over the years due to a number of different factors, including genetic gains 
by  plant  breeding,  improved  agronomic  practices  etc.  The  impact  of  these  factors  cannot  be 
disentangled.  The  strengthened  sustainability  requirements  will  contribute  to  the  abovementioned 
gains. The requirements will steer breeding to aspects as increased resistance to plant pests that will 
lead to reduced pesticide use, increased drought tolerance and more efficient use of nutrients that 
will  lead  to  more  stable  yields  in  extreme  conditions  etc.  Gains  are  expected  to  be  lowest  under 
option 1 (voluntary approach for species other than agricultural plant species) and highest in option 
2 (leaving flexibility to MS to adjust to local agro-ecological conditions). Option 3 is expected to 
result  in  intermediate  gains,  as  the  level  of  flexibility  for  MS  to  adjust  to  local  agro-ecological 
conditions is limited. In absence of data allowing more accurate calculations, it is assumed that the 
avoided loss of total crop output on top of the progress made anyway in the baseline can be used as 
a  proxy  for  all  the  benefits  for  farmers  that  derive  from  the  improved  characteristics  of  the  new 
varieties.  This  avoided  loss  of  total  crop  output  is  assumed  to  be  0.5%,  1%  and  0.75%  under 
options 1, 2 and 3 respectively. These assumptions are based on the average genetic progress that 
has  been  recorded  for  various  species  over  the  last  decades212.  With  these  assumptions  option  2 
clearly  outperforms,  with  option  1  delivering  the  least  benefits.  The  uncertainty  of  these 

212 E.g. Rijk B. et al. (2013); Voss-Fels K.P et al. (2019). 

99 

 
 
                                                 
assumptions  is  rather  high.  Therefore,  in  place  of  a  sensitivity  analysis,  a  conservative  scenario 
where  the  avoided  loss  of  total  crop  output  is  assumed  to  be  4  times  lower  (0.13%,  0.25%  and 
0.19% under options 1, 2 and 3 respectively) is also examined. In this conservative scenario, option 
2 also performs best, while for option 3 the costs are higher than the benefits. 

Table 26. Impact on farms of strengthened sustainability requirements for the acceptance of new varieties of PRM 

Impact on NCAs: 

Currently 16 MS receive the bulk of the applications for new varieties of agricultural plant species 
(corresponding  to  annual  acceptance  of  2  564  varieties  on  average  every  year).  For  meeting  the 
annual needs for implementing the VSCU for vegetable species and fruit plants (respectively 1 384 
and 39 varieties on average accepted annually) the capacity of testing stations and staff would need 
to be increased by up to 50% if all were to be carried out by the NCAs and by up to 22% if 44% 
were  done  under  official  supervision  (i.e.  assuming  the  same  rate  as  that  for  certification  under 
official  supervision).  Indicatively  the  annual  budget  of  the  French  NCA  responsible  for  variety 
registration is EUR 30.6 million, of which approximately 60% corresponds to DUS activities and 
40% to VCU (GEVES, n.d.). Assuming a similar budget for each of the 16 NCAs that receive the 
bulk  of  the  applications  and  that  an  increase  in  capacity  by  22%  to  50%  would  result  in  equal 
increase in their budget, the total annual cost for the NCAs could be in the range of EUR 43 to 98 
million  in  options  2  and  3  depending  on  the  percentage  of  operators  that  will  opt  for  official 
supervision.  

Total additional costs per NCA (16 largest ones):  

  EUR 30.6 million * 40% = EUR 12.24 million annual costs for VCU per NCA (baseline) 
  EUR  12.24  million  *  50%  =  EUR  6.12  million  additional  annual  costs  per  NCA  without 

official supervision (options 2 and 3) 

  EUR 12.24 million * 50% * 44% = EUR 2.69 million additional annual costs per NCA if 

44% of operators opt for official supervision (options 2 and 3) 

Total  additional  costs  for  NCAs  (sum  for  16  largest  ones  that  cover  the  bulk  of  applications  for 
EU27): 

  16 * EUR 6.12 million = EUR 97.92 million without official supervision (options 2 and 3) 
  16 * EUR 2.69 million = EUR 43.04 million if 44% of operators opt for official supervision 

(options 2 and 3). 

100 

Million EUR                         (current 2021 price)Impact  on farms of strengthened sustainability requirements for the acceptance of new varieties of PRMOption 1Option 2Option 3INCREASE IN COSTS13.345,85Increase in total PRM cost in agriculture (%)1%3%5%(million EUR)133,46400,38667,29Total annual intermediate consumption in agriculture260.167,89Increase in global intermediate consumption due to increase in total PRM cost in agriculture (%)0,05%0,15%0,26%BENEFITS248.656,89Avoided loss in crop output annually (%)0,50%1,00%0,75%(million EU)1.243,282.486,571.864,93Balance / optimistic scenariomillion EUR  1.109,832.086,191.197,63248.656,89Avoided loss in crop output annually (%)0,125%0,250%0,188%(million EU)310,82621,64466,23Balance / conservative scenario million EUR  177,36221,27-201,06Total annual PRM cost in agricultureTotal annual crop outputTotal annual crop output 
 
The costs for NCAs under option 1 are considered insignificant, as under that option NCAs are not 
required to increase significantly their capacity. 

6. 

IMPACT OF ASSESSMENT OF SUSTAINABILITY CHARACTERISTICS OF BASIC MATERIAL  

The average annual fee for registration of new basic material is estimated to be  EUR 1 491 based 
on  data  provided  by  4  MS213.  Both  the  targeted  survey  and  the  data  available  in  the  Common 
Catalogue  (FOREMATIS)  show  that  new  basic  material  is  on  average  registered  every  5  years. 
Based on the current annual average of 44 registrations of basic material in EU27 and assuming a 
cost increase of 5%, 10% and 15% for options 1, 2 and 3 respectively, the annual average cost for 
registration fee of basic material would be EUR 1 565, EUR 1 640 and EUR 1 714 under options 1 
to 3 respectively. 

Fee for registration of new basic material 
(EUR) 
Number of registrations per year in 
EU27 
Additional cost per registration in 
comparison to the baseline (EUR) 
Total annual additional cost for 
registration (EUR) 

Baseline  Option 1 

Option 2 

Option 3 

1 491 

1 566 

1 640 

1 715 

44 

N/A 

N/A 

44 

75 

44 

149 

44 

224 

3 280 

6 560 

9 841 

Table 27. Calculation of total annual additional cost for registration of new basic material due to extended sustainability 
assessment. 

213 Data collected from NCAs by the targeted survey under ICF(2023). 

101 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
7. 

INNOVATION AND DIGITALISATION 

This section compares the costs of marketing controls that are conducted to confirm the identity of 
the  variety  of  the  marketed  PRM.  Those  marketing  controls  can  be  done  by  control-plot  testing 
(growing  samples  of  the  marketed  PRM  and  comparing  the  phenotypic  characteristics  of  those 
sample  with  the  reference  sample  of  the  registered  variety)  (Table  28).  Alternatively,  BMTs  and 
more specifically molecular markers214 can be used to verify that the marketed PRM is identical to 
the registered plant variety (Table 29).  

As  an  estimate  of  the  data  provided  by  some  NCAs,  and  extrapolating  across  the  EU,  it  can  be 
concluded that around 50 000 post control tests are carried out per year on seed lots. 

The  following  costs  are  estimates  of  the  costs  borne  by  NCAs  to  confirm  the  identity  of  a  plant 
variety. 

Activity 
Maintenance collection plots 
Post-control tests per lot 

Average Cost 
2 450 EUR/ha 
250 EUR/lot 

Table 28. Estimation of the costs borne by NCAs to confirm the identity of a plant variety 

Equipment/staff 
Consumables + equipment 
Cost basic PCR machine 
Amortisation equipment 
Staff cost 
Other fixed costs 

Cost 
33 EUR/test 
5 000 – 15 000 EUR 
10 years 
50 EUR/test 
20 EUR/test 

Table 29. Estimation of the costs as regards the use of BMTs 

In  10  years’  time,  500  000  tests  will  be  carried  out.  This  will  entail  a  total  cost  of  125  000  000 
EUR. If 40% of those post control plot tests were done with BMTs (mainly those test that are more 
appropriate  for  the  species,  e.g.,  fruit  plants,  vine,  vegetables...)  this  would  lead  to  significant 
savings: 250- (33 + 50 + 20) =147 EUR saving per test; 147 x 500 000 x 40% = 29 400 000 EUR. 
The investment needed to carry out these tests will be worthwhile given the significant savings of 
using BMT instead of post control plot tests for some species. 

Similarily, digitalisation of the certification system will require initial investments that can be paid-
off over few years, after which there will be net benefits. OECD carried out a feasibility study on 
digitalisation to introduce digital technologies in seed certification. The study estimated the initial 
investment  by  the  OECD  Secretariat  to  be  in  the  range  of  301  000  –  481  000  USD  while  the 
tangible benefits for NCAs and operators were estimated at 398 000 USD over a period of 3 years 
but would continue to be realised in the longer term215. 

214 A molecular marker (identified as genetic marker) is a fragment of DNA that is associated with a certain location 
within  the  genome.  Molecular  markers  are  used  in  molecular  biology  and  biotechnology  to  identify  a  particular 
sequence of DNA in a pool of unknown DNA. 
215 OECD document TAD/CA/S(2021)8 OECD Seed Schemes Digitalisation Study – not published 

102 

 
 
 
                                                 
8.  DETAILED PRESENTATION OF COSTS AND BENEFITS  

8.1.  Costs of common measures 

Overview of costs of measures common to all options 

PRM/FRM users 

Operators 

NCAs 

All professional operators 
to be registered in a single 
register under the PHL 

N/A 

All certification tasks are 
permitted under official 
supervision except the 
issuing of the official label 
(PRM) and the Master 
certificate (FRM). 

N/A 

Measures 
to 
common 
all 
options 
for PRM and 
FRM 
legislation 

PRM/FRM legislation will 
directly refer to PHL for 
the list of RNPQs and 
specific measures. 
Compliance with 
requirements for QPs and 
RNQPs will remain a 
prerequisite for the 
certification of PRM/FRM. 

N/A 

Measures 
common to 
all options 
for PRM 

Decisions for addition of 
new species in (or removal 
of species from) the scope 
of the PRM legislation and 

N/A 

0 

0 

[Professional  operators  are  currently  registered  either  under  the 
marketing Directives, or PHL, or both] 

[NCAs  currently  maintain 
registers  of  professional 
operators  either under the marketing Directives, or PHL, or 
both] 

The measure provides an additional option to operators and does not 
create an obligation for them, therefore it does not lead to new costs. 
Operators  wishing  to  use  this  new  option  may  however  need  to 
invest in staff and/or equipment. 
Around  50%  of  operators  (valid  also  for  SMEs)  already  use  the 
existing  options  for  official  supervision  and  would  make  use  of 
certification conducted by operators under official supervision for all 
steps  of  the  seed  certification  process  if  this  was  made  available. 
Those operators would not need any new investments. The potential 
needs  for  investments  by  other  operators  cannot  be  monetised. 
However,  available  data  show  that costs  for  operators  are  12%  less 
for carrying out activities under official supervision in comparison to 
the costs they have under official examinations 

NCAs  will  need  to  reallocate  resources  from  carrying  out 
official  inspections  to  training,  licensing  and  supervising 
the  operators’  inspectors.  The  costs  for  NCAs  will  largely 
depend on the demand by the operators but are expected to 
be overall neutral or insignificant. 

0 

0 

[Requirements remain the same] 

[Requirements remain the same] 

N/A 

N/A 

103 

 
 
 
 
 
 
 
 
 
 
 
legislation    

Decisions on the 
equivalence to EU rules for 
third countries will be 
taken by means of tertiary 
legislation 

The transfer/notification of 
new varieties from national 
to the EU Plant Variety 
Portal will be managed by 
the MS without the need 
for a Commission Decision 

Allow MS to decide 
themselves on permitting 
temporarily the marketing 
of seed that does not 
satisfy the requirements in 
respect of minimum 
germination, if 
germination is not lower 
than 15 % than the 
required germination rate 

The possibility to deviate 
from certain requirements 
as regards uniformity will 
be provided for the DUS 
examination of organic 
varieties suitable for 
organic production. 

The rules for conservation 
varieties are lighter and 
extended to cover new 
locally adapted varieties 

The scope for 
heterogeneous material is 
broadened beyond organic 
production 

N/A 

N/A 

N/A 

N/A 

N/A 

The current simple regime 
for ornamental plants is 

N/A 

N/A 

N/A 

0 

N/A 

0 

Negligible costs not quantified. 

[The  registration  of  organic  varieties  will  be  subject  to  the  same 
procedure as currently but an option is provided for such varieties to 
deviate from uniformity requirements of the DUS examination.] 

[Some  training  of  examiners  may  be  required  in  order  to 
implement the deviation rules.] 

0 
[Current rules are simplified and scope is extended, without addition 
of new requirements] 

Negligible costs not quantified. 

[Some  training  of  staff  may  be  required  in  order  to 
implement the new rules] 

0 
[Current rules remain unchanged, only scope is extended] 

0 
[Current rules remain unchanged, only scope is extended] 

0 
[Current rules remain unchanged] 

0 
[Current rules remain unchanged] 

104 

 
 
 
 
 
 
N/A 

N/A 

maintained unchanged 

Measures 
common to 
all options 
for FRM 
legislation    

The decisions on the 
equivalence to EU rules for 
third countries will be 
taken by means of tertiary 
legislation. 

The existing empowerment 
to define the information to 
be made available to 
users/buyers of FRM is 
extended to explicitly 
cover suitability of FRM 
for climatic and ecological 
conditions. 

N/A 

Negligible costs not monetised 

[Additional  information  can  be  easily  made  available  within  the 
existing procedure] 

N/A 

N/A 

105 

 
 
 
 
 
 
 
 
 
8.2.  Benefits of common measures 

Overview of benefits of measures common to all options 

Measures 

PRM/FRM users 

Operators 

NCAs 

All professional operators 
to be registered in a single 
register under the PHL 

N/A 

All certification tasks are 
permitted under official 
supervision except the 
issuing of the official label 
(PRM) and the Master 
certificate (FRM). 

PRM/FRM legislation will 
directly refer to PHL for 
the list of RNPQs and 
specific measures. 
Compliance with 
requirements for QPs and 
RNQPs will remain a 
prerequisite for the 
certification of PRM/FRM. 

Decisions for addition of 
new species in (or removal 
of species from) the scope 
of the PRM legislation and 
Decisions on the 
equivalence to EU rules for 
third countries will be 
taken by means of tertiary 
legislation 

N/A 

N/A 

N/A 

Measures 
to 
common 
all 
options 
for PRM and 
FRM 
legislation    

Measures 
common to 
all options 
for PRM 
legislation    

EUR 1 million per year savings in registration costs 

[Over 20 000 duplicate registrations will be avoided and over EUR 800 
000 annual savings in registration costs for operators supplying PRM of 
fruit plants. Over 4 000 duplicate registrations will be avoided and there 
will  be  over  EUR  237  000  annual  savings  in  registration  costs  for 
operators supplying FRM]. 

Marginal  savings  due  to  the  fact  that  there  will  be  no 
obligation 
to  keep  separate  registers  of  professional 
operators  under  PRM/FRM  legislation  and  PHL.  Not 
monetised. 

 

 

0 

EUR 1.7 million per year in reduced certification costs (direct 
benefit)  
Efficiency gains and flexibility (indirect benefits not monetised )  

N/A 

0 

[Requirements  remain  the  same.  Efficiency  gains  and  flexibility,  not 
monetised (indirect benefits)] 

[Requirements  remain  the  same.  Efficiency  gains  and 
flexibility, not monetised (indirect benefits)] 

Shorter time to reach such decisions but the benefits are rather limited as 
only  a  small  number  of  decisions  every  year  (0-4)  are  concerned.  Not 
monetised. 

Shorter  time  to  reach  such  decisions  but  the  benefits  are 
rather  limited  as  only  a  small  number  of  decisions  every 
year (0-4) are concerned. Not monetised. 

106 

 
 
 
 
 
 
 
 
 
 
PRM  users  can  avail  of  about  4  000  new  varieties  every 
year by 1 to 4 months earlier. 
Not monetised. 

The period between acceptance in a national catalogue and access to the 
common market will be shortened by 1 to 4 months for about 4 000 new 
varieties every year.  
Not monetised. 

For the Commission the need for adoption of 24 Decisions 
every year is removed  
For  the  NCAs  the  need  to  notify  new  varieties  to  the 
Commission is removed. Not monetised. 

Reduced waiting time for concerned PRM users by at least 
15 days for each notification avoided. Not monetised. 

In average 30 notifications annually (for a total of 50 000 tonnes of seed, 
or  about  0.01%  of  the  quantities  of  seed  certified  annually)  become 
redundant.  Reduced  waiting  time  for  operators  by  at  least  15  days  for 
each notification avoided. Not monetised. 

In  average  30  notifications annually  (for  a  total  of  50  000 
tonnes  of  seed,  or  about  0.01%  of  the  quantities  of  seed 
certified annually) become redundant. 
Commission  and  NCAs:  avoiding  the  handling  of  on 
average 30 notifications per year. Not monetised 

Increased  availability  of  organic  varieties  suitable  for 
organic production. Not monetised. 

The  breeding  period  of  varieties  compliant  with  reduced  uniformity 
requirements  can  be  in  average  2  years  shorter  than  for  varieties  fully 
meeting those requirements. 

0 

The transfer/notification of 
new varieties from national 
to the EU Plant Variety 
Portal will be managed by 
the MS without the need 
for a Commission Decision 

Allow MS to decide 
themselves on permitting 
temporarily the marketing 
of seed that does not 
satisfy the requirements in 
respect of minimum 
germination, if 
germination is not lower 
than 15 % than the 
required germination rate 

The possibility to deviate 
from certain DUS 
requirements as regards 
uniformity will be 
provided for the DUS 
examination of organic 
varieties suitable for 
organic production. 

The rules for conservation 
varieties are lighter and 
extended to cover new 
locally adapted varieties 

Increased  availability  of  conservation  and  locally  adapted 
varieties. Not monetised. 

Operators making use of this possibility will therefore access the market 
faster,  with  reduced  breeding  costs  and  with  varieties  that  up  to  now 
were  restricted  from  the  market  since  it  was  not  possible  to  register 
varieties not meeting the DUS requirements. 

A  few  dozen  operators  across  EU  are  likely  to  use  this  option.  The 
number of varieties registered under these rules could be in average 100 
annually. Assuming EUR 50 000 savings in breeding costs per variety, 
concerned operators may see savings of EUR 5 million annually. 

lighter  procedures  for  access 

This  measure  creates  a  new  market  segment.  Operators  would  benefit 
from 
to  market  (no  DUS/VSCU 
requirements  for  variety  registration and no  certification  of  PRM).  The 
number  of  operators  concerned  could  be  in  the  range  of  several 
hundreds. The number of varieties marketed under these rules could be a 
few  hundred  annually.  However,  the  quantities  of  PRM  concerned  are 
expected  to  remain  limited  below  2%  of  the  market.  Potential  value 
could be up to EUR 13.3 billion /year * 2%= EUR 266 million/year. 

0 

107 

 
 
 
 
 
  
 
 
The scope for 
heterogeneous material is 
broadened beyond organic 
production 

Increased  availability  of  heterogeneous  material.  Not 
monetised. 

This  measure  creates  a  new  market  segment.  Operators  would  benefit 
from  lighter  procedures  for  access  to  market.  Number  of  operators  and 
quantities of PRM concerned are unknown. Though number of operators 
could  be  in  the  range  of  several  hundreds.  Several  hundred  or  few 
thousand  heterogeneous  material  are  expected  to  be  brought  in  the 
market over the next ten years but the quantities of PRM concerned are 
expected to be very limited and of insignificant market value.  

The current simple regime 
for ornamental plants is 
maintained unchanged 

Measures 
common to 
all options 
for FRM 
legislation    

The decisions on the 
equivalence to EU rules for 
third countries will be 
taken by means of tertiary 
legislation. 

N/A 

N/A 

The existing empowerment 
to define the information to 
be made available to 
users/buyers of FRM is 
extended to explicitly 
cover suitability of FRM 
for climatic and ecological 
conditions. 

Users  of  FRM  will  benefit  from  improved  information  as 
regards  the  suitability  of  FRM  for  climatic  and  ecological 
conditions. As a result they will be able to select the most 
appropriate  FRM  and  reduce  economic  damage  caused  by 
the  use  of  unsuitable  FRM.  This 
is  however  not 
quantifiable. 

0 

N/A 

N/A 

0 

0 

N/A 

N/A 

108 

 
 
 
 
 
 
 
8.3.  Costs per option 

Overview of costs  

Measures 

Common 
elements  for 
and 
PRM 
FRM: 

Innovative 
production 
processes, BMTs 
and digitalisation 

Option 1 

Option 2 

Option 3 

PRM/FRM users 

Operators 

NCAs 

PRM/FRM users 

Operators 

NCAs 

PRM/FRM 
users 

Operators 

NCAs 

Adoption  of  guidelines  on  innovative  production  processes, 
BMTs and digitalisation 

Introduction of basic rules on innovative production processes, 
BMTs  and  digitalisation  and  creation  of  empowerments  for 
detailing rules according to new developments 

Introduction of detailed rules on innovative production processes, BMTs 
and digitalisation 

N/A 

N/A 

The  measure  provides  new  options 
and  not  new  obligations.  Therefore, 
there  are  no  costs  imposed.  Use  of 
new  options  however  may  require 
in  equipment  and/or 
investments 
staff.  Any  investment  is  expected  to 
be recovered within few years due to 
efficiency  gains  and  lower  costs  of 
operations.  

N/A 

The measure provides new options and not 
new  obligations.  Therefore,  there  are  no 
imposed.  Use  of  new  options 
costs 
however  may 
in 
require 
equipment and/or staff. Any investment is 
expected to be recovered within few years 
due to efficiency gains and lower costs of 
operations. 

investments 

The  measure  provides  new  options  and  not  new 
obligations.  Therefore,  there  are  no  costs  imposed. 
Use  of  new  options  however  may 
require 
investments 
in  equipment  and/or  staff.  Any 
investment  is  expected  to  be  recovered  within  few 
years  due  to  efficiency  gains  and  lower  costs  of 
operations. 

Official controls  Harmonisation of OCs on production, marketing and imports 

of PRM/FRM without links to OCR 

 

 

Harmonisation of OCs on production, marketing and 
imports of PRM/FRM subject to the OCR  
Simplified import controls at appropriate places 

 

 

Harmonisation of OCs on production, marketing and imports of 
PRM/FRM subject to the OCR  
Stricter import controls at border control posts (BCPs) requiring 
special import documentation 

N/A 

rate  of 
Modified 
OCs 
(increase  or 
decrease)  depending 
on  current  situation 
per 
and 
MS 
individual  profile  of 
operator. 
each 
Globally 
neutral 
impact. 

N/A 

Reallocation 
of  resources, 
depending 
on 
current 
organisation. 
Marginal 
for 
costs 
compiling  a 
Multi-annual 
national 
control  plan 
an 
and 
annual report 
on OCs. 
Globally 

to 
In  comparison 
options  1  and  2,  the 
of 
requirement 
special 
import 
documentation  will 
result  in  significant 
costs  for  operators 
(not quantifiable).  

Modified  rate  of  OCs 
(increase  or  decrease) 
depending  on  current 
situation  per  MS  and 
individual  profile  of 
operator. 
each 
neutral 
Globally 
impact. 

N/A 

on 

Reallocation  of 
resources, 
depending 
current 
organisation. 
Marginal 
costs 
for  compiling  a 
Multi-annual 
national  control 
plan 
an 
and 
annual  report  on 
OCs. 
Globally  neutral 
impact. 

