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)
Date: 2013-05-06
Institutions: European Commission
Subjects: Community Plant Variety Office, forest certification, market approval, marketing standard, plant propagation, production standard

EUROPEAN 
COMMISSION 

Brussels, 6.5.2013  
COM(2013) 262 final 

2013/0137 (COD) 

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) 

(Text with EEA relevance) 

{SWD(2013) 162 final} 
{SWD(2013) 163 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Plant reproductive material is a fundamental input for the productivity, the diversity, 
and the health and quality of agriculture, horticulture and food and feed production 
and  our  environment.  Forests  cover  a  large  area  of  the  Union  and  fulfil  multiple 
social,  economic,  environmental,  ecological  and  cultural  functions.  The  current  EU 
legislation for making available on the market of plant reproductive material is based 
on two main pillars, namely the registration of varieties/material and the certification 
of  individual  plant  reproductive  material  lots  of  plant  species  as  identified  in  the 
Directives ('EU listed species').  

The  draft  proposal  consolidates  and  updates  the  legislation  on  marketing  of  plant 
reproductive  material  by  repealing  and  replacing  the  following  12  Directives: 
Council  Directive  66/401/EEC  on  the  marketing  of  fodder  plant  seed,  Council 
Directive  66/402/EEC  on  the  marketing  of  cereal  seed,  Council  Directive 
2002/53/EC  on  the  common  catalogue  of  varieties  of  agricultural  plant  species, 
Council  Directive  2002/54/EC  on  the  marketing  of  beet  seed,  Council  Directive 
2002/55/EC  on  the  marketing  of  vegetable  seed,  Council  Directive  2002/56/EC  on 
the  marketing  of  seed  potatoes,  Council  Directive  2002/57/EC  on  the  marketing  of 
seed  of  oil  and  fibre  plants,  Council  Directive  68/193/EEC  on  the  marketing  of 
material for the vegetative propagation of the vine, Council Directive 1998/56/EC on 
the  marketing  of  propagating  material  of  ornamental  plants,  Council  Directive 
92/33/EEC  on  the  marketing  of  vegetable  propagating  and  planting  material,  other 
than seed, Council Directive 2008/90/EC on the marketing of fruit plant propagating 
material  and  fruit  plants  intended  for  fruit  production  and  Council  Directive 
1999/105/EC of 22 December 1999 on the marketing of forest reproductive material. 

The  majority  of  Council  Directives  for  making  available  on  the  market  of  plant 
reproductive  material  have  first  been  adopted  between  1966  and  1971  and  some 
Directives  are  more  recent.  The  old  Directives  have  been  updated  both  frequently 
and substantially, creating the need for clarity and transparency. As a consequence of 
this  history,  the  Directives  are  quite  diverse  in  the  technical  backgrounds  they  are 
based on, but also in their approaches, ranging from official controls on products to 
official supervision of processes. In particular, the product control is very demanding 
for competent authorities. 

Furthermore, the complexity and fragmentation of the existing legislation is likely to 
perpetuate existing uncertainties and discrepancies in its implementation between the 
Member States. This creates an uneven playing field for professional operators on the 
single market. There is a need to harmonise implementation of the legislation, reduce 
cost and administrative burdens and support innovation. It is also important to adapt 
to the technical progress in plant breeding, and to the rapid evolution of the European 
and  global  market  of  plant  reproductive  material.  All  those  needs  make  the  update 
and  modernisation  of  the  legislative  framework  imperative.  The  aim  of  in  situ 
conservation  of  agro-biodiversity  should  be  further  strengthened.  In  addition,  the 
weak horizontal coordination with other EU legislation, policies and strategies is an 
obstacle to their more efficient implementation. In the past years, agricultural policy 
in the EU has come to be seen as strategically important for food security and safety, 
the  nutritional  value  of  food,  the  environment,  biodiversity  and  climate  change. 
"Sustainable  intensification"  and  greening  of  food  crop  production,  in  which  yields 

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are  increased  without  adverse  environmental  impact  and  without  the  cultivation  of 
more land, have become a central concern. Plant reproductive material legislation is 
critically  important  for  reaching  this  aim.  The  EU  Forest  Strategy  emphasises  the 
importance of the multifunctional role of forest and its sustainable management. 

Coherence  and  synergies  with  the  Plant  Health  Law  concerning  the  plant  health 
checks  which  are  part  of  the  plant  reproductive  material  certification  process  or 
integration of general principles relating to official controls embedded in Regulation 
(EC) No 882/2004 on official controls are needed. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

The impact assessment of this proposal builds on the results of the evaluation of the 
EU  legislation  on  the  marketing  of  seed  and  plant  propagating  material  (now  plant 
reproductive  material)  that  was  carried  out  in  2007/2008  by  the  Food  Chain 
Evaluation  Consortium  (FCEC),  on  the  results  of  a  study  on  variety  registration 
conducted by the same consortium in the first half of 2010. It is furthermore based on 
a broad survey of all interested parties, in particular the competent authorities in the 
Member  States,  private  sector  representatives  at  EU  and  at  national  level,  relevant 
international  standard  setting  bodies,  non-governmental  organisations  and  the 
Community  Plant  Variety  Office  (CPVO).  A  number  of  Commission  Horizontal 
Working  Party  meetings  covering  all  the  plant  species  were  held  in  2009-2011.  In 
May  2011,  four  task  forces  created  under  the  Hungarian  presidency  worked  on 
specific topics. In addition, the Commission consulted the working group 'Seeds and 
Propagating Material' of the Advisory Group on the Food Chain, Animal and Plant 
Health  on  several  occasions  from  2009  –  2011.  On  18 March  2009  an  open 
conference  "Ensuring  Seed  Availability  in  the  21st  Century"  was  organised  to 
present and discuss the evaluation results with different stakeholders. Finally, a web-
based stakeholder survey using an “Interactive Policy Making” (IPM) questionnaire 
to  collect  comments  on  an  "Options  and  Analysis"  paper  was  organised  from  19 
April  to  30  May  2011.  It  yielded  257 responses  from  a  very  wide  range  of 
stakeholder groups. 

The  main  objective  of  the  consultations  was  to  seek  views  on  the  provisions  and 
application  of  existing  legislation  and  the  needs  for  change.  Overall,  stakeholders 
were  satisfied  with  the  principles  underlying  the  existing  Directives,  but  supported 
the Commission's intention to revise the legislation. Room for improvement was in 
particular identified pertaining to legal simplification, cost reductions and efficiency 
gains,  increased  flexibility  for  professional  operators,  the  level  of  harmonisation 
among Member States, the role of niche and emerging markets and the conservation 
of  agro-biodiversity  and  plant  genetic  resources.  Maintaining  the  general  principles 
of the current legislation – especially the procedures for the registration of varieties 
and  the  pre-marketing  certification  of  seed  lots  –  was  strongly  supported  by  a 
majority  of  stakeholders.  In  addition,  concerning  the  EU  legislation  on  forest 
reproductive material, the stakeholders requested to maintain the current approach. 

The Impact Assessment identified the following main axes along which the system 
has  to  change  in  order  to  be  fit  for  the  changing  economic,  environmental,  social, 
scientific circumstances: (i) Simplification of the basic legal acts (from 12 Directives 
to  one  Regulation),  (ii)  Cost  recovery  and  improvement  of  the  effectiveness  and 
efficiency  of  the  system  and  (iii)  Horizontal  coordination  with  recent,  already 

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the  assurances 

for  high  quality  plant 

adopted  EU  policies.  Various  ways  –  increased  flexibility,  deregulation  or 
centralisation  –  are  explored  for  improving  the  efficiency  of  the  system,  while 
maintaining 
reproductive  material, 
competitiveness and addressing new challenges such as biodiversity. Based on these 
3 axes, 5 policy options were identified, where legal simplification and cost recovery 
are constant for all options. In the various options, issues regarding SMEs and micro-
enterprises have been addressed throughout, especially in order to ensure access for 
these  enterprises  to  public  services  for  the  execution  of  certain  tasks  they  cannot 
perform  themselves  and  to  support  and  further  develop  their  flexibility  to  gain 
improved access to the plant reproductive material market. Specific attention is given 
to  trade-offs  between  transferring  operational  work  and  keeping  of  quality  of  plant 
reproductive material. 

The  impact  assessment  concludes  that  no  single  option  succeeds  in  achieving  the 
objectives of the review in an efficient, effective and coherent manner and suggests, 
in line with stakeholder opinion, a preferred  option which combines  elements  from 
option 2, 4 and 5. The proposal thus creates an environment providing legal security 
for  professional  operators  and  consumers,  guaranteeing  high  quality  of  plant 
reproductive  material  and  securing  competitive  advantage  on  the  internal  and  the 
world  markets.  This  combination  aims  at  striking  a  balance  between  flexibility  for 
professional operators (option 2 and 4) and biodiversity (option 4) and the necessary 
rigor  in  health  and  quality  requirement  (elements  of  option  2  and  5)  for  the  fair 
functioning  of  the  market  and  for  maintaining  the  quality  and  health  of  plant 
reproductive material. This is combined with elements allowing minor crops or crops 
with particular uses low-burden access to specific or small market segments, but with 
coupled  minimum  obligations  ensuring  traceability,  health  and  information  to  the 
consumer so that a level playing for all professional operators is established. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

The  aim  of  the  proposal  is  to  replace  the  existing  12  Directives  by  one  single 
proposed Regulation.  

3.1. 

Part I – General provisions 

The scope of the proposed Regulation covers all types of plant reproductive material. 
The  largest  part  of  it  covers,  though,  the  species  currently  regulated  by  the 
12 Directives  (so  called  'listed  species').  However,  to  clarify  and  harmonise  the 
existing approaches in the Member States on the other species, i.e. plant species not 
listed  and  thus  not  covered  by  the  current  Directives,  also  these  species  will  be 
subject to some very basic rules (see Part III, Title III).  

In  order  to  take  into  account  the  needs  of  producers  and  the  requirements  of 
flexibility and proportionality, the Regulation will not to apply to plant reproductive 
material  intended  for  testing  and  scientific  purposes  and  intended  for  breeding 
(selection)  purposes.  In  addition,  it  should  not  apply  to  material  intended  to  or 
maintained  in  gene  banks,  organisations  and  networks  of  ex-situ  and  in-situ  or  on 
farm conservation of genetic resources following national strategies on conservation 
of  genetic  resources.  Furthermore,  plant  reproductive  material  exchanged  in  kind 
between two persons other than professional operators is excluded from the scope of 
the Regulation. 

As  regards  definitions,  the  main  change  is  the  introduction  of  a  common  term  to 
cover all the plant reproductive material, either in the form of seeds or other types of 

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plant propagating material. Plant reproductive material is defined to mean plants or 
parts  of  plant  capable  of  and  intended  for  producing  or  reproducing  entire  plants. 
This  includes  also  young  plants.  All  those  types  of  plant  reproductive  material  are 
subject to common principles with regard to their production with a view to making 
available on the market and with regard to making them available on the market. 

3.2. 

Part II – Professional operators 

As under this Regulation the definition of operator does not include private persons, 
the term 'professional operator' is used. Professional operators are defined by a single 
definition and shall be registered to ease the control activities. This register shall be 
combined  with  the  register  established  under  [title  of  the  new  Plant  Health 
Regulation].  Basic  obligations  will  be  introduced  for  professional  operators 
concerning the identification of the plant reproductive material they are producing or 
making  available  on  the  market,  keeping  of  records,  facilitation  of  controls  and 
maintenance  of  the  material.  The  traceability  of  any  plant  reproductive  material  is 
ensured by the obligation for the professional operators to have information one step 
before and one step after their commercial activities. 

3.3. 

Part III – Plant reproductive material other than forest reproductive material 

Title I General provisions 

Definitions of variety and its maintenance, variety with official description or variety 
with  officially  recognised  description,  clone  as  well  as  of  the  different  marketing 
categories are laid down. 

Title II Production and making available on the market of listed species 

the  basic  approach  on 

In  general, 
registration  of  varieties/material  and 
certification/inspection  of  lots  before  making  available  on  the  market  will  be 
maintained. However, more flexibility will be given to the professional operators so 
that they may decide to carry out the necessary examination for variety registration 
or inspections, sampling and analysis of plant reproductive material for certification 
under  the  official  supervision  of  the  competent  authorities.  In  addition,  secondary 
acts  will  be  adopted  setting  out  the  specific  requirements  for  the  production  and 
making available on the market of particular species and their categories (pre-basic, 
basic,  certified  and  standard  material).  This  is  important  to  increase  flexibility  for 
changes due to technical and scientific developments and at the same time respecting 
proportionality and sustainability in regulatory approach. 

The requirements for making available on the market of plant reproductive material 
may be summarised as follows:  

– 

– 

– 

– 

– 

it belongs to a variety or clone registered in accordance the provisions of this 
Regulation;  

it complies with the specific requirements adopted for the marketing category 
concerned per genera and species;  

it  bears  an  official  label  for  pre-basic,  basic  or  certified  material,  or  an 
operator's label in case of standard material; 

it complies with the handling requirements; 

it complies with the requirements for certification and identification. 

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The obligation of variety registration shall not apply to rootstocks which do not fulfil 
the  conditions  of  a  variety.  In  addition,  in  order  to  introduce  flexibility  for  future 
technical and scientific developments, heterogeneous material, which does not fulfil 
the  definition  of  a  variety,  could  be  exempted  under  certain  conditions  from  the 
requirement that that material belongs to a registered variety. Furthermore, a specific 
derogation for niche market plant reproductive material is laid down.  

Certain  genera  and  species  of  plant  reproductive  material,  which  are  listed  in  the 
current Directives, should continue to be subject to enhanced requirements relating to 
their production and making available on the market (listed species). However, there 
is a need to set criteria to decide on these plant species. Genera or species of plants 
which  represent  a  significant  area  and  value  of  production,  are  produced  and  made 
available  on  the  market  by  a  significant  number  of  professional  operators  or  they 
contain  substances  requiring  specific  rules  to  protect  human,  animal  health  or  the 
environment should be included in the list.  

Plant  reproductive  material  should  only  be  produced  and  made  available  on  the 
market  as  pre-basic,  basic,  certified  or  standard  material,  in  order  to  ensure 
transparency and informed choices for users. Detailed criteria need to be established 
to decide which genera and plant species shall not be made available on the market 
as standard material to ensure enhanced quality and health, identity and traceability 
of  plant  reproductive  material  as  well  as  food  and  feed  security.  Specific 
requirements should be adopted per genera and species for each of those categories. 
The requirements on identity, purity, health and other quality requirements, labelling, 
tests, 
lots,  packaging 
comparative tests and trial and mixtures will continue to be applied.  

including  small  packages,  post-certification  control 

Derogations 

The existing permanent derogations on making available on the market to a limited 
extent  not-yet  registered  varieties  for  testing  on  farm  and  not  finally  certified 
material  and  authorisation  of  more  stringent  national  requirements  should  be 
maintained.  This  should  also  concern  the  important  temporary  derogations  on 
emergency measures, temporary difficulties in supply and temporary experiments.  

Derogation on niche market plant reproductive material 

In addition, proportionate and sustainable rules for small scale activities concerning 
plant reproductive material, which is adapted to local conditions, and made available 
on  the  market  in  small  quantities,  should  be  established.  Such  varieties  should  be 
exempted from the requirements on registration and making available on the market. 
This material is defined as niche market plant reproductive material. The exemption 
should concern e.g. farmer-breeders or gardener-breeders whether being professional 
operators  or  not.  However,  some  basic  rules  on  labelling  and  traceability  of  the 
material  should  be  laid  down.  In  order  to  prevent  an  abuse  of  the  exemption  the 
material should only be made available on the market in a defined size of packages.  

Imports and exports 

The EU equivalence system is maintained as a basic condition for imports from third 
countries.  However,  exports  are  included  in  the  scope  of  the  Regulation.  Exports 
should  take  place  in  line  with  legislation,  standards,  code  of  practice  or  any  other 
legal  or  administrative  procedure  in  place  in  the  importing  third  country.  Where  a 
bilateral  or  multilateral  agreement  between  the  Union  and  the  third  country  exists, 
the  exports  from  the  Union  shall  comply  with  the  agreement.  Furthermore,  in  the 

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absence  of  the  latter,  an  agreement  conducted  between  the  professional  operators 
shall apply.  