109 

result 

In  comparison  to  options  1 
and  2,  the  requirement  of 
carrying  out  import  controls 
at  BCPs  will 
in 
significant costs for NCAs.  
There  are  about  500  BCPs 
designated  for  phytosanitary 
controls. Assuming that these 
would  be  the  BCPs  also  for 
PRM/FRM,  they  would  need 
to  be  equipped  by  staff  to 
of 
carry 
imported  PRM/FRM.  With  1 
person  in  average  by  BCP  at 
EUR  30  000  for  salary,  the 

sampling 

out 

 
 
PRM 

For 
legislation 
only 

Assessment of 
new varieties for 
characteristics 
contributing to 
sustainable 
production 

neutral 
impact. 

The sustainability considerations in the examination of new 
varieties are strengthened. 
The current VCU examination for agricultural plant species 
and vine is extended to include additional characteristics that 
contribute to sustainable production in order to better steer 
breeding efforts in this direction. The new examination will 
be called Value for sustainable cultivation and use (VSCU). 
 
For organic varieties suitable for organic production, it 
will be required that the VSCU examination is carried 
out under conditions adapted to the specific needs of 
organic production.  

  MS will have flexibility to implement VSCU according 

 

to their agro-ecological conditions.  

The sustainability considerations in the examination of new 
varieties are strengthened. 
The current VCU examination for agricultural plant species 
and vine is extended to include additional characteristics that 
contribute to sustainable production in order to better steer 
breeding efforts in this direction.  
The new examination will be called Value for sustainable 
cultivation and use (VSCU). It will also apply to new varieties 
of the other crop groups (fruit plants and vegetables).  
  MS will have flexibility to implement VSCU according to 

their agro-ecological conditions.  
It will be possible for operators to conduct the VSCU 
examination under official supervision.  

For  other  crop  groups  (fruit  plants  and  vegetables),  the 
assessment  will 
that  applicants 
voluntarily submit along with the application for registration 
of a new variety  

information 

rely  on 

  MS will be able to collaborate and accept results from 

 

 

MS with similar agro-ecological conditions, and/or create 
shared testing networks. 
An empowerment will be created to determine the 
minimum requirements for carrying out the VSCU 
examination and the accepted methodologies for 
assessing the individual VSCU characteristics.  
For organic varieties suitable for organic production, it 
will be required that the VSCU examination is carried out 
under conditions adapted to the specific needs of organic 
production. 

total  annual  cost  for  NCAs 
amounts to EUR 15 million. 

The sustainability considerations in the examination of new varieties are 
strengthened. 
The current VCU examination for agricultural plant species and vine is 
extended to include additional characteristics that contribute to 
sustainable production in order to better steer breeding efforts in this 
direction. The new examination will be called Value for sustainable 
cultivation and use (VSCU). It will also apply to new varieties of the 
other crop groups (fruit plants and vegetables).  
In contrast to option 2: 
 
 

Implementation of the VSCU will be harmonised between the MS. 
Detailed rules on accepted methodologies for assessing the 
individual VSCU characteristics will be introduced. 

As under option 2: 
 

It will be possible for operators to conduct the VSCU examination 
under official supervision.  

  MS will be able to collaborate and accept results from MS with 
similar agro-ecological conditions, and/or create shared testing 
networks.  
For organic varieties suitable for organic production, it will be 
required that the VSCU examination is carried out under 
conditions adapted to the specific needs of organic production. 

 

EUR 
133  million 
annually  in  increased 
PRM 
for 
costs 
farmers 

Increased 
registration  costs 
for the PRM sector 
by  EUR 
2.45 
million  annually. 
Marginal  costs  for 
FRM.  

Insignificant 
as 
costs 
NCAs 
are 
not  required 
to 
increase 
significantly 
their 
capacity. 

EUR  400  million 
in 
annually 
increased 
PRM 
costs for farmers. 

Increased 
registration costs for 
the  PRM  sector  by 
EUR  6.40  million 
annually. (PRM)  
Marginal  costs  for 
FRM.  

EUR  43  to  98 
million annually 

EUR 
667 
million  annually 
in 
increased 
PRM  costs  for 
farmers. 

Increased 
registration costs for 
the  PRM  sector  by 
EUR  7.95  million 
annually.  Marginal 
costs for FRM.  

EUR  43 
annually 

to  98  million 

Seed 
conservation 
networks, 
marketing to 
amateur 
gardeners and 

Exemption  from  the  scope  of  the  legislation  of  activities  of 
seed conservation networks, marketing to amateur gardeners 
and exchange in kind of seeds between farmers 

Subject  activities  of seed  conservation networks,  marketing  to 
amateur  gardeners  and  exchange  in  kind  of  seeds  between 
farmers to lighter rules 

Subject  activities  of  seed  conservation  networks,  marketing  to  amateur 
gardeners and exchange in kind of seeds between farmers to the general 
requirements of the legislation 

N/A 

0 
[No 

Negligible 
costs  

new 

N/A 

0 
[New 

opportunities 

Negligible  costs 
training 
[Some 

N/A 

0 
[No 

change 

in 

0 
[No  change  in  relation  to 

110 

 
 
 
 
 
exchange in kind 
of seeds between 
farmers 

obligations] 

[Some 
training 
of 
staff  may  be 
required 
in 
order  to  tell 
apart  PRM 
exempted 
from 
legislation] 

insignificant 
but  of 
market value. No new 
obligations.] 

of  staff  may  be 
required in order 
to implement the 
new rules.] 

relation 
situation] 

to  current 

current situation] 

FRM 

For 
legislation 
only 

Scope of FRM 
the legislation 

Define  forestry  and  non-forestry  purposes  but  maintain 
current scope of FRM legislation 

Define forestry and non-forestry purposes and extend scope of 
FRM legislation to include the production of FRM for specific 
non-forestry purposes 

Define  forestry  and  non-forestry  purposes  and  extend  scope  of  FRM 
legislation  to  include  the  production  of  FRM  for  specific  non-forestry 
purposes 

N/A 

0 
[Depending 
on 
current  definitions 
used  by  MS,  some 
uses  may  be  added 
or removed from the 
overall 
scope, 
in 
neutral 
costs 
certification 
for operators] 

impact 

current 

0 
[Depending 
on 
definitions 
used  by  MS, 
uses 
some 
be 
may 
added 
or 
removed 
from 
scope, 
overall 
neutral 
impact 
in 
enforcement 
costs 
for 
NCAs] 

the 

N/A 

0 
[Increased  costs  as 
FRM  for  non-forestry 
purposes  will  become 
subject to testing costs 
(certification) 
but 
limited  as  it  concerns 
10% of FRM] 

N/A 

0 
[Increased  costs 
as FRM for non-
forestry 
purposes 
will 
become  subject 
to 
certification 
but  limited  as  it 
concerns 10% of 
FRM] 

0 
[Increased  costs  as  FRM  for 
non-forestry  purposes  will 
to 
become 
certification  but  limited  as  it 
concerns 10% of FRM] 

subject 

0 
[Increased  costs  as 
FRM 
non-
for 
purposes 
forestry 
will  become  subject 
costs 
to 
but 
(certification) 
limited 
it 
as 
concerns  10%  of 
FRM] 

testing 

Assessment of 
FRM for 
characteristics 
contributing to 
sustainable 
production 

 

 

Extend sustainability requirements to cover lower FRM 
categories 
Adopt guidelines on sustainability requirements for all 
FRM categories 

 

 

Extend sustainability requirements to cover lower FRM 
categories  
Introduce general principles on sustainability 
requirements for all FRM categories with flexibility for 
MS to implement according to their environmental 
conditions 

 
 

Extend sustainability requirements to cover lower FRM categories  
Introduce detailed and harmonised rules on sustainability 
requirements for all FRM categories 

111 

 
 
N/A 

0 
[Negligible  increase 
of costs] 

N/A 

0 
[Negligible 
increase 
costs] 

of 

0 
[Negligible 
of costs] 

increase 

N/A 

0 
[Negligible 
increase 
costs] 

of 

0 
[Negligible  increase 
of costs] 

0 
[Negligible increase of costs] 

Address 
difficulties in 
supply of suitable 
FRM 

  Maintain the existing empowerment to authorise MS to 
use FRM not fulfilling all requirements when there are 
difficulties in supply 
Adopt guidelines on contingency planning to ensure 
availability of FRM 

 

  Maintain the existing empowerment to authorise MS to 
use FRM not fulfilling all requirements when there are 
difficulties in supply 
Introduce a general requirement for contingency planning 
in the MS to ensure availability of FRM 

 

  Maintain the existing empowerment to authorise MS to use FRM 
not fulfilling all requirements when there are difficulties in supply 
Introduce common rules on contingency planning in the MS to 
ensure availability of FRM 

 

Conservation and 
sustainable use of 
forest genetic 
resources 

N/A 

0 
[Negligible  increase 
of costs] 

N/A 

0 
[Negligible 
increase 
costs] 

of 

0 
[Negligible 
of costs] 

increase 

N/A 

0 
[Negligible 
increase 
costs] 

of 

0 
[Negligible  increase 
of costs] 

0 
[Negligible increase of costs] 

Adoption  of  guidelines  for  the  registration  of  basic  material 
for the purposes of conservation of forest genetic resources 

Introduction  of  a  derogation  for  the  registration  of  basic 
material  for  the  purposes  of  conservation  of  forest  genetic 
resources 

Introduction of a derogation for the registration of basic material for the 
purposes of conservation of forest genetic resources 

N/A 

0 
[Negligible  increase 
of costs] 

N/A 

0 
[Negligible 
increase 
costs] 

of 

0 
[Negligible 
of costs] 

increase 

N/A 

0 
[Negligible 
increase 
costs] 

of 

0 
[Negligible  increase 
of costs] 

0 
[Negligible increase of costs] 

112 

 
 
 
 
 
8.4.  Benefits per option 

Overview of benefits 

Measures 

Common 
elements  for 
and 
PRM 
FRM: 

Innovative production 
processes, BMTs and 
digitalisation 

Option 1 

Operators 

NCAs 

PRM/FRM 
users 

PRM/FRM 
users 

Option 2 

Option 3 

Operators 

NCAs 

PRM/FRM users 

Operators 

NCAs 

Adoption  of  guidelines  on  innovative  production 
processes, BMTs and digitalisation 

Introduction of basic rules on innovative production processes, 
BMTs  and  digitalisation  and  creation  of  empowerments  for 
detailing rules according to new developments 

Introduction of detailed rules on innovative production processes, BMTs and 
digitalisation 

N/A 

N/A 

The measure provides new options and 
not  new  obligations.  Therefore,  there 
are  no  direct  benefits.  Use  of  new 
options 
require 
however  may 
investments  in  equipment and/or  staff. 
Any  investment  is  expected  to  be 
recovered  within  few  years  due  to 
efficiency  gains  and  lower  costs  of 
operations. 

N/A 

require 

The  measure  provides  new  options  and  not 
new  obligations.  Therefore,  there  are  no 
direct benefits. Use of new options however 
may 
in  equipment 
investments 
and/or  staff.  Any  investment  is  expected  to 
be  recovered  within  few  years  due  to 
efficiency  gains  and 
lower  costs  of 
operations. 

The  measure  provides  new  options  and  not  new 
obligations.  Therefore,  there  are  no  direct  benefits. 
Use of new options however may require investments 
in equipment and/or staff. Any investment is expected 
to  be  recovered  within  few  years  due  to  efficiency 
gains and lower costs of operations. 

Official controls 

Harmonisation  of  OCs  on  production,  marketing  and 
imports of PRM/FRM without links to OCR 

 

 

Harmonisation of OCs on production, marketing and 
imports of PRM/FRM subject to the OCR  
Simplified import controls at appropriate places 

 

 

Harmonisation of OCs on production, marketing and imports of 
PRM/FRM subject to the OCR  
Stricter import controls at border controls requiring special import 
documentation 

N/A 

Efficiency gains (not monetised)   

N/A 

Efficiency gains (not monetised)   

N/A 

Efficiency gains (not monetised)   

PRM 

For 
legislation 
only 

Assessment of new 
varieties for 
characteristics 
contributing to 
sustainable production 

 

 

Extension of the current VCU requirements for 
agricultural plant species and vine to better 
address sustainability 
For all other species, reliance on information that 
applicants voluntarily submit along with the 
application for registration of a new variety  

 

 

 

 

 

Extension of the current VCU requirements for 
agricultural plant species and vine to better address 
sustainability  
Introduction of these requirements for all other crop 
groups (vegetables and fruit plants) 
Flexibility for MS to implement these requirements 
according to their agro-ecological conditions 
Permit examination of these requirements under official 
supervision 
Creation of empowerment to adopt rules on accepted 
methodologies for assessing the different characteristics 

 

 

 
 
 

Extension of the current VCU requirements for agricultural plant 
species and vine to better address sustainability 
Introduction of these requirements for all other crop groups 
(vegetables and fruit plants) 
Harmonised implementation of these requirements. 
Permit examination of these requirements under official supervision 
Introduction of detailed rules on accepted methodologies for assessing 
the different characteristics 

113 

 
 
 
Seed conservation 
networks, marketing 
to amateur gardeners 
and exchange in kind 
of seeds between 
farmers 

N/A 

N/A 

EUR 310 to 1 
243  million 
in 
annually 
of 
terms 
loss 
avoided 
crop 
in 
output. 

Reduced 
losses 
forestry 
monetised). 

in 
(not 

N/A 

N/A 

EUR  621  to  2 
million 
486 
annually 
in 
terms of avoided 
loss 
crop 
in 
output. 

Reduced 
losses 
in  forestry  (not 
monetised). 

N/A 

N/A 

EUR 466 to 1 864 
annually 
million 
of 
in 
avoided 
in 
crop output. 

terms 

loss 

Reduced  losses  in 
forestry 
(not 
monetised).  

Exemption  from  the  scope  of  the  legislation  of 
activities of seed conservation networks, marketing to 
amateur  gardeners  and  exchange  in  kind  of  seeds 
between farmers 

Subject activities  of  seed  conservation  networks,  marketing  to 
amateur  gardeners  and  exchange  in  kind  of  seeds  between 
farmers to lighter rules 

Subject  activities  of  seed  conservation  networks,  marketing  to  amateur 
gardeners  and  exchange  in  kind  of  seeds  between  farmers  to  the  general 
requirements of the legislation 

N/A 

0 
[New  opportunities  in 
the market to amateur 
gardeners 
of 
insignificant  market 
value]. 

but 

[No 
in 
change 
relation  to  current 
situation] 

N/A 

0 
[New  opportunities 
in 
to 
the  market 
amateur  gardeners 
but  of  insignificant 
market value]. 

0 
[New 
opportunities 
for 
seed 
conservation 
networks  and 
for  exchange 
in  kind  of 
seeds 
between 
farmers 
of 
insignificant 
market 
value]. 

but 

0 
[New 
opportunities for 
seed 
conservation 
networks and for 
exchange 
in 
kind  of  seeds 
between  farmers 
but 
of 
insignificant 
market value]. 

change 

in 
to  current 

[No 
relation 
situation] 

[No  change 
in 
current situation] 

relation 

to 

FRM 

For 
legislation 
only 

Scope of FRM the 
legislation 

Define forestry and non-forestry purposes but maintain 
current scope of FRM legislation 

Define forestry and non-forestry purposes and extend scope of 
FRM legislation to include the production of FRM for specific 
non-forestry purposes 

Define  forestry  and  non-forestry  purposes  and  extend  scope  of  FRM 
legislation  to  include  the  production  of  FRM  for  specific  non-forestry 
purposes 

114 

 
 
 
 
 
 
 
 
 
N/A 

0 

0 

0 

non-

Indirect 
monetary 
benefits in terms 
of 
improved 
quality  of  FRM 
for  non-forestry 
purposes  

0 

non-
Indirect 
monetary  benefits 
in 
of 
terms 
improved  quality 
of  FRM  for  non-
forestry purposes 

0 

0 

Assessment of FRM 
for characteristics 
contributing to 
sustainable production 

 

 

Extend sustainability requirements to cover 
lower FRM categories 
Adopt guidelines on sustainability requirements 
for all FRM categories 

 

 

Extend sustainability requirements to cover lower FRM 
categories  
Introduce general principles on sustainability 
requirements for all FRM categories with flexibility for 
MS to implement according to their environmental 
conditions 

 
 

Extend sustainability requirements to cover lower FRM categories  
Introduce detailed and harmonised rules on sustainability requirements 
for all FRM categories 

0 

0 

in 
of 

Indirect  non-
monetary 
benefits 
terms 
improved 
quality 
of 
FRM for non-
forestry 
purposes 

0 

non-

Indirect 
monetary 
benefits in terms 
of 
improved 
quality  of  FRM 
for  non-forestry 
purposes 

0 

0 

Indirect 
non-
monetary  benefits 
in 
of 
terms 
improved  quality 
of  FRM  for  non-
forestry purposes 

Address difficulties in 
supply of suitable 
FRM 

  Maintain the existing empowerment to authorise 

MS to use FRM not fulfilling all requirements 
when there are difficulties in supply 
Adopt guidelines on contingency planning to 
ensure availability of FRM 

 

  Maintain the existing empowerment to authorise MS to 
use FRM not fulfilling all requirements when there are 
difficulties in supply 
Introduce a general requirement for contingency planning 
in the MS to ensure availability of FRM 

 

  Maintain the existing empowerment to authorise MS to use FRM not 
fulfilling all requirements when there are difficulties in supply 
Introduce common rules on contingency planning in the MS to ensure 
availability of FRM 

 

0 

0 

Indirect  non-
monetary 
benefits 
terms 
improved 
availability of 
FRM 

in 
of 

0 

non-

Indirect 
monetary 
benefits in terms 
improved 
of 
availability 
of 
FRM 

0 

Indirect 
non-
monetary  benefits 
of 
terms 
in 
improved 
availability 
FRM 

of 

0 

0 

Conservation and 
sustainable use of 
forest genetic 

Adoption  of  guidelines  for  the  registration  of  basic 
material  for  the  purposes  of  conservation  of  forest 
genetic resources 

Introduction  of  a  derogation  for  the  registration  of  basic 
material  for  the  purposes  of  conservation  of  forest  genetic 
resources 

Introduction  of  a  derogation  for  the  registration  of  basic  material  for  the 
purposes of conservation of forest genetic resources 

115 

 
 
 
resources 

in 
of 

Indirect  non-
monetary 
benefits 
terms 
increased 
genetic 
diversity 
FRM 

of 

0 

0 

non-

Indirect 
monetary 
benefits in terms 
of 
increased 
genetic  diversity 
of FRM 

due 

0 
[Savings 
to 
reduction  of  costs  but 
insignificant 
as 
volumes 
concerned 
are very limited] 

0 
[Savings  due 
to 
reduction  of  costs 
but insignificant as 
volumes 
concerned are very 
limited] 

non-
Indirect 
monetary  benefits 
in 
of 
terms 
increased  genetic 
diversity of FRM 

due 

0 
[Savings 
to 
reduction  of  costs 
but  insignificant  as 
volumes  concerned 
are very limited] 

0 
[Savings  due  to  reduction  of 
costs  but 
as 
volumes  concerned  are  very 
limited] 

insignificant 

116 

 
 
 
 
 
8.5.  Net benefit and cost benefit analysis 

Global costs and benefits per option (excluding common measures) 

Option 1 

Option 2 

Option 3 

PRM/FRM users 

Operators 

NCAs 

PRM/FRM users 

Operators 

NCAs 

PRM/FRM users 

Operators 

NCAs 

Costs per stakeholder category 
(million EUR/year) 

133 

Global costs (million EUR/year) 

Benefits per stakeholder category 
(million EUR/year) 

from 310 to 1 243 

2 

135 

0 

0 

0 

400 

6 

from 43 to 98 

667 

8 

from 58 to 113 

from 449 to 504 

from 733 to 788 

from 621 to 2 486  

0 

0 

from 466 to 1 864 

0 

0 

Global benefits (million 
EUR/year) 

from 310 to 1 243 

from 621 to 2 486 

from 466 to 1 864 

Cost benefit analysis of options under the best scenario (highest benefits and lowest costs) 

Net benefit (million EUR/year)  

1 243 – 135 = 1 108 

2 486 – 449 = 2 037 

Benefit Cost Ratio  

1 243 / 135 = 9.20 

2 486 / 449 = 5.53 

Cost benefit analysis of options under the worst scenario (lowest benefits and highest costs) 

Net benefit (million EUR / year)  

Benefit Cost Ratio  

310 – 135 = 175 

310 / 135 = 2.29 

621 – 504 = 117 

621 / 504 = 1.23 

1 864 - 733= 1 131 

1 864 / 733 = 2.54 

466 - 788 = - 322 

466 / 788 = 0.59 

117 

 
 
 
 
 
 
9.  REDUCTION  OF  ADMINISTRATIVE  BURDENS  DUE  TO  SIMPLIFICATION  OF  ADMINISTRATIVE 

PROCEDURES 

  All professional operators to be registered in a single register under the PHL 

Over  20  000  duplicate  registrations  will  be  avoided  and  over  EUR  800  000  annual  savings  in 
registration  costs  for  operators  supplying  PRM  of  fruit  plants.  Over  4  000  duplicate  registrations 
will  be  avoided  and  there  will  be  over  EUR  237  000  annual  savings  in  registration  costs  for 
operators supplying FRM.  

There will be marginal savings for the NCAs due to the fact that there will be no obligation to keep 
separate registers of professional operators under PRM/FRM legislation and PHL. 

  Decisions for addition of new species in (or removal of species from) the scope of the 

PRM legislation will be taken by means of tertiary legislation. 

  Decisions on the equivalence to EU rules for third countries will be taken by means of 

tertiary legislation. 

Currently decision making by means of tertiary legislation is already the case for some marketing 
Directives  for  both  the  regulated  species  and  the  equivalence  for  third  countries.  However,  some 
Directives  require that for such decisions the ordinary  legislative procedure is  followed, which is 
cumbersome and disproportionate compared to the technical nature of the matter. 

These measures will result in no costs for NCAs or operators, while there will be benefits for the 
Commission, the NCAs and operators in terms of reduced hassle costs due to shorter time to reach 
decisions (not monetised as per the Better Regulation guidelines). Any benefits are expected to be 
negligible in the short term as since the adoption of the first Directives, there have been very few 
changes in the lists of regulated species and about 1 or 2 requests from third countries per year are 
examined for equivalence. In the mid- to long-term however it is expected that shorter time to reach 
decisions would be beneficial in the light of rapidly changing conditions in relation to food security. 

  The transfer/notification of new varieties from national to Common Catalogues will be 

managed by the MS without the need for a Commission Decision. 

On the basis of notifications received from MS, the Commission publishes in the Official Journal of 
the European Communities under the titles ‘Common Catalogue of Varieties of Agricultural Plant 
Species’  and  ‘Common  Catalogue  of  Varieties  of  Vegetables  Species’  lists  of  all  the  varieties  of 
which the seed and propagating material can be marketed throughout the EU. The publication of the 
supplements  to  the  Common  Catalogues  requires  a  Commission  Decision.  Currently  the 
Commission  adopts  every  year  12  Decisions  for  the  agricultural  plant  species  (in  average  2564 
varieties  every  year)  and  12  Decisions  for  the  vegetable  species  (on  average  1384  varieties  per 
year). This procedure creates unnecessary waiting time until a variety is included in the Common 
Catalogues and gets access to the common market. 

The  measure  will  result  in  no  costs  for  NCAs  or  operators,  while  there  will  be  benefits  for  the 
Commission in terms of removing the need for 24 Decisions annually and operators in terms of 
reduced  hassle  costs  (not  monetised  as  per  the  Better  Regulation  guidelines).  Depending  on  the 
current  practices  of  the  MS,  the  period  between  acceptance  in  a  national  catalogue  of  new 

118 

 
 
varieties of agricultural plant species and vegetable species and access to the common market 
will be shortened by 1 to 4 months. 

  Allow MS to decide themselves on permitting temporarily the marketing of seed that 
does not satisfy the requirements in respect of minimum germination, if germination is 
not lower than 15 % than the required germination rate. 

Currently MS wishing to use this derogation have to inform the Commission and the other MS who 
can make an offer to cover the missing supply. If no offers are received, the MS are authorised to 
allow  the  marketing  of  seed  with  lower  germination  rate  by  a  Commission  Decision.  This 
procedure  is  disproportionate  as  most  often  there  are  no  suitable  offers,  while  the  quantities 
concerned are limited (in average 50 000 tonnes of seed annually, or about 0.01% of the quantities 
of seed certified annually). Over the last five years only 5 to 12% of the requested amounts could 
be covered by seed offered by other MS. For the remaining requests, an authorisation was granted 
after  the  period  for  other  MS  to  submit  offers  had  expired.  Around  85%  of  the  requests  concern 
germination  15%  or  less  below  the  minimum  germination  as  laid  down  in  the  seed  marketing 
Directives.  

The  measure  will  result  in  no  costs  for  NCAs  or  operators.  There  will  be  benefits  for  the 
Commission and the NCAs in avoiding the handling of in average 30 notifications per year. 
There will also be benefits for operators in terms of reduced hassle costs due to shorter time (at 
least by 15 days for each avoided notification, not monetised) to cover the market needs when seed 
satisfying  the  minimum  germination  requirements  is  not  available.  The  flexibility  introduced  by 
this  measure  is  expected  to  gain  importance  in  the  mid-  to  long-term  since  problems  of  reduced 
germination are expected to occur more often under extreme conditions due to climate change.  

119 

 
 
 
 
ANNEX 5: BACKGROUND INFORMATION 

1.  THE PRM LEGISLATION AND ITS DEVELOPMENT 

The PRM Directives have been in force since the mid-1960s. The legislative framework comprises 
one horizontal Directive on the Common Catalogue of Varieties and 11 vertical Directives dealing 
with specific plant groups:  

1.  Council  Directive  2002/53/EC  on  the  common  catalogue  of  varieties  of  agricultural  plant 

species (http://data.europa.eu/eli/dir/2002/53/2004-04-18) 
66/401/EEC 

2.  Council  Directive 

the  marketing 

on 

of 

fodder 

plant 

seed 

(http://data.europa.eu/eli/dir/1966/401/2020-02-16) 

3.  Council 

Directive 

66/402/EEC 

on 

the  marketing 

of 

cereal 

seed 

(http://data.europa.eu/eli/dir/1966/402/2020-02-16) 

4.  Council 

Directive 

2002/54/EC 

on 

the 

marketing 

of 

beet 

seed 

(http://data.europa.eu/eli/dir/2002/54/2017-04-01) 

5.  Council  Directive 

2002/55/EC 

on 

the  marketing 

of 

vegetable 

seed 

(http://data.europa.eu/eli/dir/2002/55/2020-07-01) 

6.  Council  Directive 

2002/56/EC 

on 

the  marketing 

of 

seed 

potatoes 

(http://data.europa.eu/eli/dir/2002/56/2020-02-16) 

7.  Council  Directive  2002/57/EC  on  the  marketing  of  seed  of  oil  and  fibre  plants 

(http://data.europa.eu/eli/dir/2002/57/2020-02-16) 

8.  Council Directive 68/193/EEC on the marketing of material for the vegetative propagation 

of the vine (http://data.europa.eu/eli/dir/1968/193/2020-02-16) 

9.  Council  Directive  1998/56/EC  on  the  marketing  of  propagating  material  of  ornamental 

plants (http://data.europa.eu/eli/dir/1998/56/2014-06-30) 

10. Council  Directive  2008/72/EC  on  the  marketing  of  vegetable  propagating  and  planting 

material, other than seed (http://data.europa.eu/eli/dir/2008/72/2020-07-01) 

11. Council Directive 2008/90/EC on the marketing of fruit plant propagating material and fruit 

plants intended for fruit production (http://data.europa.eu/eli/dir/2008/90/2019-01-28) 

12. Council  Directive  1999/105/EC  on  the  marketing  of  forest  reproductive  material 

(http://data.europa.eu/eli/dir/1999/105/oj) 

The  majority  of  Council  Directives  for  the  marketing  of  PRM  were  adopted  between  1966  and 
1971.  Some  Directives  are  more  recent,  such  as  the  Council  Directive  for  the  marketing  of 
vegetable propagating material and planting material other than seed and the one for the marketing 
of ornamentals. These Directives have been updated both frequently and substantially. The original 
Directives on fodder plant seed and cereal seed are still in force although these have been subject to 
a large number of amendments. The SLIM initiative launched by the Commission in 1996 has led 
to the recasting of the Council Directive on the marketing of ornamental plants in 1998 as well as to 
the  ‘2002’  Directives  (2002/53/EC,  2002/54/EC,  2002/55/EC,  2002/56/EC,  and  2002/57/EC)  that 
are  codifications  of  pre-existing  Directives.  Directives  66/401/EEC  and  66/402/EEC  were  not 
included  in  this  SLIM  initiative  as  some  amendments  were  on-going  at  the  time  when  the 
Directives were recast or codified. As a follow-up to the Organisation for Economic Co-operation 

120 

 
 
and  Development  (OECD)  revision  of  its  trade  scheme  for  FRM  in  the  mid-1990s,  the  EU 
undertook to renew its old Directive so that there would be only one set of definitions and rules for 
marketing of FRM. The new Directive 1999/105/EC has standards that reflect the increase in MS 
since 1966, for example in the number of species covered. A more recent change was the adoption 
of Council Directive 2008/90/EC, a recast of Council Directive 92/34/EEC216 on the marketing of 
fruit plant propagating material and fruit plants intended for fruit production. 

Figure 4. Overview of marketing Directives and corresponding Common Catalogues 

2.  PRINCIPLES OF THE PRM LEGISLATION 

2.1.  Variety registration 

2.1.1. 

Distinctness, uniformity and stability (DUS) 

For the purposes of variety registration (‘first pillar’, Figure 5), the NCAs of the MS test by field 
trials  the  candidate  new  plant  varieties  for  their  DUS).  The  characteristics  (e.g.  shape  and 
morphology  of  the  leaves)  of  the  candidate  varieties  are  compared  with  those  of  several  existing 
plant varieties in the EU (‘reference varieties’). New varieties need to be different from reference 
varieties (distinctness requirement). The characteristics of different plants within the same variety 
should be similar (uniformity requirement). The characteristics of the plants of a new variety should 
not change over time (stability requirement). DUS tests take about two years in the case of varieties 
of agricultural and vegetable species and 5-6 years in the case of varieties of fruit plants and vine. 
Upon completion of the DUS tests, varieties of vegetable species and fruit plants are registered in 
the national  catalogue of the  MS concerned and subsequently submitted to  the corresponding  EU 
Common  Catalogue.  Each  registered  plant  variety  has  a  denomination,  i.e.  a  name  that  serves  to 
identify  that  variety217.  PRM  is  always  marketed  with  reference  to  a  plant  variety  whereby  the 
variety denomination is displayed on the official label/operator’s label. 

216 OJ L 157, 10.6.1992, p. 10. 
217 An example of a denomination of an apple variety is Boskoop Rouge Bakker. 

121 

 
 
 
                                                 
2.1.2. 

Value for cultivation and use (VCU) 

In  addition  to  the  DUS  test,  varieties  of  agricultural  species  need  to  be  assessed  for  their  VCU 
before  they  can  be  registered.  Through  comparative  field  trials  in  distinct  locations  across  the 
country, the NCAs compare the performance of new plant varieties as regards four characteristics 
with that of varieties in their national catalogues (Figure 5). The value of a variety for cultivation or 
use shall be regarded as satisfactory if, compared to other varieties accepted in the catalogue of the 
MS concerned, its qualities, taken as a whole, offer, at least as far as production in any given region 
is concerned, a clear improvement either for cultivation or as regards the uses which can be made of 
the  crops  or  the  products  derived  therefrom.  Where  other,  superior  characteristics  are  present, 
individual  inferior  characteristics  may  be  disregarded218.  Varieties  of  agricultural  species  are 
registered in the national catalogue upon completion of the DUS and VCU examinations.  

New  varieties  of  vine  undergo  a  test  similar  to  VCU  pursuant  to  Commission  Directive 
2004/29/EC219.  This  VCU-like  test  forms  part  of  the  examination  of  the  physiological 
characteristics of vine varieties carried out in the frame of the DUS test. Through field trials NCAs 
assess new vine varieties for yield, use, sensitivity/resistance to unfavourable conditions and pests. 
Commission Directive 2004/29/EC does not explicitly refer to VCU, but  it contains requirements 
similar to the VCU criteria of agricultural species. MS have diverged in their implementation of the 
legislation.  In France, the VCU examination forms  part of the registration procedure of new vine 
varieties. There is a technical examination document (‘règlement technique’) for new varieties that 
is  directly  linked  to  Directive  2004/29.  Italy  modified  the  legislation  5  years  ago.  The 
characteristics to be assessed under the new Italian Decree no longer refer to Directive 2004/29. In 
total,  75  characteristics  stemming  from  the  CPVO  protocol  for  the  DUS  examination  of  vine 
varieties need to  be  assessed  220 and the Descriptor list  of grape varieties  and  Vitis species of the 
International Organisation of Vine and Wine (OIV)221. 

The  VCU  examinations  of  plant  varieties  are  based  on  phenotypic  observation  of  the  crop  in  the 
field  according  to  the  relevant  protocols.  DUS  protocols  are  common  for  all  MS  while  VCU 
protocols  are  defined  by  each  MS.  The  use  of  BMTs  is  gaining  more  importance  as  a 
supplementary tool to phenotypic observations in the field (this Annex, Section 7).  

218  Depending  on  the  regional  conditions,  the  priorities  could  be  different.  For  example,  slightly  lower  yield  can  be 
accepted if the new variety is found to be tolerant to drought. 
219 OJ L 71, 10.3.2004, p. 22. 
220 CPVO-TP/050/2. 
221 https://www.oiv.int/public/medias/2274/code-2e-edition-finale.pdf  

122 

 
 
                                                 
Figure 5. Pillars of the PRM legislation 
1 Applies to agricultural and vegetable species, fruit plants and vine 
2 Applies to agricultural species and vine 
3 During certification the identity, quality and health of PRM is checked 

Decreasing requirements for PRM means lower PRM quality and lower market value 
of PRM 

In  the  current  legislation  on  fruit  plants,  vegetable  seed  and  vegetable  propagating  material  other 
than  seed  it  is  not  mandatory  to  carry  out  a  VCU  examination  as  part  of  the  variety  registration 
process.  Recital  (3)  to  Council  Directive  2008/90/EC222  states  that  ‘Satisfactory  results  in  the 
cultivation of fruit depend to a large extent on the quality and plant health of the material used for 
their  propagation  and  of  the  fruit  plants  intended  for  fruit  production.’  Recital  (9)  refers  to  the 
establishment of plant health and quality standards for each genus and species of fruit plant based 
on international schemes. Furthermore, it states  that ‘it is appropriate to provide, therefore, for  a 
for  a  system  of  harmonised  rules  for  the  different  categories  of  propagating  material  and  fruit 
plants to be marketed by reference to those international schemes, where available’. In the absence 
of  mandatory  common  rules  on  VCU  testing,  MS  have  diverged  in  their  implementation  of  the 
legislation.  

Poland has 5 testing stations to examine new varieties of fruit plants (apples, pears, plums, cherries, 
peaches, apricots, currants). Through comparative field experiments new varieties are evaluated for: 

-  susceptibility to diseases and pests; 
-  high nutritional value of fruit suitable for consumption; 
-  storage capacity; 
-  resistance to frost and susceptibility of flowers to spring frost; 
-  possibility of machine harvesting of fruit. 

Until 1997, Czechia assessed the VCU of apples, pears, plums, cherries, apricots, small fruits under 
various  climatic  conditions  in  accordance  with  the  VCU  examination  conducted  for  agricultural 

222 OJ L 267, 8.10.2008, p. 8. 

123 

 
 
 
                                                 
crops. VCU trials were stopped because of the high costs and the time-demanding process. Since 
1997, informal VCU trials are carried out by universities, research institutes and private growers. 
Nowadays, subsidies are given for: 

-  varieties  intended  for  integrated  production  based  on  growing  characteristics  (disease 

resistance, fruit quality, frost hardiness and stability of yields); 

-  varieties for organic production recommended by breeders, research institutions, growers’ 

associations and non-governmental institutions based on their experience. 

Efforts  are  undertaken  to  assess  sustainability  characteristics  of  new  varieties  of  fruit  plants.  The 
European  fruit  research  institutes  network  (eufrin)223  is  an  informal,  voluntary  organisation  of 
university  departments  and  research  institutes.  They  specialise  in  research,  development,  and 
extension  on  temperate  fruit  crops  and  are  based  within  countries  of  the  EU,  Switzerland,  and 
Eastern  Europe.  They  organise  working  groups  on  variety  testing  of  new  varieties  of  fruit  plants 
with a proven unified descriptor list in a wide range of climatic conditions.   

In the vegetable seed and vegetable propagating material sector there is a high turnover of varieties 
because  there  is  a  high  number  of  vegetable  varieties  in  the  EU  Plant  Variety  Portal  (±  22  000 
vegetable varieties). Each year, about 1 400 new varieties are registered. There is a large diversity 
of cultivation systems: 

a)  spring/summer/autumn crops;  
b)  indoor/outdoor cultivation;  
c)  type of medium, mechanisation and irrigation systems; 
d)  type of crop protection (hygiene, seed treatment, chemical, natural enemies,…). 

A major part of vegetables is marketed as harvested fresh produce via retailers to consumers and a 
minor  part  as  vegetable  seed.  There  are  different  uses  of  the  harvested  products.  Tomato  can  be 
used  for  direct  consumption  in  a  salad,  for  pasta  sauces  or  ketchup.  Consumer  preferences  as 
regards  colour,  size,  flavour  play  an  important  role  in  the  breeding  and  selection  process  of  new 
vegetable varieties.  It  is  very  complicated to  design harmonised VCU examinations  for vegetable 
varieties  because  of  the  different  cultivation  systems,  the  different  uses  of  vegetable  seed  and 
propagating  material  and  the  need  to  consider  consumer  preferences.  For  this  reason,  there  is 
currently no official VCU examination but there is a direct interaction between the seed company 
and the farmer to check the performance of new vegetable varieties in relation to existing varieties. 

2.2.  Certification 

2.2.1. 

Official certification 

Certification  of  PRM  (‘second  pillar’,  Figure  5)  consists  of  checking  the  identity,  quality,  and 
health of PRM during the growing (= production) of that material in the field.  Seeds are sampled 
and  tested  in  relation  to  the  respective  technical  requirements  and  finally  the  variety  identity  and 
purity is controlled by control-plot tests. The identity check serves to verify that the PRM has the 
same characteristics as the registered plant variety to which that PRM belongs. The quality of the 

223 https://eufrin.eu/frontpage 

124 

 
 
                                                 
PRM  relates  to  the  absence  of  defects  or  the  shape  of  the  plants224.  Depending  on  the  quality, 
different marketing categories of PRM are defined. The NCAs perform regular checks during the 
production of PRM to verify that it does not contain any plant pests or diseases. Upon completion 
of  all  these  inspections  the  NCAs  issue  an  official  label.  That  label  confirms  that  the  PRM  is 
officially  certified  and  that  it  can  be  marketed  throughout  the  EU.  The  PRM  legislation  also 
includes  rules  for  marketing  of  PRM  in  homogeneous  lots  that  assure  traceability  and  rules  for 
packaging, sealing, labelling and documentation. 

2.2.2. 

Certification under official supervision 

The  PRM  legislation  permits  the  transfer  of  aspects  of  the  certification  procedures  to  industry 
through  a  system  of  certification  under  official  supervision  (Figure  6).  Operators  and  staff 
(company inspector, company sampler) involved in these activities can be authorised if they follow 
a  mandatory  training  course  given  by  the  NCAs  and  are  licensed.  They  can  then  perform  field 
inspections  to  check  the  identity,  quality  and  health  of  PRM  in  the  production  site.  The  NCAs 
perform  official  check  testing  on  at  least  5%  of  the  field  inspections  performed  by  the  company 
inspectors to verify that the field inspections have been carried out in a proper way. Furthermore, 
operators  can  carry  out  seed  sampling  and  testing  and  be  authorised  to  print  official  labels.  The 
NCAs carry out official inspections on those operators (5% of which is officially check-tested) and 
their staff on a regular basis to ensure that they perform these tasks in a correct way. NCAs always 
perform  pre-  and  post-control  testing,  take  the  decision  on  the  certification  of  the  PRM  and 
authorise  the  issuing  of  the  official  labels.  For  each  of  the  aforementioned  activities  the  operator 
can  apply  for  authorisation  to  carry  out  that  activity  under  official  supervision.  For  example,  the 
NCA  performs  official  field  inspections  while  the  operator  carries  out  seed  sampling  and  testing 
under  official  supervision  of  the  NCA.  This  flexibility  as  regards  the  distribution  of  activities 
performed officially by the NCAs or by the operator under official supervision is called the mix and 
match approach. Certification under official supervision is currently allowed only for certified seed 
of  agricultural  species225  but  not  for  seed  potatoes.  The  PRM  legislation  and  the  Rules  and 
Regulations  of  the  OECD  Seed  Schemes  are  aligned  as  regards  the  conditions  for  certification 
under official supervision226. 

224  In  the  case  of  fruit  trees,  the  trees  concerned  should  have  a  main  stem  with  a  number  of  side  branches  in  a 
symmetrical form to ease mechanical harvesting. 
225 Directives 66/401/EEC, 66/402/EEC, 2002/54/EC and 2002/57/EC. 
226 OECD Seed Schemes Rules and Regulations 2022. 

125 

 
 
                                                 
Figure 6. Official certification and certification under official supervision 

2.3.  Activities of seed conservation networks and exchange in kind 

Seed conservation networks are involved in  the conservation and sustainable use of plant  genetic 
resources.  In  practice  this  means  that  they  conserve  seeds.  This  can  be  done  in  a  seed  bank  (i.e. 
seeds  stored  under  cooled  conditions)  or  in  a  live  collection  (seeds  grown  in  a  field).  Seed 
conservation  networks  exchange  seed  with  other  networks  to  grow  it  under  other  climatic 
conditions or better characterise it.  

Exchange in kind means the not-for-profit transfer of seeds from one farmer to another farmer. In 
most  marketing  Directives  this  transfer  is  considered  to  be  marketing.  For  example,  Article  2(1) 
point  (a)  of  Council  Directive  2002/55/EC227  on  the  marketing  of  vegetable  seed  states  the 
following:  ‘marketing:  shall  mean  the  sale,  holding  with  a  view  to  sale,  offer  for  sale  and  any 
disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or 
not for consideration’. This means that seed exchanged in kind has to be authorised for marketing. 
The  variety  to  which  that  seed  belongs  has  to  be  officially  registered  in  one  of  the  national 
catalogues and the seed has to be certified. As mentioned in Section 2.1.2. those varieties often do 
not meet the variety registration requirements (DUS test) as they are not sufficiently uniform or the 
available seed quantity is too low to allow its proper characterisation. In the latter case of low seed 
quantities, all available seed would have been used upon completion of the variety registration and 
seed certification. 

In most MS exchange in kind of seeds between farmers is not permitted. A couple of MS (Austria 
and  France)  have  allowed  exchange  in  kind  of  seeds  between  farmers  under  specific 
circumstances228. In France, under Article 315-5 of the Code Rural, exchange in kind of seeds and 
other PRM is permitted in the context of a ‘mutual assistance’ framework, as long as  they do not 
belong to a variety protected by a plant variety right, they are not produced within the framework of 

227 OJ L 193, 20.7.2002, p. 33. 
228 ICF(2023), Section 5.1.2.1. 

126 

 
 
 
                                                 
a multiplication contract, and are not intended for commercialisation229. In Austria230 the “exchange 
of seeds for the protection of plant genetic resources between farmers and seed users” is exempted 
from the scope of the legislation under the following conditions (1) the farmer or seed user does not 
deal  in  seed  trade,  (2)  the  variety  to  which  the  exchanged  PRM  belongs  is  not  registered  in  the 
Austrian  national  catalogue,  the  EU  common  catalogues  or  the  OECD  list  for  international  seed 
trade  (except  for  conservation  and  amateur  varieties)  and  (3)  within  species-specific  quantitative 
restrictions  limiting  the  amounts  that  can  be  exchanged.  In  Italy,  the  national  legislation  was 
amended  in  2021  to  allow  for  in-kind  exchange  between  farmers  of  a  portion  of  their  harvest231. 
The  new  legislation  does  not  provide  any  detailed  information  regarding  the  conditions  of 
exchange, including quantities or varieties that can be exchanged. 

At international level, the International Treaty on Plant Genetic Resources for Food and Agriculture 
(ITPGRFA)  recognises  the  rights  of  farmers  “to  save,  use,  exchange  and  sell  farm-saved 
seed/propagating  material,  subject  to  national  law  and  as  appropriate”232.  The  United  Nations 
Declaration on the Rights of Peasants and Other People Working in Rural Areas (UNDROP) also 
recognises  that  “peasants  and  other  people  working  in  rural  areas  have  the  right  to  save,  use, 
exchange and sell their farm-saved seed or propagating material”233. 

2.4.  Marketing to amateur gardeners 

An amateur gardener means a person who engages in  gardening as a hobby. A survey addressing 
amateur  gardeners  showed  three  major  reasons  for  being  involved  in  amateur  gardening234.  First, 
growing edible produce was an important reason for being involved in gardening. Second, amateur 
gardeners  garden  for  enjoyment  (i.e.  as  a  hobby).  Third,  they  garden  to  improve  or  maintain  the 
appearance  of  their  garden.  These  activities  are  outside  the  scope  of  the  PRM  legislation.  For 
example, amateur gardeners can exchange or sell to each other PRM without any restriction. 

PRM  that  is  intended  for  marketing  to  amateur  gardeners  has  to  be  authorised  for  marketing 
pursuant to the pillars of the PRM certification system (Figure 5). Consequently, the vast majority 
of  PRM  marketed  to  amateur  gardeners  belongs  to  registered  varieties.  The  derogatory  rules  for 
acceptance  of  varieties  and  certification  of  seeds  for  agricultural  and  vegetable  conservation 
varieties (Section 2.1.2.) cannot  meet  the demand of an important  share  of amateur  gardeners for 
diverse  and  locally  adapted  varieties.  Under  the  future  legal  framework,  amateur  gardeners  will 
have the possibility to choose between more genetically diverse and less uniform PRM on the one 
hand and certified PRM on the other.  

In 2020, France adopted a Regulation that excludes from the general PRM legislation the exclusive 
marketing to amateur gardeners of PRM that belongs to varieties that are not or no longer subject to 
intellectual  property  rights  (i.e.  plant  variety  rights)235.  In  practice  this  means  that  the  varieties 

Decreto 

229 https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000029585219/2014-10-15. 
230 Saatgutgesetz 1997 (Austrian seed law 1997) 
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10011033. 
231 
res/N2Ls?urn:nir:stato:decreto.legislativo:2021;020  
232 https://www.fao.org/plant-treaty/overview/en/. 
233 https://digitallibrary.un.org/record/1650694. 
234 ICF(2021). 
235 LOI n° 2020-699 du 10 juin 2020. 

legislativo 

febbraio 

2021, 

n.20. 

2 

https://www.normattiva.it/uri-

127 

 
 
                                                 
concerned do not have to be registered in the French national catalogue and that the PRM does not 
have  to  be  certified.  The  French  Variety  and  Seed  Study  and  Control  Group  (GEVES)  further 
clarified  that  the  varieties  of  PRM  that  are  marketed  to  both  professional  users  and  amateur 
gardeners have to be registered in the French national catalogue236. 