Title III Production and making available on the market of plant reproductive 
material belonging to non-listed genera or species  

Plant reproductive material not belonging to the listed genera and species shall also 
be  subject  to  a  few  basic  requirements  with  regard  to  its  health  status,  fitness  for 
purpose, appropriate reference to varieties, where applicable, and identification of the 
respective material and imports. 

Title IV Registration of varieties in national and Union registers 

Variety registers 

The  varieties,  in  order  to  be  made  available  on  the  market  throughout  the  Union, 
shall be included in a national register or in the Union register via direct application 
procedure  to  the  CVPO.  CPVO  will  keep  the  updated  information  on  all  plant 
varieties  that  can  be  made  available  on  the  market  in  the  Union,  including  the 
varieties registered in national registers (Union plant variety database). 

For  new  improved  varieties  the  basic  requirement  of  DUS  (distinct,  uniform  and 
stable) will be maintained. The uniformity examination should take into account the 
type  of  variety  and  type  of  reproduction.  In  addition,  by  secondary  act  it  can  be 
decided for which plant species additional requirements on value for cultivation and 
use (VCU) can be laid down. The Member States shall adopt more detailed criteria 
for  the  VCU  examination  of  these  plant  species  as  regards  their  yield,  quality 
characteristics, resilience and suitability for low input production systems including 
organic  production.  Thus,  given  the  specific  characteristics  required  for  organic 
farming,  the  methodology  and  requirements  established  for  variety  examination 
should take due account of the specific needs. 

Rules on a sustainable value for cultivation will be laid down and harmonised in the 
EU  by  adopting  specific  requirements  concerning  resistance  to  specific  pests, 
reduced need for input of resources, decreased content of undesirable substances or 
increased  adaptation  to  divergent  agro-climatic  environment.  This  is  an  important 
tool to guide the breeding process to a more sustainable direction. 

If  a  variety  has  been  granted  a  Union  Plant  Variety  Right  pursuant  to  Regulation 
(EC) No 2100/1994, or pursuant to national rules, that variety should be deemed to 
be distinct, uniform and stable and to have a suitable denomination for the purposes 
of variety registration under this Regulation. 

The basic principle of the use of a single denomination throughout the Union for one 
variety is kept. In certain specific cases synonyms will be allowed. The CPVO is best 
made  available  to  have  an  overview  of  applicable  denominations  of  varieties 
throughout  the  Union.  Therefore,  and  in  order  to  ensure  coherence  regarding  the 
assignment of denominations throughout the Union, the competent authorities should 
consult CPVO to check a denomination, before the respective variety is registered in 
a national variety register.  

The  Regulation  establishes  the  detailed  requirements  for  the  variety  registration 
procedure  regarding  conditions  for  registration,  submission  and  content  of 
applications,  formal  and  technical  examinations,  examination  reports,  decisions  on 
registration, period of validity and its renewal, revocation/deletion of registration and 

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maintenance  of  varieties.  For  coherence,  the  same  rules  shall  also  apply  to  direct 
variety applications to the CPVO for registration in the Union variety register.  

Specific  provisions  are  set  out  on  the  registration  in  the  Union  variety  register  and 
with regard to the possibility for the applicant to launch an appeal against a CPVO 
decision. Such provisions are not laid down for the registration in the national variety 
registers, because they are subject to national administrative procedures. 

A new obligation for each national variety  examination centre to be audited by the 
CPVO will be introduced with the aim to ensure the quality and harmonisation of the 
variety registration process in the Union. The examination centre of the professional 
operators will be audited and approved by the national competent authorities. In case 
of direct application to the CPVO it will audit and approve the examination centres it 
uses for variety examination. 

The  competent  authorities  and  the  CPVO  should  charge  fees  for  the  processing  of 
applications,  the  formal  and  technical  examinations  including  audits,  variety 
denomination, and the maintenance of the varieties for each year for the duration of 
the registration. Therefore, harmonised rules for those fees should be set out in this 
Regulation. The general principle of cost recovery shall prevail. However, the micro-
enterprises  shall  be  exempted  from  fees  to  fulfil  the  Commission's  commitment  to 
lower the burden on very small businesses, in line with its new policy on minimizing 
regulatory  burden  for  SMEs  and  adapting  EU  regulation  to  the  needs  of  micro-
enterprises. Moreover, the fee for registration of varieties with officially recognised 
description and heterogeneous material shall be reduced in  a manner to ensure that 
the  fee  does  not  constitute  a  barrier  to  the  registration  of  the  variety  or  material 
concerned.  

Old traditional varieties 

Concerning old varieties, such as conservation varieties (including landraces), or so 
called 'amateur varieties', less stringent requirements should continue to be laid down 
in view of promoting their on farm conservation and use as currently regulated under 
the  Directives  2008/62/EC  and  2009/145/EC.  The  varieties  will  continue  to  be 
registered, however, on the basis of an 'officially recognised description' which shall 
be recognised – but not produced – by the competent authorities. For that description 
DUS examination is no longer obligatory. The officially recognised description shall 
only describe the specific characteristics of the plants and parts of plants which are 
representative for the variety concerned and make the variety identifiable, including 
the region of origin. This description can be based on an old official description of 
the  variety,  description  produced  at  the  time  by  e.g.  a  scientific,  academic  body  or 
organisation.  The  accuracy  of  its  content  could  be  supported  by  previous  official 
inspections, unofficial examinations or knowledge gained from practical experience 
during  cultivation,  reproduction  and  use.  The  current  quantitative  restrictions  are 
abolished.  The  users  are  informed  about  the  material  by  a  label  indicating  that  this 
variety is identified by an officially recognised description and the region of origin. 
Plant  reproductive  material  belonging  to  those  varieties  should  only  be  made 
available on the market as standard material. 

3.4. 

Part IV – Production and making available on the market of forest reproductive 
material 

The EU legislation sets a specific approach including specific terminology on forest 
reproductive material. Therefore, for this area a separate part is laid down in which 

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the current basic approach is kept. The requirements for forest reproductive material 
concern  approval  of  basic  material,  inclusion  in  national  register  and  Union  list, 
master  certificate,  marketing  categories,  lots,  mixtures,  labelling,  packaging  and 
establishment  of  the  conditions  of  EU  equivalence  for  imports.  In  addition,  the 
following  derogatory  rules  need  to  be  set:  authorisation  of  more  stringent  national 
requirements, prohibition to make available to end user specified forest reproductive 
material,  rules  concerning  temporary  difficulties  in  supply  and  rules  concerning 
temporary experiments. 

3.5. 

Part V – Procedural provisions 

Rules for delegated acts and the committee procedure are laid down. 

3.6. 

Part VI – Final provisions 

The  Regulation  (EC)  NO  2100/94  on  Community  Variety  Rights  is  amended  as 
regards the name and role of CPVO. The name of the agency is amended to follow 
the  recommendations  of  the  EU  inter-institutional  working  group  to  'European 
Agency on Plant Varieties' (EAPV). The mission of CPVO is extended to the area of 
variety  registration,  in  particular  the  management  of  Union  variety  register  and  the 
registration  of  plant  varieties  via  direct  application  procedure  to  the  CPVO.  In 
addition,  a  number  of  tasks  are  attributed  to  the  CPVO  within  its  new  mission  on 
offering  recommendations  on  variety  denominations,  database  on  reference 
collections of varieties, harmonisation of technical examination of varieties, audits of 
technical examination centres, advisory tasks, training and technical support. 

The necessary rules on penalties are laid down.  

3.7. 

Part VII – Union competence, subsidiarity and legal form  

The plant reproductive material legislative framework is based on the Treaty on the 
Functioning  of  the  European  Union  (TFEU)  Article  43  implementing  the  Common 
Agricultural Policy (CAP). The objectives of that policy are to increase agricultural 
productivity,  to  ensure  a  fair  standard  of  living  for  the  agricultural  community,  to 
stabilise  markets,  to  assure  the  availability  of  supplies  and  to  ensure  that  supplies 
reach consumers at reasonable prices. Requirements with regard to the sustainability 
of agriculture have been integrated through the successive revisions of the CAP. The 
Lisbon  Treaty  qualifies  agriculture  as  shared  competence  between  the  EU  and  its 
Member  States.  It  is  obvious,  however,  that  to  a  very  large  extent  all  fields  of 
agricultural  activity  as  well  as  ancillary  activities  upstream  and  downstream  have 
been regulated at the EU level. This means that legislation is predominantly a role for 
the institutions of the European Union. 

The proposal takes the form of a Regulation of the European Parliament and of the 
Council.  Other  means  would  not  be  appropriate  because  the  objectives  of  the 
measure  can  be  achieved  most  efficiently  by  fully  harmonised  requirements 
throughout the Union, ensuring free movement of plant reproductive material. 

4. 

BUDGETARY IMPLICATION 

The  financial  appropriations  for  implementing  the  Regulation  up  to  31  December 
2020  are  being  presented  in  the  Regulation  on  laying  down  provisions  for  the 
management  of  expenditure  relating  to  the  food  chain,  animal  health  and  animal 
welfare, and relating to plant health and plant reproductive material. 

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5. 

OPTIONAL ELEMENTS 

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2013/0137 (COD) 

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) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 43(2) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee,  

Having regard to the opinion of the Committee of the Regions,  
Acting in accordance with the ordinary legislative procedure1, 

Whereas: 

(1) 

The following Directives set out rules for the production and marketing of seeds and 
propagating  material  of  agricultural  crops,  vegetables,  vine,  fruit  plants,  forest 
reproductive material and ornamental plants: 

(a)  Council  Directive  66/401/EEC  of  14  June  1966  on  the  marketing  of  fodder 

plant seed2; 

(b)  Council  Directive  66/402/EEC  OF  14  June  1966  on  the  marketing  of  cereal 

seed3; 

(c)  Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for 

the vegetative propagation of the vine4; 

(d)  Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating 

material of ornamental plants5; 

(e)  Council  Directive  1999/105/EC  of  22  December  1999  on  the  marketing  of 

forest reproductive material6; 

1 

2 
3 
4 
5 
6 

Position of the European Parliament of … and position of the Council at first reading of ... Position of 
the European Parliament of ... and decision of the Council of .... 
OJ L 125, 11.7.1966, p. 2298. 
OJ L 125, 11.7.1966, p. 2309. 
OJ L 93, 17.4.1968, p. 15. 
OJ L 226, 13.8.1998, p. 16. 
OJ L 11, 15.1.2000, p. 17. 

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(f)  Council  Directive  2002/53/EC  of  13  June  2002  on  the  common  catalogue  of 

varieties of agricultural plant species7; 

(g)  Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed8; 

(h)  Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable 

seed9; 

(i)  Council  Directive  2002/56/EC  of  13  June  2002  on  the  marketing  of  seed 

potatoes10; 

(j)  Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil 

and fibre plants11; 

(k)  Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable 

propagating and planting material, other than seed12; 

(l)  Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit 

propagating material and fruit plants intended for fruit production13.  

The  basic  objective  of  the  above  Directives  is  sustainable  agricultural,  horticultural 
and  forestry  production.  In  order  to  ensure  productivity,  the  health,  quality  and 
diversity  of  plant  reproductive  material  is  of  outmost  importance  for  agriculture, 
horticulture, food and feed security, and the economy in general. Moreover, to ensure 
sustainability,  legislation  should  take  account  of  the  need  to  meet  consumers' 
expectations,  to  ensure  the  adaptability  of  production  to  manifold  agricultural, 
horticultural  and  environmental  conditions,  to  face  the  challenges  of  climate  change 
and to foster the protection of agro-biodiversity. 

Evolution in the areas of agriculture, horticulture, forestry, plant breeding and making 
available  on  the  market  of  plant  reproductive  material  has  shown  that  the  legislation 
needs  to  be  simplified  and  further  adapted  to  the  developments  of  the  sector. 
Therefore,  the  above  Directives  should  be  replaced  by  a  single  Regulation  on  the 
production, with a view to making available on the market, and the making available 
on the market, of plant reproductive material within the Union. 

Plant reproductive material, should be defined in a comprehensive manner, including 
all plants capable of, and intended for, producing (including reproducing at any further 
stage  of  production)  entire  plants.  This  Regulation  should,  therefore,  cover  seeds,  as 
well  as  all  other  forms  of  plant  at  any  growth  stage,  intended  for  and  capable  of 
producing entire plants.  

This Regulation should also cover plant reproductive material used for the production 
of  agricultural  raw  materials  intended  for  industrial  purposes,  since  that  material 
represents a major part of several sectors and should fulfil certain quality standards. 

In  order  to  determine  the  scope  of  the  several  provisions  of  this  Regulation  it  is 
necessary to define the concepts of “professional operator” and “making available on 
the  market”.  In  particular,  in  view  of  the  marketing  developments  of  the  sector,  the 

OJ L 193, 20.7.2002, p. 1. 
OJ L 193, 20.7.2002, p. 12. 
OJ L 193, 20.7.2002, p. 33. 
OJ L 193, 20.7.2002, p. 60. 
OJ L 193, 20.7.2002, p. 74. 
OJ L 205, 1.8.2008, p. 28. 
OJ L 267, 8.10.2008, p. 8. 

(2) 

(3) 

(4) 

(5) 

(6) 

7 
8 
9 
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11 
12 
13 

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(7) 

(8) 

definition of 'making available on the market' should be as wide as possible to ensure 
all forms of transactions of plant reproductive material. That definition should include 
inter alia persons concluding sales through distance contracts (e.g. electronically) and 
persons who collect basic forest material.  

Given the needs of producers and the requirements for flexibility and proportionality, 
this Regulation should not apply to reproductive material intended solely for testing, 
scientific and breeding purposes, to gene banks, organisations and networks devoted to 
the exchange and conservation of genetic resources (including on-farm conservation), 
or to reproductive material exchanged in kind between persons other than professional 
operators. 
Directive  94/62/EC  of  20  December  1994  on  packaging  and  packaging  waste14, 
Regulation  (EC)  No  338/97/EC  of  9  December  1996  on  the  protection  of  species  of 
wild  fauna  and  flora  by  regulating  trade  therein15,  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/EEC16,  Regulation  (EC)  No  1829/2003  of  the  European  Parliament 
and  of  the  Council  of  22  September  2003  on  genetically  modified  food  and  feed17, 
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 
September  2003  concerning  the  traceability  and  labelling  of  genetically  modified 
organisms  and  the  traceability  of  food  and  feed  products  produced  from  genetically 
modified  organisms  and  amending  Directive  2001/18/EC18  and  Regulation  (EU)  No 
…/… [Office of publications, please add number of Regulation on protective measures 
against pests of plants], should also apply for the production and making available on 
the market of plant reproductive material. 

(9) 

In  order  to  ensure  transparency  and  more  effective  controls  on  the  production  and 
making available on the market of plant reproductive material, professional operators 
should  be  registered.  However,  in  order  to  reduce  the  administrative  burden  for 
professional operators, by allowing them to register only once in a single register, it is 
appropriate that they register in the public registers established by the Member States 
pursuant to Regulation (EU) No …/… (Office of Publication, please insert number of 
Regulation on protective measures against pests of plants).  

(10)  Basic  obligations  should  be  introduced  for  professional  operators  active  in  the 
production and making available on the market of plant reproductive material area to 
ensure the proper application of this Regulation. 

(11)  Experience  has  shown  that  the  reliability  and  quality  of  reproductive  material  made 
available on the market can be jeopardised where it is impossible to trace reproductive 
material not complying with applicable standards. It is therefore necessary to establish 
a  comprehensive  system  of  traceability  allowing  withdrawals  to  be  undertaken  or 
information  to  be  given  to  consumers  or  competent  authorities.  For  that  reason,  the 
keeping of the necessary information and records on transfers from and to professional 
users should be mandatory. On the basis of the principle of proportionality, that rule 
should not apply in case that supply is part of making available on the market in retail. 