2.5.  Organic  varieties 

suitable 

for  organic  production  and  organic 

heterogeneous material 

Organic varieties suitable for organic production 

According  to  the  principles  of  the  Organic  Regulation,  for  the  production  of  organic  varieties 
suitable  for  organic  production,  the  organic  breeding  activities  shall  be  conducted  under  organic 
conditions  and  shall  focus  on  enhancement  of  genetic  diversity,  reliance  on  natural  reproductive 
ability,  as  well  as  agronomic  performance,  disease  resistance  and  adaptation  to  diverse  local  soil 
and climate conditions. However, currently the biggest share of PRM for organic varieties marketed 
in the EU are varieties accepted under the DUS rules (this Annex, Section 2.1)237. Those varieties 
have  a  high  degree  of  uniformity  and  this  goes  contrary  to  the  aforementioned  principle  of 
focussing on an enhancement of genetic diversity. 

Organic heterogeneous material 

The  Organic  Regulation238  has  defined  ‘organic  heterogeneous  material’  but 
term 
‘heterogeneous material’ does not exist in the PRM legislation. Organic heterogeneous material is 
characterised by a high level of genetic and phenotypic diversity between individual reproductive 
units.  It  is  not  a  variety  nor  is  it  a  mixture  of  varieties.  The  Organic  Regulation  allows  the 
marketing  of  organic  heterogeneous  material  without  complying  with  the  requirements  for 
registration and without complying with the certification categories of pre-basic, basic and certified 
material  or  with  the  quality,  health  and  identity  requirements  for  Conformitas  Agraria 
Communitatis  (CAC),  standard  or  commercial  categories,  set  out  in  the  PRM  legislation.  This 
derogation  from  the  PRM  legislation  for  organic  heterogeneous  material  has  responded  to  the 
demand for more genetically diverse PRM. The production of this type of material is restricted to 
certified organic producers. 

the 

2.6.  Conservation varieties 

For decades since the introduction of the first seed marketing directives, only DUS varieties were 
allowed  to  be  marketed.  As  the  questions  of  biodiversity  and  the  conservation  of  plant  genetic 
resources grew in importance, derogations to the rules for acceptance of varieties and certification 
of seeds were adopted for agricultural and vegetable landraces in 2008239 and 2009240 respectively 
(termed as ‘conservation varieties’). Derogations were also introduced in 2010 for marketing fodder 

236  https://www.geves.fr/actualites/suppression-de-lobligation-dinscription-au-catalogue-officiel-francais-des-varietes-
du-domaine-public-pour-les-amateurs%E2%80%AF-quen-est-il-
precisement%E2%80%AF/#:~:text=La%20loi%20n%C2%B0%202020,Catalogue%20officiel%2C%20fran%C3%A7ai
s%20ou%20europ%C3%A9en  
237 Euroseeds (2019). 
238 Regulation (EU) 2018/848 and Commission Delegated Regulation (EU) 2021/1189. 
239 Commission Directive 2008/62/EC 
240 Commission Directive 2009/145/EC 

128 

 
 
                                                 
plant  mixtures  for  use  in  preservation  of  the  environment241.  Agricultural  and  vegetable 
conservation varieties can be registered with reduced uniformity requirements (even with unofficial 
tests instead of DUS) and without VCU for agricultural plant species. A historical linkage to their 
region  of origin  is  required.  Maintenance and marketing is  restricted within  that region  of origin. 
Furthermore, the Directives require that in order to benefit from these derogations, it is established 
that the varieties are threatened by genetic erosion. The Directives also set quantitative restrictions 
on the seed quantities that can be marketed annually for each conservation variety.  In addition to 
the vegetable conservation varieties, the category of “vegetable varieties with no intrinsic value for 
commercial  crop  production  that  have  been  developed  under  particular  conditions”,  otherwise 
known  as  ‘amateur’  varieties  has  been  established.  These  are  not  subject  to  geographic  or 
quantitative  restrictions,  but  their  seeds  have  to  be  marketed  in  small  packages  (i.e.  addressed  to 
amateur gardeners).  

At the end of 2021, there were 396 conservation varieties of agricultural plant species and 177 of 
vegetable species registered in the common catalogues (representing around 1% of the total number 
of  varieties)242,  i.e.  the  impact  of  these  derogations  has  been  minimal.  Many  landraces  are 
cultivated  in  very  small  areas  and  even  the  derogations  regime  is  considered  too  burdensome  for 
these.  The  little  volume  of  business  that  can  be  obtained  from  the  seed  commercialisation  of 
conservation varieties (due to the quantitative and geographic restrictions) are evoked as one of the 
reasons  for  the  low  number  of  such  varieties  being  registered  in  the  Common  Catalogues243. 
Finally,  the  derogations  for  conservation  varieties  are  not  catering  for  new  approaches  such  as 
participatory plant breeding methodologies that aim to develop new locally adapted varieties. 

3.  PRINCIPLES OF THE FRM LEGISLATION 

The  principles  of  the  FRM  legislation  are  quite  different  from  those  of  the  PRM  legislation.  The 
FRM  system  relies  on  approved  trees  called  ‘basic  material’.  These  trees  have  been  selected  for 
superior characteristics (e.g. morphological features, wood quality, health, and resistance) and from 
which  seeds  and  other  reproductive  material  will  be  harvested,  certified,  and  marketed  in  lots 
(Figure 7). FRM is an important driver of the forest-based industries (timber, pulp, furniture,…). 

241 Commission Directive 2010/60/EU. 
242 Data retrieved from the Common Catalogues. 
243 Spataro G. and Negri V. (2013) 

129 

 
 
                                                 
Figure 7. Pillars of the FRM certification scheme 

1 During certification the identity, quality and health of FRM is checked 

Stricter requirements for approval of basic material result in higher FRM quality and 
higher market value of FRM 

For lower quality FRM, basic material will be checked for basic characteristics (e.g. straightness of 
the  trunk  and  symmetry  of  the  side  branches).  In  the  case  of  source-identified  material  the  EU 
legislation requires that the basic material is a seed source or stand of trees located within a single 
region  of provenance244. The EU legislation does not  describe any  criteria to be met by that seed 
source  and  stand245.  The  selection  criteria  are  left  at  the  discretion  of  the  MS.  For  higher  quality 
FRM, parent trees will be selected for outstanding characteristics and crossing schemes designed. 
NCAs  approve  basic  material  through  an  official  inspection  following  which  basic  material  is 
registered  in  the  national  catalogue  of  the  MS  concerned  and  subsequently  in  the  EU  Common 
Catalogue.  Upon  harvesting  seeds  and  other  FRM  from  basic  material  NCAs  issue  a  Master 
certificate246. FRM has to meet the relevant requirements (age, development, health and resistance 
of  trees  in  stands  to  adverse  climatic  conditions)  before  the  operator  can  issue  a  supplier’s 
document or supplier’s label.  

The  registration  of  basic  material,  the  Master  certificate  and  the  supplier’s  document/label  are 
prerequisites for the marketing of FRM throughout the EU (Figure  7). Seeds of agricultural crops 
are produced, certified, and harvested in cycles of one year, while in the case of FRM it may take 
50-100  years  before  seeds  and  forest  plants  can  be  harvested  from  basic  material247.  Global 
warming  has  a  negative  and  increasing  impact  on  Europe's  forests  by  shifting  biogeographical 
regions northwards and uphill. FRM that used to be optimal for a given region may no longer be fit 

244 The provenance is the place in which trees are growing. It is also called the geographic source. For a tree species, the 
region of provenance is an area or group of areas subject to sufficiently uniform ecological conditions in which stands 
or seed sources showing similar phenotypic or genetic characters are found. 
245 Annex II to Council Directive 1999/105/EC. OJ L 11, 15.1.2000, p. 17. 
246 The Master certificate provides details about the harvested FRM such as: botanical name, type of FRM (seed unit, 
planting stock,…), FRM category (source-identified, selected, qualified or tested material), origin of basic material etc. 
247 In the Northern part of Finland and Sweden (e.g. Lapland), the main tree species (e.g. Norway spruce and  Scotch 
pine) only flower once in a decade. 

130 

 
 
 
                                                 
for that region because of the changing climatic conditions. This makes FRM diversity even more 
essential.  

The  current  FRM  legislation  does  not  require  MS  to  undertake  provenance  trials.  In  such  trials, 
material  of  different  provenances  is  planted  in  a  single  place  or  at  different  locations  spanning  a 
range  of  environmental  conditions.  These  trials  serve  to  reveal  genetic  variation  among 
provenances, as well as differences in the ability of the trees from different provenances to react to 
fluctuating  environmental  conditions.  Provenance  trials  rely  on  the  observation  of  the  phenotypic 
characteristics  of  the  trees.  Combining  molecular  markers  with  provenance  trials  provides 
information on the geographical scale of local adaptation. This information is crucial for selecting 
and  using  FRM  in  different  sites  and  habitats.  The  outcome  of  such  provenance  trials  would 
provide  information  about  the  area  in  which  FRM  is  adapted  and  this  would  in  turn  allow  FRM 
users to take informed decisions on where to best plant FRM. The existing derogatory regime for 
the conservation of forest genetic resources248 has not been applied by any MS. This is because 
the requirements for basic material intended for the purpose of conserving forest genetic resources 
are totally different from those of basic material for commercial FRM production. For conservation 
small  quantities  that  do  not  meet  the  requirements  of  basic  material  for  commercial  use  are 
needed249. Actions to conserve forest genetic resources are taken at national or regional levels, with 
the result that knowledge about the conservation and sustainable use of forest genetic resources is 
scattered across the EU. 

4. 

INTERACTION WITH OTHER EU POLICIES AND INSTRUMENTS 

The  revision  of  the  PRM  and  FRM  legislation  will  ensure  coherence  with  the  EGD,  its 
implementing  strategies,  Common  Agricultural  Policy  and  the  European  Digital  Strategy  as 
described in Figure 8. 

248 Article 2(4) to Directive 1999/105/EC. 
249 For conservation purposes the entire collection of trees should be kept while only trees with superior characteristics 
will be selected in the case of basic material for commercial purposes. It would be necessary to lay down requirements 
that are specific for basic material intended for the purpose of conserving forest genetic resources. Examples of material 
not  meeting  the  requirements  of  the  FRM  rules  are  vegetative  material  of  poplars  for  conservation  or  restoration 
activities, seed orchards for conservation purposes and FRM conserved in in situ and ex situ genebanks. 

131 

 
 
                                                 
Figure 8. Interaction with other EU policies and instruments 

132 

 
 
 
5. 

INTERACTION BETWEEN FSFS, PRM/FRM AND NGTS 

Figure 9 represents the interaction between the overarching legal framework of the FSFS initiative 
and the sectoral initiatives on PRM/FRM and NGTs.  

Figure 9. Interaction PRM/FRM initiative with NGT and FSFS initiatives 

6. 

INTERPLAY  BETWEEN  PRM/FRM  AND  NGT  INITIATIVES  AS  REGARDS  SUSTAINABILITY 
PROVISIONS  

The scope of the NGT initiative covers all plant species, while the PRM/FRM initiative covers only 
the economically most important species for European agriculture, horticulture and forestry.  

Under all options of the PRM/FRM initiative the assessment of sustainability characteristics will be 
extended to all crop groups/FRM categories beyond agricultural crops on a voluntary (option 1) or 
mandatory basis (options  2 and 3). Both  the current  VCU for agricultural  crops and vine and the 
envisaged  extended  sustainability  assessment  under  the  PRM  initiative  examine  in  field  trials  the 
overall  performance  of  new  varieties  of  the  regulated  species  compared  to  varieties  in  the 
national  catalogues  in  relation  to  a  number  of  characteristics  that  would  go  beyond  one  or  more 
introduced  traits.  The  same  principle  of  an  overall  assessment  of  basic  material  in  relation  to  a 
number of defined sustainability characteristics holds true for FRM. The PRM/FRM systems will 
not provide for the possibility to reject a variety or basic material based on a single trait as inferior 
characteristics may be discarded if the variety/basic material as a whole offers clear improvements 
in comparison with existing varieties/basic material. 

The  NGT  initiative  will  regulate  the  deliberate  release  including  placing  on  the  market  of  plants 
produced  using  targeted  mutagenesis  and  cisgenesis.  NGT  plants  of  the  species  subject  to  the 
PRM/FRM initiative will need to follow the regulatory procedures of the NGT initiative for their 
release and will also be subject to the variety performance assessment of the PRM/FRM. These two 
procedures will remain distinct and will apply consecutively, in the same way as today GMOs are 
authorised  under  the  GMO  legislation  prior  to  the  variety  assessment  (where  applicable)  under 
PRM/PRM. 

The  NGT  initiative  is  considering  options  that  include  certain  sustainability-related  provisions  as 
well  as  options  that  do  not.  Should  the  preferred  option  include  sustainability  considerations,  the 

133 

 
 
 
coherence  between  the  approaches  to  sustainability  will  need  to  be  ensured  on  the  basis  of  the 
following considerations:  

  The  NGT  initiative  considers  plants  from  the  perspective  of  the  genetic  modification 
introduced. In that regard, any sustainability-related provisions (if introduced) would focus 
only  on  the  potential  of  an  individual  trait  introduced  to  contribute  to  sustainability  (as 
opposed to the overall performance in the PRM/FRM systems). 

  The sustainability considerations relating to an individual trait in the NGT initiative (if any) 
would  not  replace  the  conduct  of  or  prejudge  the  outcome  of  the  overall  assessment  of 
performance in the PRM/FRM systems. 

  Should  regulatory  consequences  in  the  context  of  the  specific  procedure  to  deliberately 
release / place NGTs on the market be introduced in the NGT initiative for specific traits as 
regards  their  potential  contribution  to  sustainability,  the  relevant  traits  would  need  to  be 
coherent with the list of VCU/sustainability characteristics. 

7. 

INTERPLAY BETWEEN PRM/FRM LEGISLATION AND PHL 

Union  regulated  non-quarantine  pests  (RNQPs)  are  currently  regulated  both  under  the  PHL  and 
under the marketing Directives as part of the certification requirements. In certain cases, the RNQP 
provisions overlap (Table 30). Furthermore, amendments to the PHL and the marketing Directives 
are  not  simultaneous,  because  changes  to  the  PHL  are  directly  applicable  while  changes  to  the 
marketing Directives need to be transposed into national legislation. 

Regulation of RNQPs under PHL 

Implementing Regulation (EU) 2019/2072 sets out specific measures for QPs and RNQPs. Article 5 
and  Annex  IV  of  that  Implementing  Regulation  establish  the  list  of  plants  and  the  respective 
thresholds of RNQPs, for internal movement and import while Article 6 and Annex V establish the 
measures to be taken in the fields and on the lots of the plants, for internal movement and imports 
in  order  to  comply  with  those  thresholds.  With  the  exception  of  the  measures  against  RNQPs  of 
fruit plants and vine, the RNQP measures are laid down in Annex V to Implementing Regulation 
(EU) 2019/2072. RNQPs for FRM are exclusively regulated under Implementing Regulation (EU) 
2019/2072 and thus not under Council Directive 1999/105. 

Regulation of RNQPs under marketing Directives 

RNQPs are regulated under several PRM acts (Table  30). Currently there are no RNQPs for beet 
seed (Directive 2002/54).  

In 2020, the provisions of the PRM/FRM legislation were aligned with the requirements of the PHL 
including the  requirements  of Annex V to  Implementing Regulation (EU) 2019/2072  through the 
following  clause:  the  material  “shall  also  comply  with  the  requirements  concerning  Union  QPs, 
protected zone QPs and RNQPs provided for in implementing acts adopted pursuant to Regulation 
(EU)  2016/2031  as  well  as  the  measures  adopted  pursuant  to  Article  30(1)  of  that  Regulation”. 
This  means  that  compliance  with  RNQP  rules,  as  well  as  rules  on  QPs,  is  a  requirement  for  the 
issuance of an official label (under the PRM legislation) or a supplier’s label/document (under the 
FRM  legislation)  following  the  certification  process  (official  or  under  official  supervision),  as 
applicable  per  marketing  category  of  PRM  (i.e.  pre-basic,  basic  or  certified)  or  FRM  (source-
identified, selected, qualified or tested). Compliance with RNQP and QP rules is also a requirement 

134 

 
 
for  the  issuance  of  a  supplier’s  label  following  a  verification  process  for  standard/Conformitas 
Agraria Communitatis (CAC) material). However, the measures on RNQPs for fruit plants and vine 
are only included in the respective acts (Commission Implementing Directive 2014/98 and Annexes 
to Council Directive 68/193) and not in Annex V to Implementing Regulation (EU) 2019/2072. 

Type of PRM/FRM 

Fodder plant seed 

PHL: relevant reference under 
Implementing Regulation 
2019/2072) 

Part A of Annex IV 

Part A of Annex V 

Cereal seed 

Part B of Annex IV 

Part B of Annex V 

PRM/FRM: relevant reference in 
PRM/FRM marketing Directive 

Council Directive 66/401: 

Article 2(3) A and B 

Point 5 of Annex I and point 3 of 
Annex II: duplication of Part A of 
Annex IV (see column 2) 

Council Directive 66/402: 

Article 2(3) A and B 

Point 5 of Annex I and point 3 of 
Annex II: duplication of Part B of 
Annex IV (see column 2) 

Vine 

Part C of Annex IV 

Council Directive 68/193:  

Ornamental plants 

FRM 

Part D of Annex IV 

Part C of Annex V 

Part E of Annex IV 

Part D of Annex V  

Annex I: duplication of Part C of 
Annex IV (see column 2) 

RNQP measures set out exclusively 
under PRM and not in Annex V to 
Implementing Regulation 2019/2072 

Commission Directive 93/49:  

Annex:  duplication of Part D of 
Annex IV (see column 2) 

Council Directive 1999/105: 

No listing of RNQPs and thus no 
duplication of Part E of Annex IV 
(see column 2) 

Beet seed 

Currently no RNQPs 

Council Directive 2002/54: 

Vegetable seed 

Seed potatoes 

Part F of Annex IV 

Part E of Annex V 

Part G of Annex IV 

Part F of Annex V 

Currently no RNQPs 

Council Directive 2002/55: 

Annex II: duplication of Part F of 
Annex IV (see column 2) 

Council Directive 2002/56:  

Article 3 (only official certification) 

Annexes I and II: duplication of Part 
G of Annex IV (see column 2) 

Seed of oil and fibre plants  

Part H of Annex IV 

Council Directive 2002/57:  

Part G of Annex V 

Article 2(3) A and B 

Annex II:  duplication of Part H of 
Annex IV (see column 2) 

135 

 
 
 
 
 
 
 
 
 
 
 
Vegetable propagating material 

Part I of Annex IV 

Commission Directive 93/61: 

Part H of Annex V 

Fruit plants 

Part J of Annex IV 

Seed of Solanum tuberosum L. 

Part K of Annex IV 

Plants for planting of Humulus 
lupulus L. other than seeds 

Fruit propagating material and fruit 
plants intended for fruit production of 
Actinidia Lindl. other than seeds 

Part I of Annex V 

Part L of Annex IV 

Part J of Annex V 

Part M of Annex IV 

Part K of Annex V 

Annex: duplication of Part I of Annex 
IV (see column 2) 

Commission Implementing 
Directive 2014/98: 

Annexes I, II and III: duplication of 
Part J of Annex IV (see column 2)  

RNQP measures set out exclusively 
under PRM and not in Annex V to 
Implementing Regulation 2019/2072 

Not regulated under Directive 
2002/56 on seed potatoes 

Plant species not regulated under the 
marketing Directives 

Plant species not regulated under 
Council Directive 2008/90 on fruit 
plants 

Table 30. Overview of RNQPs per type of PRM and FRM and their regulation in the PHL and marketing Directives.  
Annex IV to Implementing Regulation (EU) 2019/2072 lists the RNQPs and specific plants for planting with marketing 
categories  and  thresholds.  Annex  V  to  Implementing  Regulation  (EU)  2019/2072  lists  the  measures  to  prevent  the 
presence of RNQPs on specific plants for planting 

Currently, RNQPs are regulated both under the PHL and under the marketing Directives. Under the 
PHL, plant passports are issued if it is confirmed that the plants are free from QPs and also comply 
with  the  RNQP  thresholds  (Annex  IV  to  Implementing  Regulation  2019/2072).  Under  the 
PRM/FRM  legislation,  official  labels  (or  supplier’s  labels)  are  issued  if  it  is  confirmed  that  the 
plants  comply  with  the  RNQP  thresholds.  Compliance  with  those  thresholds  is  ensured  through 
measures  under  the  regulated  certification  system  (officially  or  under  official  supervision): 
inspections in the field/production place/production site and sampling and testing of the lots of the 
PRM  intended  for  marketing/internal  movement.  These  measures  are  laid  down  in  Annex  V  to 
Implementing  Regulation  2019/2072.  However,  the  rules  on  the  certification  system  as  such  are 
missing  (notification  of  fields  to  NCAs,  data  provision  and  authorisation  process  to  carry  out 
certification under official supervision). In the case of fruit plants these measures are described in 
Commission Implementing Directive 2014/98 and in the case of vine in Council Directive 68/193. 

The  PHL  falls  under  the  scope  of  the  OCR  while  the  marketing  Directives  do  not.  Where  risk 
management  measures  against  RNQPs  are  regulated  under  the  marketing  Directives  (fruit  plants 
and vines) while the RNQPs are listed in the PHL, there is uncertainty as to whether  RNQPs fall 
under the scope of the OCR.  

The regulation of RNQPs under the PRM/FRM and PHL frameworks, the overlaps between those 
frameworks and the different  scope of OCs  (inside/outside the OCR) leads to  uncertainty  for MS 
and operators about which legislation to adhere to. Consequently, this also results in differences in 
implementation and conditions for the operators that could eventually undermine the enforcement 
and the quality of controls. 

Currently,  in  12  out  of  27  MS  the  inspections  for  RNQPs  have  been  delegated  to  the  NCA 
responsible for PRM certification. 

136 

 
 
 
 
8. 

INNOVATION AND DIGITALISATION  

The application of BMTs in variety registration and PRM/FRM certification 

BMTs is a group of molecular biological techniques comprising amongst others DNA sequencing, 
molecular markers, genotyping and polymerase chain reaction. BMTs are a promising tool for plant 
breeding and PRM certification because they can speed up the identification of plant varieties with 
interesting traits. In FRM certification, BMTs can help to certify the origin of FRM, i.e. to confirm 
that FRM has been harvested from a particular seed source. 

Several EU Horizon 2020 research projects explore the potential of BMTs in variety testing. The 
CPVO has created an ad hoc working group on the ‘Integration of molecular data into DUS testing’ 
(IMMODUS) and published the CPVO IMMODUS strategy paper in 2017250. The ‘Innovation in 
variety  testing’  (INVITE)  project  seeks  to  develop  new  phenotyping  and  genotyping  tools  to 
measure bioindicators associated with plant resource use efficiency, sustainability and resilience. It 
aims to improve both the efficiency of variety testing and the information available to stakeholders 
on  variety  performance  under  a  range  of  production  conditions  and  biotic  and  abiotic  stresses251. 
The  ‘Innovations  in  plant  variety  testing’  (Innovar)  project  aims  to  augment  and  improve  the 
efficacy  and  accuracy  of  European  crop  variety  testing  and  decision-making  using  an  integrated 
approach incorporating genomics, phenomics and machine learning252. 

In PRM, BMTs can be used to speed up DUS testing during the variety registration process or to 
allow the rapid and precise confirmation of the identity of the variety during the PRM certification 
process  and the marketing controls. The DUS test serves  to  compare the candidate variety with a 
number  of  existing  plant  varieties  (‘reference  varieties’).  BMTs  can  help  identify  which  plant 
varieties  show  the  highest  level  of  similarity  with  the  candidate  variety  thus  accelerating  the 
selection of reference varieties for variety examination. During marketing controls, samples of the 
marketed PRM are taken and grown in the field whereby the variety to be checked is compared to 
the sample of the variety that was retained at the time of variety registration (‘control plot testing’).  

Sometimes the observation of the phenotypic characteristics of the variety during the DUS test can 
be difficult because the morphological characteristics are not well-expressed. Likewise, the control 
plot tests, carried out in the frame of marketing controls, can be inconclusive. Moreover, the large 
number  of  existing  varieties,  together  with  the  great  dynamism  of  the  market  as  regards  new 
varieties  in  many  species,  make  it  impossible  for  inspectors  to  have  technical  knowledge  of  all 
existing varieties, as it is impossible to be trained to know hundreds of varieties. This is aggravated 
by staff turnover, which makes it in some cases difficult to acquire knowledge through experience.  

The OECD Seed Schemes have developed a general rule for the situation when field inspection and 
control  plot  testing  are  inconclusive.  In  that  case,  they  allow  the  use  of  any  other  test  to  obtain 
supplementary  information  in  support  of  the  certification  decision  for  the  seed  lot  concerned 
including internationally recognised biochemical and molecular techniques performed by an official 

250 https://cpvo.europa.eu/sites/default/files/documents/cpvo_imoddus_strategy_paper-endorsed_ac_march2017.pdf  
251 https://www.h2020-invite.eu/  
252 https://www.h2020innovar.eu/variety-testing-community/  

137 

 
 
                                                 
laboratory253. Moreover, the OECD maintains a list of internationally recognised methods that are 
currently used by the National Designated Authorities.  

UPOV has so far developed two models for the use of BMTs in variety testing. The first concerns 
the  use  of  BMTs  for  identifying  in  the  variety  reference  collection  (i.e.  varieties  of  common 
knowledge in the EU) the varieties with the highest level of similarity to the candidate variety for 
the  purpose  of  the  DUS  test.  The  second  concerns  the  use  of  trait-specific  molecular  markers 
whereby the reliability of the link between the marker and the trait is verified254. UPOV, OECD and 
the International seed testing association have joint initiatives in relation to BMTs. In spite of the 
fact that BMTs offer the means to increase the efficiency of PRM/FRM certification and render the 
PRM/FRM  sector  more  competitive,  the  PRM/FRM  legal  framework  currently  does  not  contain 
any  common  rules  on  BMTs  that  explicitly  allow  the  use  of  BMTs,  with  the  exception  of  the 
verification of varietal identity in the certification of agricultural plant species255. This creates legal 
uncertainty around the use of BMTs. For example, during marketing controls the verification of the 
identity of the variety by means of BMTs could be contested in the case of fraud due to the absence 
of  a  legal  framework.  As  described  above,  the  OECD  and  UPOV  allow  the  use  of  BMTs  under 
certain  conditions.  This  has  led  certain  MS  to  adopt  national  approaches  on  BMTs  while  others 
have  not256.  Additionally,  the  PRM/FRM  legal  framework  is  increasingly  diverging  from  the 
ongoing developments at international level.  

Digitalisation 

The EU digital strategy aims to make the transformation to digital technologies work for people and 
businesses, while helping to achieve its target of a climate-neutral Europe by 2050. The PRM/FRM 
legal framework does not contain any common rules on the use of digital technologies. COVID-19 
has  demonstrated  that  digital  technologies  can  help  improve  the  resilience  of  agricultural  supply 
chains  during  emergency  situations  by  issuing  digital  certificates.  Moreover,  the  use  of  digital 
certificates  and  documents  reduces  the  risk  of  fraud.  Therefore,  the  use  of  digital  labels  and 
certificates should also be introduced in the PRM/FRM legislation. The OECD Seed Schemes and 
the OECD Forest Scheme already use digital labels. Those labels can be downloaded from a secure 
website.  If  the  National  Designated  Authority  of  an  OECD  member  country  wants  to  use  digital 
labels for the marketing of PRM/FRM, they need to complete the digital label and ask the OECD 
Secretariat to authorise the use of those digital labels. 

The  use  of  digital  technologies  can  be  taken  a  step  further  by  digitalising  the  entire  seed 
certification system. The OECD Secretariat has conducted a feasibility study on this topic that was 
finalised  in  2021.  In  2023,  the  OECD  Secretariat  will  launch  a  project  on  digitalisation  of  the 
OECD  Seed  Schemes  applied  to  the  seed  certification  system  for  seed  moving  in  international 
trade, with the intention to develop a seed certification hub where all certification information will 
be stored. In the future this can be augmented by the use of blockchain technology. A blockchain 
keeps  records  shared  between  parties  in  a  network  and  stores  information  about  all  transactions 

253 OECD Seed Schemes Rule and Regulations 2022, common rules 7.4.5.1. 
254  UPOV  TGP15:  Guidance  on  the  Use  of  Biochemical  and  Molecular  Markers  in  the  Examination  of  Distinctness, 
Uniformity and Stability (DUS). 
255 Commission Implementing Directive (EU) 2021/971. 
256 For example, in Spain BMTs are used in plant breeding, to select  reference varieties for the DUS test and to carry 
out marketing controls. In Germany, BMTs are used to certify the origin of FRM. 

138 

 
 
                                                 
between  those  parties  in  a  chronological  order.  The  advantage  is  that  there  is  no  central  record-
keeping authority. The advantages that have been identified in OECD’s feasibility study would also 
apply to PRM/FRM certification. Digitalisation represents a significant opportunity to future-proof 
the existing certification system and modernise the PRM and FRM sector.  

The following benefits are expected from digitalisation of PRM/FRM certification: 

  Efficiency  gains  and  cost  reduction:  reduced  administrative  burden,  simplified  reporting 

requirements, reduced transition costs, and identification of new opportunities. 

  Risk  reduction:  increased  trust  in  the  EU  certification  framework  by  reducing  the  risk  of 

fraudulent products and increasing transparency and traceability.  

  Business  continuity:  build  a  more  resilient  PRM/FRM  sector,  help  protect  supply  chains 

against future disruptions and help identify and manage risks more quickly. 

  Spark innovation: create a sustainable future for the PRM/FRM sector and the value chain 

that utilises certified PRM/FRM.  

There  are  also  some  disadvantages  of  digital  transformation  of  the  agri-food  sector.  It  involves 
significant transaction and infrastructure costs257. For the transformation to be successful all parties 
involved  should  be  able  to  benefit  from  it258.  There  are  concerns  that  not  all  stakeholders  or  MS 
will. It may be economically challenging for SMEs to adapt to new technologies bringing them in a 
disadvantageous  position  in  comparison  to  larger  enterprises.  Most  NCAs  agreed  that  the  cost  of 
the  technology  should  decrease  for  the  benefits  of  its  implementation  to  outweigh  the  risks  as 
regards the security of new technology and costs. They recognised that there are already systems in 
place that could be extended and applied in the PRM sector with one NCA stating that in most MS 
data is already digitalised259.  

257  Goedde,  Lutz,  Joshua  Katz,  Alexandre  Menard  and  Julien  Revellat  (2020)  Agriculture’s  connected  future:  How 
technology  can  yield  new  growth.  McKinsey.  Available  at:  https://www.mckinsey.com/industries/agriculture/our-
insights/agricultures-connected-future-how-technology-can-yield-new-growth#  
258 Wang, Y., Han, J. H., and Beynon-Davies, P. (2019). Understanding blockchain technology for future supply chains: 
a systematic literature review and research agenda. Supply Chain Management: An International Journal. 
259 Reponses to interviews Section 4.2.2.4 to ICF(2021) Data gathering study. 

139 

 
 
   
                                                 
9.  OFFICIAL CONTROLS 

9.1.  Legal analysis 

Table 19 compares the requirements on OCs in the PRM and FRM Directives with those in the OCR. To allow this comparison the provisions in several 
PRM Directives on official certification and the issuance of an official label were interpreted as provisions on ‘official attestations’ within the meaning of 
the OCR. The OCR makes provisions on official attestations issued by operators under the official supervision of the NCAs, or by the NCAs themselves. 
However, in the PRM/FRM legislation official certification is a product authorisation process. In the case of the PRM and FRM legislation this means 
that official certification and the issuance of an official label can only be decided by the NCAs themselves (Annex 5, Section 2.2.1.). 

Table 19. Requirements on official controls in the PRM and FRM marketing Directives against OCR requirements 

OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

140 

 
 
 
 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Definitions 
(Art. 2  and 3) 

N  

N  

Y 

N 

N 

N 

N 

N 

Y 

Y 

Only a 
definition of 
‘official 
measures’ 260 

Only a 
definition of 
‘official 
measures’261 

Definition of 
‘official 
measures’262 

Only a definition 
of ‘official 
measures’263 

Only a 
definition of 
‘official 
measures’264 

Only a definition 
of ‘official 
measure265 

Only a 
definition of 
‘official 
measures’266 

Only a definition 
of official 
measures267 

Definition of 
‘supplier’, 
‘responsible official 
body’268.  

Definition of 
‘supplier’, 
‘responsible 
official body’269; 
‘official 
measures’270; 
‘official 
inspection’271; 
‘official 
statement’272 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
Y 

Definition of 
‘supplier’, 
‘responsible official 
body’273, “official 
inspection’274 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y 

Only a definition 
of ‘supplier’, 
‘official body’275 

260 Art. 1.E: “Official measures: measures taken (a)  by State authorities, or (b) by any legal person whether governed by public or by private law, acting under the responsibility of the State, or (c)  in the case of ancillary activities 
which are also subject to State control, by any natural person duly sworn for that purpose, provided that the persons mentioned under (b) and (c) derive no private gain from such measures.” Key concepts not defined such as: 
‘official inspections’; ‘official inspectors’; ‘official examination’; ‘seed certification authority’; ‘official seed samplers’; ‘official label’; ‘official seal’.  
261 Art. 2(1)(H), Ibidem. Key concepts not defined such as: ‘official inspections’; ‘official inspectors’; ‘official examination’; ‘seed certification authority’; ‘official seed samplers’; ‘official label’; ‘official seal’. 
262 Article 2. 
263 Article 1(g). Ibidem.  
264Article 2(1)(f), Ibidem. Key concepts not defined such as: ‘official inspections’; ‘official inspectors’; ‘official examination’; ‘seed certification authority’; ‘official seed samplers’.; ‘official label’ ; ‘official seal’. 
265 Article 2(d), Ibidem.  Key concepts not defined such as: such as: ‘official inspections’; ‘official examination’; ‘certification authority’;  ‘official label’; ‘official seal’. 
266 Article 2(1)(k), Ibidem. Key concepts not defined such as: ‘official inspections’; ‘official inspectors’; ‘official examination’; ‘seed certification authority’; ‘official seed samplers’; ‘official label’; ‘official seal.  
267 Article 2(1)(H), Ibidem. Key concepts not defined, such as ‘official control authority’; ‘official inspection’; ‘official examination’;’officially certified’; ‘‘officially checked’ ; ‘official label’; ‘official controls’. 
268  Article  2(4) : « ‘Responsible  official  body’:  (a)  an  authority,  established or  designated by  the Member  State under the  supervision  of the national government  and  responsible  for  questions  concerning quality;  (b)  any  State 
authority established: — either at national level, or — at regional level, under the supervision of national authorities, within the limits set by the constitution of the Member State concerned”.  
269 Article 3(e):  « ‘responsible official body’ means: (i) the sole and central authority, established or  designated by the Member State under the supervision of the national government and responsible for questions concerning 
quality; (ii) any State authority established: — either at national level, — or at regional level, under the supervision of the national authorities within the limits set by the national legislation of the Member State concerned.”.  
270 Article 3(f): “‘official measures’ means measures taken by the responsible official body;”. 
271 Article 3(g): « ‘official inspection’ means an inspection carried out by the responsible official body;”. 
272 Article 3(h) : « ‘official statement’ means a statement issued by, or under the responsibility of, the responsible official body;”.  
273  Article  2(11):  “  ‘responsible  official  body’  means:  (a)  an  authority,  established  or  designated by  the  Member  State  under  the  supervision  of  the  national  government  and  responsible  for  questions  concerning  the  quality  of 
propagating material and fruit plants; (b) any State authority established:  — either at national level, or — at regional level, under the supervision of the national authorities, within the limits set by the national legislation of the 
Member State concerned;”.  

141 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Rules on 
competent 
authorities276 
(Art. 4 to 8) 

N277 

.   

N278 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Y 
Confidentiality 
obligations279, 
other 
obligations of 
competent 
authorities280 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

N281 

Y 

N 

Y 

N 

Y 

Y 

Provisions on 
confidentiality 
obligations282 

Limited  
provisions on 
confidentiality 
obligations283 

Limited in the form 
of: designation of a 
responsible official 
body284 and 
notification thereof 
to the Commission 
285; official 
registration of 
suppliers286 

Limited in the 
form of 
designation of a 
responsible 
official body and 
notification 
thereof to the 
Commission287 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
Y 

Limited in the form 
of designation of a 
responsible official 
body; official 
registration of 
suppliers288 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y 

Limited in the 
form of 
designation of an 
official body and 
notification 
thereof to the 
Commission 289; 
official 
registration of 

274 Article 2(12): “‘official inspection’ means inspection carried out by the responsible official body or under the responsibility of the responsible official body;” 
275 Article 2(k): ‘Official body: (i) an authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning the control of marketing and/or the quality 
of FRM; (ii) any State authority established: 
- either at national level, or- at regional level, under the supervision of national authorities, within the limits set by the constitution of the Member State concerned.”.  
276 i.e. designation, general obligations, audits, right of appeal, confidentiality obligations.”. 
277 There are rules on the responsibilities of the seed certification authority prior to certification, in particular in the context of official examination under supervision, with no further specifications.  
278 There are rules on the responsibilities of the seed certification authority prior to certification, in particular in the context of official examination under supervision) with no further specifications.   
279 Art. 7(3).  
280 Where acceptance of a variety is refused or revoked, the results of the examinations shall be made available to persons affected by such decision (Art. 10(5)).  
281 There are rules on the responsibilities of the seed certification authority prior to certification, in particular in the context of official examination under supervision) with no further specifications.   
282 Article 7(3) (in the framework of examination of the genealogical components, obligation to treat as confidential the results of the examination and the description of the genealogical components, if the breeder so requests); 
Article 10(3) (information exchanged by MS and the Commission in relation to the files compiled by MS on each variety accepted must be treated as confidential); Article 10(5) - in case the acceptance of a variety is refused or 
revoked, the results of the examinations shall be made available to persons affected by such decision.  
283 Article 8: « Member States shall provide that the description of genealogical components which may be required is, if the breeder so requests, treated as confidential.”.  
284 Article 2(4)(a) and (b).  
285 Article 2(4), last subparagraph.  
286 Article 6.  
287 Article 3(e).  
288 Article 5(1).  
289 Article 2(k) last subparagraph.  

142 

 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                                                                                                                                                        
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Risk based 
controls291 (Art. 
9(1) and (2))  

N 

N 
- random 
checks on 
marketing292; 
fixed 
percentage of 
checks for 
official 
supervision 
(5%) 

N 
- random 
checks on 
marketing293; 
fixed 
percentage of 
checks for 
official 
supervision 
(5%) 

N 
- random checks 
onmarketing294;fix
ed percentage of 
checks for official 
supervision (5%) 

N 
-random 
checks on 
marketing295; 
fixed 
percentage of 
checks for 
official 
supervision 
(5%) 

N 
- random checks 
on marketing296 

N 
-random 
checks297; 
fixed 
percentage of 
checks for 
official 
supervision 
(5%) 

N 

N 

N 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

suppliers290 

N 

Y 
In the form of 
sampling and testing 
requirements on the 
basis of an 
assessment of the 
risk of infection of 
plants298 

290 Article 6(4).  
291 with appropriate frequency, including criteria for risk-based controls and including to identify fraudulent activities.    
292 Article 19(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of fodder plant seed, at least by random checks, to verify compliance with the requirements and conditions of this 
Directive.” 
293 Article 19(1): “ Member States shall ensure that official inspections are carried out in relation to the marketing, at least by random checks, to verify compliance with the requirements of this Directive.” 
294 Article 25(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of beet seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive. 
295 Article 39(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of vegetable seed, at least by random checks, to verify compliance with the requirements and conditions of this 
Directive.” 
296 Article 23(1) : «Member States shall ensure that official inspections are carried out in relation to the marketing of seed potatoes, at least by random checks, to verify compliance with the requirements and conditions of this 
Directive.” 
297  Article  22(1) :  «Member  States  shall  ensure  that  official  inspections are carried  out in  relation  to  the  marketing  of  seed  of  oil  and  fibre plants,  at least  by  random  checks, to  verify  compliance  with the  requirements  of  this 
Directive.”.  
298 Annex IV to Implementing Directive 2014/98/EU.  

143 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Regular 
controls (prior 
to placing on 
the market)(Art. 
9(1)) 

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Y 
detailed rules 
on 
examination 
under official 
supervision299 
+ rules on 
official 
examination 
prior to 
certification300  

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Y 
Limited rules on 
examination 
under official 
supervision310. 
Official 
examination 
required prior to 
placing on the 
market311.  

Directive 
2002/54/EC – 
marketing of 
beet seed 

Y 
detailed rules on 
examination 
under official 
supervision306+ 
rules on official 
examination prior 
to certification307 
+ 
minimum number 
of field 
inspections 
(official or carried 
out under official 
supervision)308  

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Y 
detailed rules 
on 
examination 
under official 
supervision+ 
minimum 
number of field 
inspections 
(official or 
under official 
supervision)+ 
rules on official 
examinations 
for the 
acceptance of 
varieties309  

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Y 
detailed rules 
on 
examination 
under official 
supervision301 
+ 
rules on official 
examination 
prior to 
certification302 
+ 
minimum 
number of field 
inspections 
(official or 
under official 
supervision303 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Y 

MS to provide 
that the 
acceptance of 
varieties be 
based on the 
results of 
official 
examinations, 
particularly 
growing trials, 
covering a 
sufficient 
number of 
characteristics 
for the variety 
to be 
described304+ 
minimum 
requirements 
for official 
examinations
305 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Y 
Detailed rules 
on 
examination 
under official 
supervision312 
+  rules on 
official 
examination 
prior to 
certification313 
+ minimum 
conditions and 
minimum 
number of field 
inspections 
(official or 
under official 
supervision)314 
+ examinations 
to be carried 
out in 
accordance 
with current 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

Y 
Random checks + 
implementing 
powers319 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Y 
Official 
examination 
required prior to 
certification316 + 
detailed rules on 
official 
inspections of 
growing crops317 
+ rules on official 
examinations for 
the acceptance of 
varieties318. 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y 
Approval of ‘basic 
material’, re-
inspection at 
regular 
intervals329 and 
national 
registry330 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
Y 
Official inspection 
required to 
determine if material 
meets conditions325 
+ MS 
to ensure that 
material/ fruit plants 
are officially 
inspected during 
production326 + 
detailed rules on 
official 
inspections327+ 
rules on 
examination of 
varieties prior to 
registration328 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Y 
Accreditation of 
suppliers320 + 
rules on regular 
supervision and 
monitoring of 
suppliers, 
establishments 
and 
laboratories321 + 
implementing 
powers + 
MS to ensure 
official inspection 
by sampling 
checks on 
material during 
production322 
+implementing 
powers for 
detailed 
procedures for 
such controls323   
see also Article 

299 Article 2(3).  
300 only seed found to satisfy applicable conditions by means of official examination or examination under official supervision can be certified. 
301 Article 2(3).  
302 only seed found to satisfy applicable conditions by means of official examination or examination under official supervision can be certified. 
303 Annex I, point 7.  
304 Article 7(1).  
305 Article 7(2) and Commission Directive 2003/90/EC of 6 October 2003 setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum 
by the examination and the minimum conditions for examining certain varieties of agricultural plant species (Text with EEA relevance).   
306 Article 2(3).  

144 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
307 Only seed found to satisfy applicable conditions by means of official examination or examination under official supervision can be certified.  
308 Annex I (2): “In the case of basic seed, at least one official field inspection shall be carried out. In the case of certified seed, at least one field inspection shall be carried out, officially controlled by means of check inspection of at 
least 20 % of the crop of each species”. 
309 MS to provide that acceptance of varieties be based on the results of official examinations, particularly growing trials (Article 7(1)); possibility to provide in EU implementing acts that acceptance is subject to official tests (Art. 
7(1), last subparagraph); the characteristics  to be covered as a minimum by the examinations of the various species and the  minimum requirements for carrying out the examinations are established in implementing acts  (See 
Commission Directive 2003/91/EC of 6 October 2003 setting out implementing measures for the purposes of Article 7 of Council Directive 2002/55/EC as regards the characteristics to be covered as a minimum by the examination 
and the minimum conditions for examining certain varieties of vegetable species (OJ L 254, 8.10.2003, p. 11). 
309 Article 12(1) and 13 (1)(a).  
310 Article 12(1) and 13 (1)(a):possibility of package sealing and of indelible printing of the prescribed particulars on the package  under official supervision.  
311 Article 2 (seed must be found by official examination to satisfy the conditions laid down in the Directives).  
312 Article 2(5).  
313 Article 2 (only seed found to satisfy applicable conditions by means of official examination or examination under official supervision can be certified).  
314 Annex I.5.  
316 Article 2(1) (D) to (G) (Material must be found by official examination to satisfy the conditions established in the Directive in view of the certification). Similarly, propagating material not intended for use as rootstocks, may 
only be placed on the market if it is officially checked standard material (Article 3(1)(a)).  
317 Annex I (stock nurseries and cutting nurseries, including in relation to RNQP (visual inspection, sampling and testing)). This includes including annual official crop inspections, by the official control authority, in accordance 
with rules established in Section 8 of Annex (Annex I, Section 5).  
318 Article 5d(1) (MS to ensure that acceptance of varieties is based on the results of official examinations, particularly growing trials, covering a sufficient number of characters for the variety to be described. The methods used for 
determining characters must be exact and reliable).  
319 Article 12. 
320 Article 6(1) (by the responsible official body after it has verified that their production methods and establishments meet the requirements of the Directive). 
321 Article 6(4).The supervision and monitoring of suppliers, establishments and laboratories shall be carried out regularly by or under the responsibility of the responsible official body.  
322 Article 17.  
323 Article 18.  
325 Article 2(5)(d) ; 2(6)(d) ; Article 2(7)(a)(iv) ; Article 2(7)(b)(iv).  
326 Article 13(1).  
327 Article 30 and Annex IV of Implementing Directive 2014/98/EU (visual inspections, sampling and testing).  
328 Article 7(5) and Article 6 of Commission Implementing Directive 2014/97/EU.  
329 Article 4 and Annex II (It shall be at the discretion of the Member State in each individual case as to whether a formal inspection is required except that, a formal inspection must be made where the material is destined for a 
specific forestry purpose), Annex III, IV and V.  
330 Article 10(1).  

145 

 
 
                                                                                                                                                                                                                                                        
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

international 
methods315. 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

10(3).  
+ rules of 
Directive 2002/55 
apply for 
acceptance and 
maintenance of 
varieties324.  

Regular 
controls - on 
the marketing  
(Art. 9(1)) 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Minimum 
rules- random 
checks331 

Minimum rules 
– random 
checks332  

There are no 
specific rules, 
there are 
solely 
provisions on 
maintenance 
and revocation 
of varieties  

Minimum rules – 
random checks333 

Minimum rules 
- random 
checks338 

Minimum rules 
-random 
checks334 
+ rules on 
verification of 
maintenance 
of accepted 
varieties335. 