14 
15 
16 
17 
18 

OJ L 365, 31.12.1994, p. 10–23 
OJ L 61, 3.3.1997, p. 1–69 
OJ L 106, 17.4.2001, p. 1–39 
OJ L 268, 18.10.2003, p. 1–23 
OJ L 268, 18.10.2003, p. 24–28 

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(12)  Certain  genera  and  species  of  plant  reproductive  material  should  be  subject  to 
enhanced  requirements  concerning  their  production  and  making  available  on  the 
market  due  to  their  increased  economic,  health  or  environmental  importance.  That 
importance  should  be  determined  through  the  area  or  value  of  production  of  those 
genera  or  species,  the  number  of  professional  operators  or  the  content  of  substances 
which  present  a  potential  risk  for  health  or  the  environment.  The  majority  of  those 
genera  and  species  is  currently  regulated  by  the  above  Directives.  Those  genera  and 
species should be inserted in a specific list (hereinafter: 'listed genera and species'). 

(13) 

(14) 

In  order  to  ensure  transparency  and  enable  informed  choices  by  consumers,  plant 
reproductive material belonging to listed genera and species should only be produced 
or made available on the market under predefined categories. Those categories should 
reflect  different  quality  levels  and  production  stages  and  be  named  “pre-basic”, 
“basic”, “certified” and “standard”,  

In  order  to  ensure  the  widest  possible  availability  of  plant  reproductive  material  and 
choices  by  its  users,  professional  operators  should,  in  principle,  be  able  to  make 
available  on  the  market  plant  reproductive  material  belonging  to  listed  genera  or 
species  under  any  of  the  categories.  However,  in  order  to  ensure  food  and  feed 
security,  and  to  achieve  a  high  level  of  identity,  quality  and  health  of  plant 
reproductive material, plant reproductive material should not be made available on the 
market  as  standard  material  if  the  certification  costs  are  proportionate  to  those 
objectives.  

(15)  Plant  reproductive  material  belonging 

to  varieties  with  officially  recognised 
description,  as  well  as  heterogeneous  material  and  niche  market  material,  should  be 
subject  to  minimum  requirements.  Therefore,  such  material  should  in  all  cases  be 
produced and made available on the market only as standard material. 

(16) 

(17) 

In  order  to  allow  for  informed  choices  by  users  concerning  its  identity  and 
characteristics,  plant  reproductive  material  belonging  to  listed  genera  and  species 
should  only  be  produced  and  made  available  on  the  market  if  it  belongs  to  varieties 
registered in national variety registers or in the Union variety register. 

In order to facilitate adaptation to developments in plant breeding, and to possible new 
techniques,  heterogeneous  plant  reproductive  material,  which  does  not  fulfil  the 
definition  of  a  variety  in  the  meaning  of  this  Regulation,  should  be  allowed  to  be 
produced or made available on the market, under certain conditions, without belonging 
to  a  registered  variety,  and  even  if  it  does  not  comply  with  the  requirements 
concerning registration of varieties, namely distinctiveness, uniformity or stability, or 
the requirements concerning the satisfactory value for cultivation or those concerning 
the sustainable value for cultivation. The registration of such material should take into 
account  its  contribution  to  increase  the  genetic  variability  of  agricultural  crops,  the 
genetic resource basis and biodiversity in the Union, as well as to the sustainability of 
agriculture  and  thus  to  the  adaptation  to  climate  change.  The  methodology  for  the 
registration  should  particularly  take  into  account  those  specific  characteristics  and  it 
should be based on the minimum possible burden for operators who wish to register 
such material. It would also be appropriate and proportionate to exempt from the same 
requirement rootstocks, as they have a significant commercial and practical value for 
the  sectors  where  they  are  used,  but  they  frequently  do  not  fulfil  the  definition  of  a 
variety. 

(18)  Rules should be set out for the certification of plant reproductive material, as well as 
for  the  activities  aiming  at  verifying  the  reliability  of  certification  at  the  post-

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certification  stage,  to  ensure  the  fulfilment  of  the  applicable  quality  requirements. 
Those rules should be adapted to the technical and scientific developments.  

(19)  The  quality  requirements  and  certification  schemes  should  take  into  account 
international recommendations, such as the Seed Scheme Rules and Regulations of the 
Organisation  for  Economic  Co-operation  and  Development  (OECD),  the  seed  potato 
standards of the United Nations Economic Commission for Europe (UNECE) and the 
rules on sampling and testing of the International seed testing association (ISTA).  

(20)  Given the thresholds established for the presence of quality pests by Regulation (EU) 
No  …/…  (Office  of  Publication,  please  insert  number  of  Regulation  on  protective 
measures against pests of plants) on protective measures against pests of plants19, it is 
appropriate  to  establish  detailed  inspection  and  examination  procedures  leading  to  a 
single  certification  as  regards  compliance  with  the  requirements  adopted  pursuant  to 
this Regulation and to Regulation (EU) No. .../… (Office of Publication, please insert 
number of Regulation on protective measures against pests of plants). 

(21) 

(22) 

In order to ensure the maximum possible purity of the material and the homogeneity of 
production, plant reproductive material belonging to listed genera or species should be 
kept in separate lots. 

In  view  of  the diversity  of plant  reproductive material, professional operators should 
have  the  option  to  produce  and  make  available  on  the  market  plant  reproductive 
material in the form of individual plants, packages, containers or bundles. 

(23)  Rules  should  be  adopted  for  the  labelling  of  plant  reproductive  material  of  listed 
genera or species to ensure the appropriate identification of that material. In the case of 
material of the categories subject to certification, the label (hereinafter: 'official label') 
should  be  produced  and  affixed  by  authorised  professional  operators  and  under  the 
official  supervision  of  the  competent  authorities.  However,  and  since  certain 
professional  operators  may  not  have  the  resources  to  carry  out  the  certification 
activities  and  issue  official  labels,  it  should  be  provided  that  official  labels  may  be 
issued by competent authorities upon request of professional operators. 

(24)  For the preservation of the natural environment in the context of the conservation of 
genetic  resources,  it  is  desirable  to  allow  the  mixture  of  plant  reproductive  material 
belonging to listed genera or species with non-listed genera or species. Those mixtures 
should be permitted only if their composition is naturally linked to a certain region. In 
order to ensure transparency and better control concerning the quality of the mixtures 
concerned,  the  production  and  making  available  on  the  market  of  those  mixtures 
should be subject to the authorisation by the competent authorities. 

(25)  Rules should be adopted for the import of plant reproductive material of listed genera 
or  species  into  the  Union,  only  allowing  the  import  of  plant  reproductive  material 
fulfilling the same production and quality requirements as for material produced and 
made available on the market in the Union.  

(26)  To  ensure  flexibility,  and  facilitate  adaptation  of  the  professional  operators  and  the 
markets  to  specific  circumstances,  or  in  cases  of  temporary  supply  difficulties,  it  is 
appropriate  to  provide  for  certain  derogations  from  the  general  rules  of  this 
Regulation.  Those  derogations  should  be  granted  under  specific  conditions  to  avoid 

19 

(Office of Publication, please insert OJ reference number of Regulation on protective measures against 
pest of plants). 

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abuses and to ensure that the overall purposes of this Regulation are respected. They 
should  concern  plant  reproductive  material  belonging  to  varieties,  the  registration  of 
which  is  pending,  plant  reproductive  material  which  is  not  finally  certified  or  not 
certified  as  complying  with  applicable  germination  requirements.  The  possibility 
should also exist to adopt emergency measures to address risks for human, animal and 
plant health, and the environment. 

(27)  Plant  reproductive  material  which  is  made  available  on  the  market  only  in  limited 
quantities by small producers (“niche market plant reproductive material”) should be 
exempted from the requirement of belonging to a registered variety. That derogation is 
necessary to prevent undue constraints to the making available on the market of plant 
reproductive material, which is of lesser commercial interest, but is important for the 
maintenance of genetic diversity. However, it should be ensured that that derogation is 
not  regularly  used  by  a  wide  range  of  professional  operators  and  it  is  only  used  by 
professional  operators  which  cannot  afford  the  costs  and  administrative  burden  of 
variety registration. This is important to avoid abuses of that derogation and to ensure 
the application of the rules of this Regulation. Therefore, niche market material should 
only  be  made  available  on  the  market  by  professional  operators  employing  a  small 
number of persons and with a small annual turnover.  

(28) 

It is desirable to organise temporary experiments for the purpose of seeking improved 
alternatives to any measures adopted for listed genera or species. In the organisation of 
those experiments the evolution of techniques relating to the production and control of 
plant reproductive material should be taken into account. 

(29)  Exported  plant  reproductive  material  of  listed  genera  or  species  to  third  countries 
should  comply  with  the  rules  on  plant  reproductive  material  produced  and  made 
available  on  the  market  in  the  Union,  unless  the  material  concerned  is  subject  to 
bilateral or multilateral agreements or rules of third countries.  

(30)  Basic  requirements  should  be  set  for  plant  reproductive  material  not  belonging  to 
listed  genera  or  species,  to  ensure  minimum  quality  and  identification  standards  for 
their production and making available on the market.  

(31) 

In  order  to  ensure  that  all  varieties  have  access  to  registration  and  are  subject  to 
common  rules  and  conditions  rules  should  be  established  for  the  registration  of 
varieties and should apply to varieties of listed genera or species as well as to varieties 
of non-listed species.  

(32)  Experience so far has shown that some breeders are interested in making available on 
the market  their varieties  in the  entire  Union market, or in the bigger part of it. It is 
therefore  appropriate  to  offer  the  breeders  the  option  of  registering  their  varieties 
either  in  a  national  variety  register  or  in  a  Union  variety  register.  The  task  of 
establishing , publishing and updating the Union variety register should be assigned to 
the  European  Agency  on  Plant  Varieties  (hereinafter:  'the  Agency'),  previously  titled 
'Community  Plant  Variety  Office'  as  established  pursuant  to  Article  4  of  Regulation 
(EC)  No  2100/1994  of  the  Council,  which  is  currently  in  charge  of  granting  plant 
variety  rights.  The  activities  of  the  Agency  should  thus  cover  all  aspects  of  plant 
variety management.  

(33)  Varieties  should,  in  principle,  be  registered  on  the  basis  of  an  official  description 
produced  by  a  competent  authority  or  the  Agency.  However,  in  order  to  reduce  the 
burden  for  the  competent  authorities  and  the  Agency  and  ensure  flexibility,  it  is 

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appropriate  to  provide  for  the  possibility  that  the  examinations  necessary  to  produce 
the official description may also be carried out by the applicants. 

(34)  Further  to  the  basic  registration  requirements,  varieties  belonging  to  species  with 
particular importance for the development of agriculture and horticulture in the Union 
should be subject to the additional requirements ensuring satisfactory and sustainable 
value for cultivation or use.  

(35)  The  requirements  ensuring  sustainable  value  for  cultivation  should  be  established  at 
Union  level  in  order  to  support  sustainable  development,  direct  plant  breeding  and 
meet breeders', producer and consumer demands concerning that type of development. 
The  requirements  ensuring  satisfactory  value  for  cultivation  and  use  may  be  only 
developed  by  Member  States  according  to  their  agro-climatic  and  agricultural 
conditions. Therefore, the respective varieties should only be registered in the national 
variety registers. The requirements ensuring satisfactory value for cultivation and use 
should  concern  yields  and  quality  characteristics.  When  Member  States  develop  and 
apply  such  requirements,  they  should  consider  the  constraints  characterising  specific 
agricultural  management  practices.  In  particular,  they  should  duly  take  into  account 
the specific needs of organic farming as regards resilience and low input conditions. 

(36) 

In the context of the Convention on Biological Diversity to which the Union is a party, 
the Union has committed to maintain the genetic diversity of cultivated plants, and of 
wild  relatives,  and  to  minimise  genetic  erosion.  That  commitment  complements  the 
objective  of  the  Union  to  halt  biodiversity  loss  by  2020.  In  that  context,  certain 
varieties should be allowed to be produced and made available on the market even if 
they  do  not  comply  with  the  requirements  concerning  distinctiveness,  uniformity  or 
stability,  to  ensure  their  conservation  and  sustainable  use  and  thus  contribute  to  the 
sustainability  of  agriculture  and  the  adaptation  to  climate  change.  Therefore,  those 
varieties should only be registered on the basis of an officially recognised description. 

(37)  However,  the  varieties  registered  on  the  basis  of  an  officially  recognised  description 
should  be  produced  in  the  region  where  they  have  been  historically  grown  and 
adapted,  to  ensure  their  authenticity  and  their  added  value  for  the  conservation  of 
genetic diversity and the protection of the environment. Therefore, they should only be 
included in national variety registers. For the same reason, those varieties should have 
been available on the market and/or collected e.g. in gene banks before the entry into 
force  of  this Regulation,  or,  should  have been  deleted  for  more  than  five  years  from 
the national variety register or Union variety register, in case they have been registered 
there on the basis of a technical examination concerning their distinctness, uniformity 
and stability. 

(38)  Rules should be established concerning the procedures for the registration of varieties 
and  clones  in  the  national  variety  registers  to  ensure  uniform  conditions  for  all 
applications and a transparent framework for all interested parties. 

(39)  Certain varieties which are naturally adapted to the local and regional conditions and 
threatened  by  genetic  erosion,  or  which  have  no  intrinsic  value  for  commercial  crop 
production  but  have  been  developed  for  growing  under  particular  conditions,  are 
already  accepted  in  national  catalogues,  lists  or  registers  of  varieties  pursuant  to 
Article 3 of Directive 2008/62/EC of the Commission 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 

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erosion and for marketing of seed and seed potatoes of those landraces and varieties20, 
and  pursuant  to  Article  3(1)  of  Directive  2009/145/EC  of  the  Commission  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  varieties21. 
Those  varieties  have  not  been  subject  to  complete  technical  examination  concerning 
their  distinctiveness,  uniformity  or  stability.  It  is  therefore  appropriate  that  those 
varieties  be  registered  directly  in  the  national  variety  registers  without  any  further 
proceedings as varieties with an officially recognised description.  

(40)  The  Union  variety  register  should  also  include  all  varieties  that  are  registered  in  the 
national variety registers. In this way, it will be ensured that the Union variety register 
offers a transparent overview of all varieties registered in the Union.  

(41)  Rules  should  be  adopted  for  the  registration  of  varieties  and  clones  in  the  Union 
variety register. For the purposes of consistency, those rules should be similar to the 
rules on registration in national variety registers. 

(42)  The  competent  national  authorities  and  the  Agency  should  charge  fees  for  the 
processing of applications, the formal and technical examinations and for each year of 
the registration period. This would be necessary to ensure the necessary resources for 
the  overall  system  of  registration  of  varieties,  and  that  the  main  beneficiaries  of  that 
registration  bear  the  costs  for  the  functioning  of  that  system.  Rules  concerning  the 
fixing of those fees should be set out in this Regulation. 

(43) 

(44) 

In  order  to  facilitate  the  registration  of  varieties  which  serve  at  combating  genetic 
erosion  in  the  Union,  Member  States  should  apply  a  reduced  fee  for  varieties  with 
officially  recognised  description  and  for  heterogeneous  material.  Such  reduced  fees 
should  be  sufficiently  low  as  not  to  constitute  a  deterrent  or  a  barrier  to  the  making 
available  on  the  market  of  those  varieties.  In  order  to  provide  support  to  micro-
enterprises, they should be fully exempted from the payment of fees. 

In  order  to  protect  the  commercial  interests  and  intellectual  property  of  professional 
operators,  the  results  of  the  examination  and  the  description  of  the  genealogical 
components should be treated as confidential, if the breeder so requests. For the sake 
of transparency, all descriptions of varieties listed in the national variety registers or in 
the Union variety register should be made publicly available. 

(45)  Forests  cover  a  large  area  of  the  Union  and  fulfil  social,  economic,  environmental, 
ecological  and  cultural  functions.  There  is,  therefore,  a  need  for  specific  approaches 
and actions for the different types of forests, considering the wide range of conditions 
characterising the forests in the Union. 

(46)  Forest reproductive material of tree species and artificial hybrids which are important 
for  forestry  purposes  should  be  genetically  suited  to  local  conditions  and  of  high 
quality.  The  conservation  and  enhancement  of  biodiversity  of  forests,  including  the 
genetic diversity of the trees, are essential to sustainable forest management. 