Minimum rules - 
random checks336 
+ 
further official 
examination 
required on 
tubers which are 
not rejected after 

Accepted 
varieties shall be 
officially checked 
at regular 
intervals339 + 
rules on 
verification of 
maintenance for 

Minimum rules, at 
least random checks 
and at least in 
respect of marketing 
to persons 
professionally 
engaged in 
production or 

Regular 
supervision and 
monitoring of 
suppliers, 
establishments 
and laboratories 
+ implementing 
powers344 

MS to ensure 
material/ fruit plants 
are officially 
inspected during   
marketing348 + 
detailed rules on 
official inspections in 
implementing act349 

Official 
inspections of 
registered 
suppliers to be 
carried out 
regularly351. 
MS to make 
suitable 

315 Article 3(4).  
324 Article 9(2) and (3). The provisions laid down in Articles 4 and 5 and Article 9(3) of Directive 2002/55/EC shall apply to the conditions for acceptance. Article 3(2) and (4), Articles 6, 7, 8, 9(1), (2) and (4) and Articles 10 to 15 
of that Directive shall apply mutatis mutandis to the procedures and formalities for acceptance and maintenance production. Varieties officially accepted in accordance with paragraph 2 shall be entered in the Common Catalogue of 
Varieties of Vegetable Species referred to in Article 17 of Directive 2002/55/EC. Articles 16(2), 17, 18 and 19 of that Directive shall apply mutatis mutandis. 
331 Article 19(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of fodder plant seed, at least by random checks, to verify compliance with the requirements and conditions of this 
Directive.” 
332 Article 19(1): “Member States shall ensure that official inspections are carried out in relation to the marketing, at least by random checks, to verify compliance with the requirements of this Directive.” 
333 Article 25(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of beet seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive.” 
334 Article 39(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of vegetable seed, at least by random checks, to verify compliance with the requirements and conditions of this 
Directive.” Random checks also to verify compliance with the obligations of the persons responsible for affixing the labels for the standard seed intended for marketing (Article 41(1) last subparagraph). In addition, it is required 
that MS ensure that seed of the categories ‘certified seed’ and ‘standard seed’ is subject to official post-control in the field by inspection to compare their varietal identity and varietal purity against standard controls 
335 Article 11(1) to (3). It must at all times be possible to check maintenance of accepted varieties from the records kept by the person or persons responsible for the variety. These records shall also cover the production of all 
generations prior to basic seed. 

146 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
                                                 
 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

sorting337 

sale342; 
implementing 
powers for detailed 
implementing 
procedures for 
official inspections343 

conservation of 
accepted 
varieties340. 
+ MS to establish 
a system of 
official controls of  
material during 
marketing, at 
least by check 
sampling341 

MS to ensure 
official inspection 
by sampling 
checks on 
material during 
marketing345 
+implementing 
powers for 
detailed 
procedures for 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
+ trials or tests shall 
be carried out in the 
MS on samples350 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

arrangements for 
FRM to be 
officially 
controlled during 
production with a 
view to marketing 
and 
marketing352. 

Samples may be requested from the person responsible for the variety. Such samples may if necessary be taken officially (Article 40).  
336 Article 23(1) : « 1.  Member States shall ensure that official inspections are carried out in relation to the marketing of seed potatoes, at least by random checks, to verify compliance with the requirements and conditions of this 
Directive.” 
338 Article 19(1): “1.   Member States shall ensure that official inspections are carried out in relation to the marketing of fodder plant seed, at least by random checks, to verify compliance with the requirements and conditions of this 
Directive.” 
339 Article 5e(1). 
344 Article 6(4).  
348 Article 13(1).  
349 Article 30 and Annex IV of Implementing Directive 2014/98/EU (visual inspections, sampling and testing).  
351 Article 16(1). MS to ensure, by an official control system set up or approved by them, that FRM  from individual units of approval or lots remains clearly identifiable through the entire process from collection to delivery 
to the end user 
337 Article 3(1). 
340 Article 5g(2). Verification of maintenance for conservation of varieties accepted in the catalogue on the basis of records to be kept by those responsible for maintenance; samples may be requested from those responsible for 
maintenance of a variety. Where necessary, samples may be taken officially.  
341 Article 11(1). 
342  Article  12(1):  “Member  States  shall  require  that  suppliers  take  all  necessary  measures  to  guarantee  compliance  with  the  requirements  of  this  Directive.  To  this  end  Member  States  shall  ensure  that  propagating  material  is 
officially inspected: — at least by random checks, and 
— at least in respect of marketing to persons professionally engaged in production or sale of ornamental plants or propagating material, to verify compliance with the requirements. Member States may also take samples in order to 
verify compliance. In carrying out supervision and monitoring, the responsible official bodies shall have free access to all parts of suppliers' establishments at all reasonable times.” 
343 Article 12(2). 
345 Article 17. 

147 

 
 
 
 
 
 
 
                                                                                                                                                                                                                                                        
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

N 

Other general 
rules on official 
controls353 (Art. 
11 to 15) 

Y 
Limited354 

Y 
Limited355 

Y 
Limited356 

Y 
Limited357. 

N 

Y 
Limited358.  

Y 
359 + 
implementing 
powers360 
+obligations for 
certain 
operators361  

Y 
Limited in the form 
of obligations of 
suppliers362; supplier 
label363.   

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

such controls346 
+trials or tests 
shall be carried 
out in the MS on 
samples347  
Y  
In the form of 
operators’ 
obligations364+ 
implementing 
powers365 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y 
Limited, in the form 
of operators’ 
obligations366. 

Y 
Limited in the 
form of 
suppliers’s 
obligations367 

350 Article 14(1).  
352 Article 16(5).  
346 Article 18. 
347 Article 20(1). 
353 Transparency of official controls; documented control procedures; written records of official controls; methods and techniques of official controls; obligations of operators.  
354  In  the  form  official  examination  of  seed  to  be  carried  out  in  accordance  with  current  international  methods  (Article  3(3)).  Also,  use  of  examination  techniques  in  accordance  with  applicable  international  standards  for  the 
examination of the varietal identity of the seed. 
355 Obligation for operators (record keeping in relation to maintenance of varieties (Art. 11(2)).  
356 MS to ensure that official examinations of seed are carried out in accordance with current international methods (Article 3(2)).   
357 MS to ensure that official examinations of seeds are carried out in accordance with current international methods (Article 20(4).  
358 In the form of official examinations for certification to be carried out in accordance with current international methods (Article 3(4)).  
359 In the form of methods used for official examination varieties acceptance (Article 5d(1)). The requirement is that those methods must be exact and reliable.  
360 On minimum requirements for examinations, in particular crop inspections Article 5d(2). See Commission Directive 2004/29/EC of 4 March 2004 on determining the characteristics and minimum conditions for inspecting vine 
varieties. 
361  Obligation  of  recipient  of  the  material  for  the  vegetative  propagation  of  the  vine  to  keep  the  official  label  for  at  least  one  year  and  to  make  it  available  to  the  official  control  authority  (Article  10(5)).  Obligation  of  those 
responsible for maintenance of varieties for conservation to keep records in view of inspection. Keeping of records of varieties maintained for conservation.  
362 Suppliers engaged in production of propagating material shall keep information, for examination when requested by the responsible official body (Article 7(1)). Reporting obligations (Article 7(2)). Record keeping (Article 7(3)).  
363  Article  8(2)  and  Commission  Directive  1999/66/EC  of  28  June  1999  setting  out  requirements  as  to  the  label  or  other  document  made  out  by  the  supplier  pursuant  to  Council  Directive  98/56/EC  (Official  Journal  L  164  , 
30/06/1999 P. 0076).  

148 

 
 
 
 
 
 
 
 
 
                                                                                                                                                                                                                                                        
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Staff training  
(Art. 5(4)) 

N368 

N369 

N 

N370 

N371 

N 

N372 

N 

N 

N 

N373.  

N 

364  Own  checks  (Article  5(2):  Obligation  of  suppliers  to  carry  out  own  checks,  or have  them  carried  out by  an  accredited  supplier  or  by  a  responsible  official  body  based  on principles  laid  down  in the  Directive  to  guarantee 
compliance  at all  stages  of  production and  marketing;  identification  of  critical points;  establishment  and implementation  of methods  for  monitoring  and checking  the  critical  points;   taking  samples  for  analysis  in a  laboratory 
accredited by the responsible official body for the purpose of checking compliance with the standards established by the Directive; keeping a written record or a record registered in an indelible fashion of the data referred to in the 
first, second and third indents, as well as records on production and marketing of propagating and planting material, to be held at the disposal of the responsible official body. These documents and records shall be kept for a period 
of at least one year); reporting obligations and to take corrective actions (Article 5(3)).  
365 Article 5(4). 
366 Article 30(3) of Implementing Directive 2014/98/EU (to keep records of the results and dates of all field inspections, sampling and testing carried out by them). 
367 Ariticle 16(3): “Suppliers shall provide official bodies with records, which shall contain details of all consignments detained and marketed”.  
368 Requirements are established only for inspectors and seed samplers working under official supervision.  
369 Only requirements for inspectors and seed samplers working under official supervision.  
370 Only requirements for inspectors and seed samplers working under official supervision. 
371 Only requirements for inspectors and seed samplers working under official supervision.  
372 Only requirements for inspectors and seed samplers working under official supervision 
373 Competence of suppliers’ staff is to be checked in official inspections (Article 30(2)(b) of Implementing Directive 2014/98/EU).  

149 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                                                                                                                                                        
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Y374 

Y375 

But no 
cascade of 
applicable 
methods as in 
Art. 34 of the 
OCR  

But no 
cascade of 
applicable 
methods as in 
Article 34 of 
the OCR.  

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Y 
See minimum 
requirements 
for 
examinations  

Methods of 
sampling, 
analysis, tests 
and diagnoses  
(Art. 34) 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Y376 

Y377 

Y378 

Y379 

Y380  

N 

N 

But no cascade 
of applicable 
methods as in 
Article 34 of the 
OCR. 

But no 
cascade of 
applicable 
methods s as 
in Article 34 of 
the OCR. 

But no cascade 
of applicable 
methods as in 
Article 34 of the 
OCR. 

But no 
cascade of 
applicable 
methods as in 
Article 34 of 
the OCR. 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
Y 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y 

A cascade of 
methods to be used 
for sampling381 

See provisions in 
Annexes II to V  

374  MS are  to  require  that  sampling  is performed  in accordance  with  ‘appropriate  methods’  (Art.  7);  Detailed  requirements  on  ‘sampling  under  official  supervision  (Article  7(b);  seed  samplers  must  carry  out  seed  sampling  in 
accordance with current international methods; Detailed technical rules (requirement of sampling from homogenous lots; maximum eight of the lot and minimum weight of the sample (Article 7(2) and Annex III).  
375 MS to require that, for the checking of varieties, and for the examination of seed for certification, samples are drawn officially or under official supervision in accordance with appropriate methods (Art. 7(1); seed samplers shall 
carry out seed sampling in accordance with current international methods (Art. 7(1a)(b)); detailed provisions on seed sampling (Article 7(2) and Annex III: for the examination of seed for certification, samples shall be drawn from 
homogeneous lots; the maximum weight of a lot and the minimum weight of a sample are given in Annex  III); authorised seed testing laboratories shall carry out seed testing in accordance with current international methods 
(Article 2(3)(b));  
376 Article 9(1) : “Member States shall require that, for the checking of varieties, and for the examination of seed for certification, samples are drawn officially or under official supervision in accordance with appropriate methods 
(…).”; detailed requirements on ‘sampling under official supervision’; seed samplers must carry out seed sampling in accordance with current international methods (Article 9(1a)(b)); detailed provisions on seed sampling (Annex I, 
Section 2, point 4 : “As regards sampling and testing, Member States shall apply protocols of the European and Mediterranean Plant Protection Organisation (EPPO), or other protocols which are internationally recognised. Where 
such protocols do not exist, the relevant protocols established at national level shall be applied. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission. As 
regards sampling and testing of vines in the stock nurseries intended for the production of initial propagating material, Member States shall apply biological indexing on indicator plants to assess the presence of viruses, viroids, 
virus-like diseases and phytoplasmas, or other equivalent protocols which are internationally recognised.”); authorised seed testing laboratories shall carry out seed testing in accordance with current international methods (Article 
2(3)(B)(b), last subparagraph); Use of examination techniques in accordance with applicable international standards (Annex I, A, 5a); MS shall require that, for the examination of seed for certification, samples are drawn officially 
or under official supervision in accordance with appropriate methods (Article 25); See samplers shall carry out seed sampling in accordance with current international methods (Article 25(1a)(b)).  
377 Authorised seed testing laboratories shall carry out seed testing in accordance with current international methods (Article 2(4)(B)); the methods used for determining characteristics must be accurate and reliable (Article 7(1)); for 
the  examination  of  seed  for  certification  and  for  post-control  tests,  samples  shall  be  drawn  from  homogeneous  lots;  the  maximum  weight  of  a  lot  and  the  minimum  weight  of  a  sample  are  given  in  Annex  III  (Article  25(2)); 
examination in accordance with the applicable international standards (Annex I (3a)).  
378 MS shall require that, for the examination of seed potato tubers for certification, samples are taken officially in accordance with appropriate methods (Article 7). 
379 MS shall require that, for the checking of varieties, the examination of seed for certification and the examination of commercial seed, samples are drawn officially or under official supervision in accordance with appropriate 
methods (Article 9(1)); detailed requirements on ‘sampling under official supervision’; seed samplers must carry out seed sampling in accordance with current international methods (Art. 9(1a)(b)); detailed provisions on seed 

150 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
                                                 
 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

N 

N 

N382 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N383 

N 

N 

N 

N 

N 

N 

N 

Second expert 
opinion  
(Art. 35) 

Sampling of 
animals and 
goods offered 
by means of 
distance 
communication  
(Art. 36) 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
N 

N 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

N 

N 

sampling (Article 9(2) : « 2.   For the examination of seed for certification and the examination of commercial seed, samples shall be drawn from homogeneous lots; the maximum weight of a lot and the minimum weight of a 
sample are given in Annex III.” 
  Annex I. 3a); use of examination techniques in accordance with applicable international standards (Annex I. 3a). 
380 In relation to methods of sampling and testing of stock nurseries and cutting nurseries.  
381 See recital 14 of Implementing Directive 2014/98/EU: “Where sampling and testing is carried out, it should take place in accordance with the protocols of the European and Mediterranean Plant Protection Organization (EPPO), 
or other protocols which are internationally recognised. This is necessary to ensure that the practice of sampling and testing carried out in the Union is up to date with the international scientific and technical developments. Where 
such protocols are not available, sampling and testing should take place in accordance with relevant protocols established at national level.” 
382 To be noted that MS are to ensure that any doubts which arise after the acceptance of a variety concerning the appraisal of its distinctness or of its name at the time of acceptance are clarified (Art. 13(1)).  
383 There is only a reference to the obligation of the official control authority to carry out additional checks on stock nurseries and cutting nurseries in case of cases of disputes on matters which can be decided without prejudice to 
the quality of the propagating material (Annex I, Section 5, point 3).  

151 

 
 
 
 
 
                                                                                                                                                                                                                                                        
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

N384 

N385 

N386 

N387 

N388. 

N389 

N390 

N391 

Delegation of 
tasks of the 
competent 
authorities (Art. 
28 to 33) 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

Y 
But in accordance 
with national law 392 
+ 
implementing 
powers  
for the approval of 
other legal 
persons393 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Y 
But in 
accordance with 
national law394+ 
implementing 
powers  
for  the approval 
of other legal 
persons395 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
Y 
But in accordance 
with national law396+ 
implementing 
powers  
for the approval of 
other legal 
persons397 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y 
But in accordance 
with national 
law398+ 
implementing 
powers  
for the approval 
of other legal 
persons399 

384 In the definition of ‘official measures’ reference is made to measures taken by any legal person whether governed by public or by private law, acting under the responsibility of the State; or in the case of ancillary activities which 
are also subject to State control, by any natural person duly sworn for that purpose. However, there are no further specifications. Similarly, Union comparative tests and trials may be performed by State authorities, but also by legal 
persons acting under the responsibility of the State. However, there are no further provisions concerning these legal persons. 
385 Ibidem.  
386 In the definition of ‘official measures’ reference is made to measures taken by any legal person whether governed by public or by private law, acting under the responsibility of the State; or in the case of ancillary activities which 
are also subject to State control, by any natural person duly sworn for that purpose.  
387 Ibidem.  
388 Ibidem.  
389 Ibidem.  
390 Ibidem.  
391 Ibidem.  
392 Article 2(4), second subparagraph: « The bodies referred to above  may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to 
any legal person, whether governed by public or by private law, which, under its officially approved constitution, is charged exclusively  with specific public functions, provided that such person, and its members, has no personal 
interest in the outcome of the measures it takes.” In addition, Community comparative tests and trials may be performed by State authorities and also by legal persons acting under the responsibility of the State (Article 14(7)).  
393 Article 2(4), third subparagraph.  
394 Article 3(e), second and third subparagraph. See also Article 20(7) in relation to comparative tests and trials. 
395 Article 3(e), fourth subparagraph (established on behalf of the responsible official bodies and acting under the authority and supervision of such body).  
396 Article 13(2), first subparagraph: ‘The responsible official bodies may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to 
any legal person, whether governed by public or private law, which, under its officially approved statute, is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in 
the outcome of the measures it takes.”. See also definition of ‘official inspections’. See also provisions on tests and trials only by State authorities or legal persons acting under the responsibility of the State Tests and trials only by 
State authorities or legal persons acting under the responsibility of the State (Article 14(7)). 
397 Article 13(2), second subparagraph.  

152 

 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Official 
laboratories 
(Article 37 to 
42) 

N 

Y  
Limited400, no 
requirement on 
designation or 
accreditation 
of similar to 
the OCR  

Y  
Limited401, no 
requirement of 
designation or 
accreditation 
similar to the 
OCR  

N404 

Y  
Limited402, no 
requirement of 
designation or 
accreditation 
similar to the 
OCR  

Y  
Limited403, no 
requirement of 
designation or 
accreditation 
similar to the 
OCR  

N 

Y 
Limited405, no 
requirement of 
designation or 
accreditation 
similar to the 
OCR 

Y 
Partly included–- but 
minimal, laboratories 
where samples are 
analysed should 
have "suitable 
facilities and 
expertise" 

Y 
Responsible 
official body to 
accredit 
laboratories after 
verification of 
compliance + 
implementing 
powers406 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

N 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Y 
in view of 
certification, 
obligation of 
responsible official 
bodies to submit 
samples to 
laboratories officially 
accepted by them, 
but no requirements 
on ‘acceptance ‘407 

Risk based 
import controls 
(Article 43 OCR)  

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

398 Article 2(k), second subparagraph: «The bodies referred to above may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to 
any legal person, whether governed by public or by private law, which, under its officially approved constitution, is charged exclusively with specific public functions, provided that such person, and its members, has no personal 
interest in the outcome of the measures it takes.». 
399 Article 2(k), third subparagraph. 
400 Article 2(3)(b), limited, in the form of provisions on official seed testing in the framework of examination under official supervision with no further specifications/requirements.  
401 Provisions on official seed testing in the framework of examination under official supervision, with no further requirements.  
402 Provisions on official seed testing in the framework of examination under official supervision, with no further requirements.  
403 Provisions on official seed testing in the framework of examination under official supervision, with no further requirements. 
404 There are no rules on seed testing. 
405 Provisions on official seed testing in the framework of examination under official supervision, with no further requirements. 
406 Provisions on official seed testing in the framework of examination under official supervision, with no further requirements (Article 6(2)).  
407 Annex IV of Implementing Directive 2014/98. 

153 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                                                                                                                                                        
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Import controls  
(Art. 43 to 64) 

N408 

Actions in the 
event of non-
compliance of 
animals and 
goods entering 
the Union (Art. 
65 to 76) 
Approval of the 
pre-export 
controls (Art. 73 
and 74) 

Cooperation 
between 
authorities in 

N 

N 

N 

N409 

N 

N 

N 

N 

N 

N 

N 

N410 

N 

N 

N 

N411 

N 

N 

N 

N412 

N 

N 

N 

N413 

N 

N 

N 

N414 

N 

N 

N 

N415 

N 

N 

N 

N 

N 

N 

N 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
N 

N 

N 

N 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

N 

N 

N 

N 

408 The general requirement of ‘random checks’ on marketing applies. There is also a requirement on supply of certain information during the marketing of quantities ˃2kg of seed imported from TCs (Art. 19(2)). 
409 The general requirement of ‘random checks’ on marketing applies. There is also a requirement on supply of certain information during the marketing of quantities ˃2kg of seed imported from TCs (the particulars are: species; 
variety; category; country of production and official inspection authority; country of dispatch; importer; quantity of seed).  
410 The general requirement of ‘random checks’ on marketing applies. There is also a requirement on supply of certain information during the marketing of quantities ˃2kg of seed imported from TCs (the particulars are: species; 
variety; category; country of production and official inspection authority; country of dispatch; importer; quantity of seed - Article 25(2)).  
411 The general requirement of ‘random checks’ on marketing applies. No specific rules on import controls, with the exception of the requirement on supply of certain information during the marketing of quantities ˃2kg of seed 
imported from TCs (Article 39(2)).  
412 The general requirement of ‘random checks’ on marketing applies. No specific rules on import controls, with the exception of the requirement on supply of certain information during the marketing of quantities ˃2kg of seed 
imported from TCs Article 23(2)).  
413 The general requirement of ‘random checks’ on marketing applies. No specific rules on import controls, with the exception of the requirement on supply of certain information during the marketing of quantities ˃2kg of seed 
imported from TCs (Article 22(2)).  
414 No specific rules on import controls, with the exception of the requirement on supply of certain information to the competent authorities during the marketing of propagating material imported from a third country (Article 
11(2)).   
415 See however Article 11(3) (obligation of importer to notify the responsible official bodies of material imported under Article 11(2) and to keep documentary evidence of his contract with the supplier in the third country) and 
implementing powers in Article 11(4) for rules on the procedure to be followed and further requirements to be met by importers.  

154 

 
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

relation to 
consignments 
from TCs (Art. 
75 and 76)  
Financing of 
official controls 
by the Member 
States (Art. 78 
to 85) 
Official 
certification426  

N416 

N417 

N427 

N428 

N 

N 

N418 

N419 

N420 

N421 

N422 

N423 

N424 

N425 

N 

N429 

N430 

N431 

N432 

N433 

N 

N 

N434 

Y435     

416 There are provisions in relation to EU contribution to Community comparative tests and trials.  
417 Ibidem.  
418 Ibidem.  
419 Ibidem.  
420 Ibidem.  
421 Ibidem, Article 23. 
422 Ibidem, Article 16(4) and (5).  
423 Ibidem, Article 14(5) and (6).  
424 Ibidem, Article 20(5) and (6).  
425 Ibidem, Article 14(5) and (6).  
426 General requirements, signature and issuance, guarantees of reliability of certificates, implementing powers.  
427 The rules referring to official certification in the Directive qualify as rules on ‘official attestations’ within the meaning of the OCR; ‘official label’ in the Directive qualifies as an ‘official attestation’ within the meaning of the 
OCR See definition of ‘official attestation’ in Article 3(28) of the OCR and Article 91 of the OCR. There is no requirement of the ‘official label’ to be signed by a certifying office. 
428 Ibidem. 
429 Ibidem. 
430 Ibidem.  
431 Ibidem.  
432 Ibidem. 
433 Ibidem.  
434 Ibidem.  
435 Master certificate for all reproductive material derived from approved basic material (Article 12) and model thereof (Annex VIII).  

155 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

 (Art. 3(25) and 
(26), Art. 87 to 
90) 
Official 
attestations 
(Art. 3(28) and 
91) 

Y436 
no 
requirements 
comparable to 
Article 91 
(2)(a), (3) and 
(4) of the 
OCR.  

Y437  

N 

Y438  

Y439 

Y440 

Y441 

Y442 

N 

N 

Y443 

N 

no 
requirements 
comparable to 
Article 91 
(2)(a), (3) and 
(4) of the 
OCR.  

no 
requirements 
comparable to 
Article 91 
(2)(a), (3) and 
(4) of the 
OCR.  

no requirements 
comparable to 
Article 91 (2)(a), 
(3) and (4) of the 
OCR.  

no 
requirements 
comparable to 
Article 91 
(2)(a), (3) and 
(4) of the 
OCR.  

no requirements 
comparable to 
Article 91 (2)(a), 
(3) and (4) of the 
OCR.  

no 
requirements 
comparable to 
Article 91 
(2)(a), (3) and 
(4) of the 
OCR.  

no requirements 
comparable to 
Article 91 (2)(a), 
(3) and (4) of the 
OCR.  

no requirements 
comparable to 
Article 91(2)(a), (3) 
and (4) of the OCR.  

. 

436 Seed must be officially certified in order to be placed on the market and packages of basic seed and certified seed must be labelled on the outside with an official label (Article 10(1)(a))and contain an official document (Article 
10(1)(b)).  
437 Seed must be officially certified in order to be placed on the market (Article 3(1) : “Member States shall provide that cereal seed may not be placed on the market unless it has been officially certified as ‘basic seed’, ‘certified 
seed’, ‘certified seed, first generation’ or ‘certified seed, second generation’.”). Packages of basic seed and certified seed must be labelled on the outside  with an official label (Article 10(1)(a)) and contain an official document 
(Article 10(1)(b)) 
438 Seed must be officially certified in order to be placed on the market (Article 3(1) : “Member States shall provide that cereal seed may not be placed on the market unless it has been officially certified as ‘basic seed’, ‘certified 
seed’, ‘certified seed, first generation’ or ‘certified seed, second generation’.”). Packages of basic seed and certified seed must be labelled on the outside with an official label (Article 12(a)) and contain an official document (Article 
12(b)).  
439 MS shall provide that seed of industrial chicory may not be placed on the market unless it has been officially certified as ‘basic seed’ or ‘certified seed’ (Article 20(1)); MS shall provide that seed of other vegetable species may 
not be placed on the market unless it has been officially certified as ‘basic seed’ or ‘certified seed’, or is standard seed (Article 20(2)). Packages of basic seed and certified seed must be labelled on the outside with an official label 
(Article 28(1)(a)) and contain an official document (Article 28(1)(b)). Vegetable seed may no be certified, verified as standard seed and marketed unless the variety is officially accepted in one or more Member States (Article 3(1)).  
440 Seed potatoes may not be placed on the market unless they have been officially certified as ‘basic seed potatoes’ or ‘certified seed potatoes’ (Article 3(1)). Packages and containers of basic seed potatoes and certified seed 
potatoes must be labelled on the outside with an official label (Article 13(1)(a)) and contain an official document (Article 13(1)(a)).  
441 Seed may not be placed on the market unless they have been officially certified (Article 3(1) to (3)). Packages of basic seed, certified seed of all categories and commercial seed must be labelled on the outside with an official 
label (Article 12(1)(a)) and contain an official document (Article 12(1)(b)).  
442 Propagating material may not be placed on the market unless it has been officially certified as ‘initial propagating material’, ‘basic propagating material’ or ‘certified propagating material’ (Article 3(1)(a)). MS to require that an 
official label in one of the official languages of the Community, conforming to the specification in Annex IV, be affixed on the outside of packages and bundles of propagating material (Article 10(1)). All conditions applicable to 
the official labelling and plant passports are defined and must be recognised as equivalent (Article 10(4)).  
443 Requirement of official certification of material and fruit plants for placing on the market (Article 3(1)).  

156 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Reference 
laboratories 
and reference 
centres (Art. 92 
to 101) 
Administrative 
assistance and 

N 

N 

N 

N 

N 

Y 
Very limited444 

Y  
Very limited445 

Y 
Limited446 

Y 
Very limited447 

Y 
Limited448. 

N 

N 

N 

N 

Y 
Very limited449 

Y 
Limited450 

N 

N 

N 

N 

N 

Y 
Limited451 

Y 
Limited452 

Y 
Detailed rules on 

444 MS making use of a specific derogation are required to "assist each other administratively as regards inspection". 
445 MS to assist each other administratively as regards inspection in case they make use of the derogation to authorize official certification and marketing although not all applicable conditions are met (Article 4(4)).  
446 Implementing powers for administrative assistance in relation to growing trials (Art. 7(2)(c)). Notification to the other MS and to the Commission of any application or withdrawal of an application for acceptance of a variety, 
any entry in a catalogue of varieties as well as any amendment (Article 10(1)). Where maintenance takes place in a Member State other than the one in which the variety was accepted, the Member States concerned shall assist each 
other administratively as regards verification (Art. 11(4)).  
447 MS to assist each other administratively as regards inspection in case they make use of the derogation to authorize official certification and marketing although not all applicable conditions are met (Article 5, last subparagraph).  
448 Where maintenance of accepted varieties takes place in a MS other than that in which the variety was accepted, the MS concerned shall assist each other administratively as regards checks (Article 11(4)). Notification obligations 
to other MS and the Commission in relation to accepted varieties (Article 10).  
449 MS to assist each other administratively as regards inspection in case they make use of the derogation to authorize official certification and marketing although not all applicable conditions are met (Article 5).  
450 MS to immediately communicate to the other MS ad the Commission all applications or withdrawals of applications for acceptance of a variety, entries in a catalogue of varieties and amendments made to it (Article 5e(2)). In 
case maintenance of a variety for conservation is carried out in a MS other than that in which the variety was accepted, MS in question to assist each other administratively as regards control (Article 5g(4)).  
451 In the form of obligation of the MS to notify to the Commission and to the competent national authorities in the MS if a supplier is forbidden to market vegetable propagating and planting material (Article 19(2)).  
452 In the form of obligation of the MS to notify to the Commission and to the competent national authorities in the MS if a supplier is forbidden to market propagating material and fruit plants (Article 16(3)).  

157 

 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 

cooperation 
(Art. 102-108) 

Planning (Art. 
109- 111) 

Reporting to 
the 
Commission 
(Art. 113 ) 
Coordinated 
control 
programmes 
and information 
and data 
collection 
(Art.112 OCR) 

N 

N 

N 

N 

N 

N 

Y455  

Y 
Data collection 
in the form of 
Community 
comparative 
tests and 
trials456  

Y 
Data collection 
in the form of 
Community 
comparative 
tests and trials 
shall be 
carried457. 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N  

Y 
Data collection in 
the form of 
Community 
comparative tests 
and trials458. 

Y 
Data collection 
in the form of 
Community 
comparative 
tests and 
trials459. 

Y 
Data collection in 
the form of 
Community 
comparative tests 
and trials460 

Y 
Data collection 
in the form of 
Community 
comparative 
tests and 
trials461. 

Y 
Data collection in 
the form of 
Community 
comparative tests 
and trials462.  

Y 
Data collection in 
the form of 
Community 
comparative tests 
and trials 463 

Y 
Data collection in 
the form of 
Community 
comparative tests 
and trials464 

Y 
Data collection in 
the form of 
Community 
comparative tests 
and trials465 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

administrative 
assistance453+ 
communication to 
Commission and 
other MS454 
N 

N 

N 

453 Article 16(2) and Commission Regulation (EC) No 1598/2002 of 6 September 2002 laying down detailed rules for the application of Council Directive 1999/105/EC as regards the provision of mutual administrative assistance 
by official bodies. MS to ensure that the respective official bodies assist each other administratively in order to obtain appropriate information necessary to ensure the proper functioning of this Directive, particularly  where FRM 
moves from one Member State to another (Art.16(2)).  
454 MS to communicate to the Commission and to the other MS maps showing the demarcations of the regions of provenance of basic material intended for the production of reproductive material of the "source-identified" and 
"selected" categories (Art. 9(2)). A national list of the basic material of the various species approved  on its territory shall be drawn up by each Member State and shall be available on request to the Commission and the other 
Member States (Art. 10(2)).  
455 Reporting obligation until 28 February 2030 for the responsible certification authority to the Commission and the other MS (Annex I, 5b, last subparagraph).  
456 Article 20.  See also 2004/11/EC: Commission Decision of 18 December 2003 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants of agricultural and 
vegetable species and vine under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC for the years 2004 and 2005 (Text with EEA relevance) (notified 
under document number C(2003) 4836) (OJ L 3, 7.1.2004, p. 38); Commission Decision of 27 December 2004 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain 
plants of agricultural and vegetable species and vine under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC for the years 2005 to 2009 (notified under 
document number C(2004) 5264) (Text with EEA relevance) (2005/5/EC)( (OJ L 002, 5.1.2005, p.12).  
457 Article 20.  

158 

 
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

N 

N 

Commission 
controls in MS 
(Art. 116 to 119) 

Commission 
controls in the 
TCs (Art. 120 to 
124)  

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

Y466 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Y467  
as a possibility 
(‘may’) 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
Y  
As a possibility 
(‘may’)468  

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y 
As a possibility 
(‘may’)469 

N 

N 

N 

N 

458 Article 26(2). 
459 Article 43. 
460 Article 20.  
461 Article 23(2).  
462 Article 16(2).  
463 Article 14.  
464 Article 20(2). The Commission to inform the PAFF committee of the results. 
465 Article 14.  
466 Article 14(1): “1.  Where appropriate, trials or tests shall be carried out in the Member States on samples to check that propagating material complies with the requirements and conditions of this Directive. The Commission may 
organise inspections of trials by representatives of the Member States and of the Commission.” 
467 On the spot checks, in particular to verify compliance by the suppliers, but as a possibility, not as an obligation + implementing powers (Article 7). Inspections of the trials, but as a possibility (Article 20(1): The Commission 
may organise inspections of the trials by representatives of the Member States and of the Commission).  
468 The Commission may organise inspections of the trials by representatives of the MS and of the Commission (Article 14(1)). On the spot checks, in particular to verify compliance by the suppliers, but as a possibility, not as an 
obligation and implementing powers (Article 15). 
469 Article 16(5): “Experts from the Commission may, in cooperation with the official bodies of the Member States, make on-the-spot checks so far as this is necessary to ensure uniform application of this Directive. They may in 
particular verify whether FRM is complying with the requirements of this Directive. A Member State in whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The 
Commission shall inform the Member States of the results of the investigation”. 

159 

 
 
 
 
 
 
                                                                                                                                                                                                                                                        
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Import 
conditions, (Art. 
125 to 128) 

Y 
Only officially 
certified seed 
may be placed 
on the EU 
market470 

Y 
Only officially 
certified seed 
may be placed 
on the EU 
market471  

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

N 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Y 
Only officially 
certified seed 
may be placed on 
the EU market472 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Y 
Only officially 
certified seed 
may be placed 
on the EU 
market473 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Y 
Only officially 
certified seed 
may be placed on 
the EU market474 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Y 
Only officially 
certified seed 
may be placed 
on the EU 
market475 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

Y 
Only officially 
certified seed 
may be placed on 
the EU market 
Pending 
equivalence 
decisions, MS are 
authorised to take 
such decisions476. 

Y 
Pending 
equivalence 
decision, import is 
prohibited except 
where the importer 
provides assurances 
477 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Y 
By MS, pending 
an equivalence 
decision by the 
Commission478. 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
Y 
By MS, pending an 
equivalence 
decision by the 
Commission479 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y 
By Council acting 
on a proposal 
from the 
Commission480  
By MS, pending 
an equivalence 
decision by 
Council481 

470 Article 3.  
471 Article 3(1) OCR. There are specific rules on official certification in MS of cereal seed harvested in a TC in Article 15(3). 
472 Article 3(1). Specific rules on official certification in MS of cereal seed harvested in a TC (Article 22(3)).  
473 There are also specific rules on official certification in MS of cereal seed harvested in a TC.  
474 Article 3(1).  
475 Article 3. There are also rules concerning official certification of seed harvested in a TC (Article 19(3)) and of seeds produced from seeds officially certified in a TC which has been granted equivalence (Article 19(1)).  
476 Article 15(2)(c).  
477 Article 11(2) and (3).   
478 MS importing such material from TCs may, until 31 December 2022, apply to such products import conditions at least equivalent to those applicable to similar Union products (Article 16(2) and Commission Implementing 
Decision (EU) 2022/1400 of 11 August 2022 amending Council Directive 2008/72/EC to extend the period during which Member States may decide on the import conditions for vegetable propagating and planting material, other 
than seed, from third countries (notified under document C(2022) 5723) (OJ L 213, 16.8.2022, p. 57)).  
479 MS importing such material from TCs may, until 31 December 2022, apply to such products import conditions at least equivalent to those established pursuant to Article 4 (Article 12(2) and Commission Implementing Directive 
2014/97/EU).  
480 In addition to the equivalence decision, Council is to determine the species, type of basic material and categories of FRM, together with its region of provenance, which may be permitted to be marketed within the Union (Article 
19(2)).  
481 Article 19(3) and Commission Implementing Decision (EU) 2021/773 of 10 May 2021 authorising Member States, in accordance with Council Directive 1999/105/EC, to temporarily decide on the equivalence of FRM of certain 
categories produced in certain third countries (notified under document C(2021) 3194) 
C/2021/3194 (OJ L 169, 12.5.2021, p. 1). Master certificate or official certificate to be issued by the TC of origin.  

160 

 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Equivalence TC 
requirements  
(Art. 129) 

EU training of 
staff (BTSF) 
(Art. 130) 

Y 482 483  

Y484 

Y485 

Y486  

Y487 

Y488. 

Y489 

Y490. 

Y491 

N 

N 

N 

N 

N 

N 

N 

N 

N 

Y492 

N 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
Y493 

N 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

Y494 

N 

482 Recognition by Council acting by a qualified majority on a proposal from the Commission of equivalence of field inspection and of seed (Article 16).  
483 competence of the COM to adopt such measures; conditions for the granting of equivalence; implementing powers to set out the practical arrangements for the entry into the Union of such goods.  
484 Recognition by Council, acting by a qualified majority on a proposal from the Commission of equivalence of field inspection and of seed.  
485 Recognition by Council, acting by qualified majority, on a proposal from the Commission, that official examinations of varieties carried out in the TC afford the same assurances as those provided for in Article 7 and carried out 
in the Member States; the checks on practices for the maintenance of varieties carried out in the third country afford the same assurances as those carried out by the Member States (Article 22).  
486 Recognition by Council, acting by a qualified majority on a proposal from the Commission. See Council Decision 2003/17/EC of 16 December 2002 on the equivalence of field inspections carried out in third countries on seed-
producing crops and on the equivalence of seed produced in third countries (Text with EEA relevance) (OJ L 008 14.1.2003, p. 10).  
487 Recognition by Council, acting by a qualified majority on a proposal from the Commission official examinations of varieties, checks on practices for the maintenance of the varieties, of field inspections, of 
vegetable seed harvested in a third country (Article 37(1)).  
488 Recognition by Council, acting by a qualified majority on a proposal from the Commission that seed potatoes harvested in a third country are equivalent to basic seed potatoes or certified seed potatoes harvested within the 
Community and complying with the provisions of this Directive (Article 21(1)).  
489 Recognition by Council, acting by a qualified majority on a proposal from the Commission of equivalence of field inspections and of seed of oil and fibre plants.  
490 Determination by Council, acting by a qualified majority on a proposal from the Commission whether material for the vegetative propagation of the vine produced in a TCs offers, as regards the conditions for its acceptance and 
the measures taken to ensure its production with a view to its marketing, the same guarantees as material produced in the Community and meets the requirements of the Directive (Article 15(2)(a)). Determination of the types of 
material and the categories of material for the vegetative propagation of the vine that may be admitted to marketing within the territory of the Community under equivalence (Article 15(2)(b)). 
491 By the Commission Implementing Acts on equivalent guarantees of propagating material produced in a TCs in all respects to material produced in the Community in accordance with this Directive (Article 11(1)).  
492  In  Commission  implementing  acts,  decision  whether  vegetable  propagating  and  planting  material  produced  in  a  third  country  is  equivalent  to  vegetable  propagating  and  planting  material  produced  in  the  Community  and 
complying with the requirements and conditions of this Directive (Article 16(1)).  
493  In  Commission implementing  acts, decision  whether  propagating  material  and  fruit  plants produced in a  third  country  is  equivalent  to  material/plants  produced in  the  Community  and  complying  with  the  requirements and 
conditions of the Directive (Article 12(1)).   
494 Recognition by Council acting by a qualified majority on a proposal from the Commission that FRM provides the same assurances as regards the approval of its basic material and the measures taken for its production with a 
view to marketing as does FRM produced within the Union and complying with the provisions of this Directive (Art. 19(1)).  

161 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

Information 
management 
system (Art. 
131 to 136)  
Enforcement 
action (Art. 137 
and 138) 

N 

Y  
Limited  

N 

N 

N 

Y495 

N 

Y 

N 

N 

N 

N 

N 

Y496 

Y 
Limited497  

Y 
Limited498  

Y 
Limited499.  

Y  
 appropriate 
measures in relation 
to material 500 and to 
the particular 
supplier501 + 
withdrawal of 
measures502 

N 

Y503 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
N 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

N 

Y 
Limited506 

Y 
in relation to non-
compliant material504 
and to non-
compliant 
suppliers505 

495 Revocation of acceptance of variety (Art. 14) and its deletion (Art. 15).  
496 Member States shall ensure that any doubts which arise after the acceptance of a variety concerning the appraisal of its distinctness or of its name at the time of acceptance are removed and related implementing powers (Article 
13). Replacement or revocation of acceptance of a variety (Article 13(2) and 14) and deletion (Article 15). Adaptation of the name of an accepted variety (Article 13 (3)). MS to prohibit marketing of seeds in case of repeated non-
compliance found during post-control tests carried out in the field (Article 42(1)). MS shall ensure that any certification of the seed sampled is annulled in the event of contravention unless it can be shown that such seed still meets 
all relevant requirements (Article 25(1a)(f)). 
497 Sorting of seed potatoes which do not, during marketing, satisfy the minimum conditions laid down in Annex II (Article 3(1).  
498  Only  in  relation  to  examination  under  official  supervision,  MS  to  ensure  that  any  certification  of  the  seed  sampled  is  annulled  in  the  event  of  contravention  unless  it  can  be  shown  that  such  seed  still  meets  all  relevant 
requirements (Article 2(5)(A)(e) ; Article 2(5)(B)(f)).  
499 Revocation of acceptance of varieties and deletion from the catalogue if any of the conditions for acceptance for certification or checking is no longer satisfied (Article 5e(1)).  
500 Article 13(1) : «If, during official inspections referred to in Article 12, or the trials referred to in Article 14, it is found that propagating material does not meet the requirements of this Directive, the responsible official body shall 
ensure that the supplier takes appropriate corrective action or, if that is not possible, shall prohibit the marketing of that propagating material in the Community.” 
501 Article 13(2) : « If it is found that propagating material marketed by a particular supplier does not comply with the requirements of this Directive, the Member State concerned shall ensure that appropriate measures are taken in 
relation to that supplier.” 
502 Article 13(3) : « 3.  Any measures taken under paragraph 2 shall be withdrawn as soon as it has been established with sufficient certainty that the propagating material intended for marketing by the supplier will, in future, 
comply with the requirements and conditions of this Directive.” 
503 The responsible official body must take appropriate action in case official controls reveal non-compliance (Article 6(4) last subparagraph), including in relation to accreditation of suppliers and laboratories (Article 6(3)). MS 
shall take appropriate action to ensure that: non-compliant material does comply or, if that is not possible, to ban its marketing in the Community (Article 19(1)) and take appropriate measures against the supplier (Article 19(2)). 
MS to take appropriate official measures to eliminate any plant health risk (Article 23(2)).  
504 Article 16(2).  
505 Article 16(3).  

162 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OCR 
requirements  

PRM and FRM Directives  

Directive 
66/401/EEC – 
marketing of 
fodder plant 
seed 

Directive 
66/402/EEC – 
marketing of 
cereal seed 

Directive 
2002/53/EC – 
common 
catalogue of 
agricultural 
plant species 

Directive 
2002/54/EC – 
marketing of 
beet seed 

Directive 
2002/55/EC – 
marketing of 
vegetable 
seed 

Directive 
2002/56/EC – 
marketing of 
seed potatoes 

Penalties (Art. 
139(1)) 

Y  
Limited507 

Y 
Limited508 

Penalties for 
violations 
through fraud 
(Art. 139(2)) 
Whistle blowing 
(Art. 140)  
EU enforcement 
measures (Art. 
141)  

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

Y 
Limited509 

Y 
Limited510 

N 

N 

N 

N 

N 

N 

N 

N 

N 

Y512  

Directive 
2002/57/EC – 
marketing of 
seed of oil 
and fibre 
plants 

Y511 

N 

N 

N 

Directive 
68/193/EEC – 
marketing of 
material for the 
propagation of 
the vine 

Directive 
1998/56/EC – 
marketing of 
propagating 
material of 
ornamental plants 

 Directive 
2008/72/EC – 
marketing of 
vegetable 
material, other 
than seed 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

N 

Directive 
2008/90/EC – 
marketing of fruit 
propagating 
material and fruit 
plants for fruit 
production 
N 

N 

N 

N 

Directive 
1999/105/EC – 
marketing of 
forest 
reproductive 
material 

N 

N 

N 

N 

506 Withdrawal of approval of basic material (Art. 4(3)(a)).  
507 Only in relation to penalties applicable to infringements of the national provisions governing examination under official supervision and the focus is on infringements by field inspectors, seed testing laboratories, and not on 
infringements by the operators. Also, there are no rules on notification to the Commission of these rules, similar to those in the OCR.  
508 Ibidem.  
509 Ibidem.  
510 Ibidem.  
511 Ibidem (Article 2(5)(A)(e) ; Article 2(5)(B)(f). 
512 Prohibition of the marketing of seed potatoes harvested in a particular area of the Union in case of non-compliance for 3 consecutive years in Community tests and trials (Article 20(7) and (8)).  

163 

 
 
 
 
 
 
                                                                                                                                                                                                                                                        
9.2. 

Information on official controls from consultation activities 

9.2.1. 

Controls  on  operators  carrying  out  certification  under  official 
supervision  

Just  under  half  of  responding  NCAs  (N=25)  reported  that  they  carry  out  controls  on  certification 
under official supervision.  

Figure 10. Overview of responses to the question ‘Do you currently carry out controls of certification activities 
under official supervision? (N=25) 

9.2.2. 

PRM import controls 

Percentage of 
consignments checked 

PRM 

FRM 

Less than 10% 

10-25% 

26-50% 

51-75% 

over 75% 

I don't know 

3 

2 

2 

1 

6 

3 

3 

0 

0 

0 

3 

2 

Table 31. Overview of controls on imported PRM/FRM consignments to check the identity of 
PRM/FRM on an annual basis 

164 

 
 
 
9.2.3. 

Types of import controls: 

Figure  11.  Overview  of  the  type  of  import  controls  (N=3-22)  and  the  relative  proportion  (%)  in  relation  to  the 
total  number  of  imports.  Responses  to  other  (N=3):  not  responsible,  post-controls  depend  on  another  NCA,  all 
pre-basic and basic PRM of agricultural crops is checked in grow out plots. 

Figure 12. Overview of criteria used for carrying out documentary checks (N=22).  

9.2.4. 

Controls on operators at production stage of PRM/FRM 

The estimated total number of controls that NCAs carry out on operators at production stage on an 
annual  basis, varied significantly from  a few times a  year to  1 000. However, the type of control 
varied which may explain the variation in responses. Similar to the import control checks operators 

165 

 
 
 
 
 
at  the  production  stage  are  also  most  frequently  undergoing  documentary  checks  and  visual 
inspections while pest control tests are the least frequent.   

Figure 13. Overview of types of controls on operators at production stage of PRM/FRM? (N=25) 

Figure  14.  Overview  of  the  type  of  controls  on  operators  at  production  stage  of  PRM/FRM  (N=7-22)  and  the 
percentage of operators checked at production stage. Responses to other (N=7): interview, soil and plant material 
sampling & testing, sampling and testing of plants other than seed, GMO tests where applicable, the answer is all 
regarding the certification of seed, N/A, it is not clear which type of control is involved. 

166 

 
 
 
 
Figure 15. Overview of criteria used for carrying out documentary checks (N=23). 

9.2.5. 

PRM marketing controls 

Figure  16.  Overview  of  the  type  of  PRM/FRM  marketing  controls  (N=4-23)  and  the  percentage  of  PRM/FRM 
checked during marketing.  

167 

 
 
 
 
 
Figure 17. Overview of criteria used for carrying out documentary checks (N=23). 