20 
21 

OJ L 162, 21.6.2008, p. 13–19. 
OJ L 312, 27.11.2009, p. 44–54. 

EN 

18 

   EN 

                                                 
(47)  Requirements should be set for forest reproductive material as regards basic material, 
categories  under  which  the  material  may  be  made  available  on  the  market,  lots, 
labelling,  small  packages,  to  ensure  the  appropriate  quality  and  marketing  standards, 
and to adapt to the technical and scientific developments of the sector. 

(48) 

In  order  to  ensure  flexibility  and  adaptation  to  particular  circumstances,  derogations 
should be provided, under conditions, for the production and making available on the 
market  of  forest  reproductive  material.  Those  derogations  should  concern  the 
possibility  for  Member  States  to  adopt  more  stringent  requirements,  the  case  of 
temporary  difficulties  of  supply,  the  need  of  making  seed  rapidly  available  on  the 
market,  the  conduct  of  temporary  experiments  and  the  adoption  of  emergency 
measures. 

(49) 

In  order  to  serve  the  interest  of  conservation  and  sustainable  use  of  forestry  plant 
genetic  resources,  Member  States  should  be  allowed  to  adopt  less  stringent 
requirements  on  forest  reproductive  material  which  is  naturally  adapted  to  the  local 
and regional conditions and threatened by genetic erosion. 

(50)  The  competent  authorities  should  charge  fees  for  the  registration/approval  of  basic 
forest  material  and  the  issuance  of  master  certificates  for  the  forest  material  derived 
from registered/approved basic forest material. This would be necessary to ensure the 
necessary  resources  for  the  certification  of  forest  reproductive  material,  and  that  the 
main  beneficiaries  of  that  certification  bear  the  respective  costs.  In  order  to  provide 
support to micro-enterprises, they should be fully exempted from the payment of fees. 
The rules concerning those fees should be set out in this Regulation, as they concern 
the  effective  production,  registration  and  making  available  on  the  market  of  forest 
reproductive material. 

(51)  Regulation (EC) No 2100/1994 needs to be amended to include variety registration in 
the  mission  of  the  Agency  and  to  amend  its  former  title  'Community  Plant  Variety 
Office'. 

(52) 

(53) 

(54) 

(55) 

In order to ensure that the Annexes of this Regulation are adapted to the technical and 
scientific developments, the power to adopt acts in accordance with Article 290 TFEU 
should  be  delegated  to  the  Commission  in  respect  of  amending  the  Annexes  of  this 
Regulation. 

In order to follow the technical and economic developments of the sector, the power to 
adopt  acts  in  accordance  with  Article  290  TFEU  should  be  delegated  to  the 
Commission  in  respect  of  listing  the  genera  or  species  whose  plant  reproductive 
material may not be placed on the market as standard material.  

In order to follow the technical and economic developments of the sector, the power to 
adopt  acts  in  accordance  with  Article  290  TFEU  should  be  delegated  to  the 
Commission  in  respect  of  setting  out  the  plant  reproductive  material  which  may  be 
produced and made available on the market without belonging to a registered variety, 
and the requirements for its production and making available on the market. 

In  order  to  ensure  that  plant  reproductive  material  of  listed  genera  or  species,  and 
certain  types  of  forest  reproductive  material,  fulfils  the  highest  possible  identity, 
quality  and  health  requirements,  as  appropriate  for  the  characteristics  of  the  genera, 
species  or  categories  concerned,  the  power  to  adopt  acts  in  accordance  with  Article 
290 TFEU should be delegated to the Commission in respect of adopting production 
and quality requirements, and certification schemes, for those genera or species, and in 
respect of adopting quality requirements for making available on the market specific 

EN 

19 

   EN 

(56) 

(57) 

(58) 

(59) 

(60) 

(61) 

parts  of  plants  and  planting  stock  of  species  and  artificial  hybrids  of  forest 
reproductive material.  

In  order  to  ensure  that  plant  reproductive  material  is  made  available  on  the  market 
under conditions adapted to the specific characteristics of particular genera or species 
to  which  it  belongs,  the  power  to  adopt  acts  in  accordance  with  Article  290  TFEU 
should be delegated to the Commission in respect of the maximum size, composition 
and  identification  of  lots,  and  the  requirements  concerning  small  packages,  of  plant 
reproductive material belonging to particular genera or species.  

In  order  to  adapt  the  rules  concerning  the  official  labels  and  operators'  labels  to  the 
characteristics of certain types of plant reproductive material, the power to adopt acts 
in  accordance  with  Article  290  TFEU  should  be  delegated  to  the  Commission  in 
respect of setting out additional rules concerning the label for specific categories and 
other  groups  of  plant  reproductive  material,  indications  concerning  a  label  number, 
indications  of  generations  of  pre-basic,  basic,  certified  and  standard  material,  the 
indication  of  variety  types  including  intraspecific  or  interspecific  hybrids,  the 
indication  of  subdivisions  of  categories  satisfying  different  conditions,  in  case  of 
mixtures,  the  indication  of  the  percentage  by  weight  of  the  various  components  by 
species  and,  where  appropriate,  by  variety,  and  indications  concerning  the  intended 
use of the material.  

In  order  to  ensure  the  ability  of  the  professional  operators  to  properly  carry  out  a 
reliable certification of the plant reproductive material concerned, the power to adopt 
acts in accordance with Article 290 TFEU should be delegated to the Commission in 
respect  of  setting  out  more  detailed  requirements  concerning  the  qualification  of 
professional operators and of the inspectors which may be entrusted with certification 
activities, suitability of premises and availability of particular equipment to be used by 
the professional operators and laboratories.  

In order to ensure updated standards for the official supervision of certification carried 
out by operators as appropriate for the characteristics of particular genera or species, 
the power to adopt acts in accordance with Article 290 TFEU should be delegated to 
the  Commission  in  respect  of  setting  out  more  detailed  requirements  concerning  the 
way competent authorities must supervise the certification.  

In  order  to  ensure  updated  standards  for  post-certification  as  appropriate  for  the 
characteristics  of  particular  genera  or  species,  the  power  to  adopt  acts  in  accordance 
with  Article  290  TFEU  should  be  delegated  to  the  Commission  in  respect  of  setting 
out  requirements  concerning  proportion  of  samples  to  be  submitted  to  tests  and 
concerning testing procedures.  

In order to ensure that mixtures of plant reproductive material are produced and made 
available  on  the  market  pursuant  to  the  appropriate  quality  requirements  per  genera 
and species, and in order to ensure informed choices for their users, the power to adopt 
acts in accordance with Article 290 TFEU should be delegated to the Commission in 
respect  of  adopting  rules  concerning  the  production  and  making  available  on  the 
market  of  mixtures  of  plant  reproductive  material  belonging  to  different  genera  or 
species  listed  in  Annex  I,  or  different  varieties  of  those  genera  or  species,  and  in 
respect of adopting rules concerning mixture of plant reproductive material belonging 
to  genera  or  species  listed  in  Annex  I,  with  plant  reproductive  material  belonging  to 
genera or species not listed in Annex I. 

EN 

20 

   EN 

(62) 

(63) 

(64) 

(65) 

(66) 

(67) 

(68) 

In order to ensure that plant reproductive material belonging to varieties, registration 
of which is pending, is made available on the market in a transparent manner and to a 
limited  extent  only,  the  power  to  adopt  acts  in  accordance  with  Article  290  TFEU 
should  be  delegated  to  the  Commission  in  respect  of  setting  out  requirements 
concerning labelling of packages and the maximum authorised quantities which may 
be made available on the market for specific genera or species.  

In  order  to  ensure  that  niche  market  material  is  made  available  on  the  market  in  a 
limited and transparent manner, the power to adopt acts in accordance with Article 290 
TFEU should be delegated to the Commission in respect of setting out the maximum 
size of packages, containers or bundles, and requirements concerning traceability, lots, 
and labelling of the niche market material concerned.  

It is important to ensure that plant reproductive material not finally certified, and seed 
not  confirmed  as  complying  with  germination  requirements,  can  be  produced  and 
made  available  on  the  market  under  particular  conditions.  Therefore,  the  power  to 
adopt  acts  in  accordance  with  Article  290  TFEU  should  be  delegated  to  the 
Commission  in  respect  of  setting  out  specific  rules  for  plant  reproductive  material 
concerning  the  packages,  containers  and  bundles,  rules  on  small  packages  and 
containers,  the  labelling  of  that  material,  the  duration  of  period  in  which  such  seed 
may  be  made  available  on  the  market,  and  the  content  of  the  provisional  analytical 
reports concerning germination. 

It is important to ensure that plant reproductive material imported from third countries 
fulfils  the  requirements  of  this  Regulation.  Therefore,  the  power  to  adopt  acts  in 
accordance with Article 290 TFEU should be delegated to the Commission, in respect 
of  deciding  whether  plant  reproductive  material  of  specific  genera,  species  οr 
categories  produced  in  a  third  country,  or  particular  areas  of  a  third  country,  fulfils 
requirements equivalent with those applicable to plant reproductive material produced 
and made available on the market in the Union. 

It  is  important  to  ensure  that  the  production  and  making  available  on  the  market  of 
plant  reproductive  material  of  particular  genera  or  species  responds  to  increased 
requirements  of  the  society  concerning  their  agricultural  performance  and  quality 
characteristics  for  processing.  In  order  to  follow  the  technical  and  economic 
developments  of  the  sector,  the  power  to  adopt  acts  in  accordance  with  Article  290 
TFEU  should  be  delegated  to  the  Commission  in  respect  of  listing  the  genera  or 
species with particular importance for the satisfactory and sustainable development of 
agriculture in the Union.  

In order to ensure updated standards for the registration of varieties as appropriate for 
the characteristics of genera or species with particular importance for the sustainable 
development of agriculture in the Union, the power to adopt acts in accordance with 
Article  290  TFEU  should  be  delegated  to  the  Commission  in  respect  of  setting  out 
rules for the registration of varieties of those genera or species concerning resistance to 
pests,  reduced  need  for  input  of  specific  resources,  decreased  content  of  undesirable 
substances and increased adaptation to divergent agro-climatic environment.  

In  order  to  ensure  updated  conditions  for  the  suitability  of  variety  denominations  in 
particular cases, the power to adopt acts in accordance with Article 290 TFEU should 
be delegated to the Commission in respect of setting out rules concerning the relation 
of  denominations  to  trade  marks,  their  relation  to  geographical  indications  or 
designations  of  origin  for  agricultural  products,  written  consents  of  holders  of  prior 
rights to remove impediments to the suitability of a denomination, specific criteria to 

EN 

21 

   EN 

(69) 

(70) 

(71) 

(72) 

(73) 

(74) 

(75) 

determine  whether  a  denomination  is  misleading  or  confusing,  and  the  use  of  a 
denomination in the form of a code.  

It is important to ensure that plant reproductive material belonging to clones may only 
be  produced  and  placed  on  the  market  if  it  fulfils  particular  quality  and  health 
requirements, and also belongs to genera or species which have a particular value for 
particular  market  sectors.  Therefore,  the  power  to  adopt  acts  in  accordance  with 
Article  290  TFEU  should  be  delegated  to  the  Commission  in  respect  of  adopting 
quality  and  health  requirements  for  clones  of  particular  genera  or  species,  and  in 
respect of listing the genera or species, to which the clones must belong in order to be 
made available on the market. 

In order to ensure that the information provided in the applications for registration of 
varieties  remain  up  to  date  to  the  developments  of  the  sector,  and  is  relevant  to  the 
particular features of the varieties belonging to those genera or species, the power to 
adopt  acts  in  accordance  with  Article  290  TFEU  should  be  delegated  to  the 
Commission in respect of setting out additional items to be included in the application 
for particular genera or species.  

In order to ensure updated standards for the audits by the Agency and the competent 
authorities  of  premises  of  technical  examinations  and  of  the  organisation  of  those 
examinations, the power to adopt acts in accordance with Article 290 TFEU should be 
delegated to the Commission in respect of setting out rules concerning those audits.  

In  order  to  ensure  updated  standards  for  the  technical  examinations  of  varieties,  the 
power to adopt acts in accordance with Article 290 TFEU should be delegated to the 
Commission in respect of setting out rules concerning obligations for the qualification 
and  training  of  the  staff  of  competent  authorities  or  the  applicants,  the  equipment 
necessary to carry out the technical examination, the establishment of variety reference 
collections,  the  establishment  of  quality  management  systems,  and  the  conduct  of 
growing trials and laboratory tests for particular genera or species.  

In order to ensure proportionate, fair and updated amounts for the fees to be paid by 
the applicants for the registration of a variety in the Union variety register, the power 
to  adopt  acts  in  accordance  with  Article  290  TFEU  should  be  delegated  to  the 
Commission  in  respect  of  setting  out  the  amount  of  the  fees  to  be  paid  by  the 
applicant. 

In order to ensure a comprehensive submission of information for particular categories 
or species of forest reproductive material, the power to adopt acts in accordance with 
Article  290  TFEU  should  be  delegated  to  the  Commission  in  respect  of  setting  out 
conditions  under  which  the  operator's  label  be  supplemented  by  another  document 
produced by the professional operator. 

In  order  to  avoid  risks  in  relation  to  quality  and  health  of  the  forest  reproductive 
material  concerned,  the  power  to  adopt  acts  in  accordance  with  Article  290  TFEU 
should be delegated to the Commission in respect of supplementing the requirements 
set out in this Regulation concerning clones and clonal mixtures, by determining the 
maximum number of years or the maximum number of ramets to which the approval 
of clones or clonal mixtures should be restricted. 

(76) 

In order to ensure that the exemption of small quantities of seeds of forest reproductive 
material,  from  the  information  requirements  concerning  germination  or  viability,  is 
applied in a proportionate manner, the power to adopt acts in accordance with Article 
290  TFEU  should  be  delegated  to  the  Commission  in  respect  of  setting  out  the 

EN 

22 

   EN 

(77) 

(78) 

maximum  quantities  of  those  small  quantities  for  particular  types  of  forest 
reproductive material. 

In order to ensure that the cost items for the fees charged by the competent authorities 
on  the  registration  of  approved  basic  forest  material  and  the  issuance  of  master 
certificates are appropriate to the conducted work and updated, the power to adopt acts 
in  accordance  with  Article  290  TFEU  should  be  delegated  to  the  Commission  in 
respect of setting out those items.  

It is of particular importance that the Commission carry out appropriate consultations 
during  its  preparatory  work  for  the  adoption  of  delegated  acts,  including  at  expert 
level. The Commission, when preparing and drawing-up delegated acts, should ensure 
a  simultaneous,  timely  and  appropriate  transmission  of  relevant  documents  to  the 
European Parliament and to the Council. 

(79) 

Implementing  powers  should  be  conferred  on  the  Commission  in  order  to  ensure 
uniform  conditions  for  the  implementation  of  the  provisions  of  this  Regulation 
concerning the following: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

authorisation  of  Member  States  to  adopt  more  stringent  requirements  than 
those  adopted  pursuant  to  this  Regulation  concerning  plant  reproductive 
material  of  listed  genera  or  species  and  forest  reproductive  material  of  listed 
species and artificial hybrids,  

adoption of emergency measures,  

authorisation of Member States to permit, for a maximum period of one year, 
the  production  and  making  available  on  the  market  of  plant  reproductive 
material belonging to a variety of listed genera or species not yet included in a 
national variety register or in the Union register,  

authorisation of Member States to permit, for a maximum period of one year, 
the  making  available  on  the  market  of  plant  reproductive  material  of  listed 
genera  or  species  complying  with  lower  requirements  that  those  adopted 
pursuant to this Regulation,  

the organisation of temporary experiments,  

the format of the national variety registers and the Union variety register, 

the format for the application for the registration of varieties, 

(h)  modalities  concerning 
registration of varieties,  

the  submission  of  notifications  concerning 

the 

(i) 

(j) 

the form of national lists concerning forest reproductive material, 

the format of the notification of inclusion of forest reproductive material in the 
national list, and 

(k) 

the format of master certificates for forest reproductive material. 

(80)  Those implementing powers should be exercised in accordance with Regulation (EU) 
No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011 
laying  down  the  rules  and  general  principles  concerning  mechanisms  for  control  by 
Member States of the Commission’s exercise of implementing powers. 