168 

 
 
 
 
 
10.   FURTHER DETAILS ON OPTION 2 (PREFERRED OPTION) 

10.1.  Current  and  potential  future  approach  for  variety  registration  and  PRM 

certification  

Figure 18. Schematic representation of the current and potential future approach for variety registration and PRM 
certification under policy option 2 

The upper part of Figure 18 shows the current legal framework. The lower part shows the potential 
future approach for variety registration and certification based on the preferred policy option of this 
impact  assessment,  namely  option  2.  Under  the  current  legal  framework,  DUS  testing  and  VCU 
examination  in  the  case  of  agricultural  species,  seed  potatoes  and  vine  is  a  condition  for  variety 
registration.  As  regards  the  VCU  examination,  MS  can  decide  which  characteristics  of  the  VCU 
examination they deem  to be important.  In practice, the VCU examination is  mainly  focussed on 
yield while limited attention is given to the assessment of characteristics contributing to sustainable 
production. PRM of registered varieties is certified as pre-basic, basic or certified material or meets 
the  requirements  of  standard  or  Conformitas  Agraria  Communitatis  (CAC)  material.  PRM  is 
marketed under one of those 4 categories. 

Derogations  from  the  DUS  testing  requirement  for  variety  registration  have  been  introduced 
through  the  legislation  on  conservation  varieties  (including  landraces).  The  intention  of  these 
derogations was to increase the diversity of PRM available on the market, but a limited number of 
conservation varieties has been authorised for marketing. The PRM concerned is not certified. It is 
marketed with a label issued by the operator that mentions the type of variety. 

The current legislation has limited possibilities as regards the conservation and sustainable use of 
plant genetic resources because transfer of PRM is considered as marketing. This implies that the 
activities  of  seed  conservation  networks  and  the  exchange  in  kind  of  PRM  between  farmers  fall 
within  the  scope  of  the  marketing  legislation.  The  varieties  concerned  have  to  be  officially 

169 

 
 
 
registered and the PRM certified and marketed as pre-basic, basic or certified or the PRM meets the 
requirements to be marketed as standard/Conformitas Agraria Communitatis (CAC) material. 

Under the future legal framework, the variety registration and certification pillars will remain but in 
addition  there  will  be  a  notification  procedure  for  heterogeneous  and  organic  heterogeneous 
material and lighter rules for the activities of seed conservation networks and exchange in kind of 
seeds between farmers. Under the first pillar of variety registration the existing derogatory regime 
for conservation varieties and landraces will be expanded to include new locally adapted varieties. 
Lighter  rules  for  the  activities  of  seed  conservation  networks  and  exchange  in  kind  of  seeds 
between farmers will ensure a minimum level of quality and traceability of the PRM concerned.  

As regards the second pillar, only PRM of registered varieties will be certified as pre-basic, basic or 
certified  material  or  meet  the  requirements  of  standard  or  Conformitas  Agraria  Communitatis 
(CAC)  material.  PRM  will  be  marketed  under  one  of  those  4  categories.  PRM  of  conservation 
varieties  and  new  locally  adapted  varieties,  heterogeneous/organic  heterogeneous  material,  PRM 
exchanged by seed conservation networks or farmers will not be subject to certification.  

10.2.  Potential  future  approach  for  variety  registration,  activities  of  seed 

conservation networks and exchange in kind of seeds  

Figure  19.  Schematic  representation  of  the  potential  future  approach  for  variety  registration,  activities  of  seed 
conservation networks and exchange in kind of PRM between farmers under policy option 2 

Figure  19  describes  the  potential  future  approach  for  variety  registration,  notification  of 
heterogeneous/organic heterogeneous material, PRM exchanged by seed conservation networks or 
farmers  based  on  the  preferred  policy  option  of  this  impact  assessment,  namely  option  2.  Upon 
registration of a new conventional or organic variety based on an official description, there will be 
an  assessment  of  characteristics  contributing  to  sustainable  production  (VSCU).  Furthermore,  the 
DUS and VSCU examinations will be adapted to cater for the needs of organic varieties suitable for 

170 

 
 
 
 
 
organic production that cannot meet the stringent uniformity requirements applied to conventional 
varieties. For varieties of fruit plants and vegetables there will be, instead of the VCU examination, 
trials assessing the performance of varieties containing sustainability characteristics in relation to a 
number of reference varieties without those sustainability characteristics.  

In  the  case  of  conservation  varieties  and  new  locally  adapted  varieties,  the  registration  will  not 
require  an  official  examination  but  will  be  based  on  an  officially  recognised  description.  The 
notification procedure for heterogeneous and organic heterogeneous material will be based on the 
existing  notification  procedure  for  organic  heterogeneous  material513.  PRM  of  heterogeneous  and 
organic heterogeneous material will be allowed for marketing following a notification made by the 
breeder to  the NCA based on a dossier containing (1) the  contact  details  of the applicant,  (2) the 
species  and  the  denomination  of  the  heterogeneous/organic  heterogeneous  material  as  applicable, 
(3) the description of the main agronomic and phenotypic characteristics that are common to that 
plant grouping and a declaration by the applicant concerning the truth of the elements in points (1), 
(2) and (3). Upon acceptance by the NCA that heterogeneous/organic heterogeneous material will 
be listed in a separate section of the EU Plant Variety Portal. 

The  future  legal  framework  will  establish  lighter  rules  for  the  activities  of  seed  conservation 
networks and exchange in kind of PRM between farmers. Any natural or legal person involved in 
one  of  the  aforementioned  activities  cannot  have  a  contractual  relationship  with  a  seed  company 
(e.g. service contract to multiply seed for a seed company). The PRM concerned does not belong to 
a variety that is registered in the EU Plant Variety Portal, nor does it belong to a variety protected 
by  a  national  or  Community  plant  variety  right.  MS  will  lay  down  species-specific  quantitative 
restrictions.  

10.3.  Value for sustainable cultivation and use (VSCU) 

In  the  future  PRM  legislation  Member  States  will  need  to  assess  the  value  for  sustainable 
cultivation and use (VSCU) of candidate varieties of all crop groups. The aim of this examination is 
to  assess  if  the  characteristics  of  those  candidate  varieties,  taken  as  a  whole,  offer  a  clear 
improvement  either  for  sustainable  cultivation  or  as  regards  the  uses,  which  can  be  made  of  the 
crops,  other  plants  or  the  products  derived  therefrom.  Where  other,  superior  characteristics  are 
present, individual inferior characteristics may be disregarded.  The characteristics, as regards that 
examination, would be as appropriate for the species, regions and uses concerned: 

a)  Yield and yield stability; 
b)  Tolerance/resistance to biotic stresses including plant diseases caused by nematodes, fungi, 

bacteria, viruses, pests; 

c)  Tolerance/resistance to abiotic stresses, including climate adaptation; 
d)  Improved utilisation of resources; 
e)  Enhanced storage performance; 
f)  Production of substances or characteristics of industrial interest; 
g)  Quality or nutritional characteristics and characteristics important for processing. 

513 Article 13(2) to Regulation (EU) 2018/848. OJ L 150, 14.6.2018, p. 1 

171 

 
 
 
                                                 
In the future FRM legislation a list of sustainability characteristics will be established in order to 
ensure  that  basic  material  will  have  improved  performance  in  relation  to  one  of  those  listed 
characteristics. Even though this list will be established under tertiary legislation, indicatively the 
following characteristics would be considered:  

a)  Suitability  of  tree  species  for  particular  climatic  conditions  (including  conditions  under 

future climate change projections); 

b)  Suitability  of  provenances  of  basic  material  for  particular  climatic  conditions  (including 

conditions under future climate change projections); 

c)  Adaptability of FRM (e.g. to water stress, drought, heat, cold, wind hoses, wind throws); 
d)  Resistance of FRM to plant pests. 

10.4.  Certification under official supervision 

All certification tasks will be permitted under official supervision for all PRM categories (pre-basic, 
basic  and  certified  material)  and  all  crop  groups.  In  the  case  of  agricultural  species  certification 
under  official  supervision  will  be  extended  to  the  pre-basic  and  basic  categories  (Figure  20). 
Certification under official supervision will also become possible for seed potatoes and vegetables 
species514.  

Figure 20. Official certification and certification under official supervision – agricultural species 

514 Certification under official supervision will also apply to Directives 2002/55/EC, 2002/56/EC and 2008/72. 

172 

 
 
 
 
 
                                                 
Figure 21. Official certification and certification under official supervision – Fruit plants and vine 

Figure 21 shows a preliminary scheme to conduct certification under official supervision in the case 
of  fruit  plants  and  vine.  The  terminology  used  is  slightly  different.  Reference  is  made  to  the 
production site or place because the highest category or reproductive material (pre-basic material in 
the  case  of  fruit  plants  and  initial  propagating  material  for  vine)  is  produced  in  insect  proof 
facilities, but there may be exceptions to this rule. The lower PRM categories are produced under 
non-insect proof conditions in the field (fruit plants) and nurseries (vine). Plant health requirements 
are an important aspect for the certification of PRM of fruit plants and vine. Compliance with plant 
health requirements will be dealt with under the PHL (Annex 6, Section 6.5.). The main part of the 
certification scheme will concern the inspection of the production site/place and of the PRM. The 
principles  of  certification  under  official  supervision  will  be  similar  to  those  of  seed  certification 
under  official  supervision.  The  operators  and  their  staff  may  be  authorised  to  conduct  certain 
activities  under  official  supervision  if  they  are  trained  and  licensed  by  the  NCA.  NCAs  will 
regularly verify that the activities carried out under official supervision are done in a correct way. 
NCAs  will  always  approve  the  production  site/place,  decide  about  the  certification  of  PRM  and 
authorise the issuing of the official labels. 

173 

 
 
 
 
 
Figure 22. Official certification and certification under official supervision – FRM 

The  marketing  Directive  on  FRM  implicitly  refers  to  certification  under  official  supervision  but 
does not specify which activities may be carried out under official supervision515. Operators can be 
authorised to perform the FRM certification process under the official supervision of the NCAs, as 
depicted  in  Figure  22.  This  authorisation  to  conduct  certification  activities  under  official 
supervision  will  be  subject  to  the  same  principles  as  described  above  for  the  seed  certification 
scheme:  training  and  licensing  of  operators  and  OCs  on  the  activities  carried  out  under  official 
supervision. The following activities will always be carried out officially: the decision to issue the 
Master certificate regarding all FRM collected from approved basic material and the authorisation 
for the operator to print the supplier’s label/document. 

10.5.  Future regulation of RNQPs 

1.  The current repetition of RNQP requirements in the two legal frameworks (PHL and PRM) 

will be abolished.  

2.  The identification of RNQPs, their thresholds and specific measures will be laid down under 

the PHL only.  

3.  The PRM/FRM legislation will only refer to compliance with PHL requirements as regards 

QPs and RNQPs. 

4.  Compliance with QPs and RNQPs would lead to the issuance of plant passport under plant 

health rules. 

5.  The certification rules under the PRM/FRM legislation will concern the identity and quality 

and also require compliance with the plant health rules (QPs and RNQPs).  

515 Article 2, point k to Directive 1999/105/EC 

174 

 
 
 
 
                                                 
6.  The PRM/FRM legislation will make, for the purpose of clarity, a general reference to PHL, 

as is already now the case in several marketing Directives. 

7.  The  material  shall  also  comply  with  the  requirements  concerning  Union  quarantine  pests, 
protected  zone  quarantine  pests  and  RNQPs  provided  for  in  Annex  IV  to  Implementing 
Regulation  (EU)  2019/2072  as  well  as  the  measures  in  Annex  V  to  that  Implementing 
Regulation. 

175 

 
 
 
 
 
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Wu H. X. (2019) Benefits and risks of using clones in forestry – a review. Scandinavian Journal of 
forest research 34 no. 5, 352 – 359  

2.  DOCUMENTS OF THE EUROPEAN COMMISSION 

COM(2013)  262  final  -  Proposal  for  a  REGULATION  OF  THE  EUROPEAN  PARLIAMENT 
AND  OF  THE  COUNCIL  On  the  production  and  making  available  on  the  market  of  plant 
law).  https://eur-lex.europa.eu/legal-
reproductive  material 
content/EN/TXT/?uri=celex:52013PC0262 

reproductive  material 

(plant 

COM(2019) 640 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN ECONOMIC 
AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS The European Green 
Deal https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2019%3A640%3AFIN  

COM(2020) 380 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 
AND THE COMMITTEE OF THE REGIONS EU Biodiversity Strategy for 2030 Bringing nature 
back into our lives https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0380  

COM(2020) 381 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 

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AND  THE  COMMITTEE  OF  THE  REGIONS  A  Farm  to  Fork  Strategy  for  a  fair,  healthy  and 
https://eur-lex.europa.eu/legal-
environmentally-friendly 
content/EN/TXT/?uri=CELEX%3A52020DC0381  

system 

food 

COM(2021) 82 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 
AND  THE  COMMITTEE  OF  THE  REGIONS  Forging  a  climate-resilient  Europe  -  the  new  EU 
Strategy 
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=COM%3A2021%3A82%3AFIN  

Adaptation 

Climate 

Change 

on 

to 

COM(2021)118 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 
AND THE COMMITTEE OF  THE REGIONS  2030 Digital Compass:  the European way  for the 
Digital Decade https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A52021DC0118  

COM(2021) 572 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 
AND  THE  COMMITTEE  OF  THE  REGIONS  New  EU  Forest  Strategy  for  2030  https://eur-
lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52021DC0572  

COM(2021)  786  final  -  REPORT  FROM  THE  COMMISSION  TO  THE  EUROPEAN 
PARLIAMENT  AND  THE  COUNCIL  on  the  enforcement  and  effectiveness  of  plant  health 
measures 
territory  https://eur-lex.europa.eu/legal-
the  Union 
content/EN/TXT/PDF/?uri=CELEX:52021DC0786  

imports 

relating 

into 

to 

final 

-  COMMISSION  STAFF  WORKING  DOCUMENT 

IMPACT 
SWD(2013)  162 
ASSESSMENT  Accompanying 
the  document  Proposal  for  a  REGULATION  OF  THE 
EUROPEAN PARLIAMENT AND OF THE COUNCIL On the production and making available 
on  the  market  of  plant  reproductive  material  (plant  reproductive  material  law)  https://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013SC0162&from=EN  and  https://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013SC0163&from=EN  

SWD(2013)  0163  final  -  COMMISSION  STAFF  WORKING  DOCUMENT  EXECUTIVE 
SUMMARY  OF  THE  IMPACT  ASSESSMENT  Accompanying  the  document  Proposal  for  a 
REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL  On  the 
production and making  available on the market  of plant reproductive material (plant  reproductive 
material law) https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A52013SC0163  

SWD(2021)90  final  -  COMMISSION  STAFF  WORKING  DOCUMENT  Study  on  the  Union’s 
options  to  update  the  existing  legislation  on  the  production  and  marketing  of  plant  reproductive 
material https://data.consilium.europa.eu/doc/document/ST-8287-2021-INIT/en/pdf  

SWD(2023)  4  final  COMMISSION  STAFF  WORKING  DOCUMENT  Drivers  of  food  security. 
https://commission.europa.eu/system/files/2023-
01/SWD_2023_4_1_EN_document_travail_service_part1_v2.pdf  

3.  EU LEGISLATION (OTHER THAN THAT LISTED IN SECTION 1 OF ANNEX 5)  

Commission Delegated Regulation (EU) 2021/1189 of 7 May 2021 supplementing Regulation (EU) 
2018/848 of the European Parliament and of the Council as regards the production and marketing 

180 

 
 
of plant reproductive material of organic heterogeneous material of particular genera or species. OJ 
https://eur-lex.europa.eu/legal-
L 
content/EN/TXT/?uri=CELEX%3A32021R1189  

20.7.2021, 

258, 

18 

p. 

Commission  Directive  2004/29/EC  of  4  March  2004  on  determining  the  characteristics  and 
minimum  conditions  for  inspecting  vine  varieties.  OJ  L  71,  10.3.2004,  p.  22  https://eur-
lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32004L0029  

Commission  Directive  2008/62/EC  of  20  June  2008  providing  for  certain  derogations  for 
acceptance  of  agricultural  landraces  and  varieties  which  are  naturally  adapted  to  the  local  and 
regional conditions and threatened by genetic erosion and for marketing of seed and seed potatoes 
of  those  landraces  and  varieties.  OJ  L  162,  21.6.2008,  p.  13  https://eur-lex.europa.eu/legal-
content/EN/ALL/?uri=celex%3A32008L0062  

Commission  Directive  2009/145/EC  of  26  November  2009  providing  for  certain  derogations,  for 
acceptance of vegetable landraces and varieties which have been traditionally grown in particular 
localities  and  regions  and  are  threatened  by  genetic  erosion  and  of  vegetable  varieties  with  no 
intrinsic  value  for  commercial  crop  production  but  developed  for  growing  under  particular 
conditions and for marketing of seed of those landraces and varieties. OJ L 312, 27.11.2009, p. 44 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009L0145  

Commission  Directive  2010/60/EU  of  30  August  2010  providing  for  certain  derogations  for 
marketing  of  fodder  plant  seed  mixtures  intended  for  use  in  the  preservation  of  the  natural 
environment. 
https://eur-lex.europa.eu/legal-
content/EN/ALL/?uri=CELEX%3A32010L0060  

31.8.2010, 

228, 

OJ 

10 

p. 

L 

Commission  Implementing  Decision  2012/340/EU  of  25  June  2012  on  the  organisation  of  a 
temporary  experiment  under  Council  Directives  66/401/EEC,  66/402/EEC,  2002/54/EC, 
2002/55/EC  and  2002/57/EC  as  regards  field  inspection  under  official  supervision  for  basic  seed 
and  bred  seed  of  generations  prior  to  basic  seed.  OJ  L  166,  27.6.2012,  p.  90.  https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02012D0340-20170705  

Commission  Implementing  Decision  2014/150/EU  of  18  March  2014  on  the  organisation  of  a 
temporary  experiment  providing  for  certain  derogations  for  the  marketing  of  populations  of  the 
plant  species  wheat,  barley,  oats  and  maize  pursuant  to  Council  Directive  66/402/EEC.  OJ  L  82, 
20.3.2014, p. 29. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32014D0150  

Commission  Implementing  Decision  (EU)  2020/1106  of  24  July  2020  on  the  organisation  of  a 
temporary  experiment  under  Council  Directives  66/401/EEC,  66/402/EEC,2002/54/EC  and 
2002/57/EC as regards the official checking rate for field inspection under official supervision for 
basic seed, bred seed of generations prior to basic seed and certified seed. OJ L 242, 28.7.2020, p. 
7. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020D1106 

Commission  Implementing  Directive  2014/98/EU  of  15  October  2014  implementing  Council 
Directive  2008/90/EC  as  regards  specific  requirements  for  the  genus  and  species  of  fruit  plants 
referred  to  in  Annex  I  thereto,  specific  requirements  to  be  met  by  suppliers  and  detailed  rules 
concerning  official  inspections.  OJ  L  298,  16.10.2014,  p.  22  https://eur-lex.europa.eu/legal-
content/en/ALL/?uri=CELEX:32014L0098  

181 

 
 
Commission Implementing Directive (EU) 2021/971 of 16 June 2021 amending Annex I to Council 
Directive  66/401/EEC  on  the  marketing  of  fodder  plant  seed,  Annex  I  to  Council  Directive 
66/402/EEC  on  the  marketing  of  cereal  seed,  Annex  I  to  Council  Directive  2002/54/EC  on  the 
marketing  of  beet  seed,  Annex  I  to  Council  Directive  2002/55/EC  on  the  marketing  of  vegetable 
seed and Annex I to Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants, 
as regards the use of biochemical and molecular techniques. OJ L 214, 17.6.2021, p. 62 https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021L0971  

Commission Implementing Directive (EU) 2022/1647 of 23 September 2022 amending Directive 
2003/90/EC as regards a derogation for organic varieties of agricultural plant species suitable for 
organic production. OJ L 248, 26.9.2022, p. 46 https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.248.01.0046.01.ENG&toc=OJ%3AL%3A2022%3A
248%3ATOC  

Commission  Implementing  Directive  (EU)  2022/1648  of  23  September  2022  amending  Directive 
2003/91/EC as regards a derogation for organic varieties of vegetable species suitable for organic 
https://eur-lex.europa.eu/legal-
production. 
content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.248.01.0052.01.ENG&toc=OJ%3AL%3A2022%3A
248%3ATOC  

26.9.2022, 

248, 

OJ 

52 

p. 

L 

Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform 
conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and 
the  Council,  as  regards  protective  measures  against  pests  of  plants,  and  repealing  Commission 
Regulation  (EC)  No  690/2008  and  amending  Commission  Implementing  Regulation  (EU) 
2018/2019. OJ L 319, 10.12.2019, p. 1 https://eur-lex.europa.eu/eli/reg_impl/2019/2072/oj  

Commission  Implementing  Regulation  (EU)  2022/1372  of  5  August  2022  as  regards  temporary 
measures to prevent the entry into, the movement and spread within, the multiplication and release 
in  the  Union  of  Meloidogyne  graminicola  (Golden  &  Birchfield).  OJ  L  206,  8.8.2022,  p.  16 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R1372  

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 
L 293, 14.11.2019, p. 105 https://eur-lex.europa.eu/eli/dec/2019/1905/oj  

Council  Regulation  (EC)  No  2100/94  of  27  July  1994  on  Community  plant  variety  rights.  OJ  L 
227, 1.9.1994, p. 1 https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A31994R2100  

Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive  90/220/EEC. 
  OJ  L  106,  17.04.2001,  p.  1  https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=celex%3A32001L0018  

Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the  Council  of  22  September 
2003  on  genetically  modified  food  and  feed.  OJ  L  268,  18.10.2003,  p.  1  https://eur-
lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32003R1829  

182 

 
 
Regulation (EC) No 138/2004 of the European Parliament and of the Council of 5 December 2003 
on  the  economic  accounts  for  agriculture  in  the  Community  OJ  L  33,  5.2.2004,  p.  1  https://eur-
lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32004R0138  

Regulation  (EU)  2016/2031  of  the  European  Parliament  of  the  Council  of  26  October  2016  on 
protective  measures  against  pests  of  plants,  amending  Regulations  (EU)  No  228/2013,  (EU)  No 
652/2014  and  (EU)  No  1143/2014  of  the  European  Parliament  and  of  the  Council  and  repealing 
Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 
2007/33/EC. 
https://eur-lex.europa.eu/legal-
L 
content/EN/TXT/?uri=CELEX%3A32016R2031  

23.11.2016, 

317, 

OJ 

p. 

4 

Regulation  (EU)  2017/625  of  the  European  Parliament  and  of  the  Council  of  15  March  2017  on 
official  controls  and other official  activities performed to  ensure the  application of food and feed 
law,  rules  on  animal  health  and  welfare,  plant  health  and  plant  protection  products,  amending 
Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) 
No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament 
and  of  the  Council,  Council  Regulations  (EC)  No  1/2005  and  (EC)  No  1099/2009  and  Council 
Directives  98/58/EC,  1999/74/EC,  2007/43/EC,  2008/119/EC  and  2008/120/EC,  and  repealing 
Regulations  (EC)  No  854/2004  and  (EC)  No  882/2004  of  the  European  Parliament  and  of  the 
Council,  Council  Directives  89/608/EEC,  89/662/EEC,  90/425/EEC,  91/496/EEC,  96/23/EC, 
96/93/EC  and  97/78/EC  and  Council  Decision  92/438/EEC  (Official  Controls  Regulation).  OJ  L 
95, 7.4.2017, p.1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32017R0625  

Regulation  (EU)  2018/848  of  the  European  Parliament  and  of  the  Council  of  30  May  2018  on 
organic  production  and  labelling  of  organic  products  and  repealing  Council  Regulation  (EC)  No 
834/2007. 
https://eur-lex.europa.eu/legal-
14.6.2018, 
L 
content/EN/ALL/?uri=CELEX%3A32018R0848  

150, 

OJ 

p. 

1 

Regulation  (EU)  2021/2115  of  the  European  Parliament  and  of  the  Council  of  2  December  2021 
establishing  rules  on  support  for  strategic  plans  to  be  drawn  up  by  MS  under  the  common 
agricultural  policy  (CAP  Strategic  Plans)  and  financed  by  the  European  Agricultural  Guarantee 
Fund  (EAGF)  and  by  the  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013. OJ L 435, 6.12.2021, p. 1–186 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02021R2115-20220422  

183