(81)  This Regulation respects the fundamental rights and observes the principles recognised 
in particular by the Charter of Fundamental Rights of the European Union and notably 
respect for private and family life, the right to property, the protection of personal data, 

EN 

23 

   EN 

freedom  to  conduct  business  and  the  freedom  of  art  and  science.  This  Regulation 
should  be  applied  by  the  Member  States  in  accordance  with  those  rights  and 
principles. 

(82)  Since  the  objective  of  this  Regulation,  namely  to  establish  the  rules  concerning 
production  and  making  available  on  the  market  of  plant  reproductive  material  to 
ensure  quality  of  the  material  and  informed  choices  for  the  users,  cannot  be 
sufficiently achieved by the Member States and can therefore, by reason of its effect, 
complexity, trans-border and international character, be better achieved at Union level, 
the Union may adopt measures, in accordance with the principle of subsidiarity as set 
out in Article 5 of the Treaty on European Union. In accordance with the principle of 
proportionality,  as  set  out  in  that  Article,  this  Regulation  does  not  exceed  what  is 
necessary in order to achieve that objective, 

HAVE ADOPTED THIS REGULATION: 

EN 

24 

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PART I 
GENERAL PROVISIONS 

Article 1 
Scope 

This Regulation lays down rules on:  

(a) 

the production, with a view to making available on the market, of plant reproductive 
material; and  

(b) 

the making available on the market of plant reproductive material. 

This Regulation shall not apply to plant reproductive material:  

Article 2 
Exclusions 

(a) 

(b) 

(c) 

intended solely for testing or scientific purposes; 

intended solely for breeding purposes;  

intended  solely  for,  and  maintained  by,  gene  banks,  organisations  and  networks  of 
conservation  of  genetic  resources,  or  persons  belonging  to  those  organisations  or 
networks;  

(d) 

exchanged in kind between persons other than professional operators.  

Article 3 
Definitions 

For the purposes of this Regulation, the following definitions shall apply: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

'plants' means plants as defined in Article 2(1) of Regulation (EU) No …/… (Office 
of Publications, please insert number of Regulation on protective measures against 
pests of plants) on protective measures against pests of plants; 

'plant reproductive material' means plant(s) capable of, and intended for, producing 
entire plants; 

'mother  plant'  means  an  identified  plant  from  which  plant  reproductive  material  is 
taken for reproduction of new plants; 

'generation' means a group of plants constituting a single step in the line of descent of 
plants; 

‘making  available  on  the  market’  means  the  holding  for  the  purpose  of  sale  within 
the Union, including offering for sale or for any other form of transfer, and the sale, 
distribution,  import  into,  and  export  out  of,  the  Union  and  other  forms  of  transfer, 
whether free of charge or not; 

'professional  operator'  means  any  natural  or  legal  person  carrying  out,  as  a 
profession, at least one of the following activities with regard to plant reproductive 
material:  

(a) 

producing;  

(b)  breeding;  

EN 

25 

   EN 

(c)  maintaining;  

(d)  providing services;  

(e) 

preserving, including storing; and  

(f)  making available on the market.  

(7) 

(8) 

(9) 

'competent  authorities'  means  competent  authorities  as  defined  in  accordance  with 
Article  2(5)  of  Regulation  (EU)  No  …/….  [Office  of  Publication,  please  insert 
number of Regulation on Official Controls]; 

'genetically modified organism' means a genetically modified organism as defined in 
Article 2(2) of Directive 2001/18/EC; 

'forest reproductive material' means plant reproductive material intended for forestry 
purposes; 

(10) 

'lot'  means  a  unit  of  plant  reproductive  material,  identifiable  by  its  homogeneity  of 
composition and origin. 

Article 4 
Free circulation 

Plant  reproductive  material  shall  be  subject  to  no  restrictions  concerning  its  production  and 
making  available  on  the  market,  other  than  those  laid  down  in  this  Regulation,  in  Directive 
94/62/EC,  Regulation  (EC)  No  338/97,  Directive  2001/18/EC,  Regulation  (EC)  No 
1829/2003, Regulation (EC) No 1830/2003, Regulation (EU) No …/… [Office of Publication, 
please  insert  number  of  Regulation  on  protective  measures  against  pests  of  plants]  and  in 
Union  legislation  restricting  the  production  or  making  available  on  the  market  of  invasive 
alien species. 

EN 

26 

   EN 

PART II 
PROFESSIONAL OPERATORS 

Article 5 
Registers of professional operators 

Professional  operators  shall  be  registered  in  the  registers  referred  to  in  Article  61  of 
Regulation  (EC)  No  …/…  (Office  of  Publication,  please  insert  number  of  Regulation  on 
protective measures against pests of plants) in accordance with the provisions of Article 62 of 
that Regulation. 

Article 6 
General responsibilities of professional operators 

Professional  operators  shall  ensure  that  plant  reproductive  material  produced  and  made 
available on the market under their control fulfils the requirements of this Regulation. 

Article 7 
Specific responsibilities of professional operators producing plant reproductive material 

Professional operators producing plant reproductive material shall: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

be available personally, or designate a person, to liaise with the competent authorities 
for the purpose of facilitating the official controls; 

identify  and  monitor  the  critical  points  of  the  production  process,  or  of  the  making 
available  on  the  market,  which  may  influence  the  quality  of  the  plant  reproductive 
material; 

keep  records  of  the  monitoring  of  the  critical  points  referred  to  in  point  (b),  which 
shall be available for examination when requested by the competent authorities; 

ensure that lots remain separately identifiable; 

keep updated information on the premises and other locations used for the production 
of plant reproductive material; 

make  sure  that  competent  authorities  have  access  to  the  premises  of  production, 
including  premises  and  fields  of  third  contracting  parties,  and  to  the  records  of  the 
monitoring and all related documents; 

take  measures,  where  appropriate,  for  the  maintenance  of  the  identity  of  the  plant 
reproductive  material  in  accordance  with  the  applicable  requirements  of  this 
Regulation; 

make  available  to  the  competent  authorities,  on  request,  any  contracts  with  third 
parties. 

Article 8 
Traceability 

1. 

Professional operators shall ensure that plant reproductive material is traceable at all 
stages of production and making available on the market. 

EN 

27 

   EN 

2. 

3. 

4. 

For  the  purpose  of  paragraph  1,  professional  operators  shall  keep  information 
allowing them to identify the professional operators, which have supplied them with 
plant reproductive material, and the material concerned.  

On request, they shall make such information available to the competent authorities. 

For  the  purpose  of  paragraph  1,  professional  operators  shall  keep  information 
allowing them to identify the persons to whom they have supplied plant reproductive 
material and the material concerned, unless that material has been supplied in retail. 

On request, they shall make such information available to the competent authorities. 

In  the  case  of  plant  reproductive  material,  other  than  forest  reproductive  material, 
professional operators shall keep records of the plant reproductive material referred 
to  in  paragraphs  2  and  3  for  three  years  after  that  material  has  been  respectively 
supplied to or by them.  

In the case of forest reproductive material, the respective period shall be ten years. 

EN 

28 

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PART III 
PLANT REPRODUCTIVE MATERIAL OTHER THAN 
FOREST REPRODUCTIVE MATERIAL 

TITLE I 
General Provisions 

Article 9 
Scope  

This Part shall apply to the production, with a view to making available on the market, and to 
the  making  available  on  the  market  of  plant  reproductive  material  other  than  forest 
reproductive material. 

Article 10 
Definitions 

For the purposes of this Part, the following definitions shall apply: 

(1) 

'variety' means a plant grouping within a single botanical taxon of the lowest known 
rank, which fulfils all of the following requirements: 

(a) 

(b) 

(c) 

it  is  defined  by  the  expression  of  the  characteristics  that  results  from  a  given 
genotype or combination of genotypes; 

it is distinguished from any other plant grouping by the expression of at least 
one of the characteristics referred to in point (a); and  

it  is  considered  as  a  unit  with  regard  to  its  suitability  for  being  reproduced 
unchanged; 

'official  description'  means  a  variety  description  that  has  been  produced  by  a 
competent authority, includes the specific characteristics of the variety and makes the 
variety identifiable by examination of its distinctiveness, uniformity and stability; 

'officially  recognised  description'  means  a  description  of  a  variety,  which  has  been 
recognised  by  a  competent  authority,  includes  the  specific  characteristics  of  the 
variety, makes it identifiable and has been obtained by means other than examination 
of  the  variety's  distinctiveness,  uniformity  and  stability  pursuant  to  the  rules 
applicable at the time of registration of that variety in accordance with Article 79;  

'clone'  means  an  individual  progeny,  originally  derived  from  another  plant  by 
vegetative reproduction, which remains genetically identical to the latter; 

'variety  maintenance'  means  the  actions  to  ensure  that  a  variety  remains  consistent 
with its description; 

'pre-basic  material'  means  plant  reproductive  material  which  is  at  the  first  step  of 
production  and  is  intended  for  the  production  of  other  categories  of  plant 
reproductive material; 

'basic  material'  means  plant  reproductive  material  which  has  been  produced  from 
pre-basic material, and is intended for the production of certified material; 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

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(8) 

(9) 

(10) 

'certified material" means plant reproductive material which has been produced from 
pre-basic or basic material; 

'standard  material'  means  plant  reproductive  material  other  than  pre-basic,  basic  or 
certified material; 

'category'  means  pre-basic  material,  basic  material,  certified  material  or  standard 
material.  

TITLE II 
Production and making available on the market of plant 
reproductive material belonging to genera and species listed in 
Annex I 

CHAPTER I 
Introductive Provisions 

Article 11 
Scope 

1. 

This Title shall apply to the production and making available on the market of plant 
reproductive  material  belonging  to  genera  and  species  which  comply  with  one  or 
more of the following criteria: 

(a) 

they represent a significant area of production; 

(b) 

they represent a significant value of production; 

(c) 

(d) 

they are produced or made available on the market by a significant number of 
professional operators in the Union; 

they  contain  substances  which,  for  all  or  particular  uses,  must  be  subject  to 
particular rules concerning the protection of human and animal health, and the 
environment. 

The genera and species referred to in paragraph 1 are listed in Annex I. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, amending Annex I in order to adapt it to the developments of technical 
knowledge, scientific knowledge and economic data. 

This Title shall also apply to rootstocks and other parts of plants (hereinafter jointly 
referred to as "rootstocks"), which belong to genera and species not listed in Annex I, 
if  material  of  one  of  the  genera  or  species  listed  in  Annex  I,  or  their  hybrids,  is 
grafted on them. 

2. 

3. 

4. 

Article 12 
Categories of plant reproductive material 

1. 

Plant reproductive material may only be produced and made available on the market, 
under one of the following categories: 

(a) 

pre-basic material, 

(b)  basic material, 

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(c) 

certified material, 

(d) 

standard material. 

2. 

3. 

4. 

Plant reproductive material may not be produced and made available on the market 
as  standard  material,  if  it  belongs  to  genera  or  species  for  which  the  costs  and 
certification activities necessary to produce and make available on the market plant 
reproductive material as pre-basic, basic and certified material are proportionate:  

(a) 

(b) 

to the purpose of ensuring food and feed security; and  

to  the  higher  level  of  identity,  health  and  quality  of  the  plant  reproductive 
material  which  result  from  the  fulfilment  of  the  requirements  for  pre-basic, 
basic and certified material compared to those for standard material. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, listing the genera or species whose plant reproductive material may not 
be placed on the market as standard material, as referred to in paragraph 2. 

By way of derogation to paragraph 2 and 3, plant reproductive material shall only be 
produced and made available on the market as standard material if one or more of the 
following cases apply: 

(a) 

it belongs to a variety provided with an officially recognised description; 

(b) 

it is heterogeneous material in the meaning of Article 14(3); 

(c) 

it is niche market material in the meaning of Article 36(1). 

CHAPTER II 
Requirements for the production and making available on the 
market 

SECTION 1 
LIST OF REQUIREMENTS 

Article 13 
Production and making available on the market of pre-basic, basic, certified and standard 
material 

1. 

Plant reproductive material produced and made available on the market shall comply 
with: 

(a) 

(b) 

(c) 

(d) 

the registration requirements set out in Section 2; 

the  production  and  quality  requirements  set  out  in  Section  3  for  the  relevant 
category; 

the handling requirements set out in Section 4; 

the  identification,  and,  where  applicable,  certification  requirements  set  out  in 
Section 5. 

2. 

Paragraph  1(b)  shall  not  apply  to  production  requirements  of  plant  reproductive 
material referred to in Article 14(3) and Article 36. 

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1. 

2. 

3. 

Article 14 
Requirement to belong to registered varieties 

Plant reproductive material may be produced and made available on the market only 
if it belongs to a variety registered in a national variety register referred to in Article 
51 or in the Union variety register referred to in Article 52.  

By way of derogation to paragraph 1 of this Article, rootstocks may be produced and 
made available on the market without belonging to a variety registered in a national 
variety register or in the Union variety register. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out  that,  by  way  of  derogation  to  paragraph  1  of  this  Article, 
plant  reproductive  material  may  be  produced  and  made  available  on  the  market 
without  belonging  to  a  variety  in  the  meaning  of  point  (1)  of  Article  10  ('hereafter 
'heterogeneous  material')  and  not  fulfilling  the  requirements  on  distinctiveness, 
uniformity and stability as set out in articles 60, 61 and 62 and satisfactory value for 
cultivation  and/or  use  or  sustainable  value  for  cultivation  and/or  use  as  set  out  in 
articles 58 and 59. 

Those  delegated  acts  may  set  out  one  or  more  of  the  following  for  heterogeneous 
material: 

(a) 

(b) 

(c) 

(d) 

(e) 

rules on labelling and packaging; 

rules  concerning  description  of  the  material,  including  the  breeding  methods 
and parental material used, description of the production scheme for the plant 
reproductive material and availability of standard samples; 

rules  relating  to  information  and  samples  of  production  to  be  kept  by  the 
professional operators and the maintenance of the material; 

establishment  by  the  competent  authorities  of  registers  for  heterogeneous 
material, modalities for registration and content of those registers; 

establishment  of  fees,  and  cost  items  for  the  calculation  of  those  fees, 
concerning the registration of heterogeneous material referred to in point (d) in 
a manner ensuring that the fee does not constitute a barrier to the registration of 
the heterogeneous material concerned. 

Those delegated acts shall be adopted by [Office of Publications, please insert date 
of  application  of  this  Regulation…].  They  may  be  adopted  per  particular  genera  or 
species.  

Article 15 
Requirement to belong to registered clones 

Plant reproductive material belonging to a clone may be produced and made available on the 
market only if that clone is registered in a national variety register referred to in Article 51 or 
in the Union variety register referred to in Article 52. 

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SECTION 2 
PRODUCTION AND QUALITY REQUIREMENTS 

Article 16 
Production and quality requirements for plant reproductive material 

Plant  reproductive  material  shall  be  produced  in  accordance  with  the  production 
requirements set out in Part A of Annex II and shall be made available on the market 
only if it fulfils the quality requirements set out in Part B of Annex II.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  supplementing  the  requirements  referred  to  in  paragraph  1.  Where 
appropriate, those delegated acts may specify those requirements set out in Part D of 
Annex II.  

Those delegated acts shall take into account the relevant international technical and 
scientific standard recommendations:  

(a) 

(b) 

(c) 

(d) 

the Seed Scheme Rules and Regulations of the Organisation for Economic Co-
operation and Development (hereinafter: 'OECD');  

the  seed  potato  standards  of  the  United  Nations  Economic  Commission  for 
Europe (hereinafter: 'UNECE');  

the rules on sampling and testing of the International Seed Testing Association 
(hereinafter 'ISTA'); and  

the  rules  of  the  European  and  Mediterranean  Plant  Protection  Organisation 
(EPPO). 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, amending Part A and Part B of Annex II to adapt them to the technical 
and scientific developments. 

SECTION 3 
HANDLING REQUIREMENTS 

Article 17 
Lots 

Plant reproductive material shall be made available on the market in lots. Those lots 
shall be sufficiently homogeneous and identified as distinct from other lots of plant 
reproductive material. 

During  processing,  packaging,  storage,  transport  or  at  delivery,  lots  of  plant 
reproductive material of different origins may be merged into a new lot. In that case 
the  professional  operator  shall  keep  records  including  data  about  the  origin  of  the 
individual components of the new lot.  

During  processing,  packaging,  storage,  transport  or  at  delivery,  lots  of  plant 
reproductive material may be split into two or more lots. In that case the professional 
operator shall keep records concerning the origin of the new lots.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, establishing additional rules for particular genera or species in relation to 
one or more of the following elements: 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

4. 

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1. 

2. 

3. 

4. 

5. 

(a)  maximum size of lots to ensure homogeneity of the plant reproductive material 

concerned;  

(b) 

(c) 

composition  of  lots  to  ensure  the  maintenance  of  the  identity  of  the  plant 
reproductive material concerned; 

identification of lots to ensure the traceability of the plant reproductive material 
concerned. 

Article 18 
Packages, containers and bundles, and rules on small packages and containers 

Plant  reproductive  material  shall  be  made  available  on  the  market  as  individual 
plants, or in packages, containers or bundles. 

Packages  and  containers  shall  be  closed  in  such  a  way  that  they  cannot  be  opened 
without damaging the closure and, in the case of packaging, without the packaging 
showing signs of tampering. 

Bundles shall be tied up in such a way that the material forming parts of the bundles 
cannot be separated without damaging the tie or ties. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out  rules  for  specific  genera  or  species  one  or  more  of  the 
following elements:  

(a) 

(b) 

the closure, including sealing or resealing, of packages, containers or bundles 
to ensure the identity of the plant reproductive material concerned and to avoid 
uncontrolled mixtures of lots; 

the  establishment  of  a  requirement  that  plant  reproductive  material  is  to  be 
made available on the market only in packages, containers or bundles in order 
to facilitate the traceability of the lots concerned. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, setting out specific rules for the production and making available on the 
market  of  particular  genera  or  species  in  small  packages,  containers  or  bundles. 
Those rules may concern one or more of the following elements: 

(a)  maximum size and volume of the small packages, containers or bundles; 

(b) 

(c) 

colour and content of labels, and methods of labelling, of the small packages, 
containers or bundles; 

examination  of  the  small  packages,  containers  or  bundles  and  the  contained 
plant reproductive material; 

(d) 

closure of the small packages. 

SECTION 4 
CERTIFICATION, IDENTIFICATION AND LABELLING REQUIREMENTS 

Article 19 
Certification and identification of pre-basic, basic or certified material, and identification 
of standard material 

1. 

Pre-basic,  basic  or  certified  material  shall  be  certified  and  identified  through  an 
official label ('official label'). 

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2. 

3. 

4. 

5. 

1. 

2. 

3. 

3. 

1. 

2. 

3. 

4. 

5. 

Official  labels  shall  certify  that  pre-basic,  basic  or  certified  material  complies  with 
the relevant production and quality requirements as referred to in Article 16. 

The certification referred to in paragraphs 1 and 2 shall be based on field inspections, 
sampling and testing carried out in accordance with the rules referred to in Article 20 
(hereinafter: 'certification schemes') and with the provisions of Articles 22 to 26. 

Standard material shall be identified through an operator's label ('operator's label'). 

Operators' labels shall attest that standard material complies with the relevant quality 
requirements as referred to in Article 16. 

Article 20 
Certification schemes 

The certification schemes for pre-basic, basic or certified material are set out in Part 
C of Annex II.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  supplementing  the  certification  schemes.  Where  appropriate,  those 
delegated acts may specify those schemes, as set out in Part D of Annex II.  

Those delegated acts shall take into account the applicable international technical and 
scientific standard recommendations such as:  

(a) 

the Seed Scheme Rules and Regulations of OECD;  

(b) 

the seed potato standards of UNECE;  

(c) 

the rules on sampling and testing of ISTA; and  

(d) 

the rules of EPPO. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, amending Part C and Part D of Annex II to adapt them to the technical 
and scientific developments. 

Article 21 
Content of the official label and operator's label 

The official label and the operator's label shall contain the information set out in Part 
A of Annex III. 

The official label and the operator’s label shall be written in one of the official Union 
languages. They shall be legible, indelible, printed on one side, not previously been 
used and easily visible. 

The  official  label  shall  have  a  distinct  colour  per  category  of  plant  reproductive 
material. 

In  case  the  issuance  of  a  plant  passport  is  required  pursuant  to  Article  74(1)  and 
Article  75(1)  of  Regulation  (EU)  No  …/…  [Office  of  Publication,  please  insert 
number  of  Regulation  on  protective  measures  against  pests  of  plants],  the  official 
label shall include the plant passport as set out in Article 78(3) of that Regulation. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out  requirements,  further  to  the  requirements  referred  to  in 
paragraphs 1 and 2, for official labels and operators' labels. Those requirements shall 
concern one or more of the following elements: 

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(a) 

the  colours  of  the  label  for  specific  categories  and  other  groups  of  plant 
reproductive material;  

(b) 

indications concerning a label number; 

(c) 

indications of generations of pre-basic, basic, certified and standard material; 

(d) 

the indication of variety types including intraspecific or interspecific hybrids;  

(e) 

(f) 

the indication of subdivisions of categories satisfying different conditions; 

in case of mixtures, the indication of the percentage by weight of the various 
components by species and, where appropriate, by variety;  

(g) 

indications concerning the intended use of the material. 

6. 

7. 

This  Article  shall  apply  without  prejudice  to  Article  49(4)  of  Regulation  (EC)  No 
1107/2009  concerning  the  label  and  the  documents  accompanying  treated  seeds  in 
the meaning of that Regulation. 

The  Commission  shall,  by  means  of  implementing  acts,  adopt  the  format(s)  of  the 
official  label  and  operator's  label.  Those  formats  may  be  adopted  per  genera  or 
species.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 141(3).  

Article 22 
Responsibility to produce and affix official labels 

The official labels shall be produced and affixed by: 

(a) 

(b) 

the professional operator, under the official supervision of the competent authority; 
or 

the  competent  authority,  if  requested  so  by  the  professional  operator,  or  if  the 
professional operator concerned is not authorised pursuant to Article 23. 

Article 23 
Authorisation of professional operators to carry out certification and produce official labels  

1. 

Professional operators may be authorised by the competent authority to carry out the 
certification and produce the official labels under official supervision, as referred to 
in point (a) of Article 22, only if they fulfil all of the following conditions: 

(a) 

(b) 

(c) 

they  possess  the  necessary  knowledge  to  fulfil  the  production  and  quality 
requirements  and  comply  with  the  certification  schemes  adopted  pursuant  to 
Articles 16(2) and 20(2), and, where applicable, fulfil the requirements adopted 
pursuant to point (a) of paragraph 3 of this Article;  

they possess, or have access to, adequate equipment and laboratories to apply 
correctly  and  efficiently  the  requirements  referred  to  in  Articles  16(2)  and 
20(2), 
the 
requirements adopted pursuant to point (b) and (c) of paragraph 3;  

in  particular  equipment  and 

laboratories  complying  with 

they  have  identified,  and  have  the  capability  to  monitor,  the  critical  points  of 
the  production  process  which  may  influence  the  quality  and  identity  of  the 
plant reproductive material, and keep records of the results of that monitoring; 

(d) 

they  are  capable  to  ensure  that  lots  remain  identifiable  as  referred  to  in 
Article 7; 

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2. 

3. 

1. 

2. 

3. 

4. 

(e) 

(f) 

they  have  in  place  systems  and  provisions  to  ensure  the  fulfilment  of  the 
traceability requirements set out in Article 8; 

they  use  appropriately  qualified  inspection  and  laboratory  staff,  in  particular 
inspection  and  laboratory  staff,  complying  with  the  requirements  adopted 
pursuant to point (c) of paragraph 3. 

The  authorisation  referred  to  in  paragraph  1  may  be  granted  for  particular  or  all 
genera or species.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, supplementing the provisions of paragraph 1, to ensure the ability of the 
professional  operators  to  properly  carry  out  a  reliable  certification  of  the  plant 
reproductive material concerned. Those delegated acts may concern one or more of 
the following elements:  

(a) 

(b) 

(c) 

qualification,  training  and  activities  of  professional  operators,  and  of  other 
persons  which  may  be  entrusted,  by  the  professional  operators,  with  field 
inspections, sampling and testing; 

suitability  of  premises  and  availability  of  particular  equipment  to  be  used  by 
the professional operators concerned; 

requirements  for  laboratories  which  may  be  entrusted  with  testing  by  the 
professional operators. 

Article 24 
Official supervision by the competent authorities 

For  the  purposes  of  the  official  supervision  referred  to  in  point  (a)  of  Article  22, 
competent authorities shall, at least once per year, conduct audits to ensure that the 
professional operator fulfils the requirements referred to in Article 23.  

For  the  purposes  of  the  official  supervision  referred  to  in  point  (a)  of  Article  22, 
competent  authorities  shall  furthermore  carry  out  official  inspection,  sampling  and 
testing  on  a  proportion  of  the  crops  in  the  fields  and  the  lots  of  plant  reproductive 
material,  to  confirm  compliance  of  that  material  with  the  production  and  quality 
requirements referred to in Article 16(2). That proportion shall be determined on the 
basis of the potential risk of non-compliance with those requirements. 

In  addition  to  the  inspection,  sampling  and  testing  referred  to  in  paragraph  2,  the 
competent authorities may carry out further field inspections, sampling or testing, if 
requested so by the professional operator. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, supplementing the provisions of paragraphs 1, 2 and 3. Those delegated 
acts may concern one or more of the following elements:  

(a) 

the proportion of the crops in the fields to be subject to inspections, sampling 
and testing, as referred to in paragraph 2, for particular genera or species;  

(b)  monitoring activities to be carried out by the competent authorities. 

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Article 25 
Official labels produced by the competent authorities 

Where the official labels are produced by the competent authorities, as referred to in point (b) 
of  Article  22,  the  competent  authorities  shall  carry  out  all  necessary  field  inspections, 
sampling and testing in accordance with the certification schemes, adopted pursuant to Article 
20(2), to confirm compliance with the production and quality requirements adopted pursuant 
to Article 16(2). 

Article 26 
Withdrawal or modification of the authorisation  

1. 

2. 

Where  a  competent  authority  finds,  after  granting  the  authorisation  referred  to  in 
Article 23(1), that a professional operator does not fulfil the requirements referred to 
in  that  Article,  it  shall  request  the  professional  operator  to  take  corrective  actions 
within a specified period of time. 

The competent authority shall without delay withdraw, or modify as appropriate, the 
authorisation  if  the  professional  operator  does  not  apply  the  corrective  measures 
referred to in paragraph 1 of this Article within the specified period of time.  

Article 27 
Notification of the intended production and certification of pre-basic, basic and certified 
material 

Professional operators shall inform the competent authorities in due time about their intention 
to produce pre-basic, basic and certified material plant reproductive material, and to carry out 
the certification referred to in Article 19(1). That notification shall state the plant species and 
categories concerned. 

Article 28 
Production of operator's label for standard material 

Operators'  labels  shall  be  produced  and  affixed  by  the  professional  operator  after  verifying 
through  its  own  inspections,  sampling  and  testing,  that  the  plant  reproductive  material 
complies with the production and quality requirements as referred to in Article 16. 

Article 29 
Reference to lots 

1. 

2. 

The official label and the operator's label shall be produced with reference to a lot. 
They  shall  be  affixed,  where  applicable,  to  individual  plants  or  on  the  outside  of 
packages, containers and bundles.  

If a lot is split into more lots, a new official label or operator's label shall be issued 
for  each  lot.  If  several  lots  are  merged  into  a  new  lot,  a  new  official  label  or 
operator's label shall be issued for that new lot. 

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CHAPTER III 
Tests 

1. 

2. 

3. 

4. 

1. 

2. 

Article 30 
Post certification tests for pre-basic, basic and certified material 

After  the  certification  referred  to  in  Article  19(1),  the  competent  authorities  may 
carry out tests on the plant reproductive material (hereinafter 'post certification tests') 
to  confirm  that  it  complies  with  the  quality  requirements  as  referred  to  in  Article 
16(2) and the certification schemes adopted pursuant to Article 20(2). 

Competent authorities shall design and plan the post certification tests on the basis of 
a  risk  analysis  concerning  possible  non-compliance  of  the  respective  plant 
reproductive material with those requirements. 

Post certification tests shall be carried out through samples taken by the competent 
authority. They shall assess the identity and purity of the plant reproductive material 
concerned. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out  rules  for  the  post  certification  tests  of  plant  reproductive 
material belonging to particular genera or species. Those rules shall take into account 
the  development  of  scientific  and  technical  knowledge.  They  may  concern  the 
following: 

(a) 

the  proportion  of  samples  per  genera  and  species  and  categories  submitted  to 
tests;  

(b) 

the testing procedure. 

Article 31 
Non-compliance of professional operators with quality requirements and certification 
schemes 

Where the post certification tests show that pre-basic, basic or certified material has 
not  been  produced  or  made  available  on  the  market  in  compliance  with  the 
production  and  quality  requirements  referred  to  in  Article  16(2),  and  with  the 
certification  schemes  referred  to  in  Article  20(2),  the  competent  authorities  shall 
ensure  that  the  professional  operator  concerned  takes  the  necessary  corrective 
actions. Those actions shall ensure that the material concerned either complies with 
those requirements or is withdrawn from the market. 

If  it  is  repeatedly  found,  during  the  post  certification  tests,  that  a  professional 
operator  produces  or  makes  available  on  the  market  plant  reproductive  material 
which does not comply with the quality requirements referred to in Article 16(2), or 
with  the  certification  schemes  referred  to  in  Article  20,  the  provisions  of  Article 
26(2) shall apply. 

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CHAPTER IV 
Mixtures 

Article 32 
Mixtures of genera and species listed in Annex I 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  adopting  rules  concerning  the  production  and  making  available  on  the 
market  of  mixtures  of  plant  reproductive  material  belonging  to  different  genera  or 
species listed in Annex I, or different varieties of those genera or species. Those rules 
may derogate from the following provisions:  

(a) 

the production and quality requirements adopted pursuant to Article 16(2);  

(b) 

the provisions of Article 17 concerning lots;  

(c) 

(d) 

the provisions of Article 18 concerning packages, containers and bundles, and 
rules on small packages and containers; and 

the provisions of Article 21, concerning the content and format of the official 
label and operator's label. 

2. 

The  rules  referred  to  in  paragraph  1  shall  concern  one  or  more  of  the  following 
elements: 

(a)  maximum size and volume of lots, packages, containers or bundles; 

(b) 

colour and content of labels; 

(c) 

denomination of the mixture and description of the composition of the mixture; 

(d) 

closure of packages, containers or bundles; 

(e) 

(f) 

requirements for the production and inspections of those mixtures; 

requirements  facilitating  the  traceability  of  the  percentage  by  weight  of  the 
various components shown by species and, where appropriate, by variety. 

Article 33 
Preservation mixtures  

1. 

2. 

3. 

Competent  authorities  may  authorise  the  production  and  making  available  on  the 
market  of  a  mixture  of  plant  reproductive  material  belonging  to  genera  or  species 
listed in Annex I, with plant reproductive material belonging to genera or species not 
listed in Annex I, if that mixture fulfils both of the following conditions: 

(a) 

(b) 

it contributes to the conservation of genetic resources and the preservation of 
the natural environment; 

it  is  naturally  associated  with  a  particular  region  (hereinafter:  'region  of 
origin'). Hereinafter, such mixture is referred to as 'preservation mixture'. 

When a competent authority authorises the production and making available on the 
market  of  a  preservation  mixture,  it  shall  identify  the  region  of  origin  taking  into 
account information from plant genetic resource authorities or organisations.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out,  with  regard  to  all  or  particular  genera  or  species,  the 
following: 

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(a) 

(b) 

a procedure for the authorisation referred to in paragraph 1; 

requirements  for  the  authorisation  referred  to  in  paragraph  1,  further  to  the 
requirements set out in that paragraph; 

(c) 

requirements for the packages and containers of a preservation mixture; 

(d) 

labelling requirements for preservation mixtures; 

(e) 

(f) 

(g) 

rules on the identification of region of origin; 

the  obligation  for  professional  operators  to  report  on  the  production  and 
making available on the market of preservation mixtures; 

the  obligation  for  Member  States  to  report  to  the  Commission  on  the 
application of the provisions of this Article. 

CHAPTER V 
Derogations 

SECTION 1 
DEROGATIONS FROM REGISTRATION REQUIREMENTS 

Article 34 
Plant reproductive material of varieties whose registration is pending 

By  way  of  derogation  from  Article  14(1),  competent  authorities  may  authorise 
professional  operators,  for  a  specified  period  of  time,  to  make  available  on  the 
market  for  tests  and  trials,  on  farms  or  other  production  premises,  maximum 
quantities  of  plant  reproductive  material  belonging  to  a  variety  not  registered  in  a 
national variety register pursuant to Article 79 or the Union variety register pursuant 
to Article 94(1). 

The  authorisation  referred  to  in  paragraph  1  may  only  be  granted  if  the  plant 
reproductive  material  belongs  to  a  variety  for  which  an  application  has  been 
submitted for registration in a national variety register pursuant to Article 66 or for 
registration in the Union variety register pursuant to Article 94. 

In  order  to  obtain  the  authorisation  referred  to  in  paragraph  1,  the  professional 
operator shall submit to the competent authorities of the Member States, where the 
relevant tests and trials are to take place, a request with the following information:  

(a) 

a description of the proposed tests and trials; 

(b) 

the objectives pursued by those proposed tests and trials; 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

the locations in which those tests and trials are to be carried out; 

the  provisional  denomination  of  the  variety  indicated  in  the  application  for 
registration; 

the procedure for the maintenance of the variety; 

information about the authority before which the application for the registration 
of the variety is pending, and the reference assigned to that application; 

the duration of the authorisation requested; 

the quantities of the material to be made available on the market. 

1. 

2. 

3. 

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41 

   EN 

4. 

5. 

6. 

The  Member  States  whose  competent  authorities  have  granted  the  authorisation 
referred  to  in  paragraph  1  shall  inform  thereof  the  other  Member  States,  the 
Commission  and  the  European  Agency  for  Plant  Varieties  (hereinafter:  "the 
Agency"). 

By  31  March  of  each  year,  the  Agency  shall  report  to  the  Commission  and  the 
Member  States  on  the  authorisations  granted  pursuant  to  paragraph  1  and  the 
information submitted pursuant to paragraph 3 during the preceding year. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  supplementing  paragraphs  1,  2  and  3  by  setting  out  requirements 
concerning the following elements:  

(a) 

(b) 

labelling of packages; and  

the  maximum  quantities  which  may  be  made  available  on  the  market  for 
specific genera or species pursuant to paragraph 1.  

Article 35 
Derogations from registration requirements in the case of temporary difficulties in supply 

1. 

2. 

3. 

4. 

5. 

By  way  of  derogation  from  Article  14(1),  and  in  order  to  remove  temporary 
difficulties in the general supply of plant reproductive material that may occur in the 
Union,  the  Commission  may,  by  means  of  implementing  acts,  authorise  Member 
States  to  permit,  for  a  maximum  period  of  one  year,  the  production  and  making 
available  on  the  market  of  plant  reproductive  material  belonging  to  a  variety  not 
included  in  a  national  variety  register  or  in  the  Union  variety  register.  Those 
implementing  acts  may  set  out  the  maximum  quantities  which  may  be  made 
available on the market per genera or species.  

The implementing acts referred to in paragraph 1 shall be adopted in accordance with 
the examination procedure referred to in accordance with Article 141(3). 

The  authorisations  referred  to  in  paragraph  1  shall  be  granted  on  the  basis  of  a 
reasoned request submitted by the Member State concerned.  

Those authorisations shall only be granted if the derogation referred to in paragraph 1 
is necessary and proportionate to the objective of removing the temporary difficulties 
in the general supply of the plant reproductive material concerned. 

The label of the plant reproductive material made available on the market pursuant to 
paragraph  1  shall be brown.  It shall state that the reproductive  material in question 
belongs to a non-registered variety. 

Article 36 
Derogations from registration requirements in the case of niche market plant reproductive 
material 

1. 

Article 14(1) shall not apply to plant reproductive material where all of the following 
conditions are fulfilled:  

(a) 

it  is  made  available  on  the  market  in  small  quantities  by  persons  other  than 
professional  operators,  or  by  professional  operators  employing  no  more  than 
ten persons and whose annual turnover or balance sheet total does not exceed 
EUR 2 million; 

(b) 

it is labelled with the indication 'niche market material'. 

EN 

42 

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2. 

3. 

1. 

2. 

That plant reproductive material is hereinafter referred to as 'niche market material'. 

The persons who produce niche market material shall keep records of the quantities 
of  the  material  produced  and  made  available  on  the  market,  per  genera,  species  or 
type  of  material.  On  request,  they  shall  make  those  records  available  to  the 
competent authorities. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out,  with  regard  to  the  production  and  making  available  on  the 
market of niche material belonging to particular genera or species, one or more of the 
following:  

(a) 

(b) 

the maximum size of packages, containers or bundles; 

requirements  concerning  traceability,  lots  and  labelling  of  the  niche  market 
material concerned. 

(c)  modalities of making available on the market. 

SECTION 2 
DEROGATION FROM PRODUCTION AND QUALITY REQUIREMENTS 

Article 37 
Reduced germination requirements, and other reduced quality requirements, in case of 
temporary difficulties in supply 

In order to remove temporary difficulties in the general supply of plant reproductive 
material that may occur in a Member State, the competent authority of the Member 
State  concerned  may  authorise  the  making  available  on  the  market  of  seed  with  a 
reduced  germination  rate,  provided  that  such  rate  is  reduced  by  less  than  5% 
compared to the germination rate required pursuant to Article 16(2).  

That authorisation shall be granted, on the basis of a reasoned request submitted by 
the  professional  operator  concerned,  for  a  specific  period  of  time  which  shall  not 
exceed four months.  

The  label  of  the  seed  referred  to  in  paragraph  1  shall  indicate  the  actual  lower 
germination rate. 

In order to remove temporary difficulties in the general supply of plant reproductive 
material that may occur in a Member State, the competent authority of the Member 
State  concerned  may  authorise  the  making  available  on  the  market  of  plant 
reproductive  material  with  reduced  quality  requirements,  other  than  the  reduced 
germination  requirements  as  referred  to  in  paragraph  1,  compared  to  the  quality 
requirements applicable pursuant to Article 16(2).  

That authorisation shall be granted, on the basis of a reasoned request submitted by 
the  professional  operator  concerned,  for  a  specific  period  of  time  which  shall  not 
exceed four months.  

The label of the plant reproductive material made available on the market pursuant to 
this paragraph shall be brown. It shall state that the reproductive material in question 
complies with lower quality requirements than those referred to in Article 16(2). 

3. 

Member  States  shall  notify  the  Commission  and  the  other  Member  States  of  each 
authorisation granted pursuant to paragraphs 1 and 2. 

EN 

43 

   EN 

4. 

1. 

2. 

3. 

4. 

5. 

6. 

The Commission may decide, by means of implementing acts, that the authorisations 
referred  to  in  paragraphs  1  or  2  are  to  be  repealed  or  amended,  in  case  those 
measures  are  not  in  compliance  with  the  conditions  of  those  paragraphs,  or  are 
deemed  inappropriate  or  disproportionate  to  achieve  the  objectives  of  those 
paragraphs.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 141(3). 

SECTION 3 
DEROGATIONS FROM LABELLING, CERTIFICATION AND IDENTIFICATION 
REQUIREMENTS 

Article 38 
Plant reproductive material which is not finally certified 

Plant reproductive material, other than the seeds referred to in Article 39, which has 
been  harvested  in  one  Member  State,  but  has  not  yet  been  finally  certified  as  pre-
basic, basic or certified material pursuant to Article 19(1), may be made available on 
the market by reference to those categories if: 

(a) 

prior to the harvesting, a field inspection has been carried out by the competent 
authority  and  has  confirmed  compliance  of  that  material  with  the  production 
and quality requirements referred to in Article 16(2); 

(b) 

the  plant  reproductive  material  is  identified  as  not  finally  certified  material 
pursuant to Article 19; and 

(c) 

the requirements set out in paragraphs 2 to 6 are fulfilled.  

Plant reproductive material referred to in paragraph 1 may be made available on the 
market  only  once  from  one  professional  operator  to  another,  without  being  further 
transferred to any other person.  

The professional operator shall inform in advance the competent authority concerned 
of its intention to make available on the market plant reproductive material referred 
to in paragraph 1. 

If  the  Member  State,  where  the  plant  reproductive  material  has  been  harvested 
(hereinafter:  'Member  State  of  production'),  and  the  Member  State  where  the  plant 
reproductive  material  is  certified  pursuant  to  Article  19(1)  (hereinafter:  'Member 
State of certification') are different, the competent authorities of the Member States 
concerned shall exchange the relevant information concerning the making available 
on the market of that material. 

On  request,  the  Member  State  of  production  shall  supply  all  relevant  production 
information to the Member State of certification. The Member State of certification 
shall  supply  information  on  the  quantities  certified  to  the  Member  State  of 
production.  

The  Commission  shall  be  empowered  to  adopt,  in  accordance  with  Article  140, 
delegated acts setting out specific rules for plant reproductive material referred to in 
paragraph 1, concerning the following elements:  

(a) 

packages, containers and bundles, and rules on small packages and containers; 

(b) 

the labelling of that material. 

EN 

44 

   EN 

7. 

Plant reproductive material, other than the seeds referred to in Article 39, which has 
been harvested in a third country, but has not yet been finally certified as pre-basic, 
basic  or  certified  material  pursuant  to  Article  19(1),  may  be  made  available  on  the 
market by reference to those categories if: 

8. 

1. 

2. 

3. 

(a) 

(b) 

(c) 

a decision on equivalence has been adopted pursuant to Article 44 concerning 
that third country,  

the  requirements  set  out  in  paragraphs  1(a)  and  (b),  2  and  3  and  adopted 
pursuant to paragraph 6 are fulfilled,  

the  competent  authorities  of  the  Member  State  and  third  country  concerned 
exchange  the  relevant  information  concerning  the  making  available  on  the 
market of that material, and 

(d)  on  request,  the  competent  authorities  of  third  country  concerned  supplies  all 

relevant production information to the Member State of certification. 

For  that  purpose  references  made  in  those  paragraphs  to  the  Member  States  of 
production shall be construed as references made to the third country concerned, and 
references made in those paragraphs to the requirements set out pursuant to Article 
16(2) shall be construed as references made to equivalent requirements. 

Article 39 
Seeds not certified as complying with applicable germination requirements  

Competent authorities may authorise the making available on the market of seeds for 
a  specific  period  of  time,  as  pre-basic,  basic  or  certified  material,  without  the 
germination  requirements  established  pursuant  to  Article  16(2)  having  been  yet 
confirmed,  if  this  is  considered  necessary  to  make  seed  rapidly  available  on  the 
market.  

Seed referred to in paragraph 1 may be made available on the market only once, from 
one  professional  operator  to  another,  without  being  further  transferred  to  any  other 
person, on the basis of a provisional analytical report concerning germination. 

The  Commission  shall  be  empowered,  in  accordance  with  Article  140,  to  adopt 
delegated  acts  setting  out  the  conditions  under  which  seed  of  particular  genera  or 
species may be made available on the market as pre-basic, basic material or certified 
material  pursuant  to  paragraphs  1  and  2.  Those  conditions  may  concern  the 
following:  

(a) 

(b) 

labelling requirements;  

the  duration  of  period  in  which  such  seed  may  be  made  available  on  the 
market; and  

(c) 

the content of the provisional analytical reports concerning germination.  

SECTION 4 
DEROGATIONS FROM MISCELLANEOUS REQUIREMENTS 

Article 40 
More stringent quality requirements 

1. 

The Commission may authorise Member States, by means of implementing acts, to 
adopt  more  stringent  production  and  quality  requirements  than  those  referred  to  in 

EN 

45 

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Article  16(2),  or  more  stringent  certification  rules  than  those  referred  to  in  Article 
20(1).  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 141(3). 

2. 

In order to obtain the authorisation referred to in paragraph 1, Member States shall 
submit to the Commission a request setting out: 

(a) 

the draft provisions containing the proposed requirements; 

(b) 

a justification on the necessity and proportionality of such requirements; and 

(c)  whether  the  proposed  requirements  would  be  permanent  or  for  a  specified 

period. 

3. 

The  authorisation  referred  to  in  paragraph  1  shall  be  granted  only  if  the  following 
conditions are fulfilled: 

(a) 

the  implementation  of  the  draft  provisions,  as  referred  to  in  point  (a)  of 
paragraph  2,  ensures  improvement  of  the  quality  of  the  plant  reproductive 
material  concerned,  protection  of  the  environment  or  sustainability  of 
agricultural development; and 

(b) 

the draft provisions are necessary and proportionate to their objective. 

1. 

2. 

3. 

4. 

5. 

Article 41 
Emergency measures  

Where  plant  reproductive  material  is  likely  to  constitute  a  serious  risk  to  human, 
animal  and  plant  health  and  environment,  and  such  risk  cannot  be  contained 
satisfactorily  by  means  of  measures  taken  by  the  Member  State  concerned,  the 
Commission  shall  take  without  delay,  by  means  of  implementing  acts,  any 
appropriate  interim  emergency  measures.  Those  measures  may  include  provisions 
restricting  or  prohibiting  the  making  available  on  the  market  of  the  plant 
reproductive material concerned, depending on the gravity of the situation.  

The  measures  referred  to  in  paragraph  1  may  be  taken  on  the  Commission’s  own 
initiative or at the request of a Member State. They shall be adopted in accordance 
with the examination procedure referred to in Article 141(3). 

On duly justified imperative grounds of urgency to address a serious risk to human 
health,  the  Commission  shall  adopt  immediately  applicable  implementing  acts  in 
accordance with the procedure referred to in Article 141(4). 

Where  a  Member  State  officially  informs  the  Commission  of  the  need  to  take 
emergency  measures  and  the  Commission  has  not  acted  in  accordance  with 
paragraph  1,  that  Member  State  may  adopt  any  appropriate  interim  emergency 
measures.  Those  measures  may  include  provisions  restricting  or  prohibiting  within 
the  territory  of  that  Member  State  the  making  available  on  the  market  of  the  plant 
reproductive  material  concerned,  depending  on  the  gravity  of  the  situation.  The 
Member State concerned shall immediately inform the other Member States and the 
Commission of the measures adopted, stating the grounds for its decision. 

The  Commission  may  decide,  by  means  of  implementing  acts,  that  the  national 
interim  emergency  measures  referred  to  in  paragraph  4  are  to  be  repealed  or 
amended.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination  procedure  referred  to  in  Article  141(3).  The  Member  State  concerned 

EN 

46 

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6. 

1. 

2. 

3. 

may maintain its national interim emergency measures until the date of application of 
the implementing acts referred to in this paragraph.  

This  Article  shall  apply  without  prejudice  to  any  measures  adopted  pursuant  to 
Article  23(2)  of  Directive  2001/18/EC  or  Article  34  of  Regulation  (EC)  No 
1829/2003  which  prohibits  or  restricts  the  cultivation  of  genetically  modified 
organisms. 

Article 42 
Temporary experiments 

The  Commission  may,  by  means  of  implementing  acts,  decide  the  organisation  of 
temporary experiments to identify improved alternatives to any measures set out in, 
or  adopted  under,  this  Part.  Those  implementing  acts  may  provide  for  derogations 
from  the  provisions  of  this  Part.  They  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 141(3). 

The implementing acts referred to in paragraph 1 shall specify the genera or species 
concerned,  the  conditions  of  the  experiments  per  genera  or  species,  the  duration  of 
the  experiments,  and  the  monitoring  and  reporting  obligations  of  the  participating 
Member  States.  They  shall  take  into  account  the  evolution  of  techniques  for 
reproduction, production and control of the plant reproductive material concerned.  

The  duration  of  an  experiment  shall  not  exceed  seven  growing  cycles  of  the  plant 
reproductive material concerned, and shall in any case, not exceed seven years. 

CHAPTER VI 
Imports from and exports to third countries 

SECTION 1 
IMPORTS 

Article 43 
Imports on the basis of Union equivalence 

Plant  reproductive  material  may  be  imported  from  third  countries  only  if  it  is  established, 
pursuant  to  Article  44,  that  it  fulfils  requirements  equivalent  to  those  applicable  to  plant 
reproductive material produced and made available on the market in the Union. 

Article 44 
Commission Decision on equivalence 

1. 

The  Commission  may  decide,  by  means  of  implementing  acts,  whether  plant 
reproductive  material  of  specific  genera,  species  οr  categories  produced  in  a  third 
country,  or  particular  areas  of  a  third  country,  fulfils  requirements  equivalent  with 
those applicable to plant reproductive material produced and made available on the 
market in the Union, on the basis of:  

(a) 

a thorough examination of information and data provided by the third country 
concerned pursuant to Article 124(1) of Regulation (EU) No …/… [Office of 
Publications, please insert the number of the Regulation on official controls]; 
and 

EN 

47 

   EN 

(b) 

the  satisfactory  outcome  of  a  control  performed  in  accordance  with  Article 
119(1) of Regulation (EU) No …/… [Office of Publications, please insert the 
number of the Regulation on official controls]. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 141(3). 

2. 

When  adopting  the  decisions  referred  to  in  paragraph  1,  the  Commission  shall 
consider whether: 

(a) 

the controls on variety maintenance carried out in the third country afford the 
same assurances as those provided for in Article 86, if varieties registered in a 
national variety register or in the Union variety register are to be maintained in 
the third country concerned; and 

(b) 

the  requirements  in  the  third  country  concerning  the  production  and  making 
available on the market of plant reproductive material: 

(i) 

(ii) 

afford the same assurances as the production requirements set out in Part 
A to Annex II, and the requirements adopted pursuant to Article 16(2); 

afford the same assurances as the quality requirements set out in Part B to 
Annex II, and the requirements adopted pursuant to Article16(2); 

(iii)  afford  the  same  assurances  as  the  certification  schemes  of  Part  C  to 
Annex II, and the requirements adopted pursuant to Article 20(1); 

(iv)  afford  the  same  assurance  as  the  controls  carried  out  according  to 
Regulation (EU) No …/… [Office of Publications, please insert number 
of Regulation on Official Controls]. 

3. 

For the purpose of adopting the decisions referred to in paragraph 1, the Commission 
may  apply  the  provisions  of  Article  71  of  Regulation  (EU)  No  …/…  [Office  of 
Publication, please insert number of Regulation on Official Controls] concerning the 
approval of pre-export controls carried out by third countries. 

Information to be provided in the case of imports 

Article 45 

1. 

Plant reproductive material imported from third countries shall be made available on 
the market with the following information: 

(a) 

(b) 

(c) 

an  indication  that  the  plant  reproductive  material  concerned  'meets  EU  rules 
and standards'; 

the species, variety, category and lot number of the plant reproductive material 
concerned; 

the  date  of  official  closure,  in  case  of  making  available  on  the  market  in 
containers, packages or bundles; 

(d) 

the third country of production and the respective competent authority; 

(e)  where applicable, the last third country where the plant reproductive material is 

imported from;  

(f) 

the declared net or gross weight of the imported plant reproductive material or 
declared number of imported lots of plant reproductive material; 

(g) 

the person importing the plant reproductive material. 

EN 

48 

   EN 

 
2. 

The information referred to in paragraph 1 shall be provided:  

(a) 

in the case of pre-basic, basic or certified material, on an official document or 
on an additional official label;  

(b) 

in the case of standard material, on the operator's label.  

SECTION 2 
EXPORTS 

Article 46 
Exports from the Union 

1. 

2. 

3. 

Where the export of plant reproductive material to a third country is governed by an 
agreement with that third country, that export shall comply with that agreement.  

Where the export of plant reproductive material to a third country is not governed by 
an agreement with that country, that export shall  take place in  accordance with the 
rules  of  the  third  country  into  which  that  plant  reproductive  material  is  to  be 
exported.  

Where the export of plant reproductive material to a third country is neither governed 
by an agreement with a third country nor by the rules of the third country into which 
that  plant  reproductive  material  is  to  be  exported,  the  requirements  for  production 
and making available on the market of plant reproductive material within the Union 
territory, as set out in Articles 13 to 42, shall apply.  

TITLE III 
Production and making available on the market of plant 
reproductive material not belonging to genera or species listed in 
Annex I 

Article 47 
Scope 

This  Title  shall  apply  to  the  production  and  making  available  on  the  market  of  plant 
reproductive material belonging to genera and species other than the ones listed in Annex I. 

Article 48 
Basic requirements 

1. 

Plant reproductive material shall be made available on the market in accordance with 
the following requirements: 

(a) 

(b) 

(c) 

it shall be visually free from any defects likely to impair its usefulness for the 
purposes it is intended; 

it  shall  have  good  vigour  and  appropriate  dimensions,  as  appropriate  for  the 
genera  and  species  concerned,  to  ensure  its  usefulness  for  the  purposes  it  is 
intended; 

in  the  case  of  seeds,  it  shall  have  satisfactory  germination,  as  appropriate  for 
the genera and species concerned, to allow an appropriate number of plants per 
area  after  sowing,  and  to  ensure  the  maximum  yield  and  quality  of  the 
production; 

EN 

49 

   EN 

(d) 

(e) 

if  made  available  on  the  market  with  reference  to  a  variety,  it  shall  have 
sufficient varietal identity and purity, as appropriate for the genera and species 
concerned, to ensure informed choices by its users; 

it  shall  at  least  on  visual  inspection,  be  substantially  free  from  any  pests 
impairing  quality,  or  any  signs  or  symptoms  thereof,  which  reduce  its 
usefulness. 

2. 

Compliance with the requirements of points (a), (b), (c), (d) and (e) of paragraph 1 
shall be assessed in light of the applicable international standard recommendations:  

(a) 

the Seed Scheme Rules and Regulations of OECD;  

(b) 

the seed potato standards of UNECE;  

(c) 

the  rules  on  sampling  and  testing  of  the  International  seed  testing  association 
ISTA for the genera or species concerned;  

(d) 

and the rules of EPPO. 

Where  no  international  standard  recommendations  exist  for  genera  or  species 
concerned,  compliance  with  the  requirements  of  points  (a),  (b),  (c),  (d)  and  (e)  of 
paragraph  1  shall  be  assessed  in  the  light  of,  the  relevant  national  standards  of  the 
Member State, where the plant reproductive material is for first time made available 
on the market 

Plant reproductive material shall be made available on the market in lots. Where lots 
of plant reproductive material of different origins are merged into a new lot during 
packaging,  storage,  transport  or  at  delivery,  the  professional  operator  shall  keep 
records  including  data  about  composition  and  the  origin  of  the  individual 
components of the new lots. 

If a lot is split into more lots, the professional operator shall keep records for each 
new lot and its origin. 

Article 49 
Labelling 

Plant  reproductive  material,  when  made  available  on  the  market,  shall  be 
accompanied by a label, containing the information set out in Part B to Annex III. 

The label referred to in paragraph 1 shall be produced by the professional operator 
and shall be clear and indelible. It shall be affixed on the outside of the package, the 
container or the bundle of plant reproductive material. It shall be printed in at least 
one of the official languages of the Union. 

Where  reproductive  material  is  made  available  on  the  market  with  a  reference  to 
genera or species rather than a variety, the professional operator shall indicate on the 
label referred to in paragraph 1 the species or group of species in such a way as to 
avoid confusion with any varietal denomination. 

The colour and form of the label shall be substantially distinct from the colour and 
the form of the official labels referred to in Articles 19(1). 

This  Article  shall  apply  without  prejudice  to  Article  49(4)  of  Regulation  (EC)  No 
1107/2009  concerning  the  label  and  documents  accompanying  treated  seeds  in  the 
meaning of that Regulation. 

3. 

4. 

1. 

2. 

3. 

4. 

5. 

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Article 50 
Making available on the market with reference to varieties 

1. 

Plant reproductive material shall be made available on the market with reference to a 
variety only in one or more of the following cases: 

(a) 

(b) 

(c) 

the variety is legally protected by a plant variety right in accordance with the 
provisions  of  Regulation  (EC)  No  2100/94  or  in  accordance  with  national 
provisions; 

the variety is registered in a national variety register as referred to in Article 51 
or in the Union variety register as referred to in Article 52;  

the variety has been entered in any other public or private list with an official 
or officially recognised description and a denomination. 

2. 

Plant reproductive material made available on the market pursuant to points (a) and 
(b) of paragraph 1 shall bear the same variety denomination in all Member States. 

Where the variety is not protected by a plant variety right or registered pursuant to 
Title IV, as referred to in points (a) and (b) of paragraph 1, but has been entered in a 
public  or  private  list  with  an  official  or  officially  recognised  description  and  a 
denomination as referred to in points (b) and (c) of that paragraph, the professional 
operator  may  request  the  advice  of  the  Agency  concerning  the  suitability  of  the 
denomination  pursuant  to  the  provisions  of  Article  64.  Following  that  request,  the 
Agency  shall  submit  to  the  applicant  a  recommendation  on  the  suitability  of  the 
variety  denomination,  as  requested  by  the  applicant,  taking  into  account  the 
requirements set out in Article 64.  

TITLE IV 
Registration of varieties in national and Union variety registers 

CHAPTER I 
Establishment of national and Union variety registers 

Article 51 
Establishment of national variety registers 

1. 

2. 

Each  Member  State  shall  establish,  publish  and  update  a  single  national  register  of 
varieties and clones (hereinafter 'national variety register'). 

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format  of  the 
national  variety  registers.  Those  implementing  acts  shall  be  adopted  in  accordance 
with the examination procedure referred to in Article 141(3). 

Article 52 
Establishment of a Union variety register 

1. 

The  Agency  shall  establish,  publish  and  update  a  single  register  of  varieties  and 
clones (hereinafter "Union variety register"). 

The Union variety register shall include the following: 

(a) 

varieties  and  clones  directly  registered  in  the  Union  variety  register  in 
accordance with Chapter V; and  

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(b)  varieties and clones registered in national variety registers in accordance with 
Chapter IV, as notified by the Member States to the Agency in accordance with 
Chapter VI. 

2. 

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format  of  the 
Union variety register. Those implementing acts shall be adopted in accordance with 
the examination procedure referred to in Article 141(3). 

CHAPTER II 
Content of the national and Union variety registers 

1. 

For varieties, the national and Union variety registers shall include at least: 

Article 53 
Data concerning varieties 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the name of the genus or species to which the variety belongs; 

the denomination of the variety and, for varieties made available on the market 
before the entry into force of this Regulation, where applicable, its synonyms; 

the name, and, where applicable, the reference number, of the applicant; 

the date of the registration of the variety and, where applicable, of the renewal 
of the registration; 

the date of the end of validity of registration; 

the  official  description  of  the  variety,  or,  where,  applicable,  the  officially 
recognised description of the variety with an indication of the region(s) where 
the  variety  has  historically  been  grown  and  to  which  it  is  naturally  adapted 
("region(s) of origin"); 

(g) 

the  name  of  the  professional  operator  responsible  for  the  maintenance  of  a 
variety; 

(h)  where applicable, the indication that the variety contains a genetically modified 

organism; 

(i)  where  applicable,  the  indication  that  the  variety  is  a  component  variety  of 

another registered variety; 

(j)  where  applicable,  the  indication  that  plant  reproductive  material  belonging  to 

the variety is only produced and made available on the market in rootstocks; 

(k)  where applicable, a summary of the results of the examinations for satisfactory 
value for cultivation and/or use as referred to in Article 58, or sustainable value 
for cultivation and/or use as referred to in Article 59. 

Notwithstanding  point  (g)  of  paragraph  1,  the  names  of  the  professional  operators 
need  not  be  indicated  in  the  register  when  several  professional  operators  are 
responsible  for  the  maintenance  of  the  variety.  In  that  case,  the  national  variety 
registers and the Union variety register shall indicate the competent authority holding 
the  list  of  names  of  professional  operators  responsible  for  the  maintenance  of  the 
variety. 

2. 

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Article 54 
Data concerning clones 

For clones, the national and Union variety registers shall include at least: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

the name of the genus or species to which the clone belongs; 

the reference under which the variety, to which the clone belongs, is registered in the 
national variety register or Union variety register; 

the  denomination  of the  variety to  which the clone belongs  and, for varieties made 
available  on  the  market  before  the  entry  into  force  of  this  Regulation,  where 
applicable its synonyms; 

the date of the registration of the clone and, where applicable, of the renewal of the 
registration; 

the end of validity of the registration; 

where applicable, the indication that the variety to which the clone belongs has been 
registered with an officially recognised description, including the region of origin of 
that variety; 

where applicable, the indication that the clone contains, or consists of, a genetically 
modified organism. 

Article 55 
Additional data to be included in the Union variety register 

In the case of a variety or clone, notified by a Member State to the Agency in accordance with 
Chapter VI, the Union variety register shall include, in addition to the data required pursuant 
to Articles 53 and 54: 

(a) 

(b) 

the  name  of  the  Member  States  having  established  the  relevant  national  variety 
register(s); and 

the  reference  under  which  the  variety  or  clone  has  been  registered  in  the  national 
variety register(s). 

CHAPTER III 
Requirements for registration in the national and Union variety 
registers  

SECTION 1 
VARIETIES 

Article 56 
Registration requirements for varieties 

1. 

Varieties may be registered in a national variety register pursuant to Chapter IV, or in 
the  Union  variety  register  pursuant  to  Chapter  V,  only  if  they  fulfil  the  following 
requirements: 

(a) 

(b) 

they bear a denomination deemed suitable pursuant to Article 64; 

they do not pose an  unacceptable risk for human, animal and plant health, or 
the environment; 

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(c) 

in case of varieties belonging to a genetically modified organism, that organism 
is  authorised  for  cultivation  pursuant  to  Directive  2001/18/EC  or  Regulation 
(EC) 1829/2003. 

2. 

In  order  to  be  registered  in  a  national  variety  register  pursuant  to  Chapter  IV, 
varieties  shall  fulfil,  in  addition  to  the  requirements  set  out  in  paragraph  1,  the 
following requirements: 

(a) 

(b) 

(c) 

they have an official description showing compliance with the requirements of 
distinctiveness, uniformity and stability set out in Articles 60, 61 and 62, or are 
provided with an officially recognised description pursuant to Article 57; 

in  case  they  belong  to  genera  or  species  with  particular  importance  for  the 
satisfactory  development  of  agriculture  in  the  Union,  as  referred  to  in 
paragraph 5, they have a satisfactory value for cultivation and/or use pursuant 
to Article 58; 

in  case  they  belong  to  genera  or  species  with  particular  importance  for  the 
sustainable development of agriculture in the Union, as referred to in paragraph 
6, they have a sustainable value for cultivation and/or use pursuant to Article 
59. 

The requirements set out in paragraph 2(b) and (c) shall not apply to the following 
varieties: 

(a) 

varieties provided only with an officially recognised description; 

(b)  varieties  used  only  as  components  for  the  creation  or  production  of  other 

varieties. 

In order to be registered in the Union variety register pursuant to Chapter V, varieties 
shall  fulfil,  in  addition  to  requirements  set  out  in  paragraph  1,  the  following 
requirements: 

(a) 

(b) 

(c) 

they have an official description showing compliance with the requirements of 
distinctiveness, uniformity and stability set out in Articles 60, 61 and 62; 

they  do  not  belong  to  genera  or  species  with  particular  importance  for  the 
satisfactory  development  of  agriculture  in  the  Union,  as  referred  to  in 
paragraph 5;  

in  case  they  belong  to  genera  or  species  with  particular  importance  for  the 
sustainable development of agriculture in the Union, as referred to in paragraph 
6, they have a sustainable value for cultivation and/or use pursuant to Article 
59; 

(d) 

they are not used as mere components for the creation or production of other 
varieties. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  listing  the  genera  or  species  with  particular  importance  for  the 
satisfactory development of agriculture in the Union. Those genera or species shall 
be listed in accordance with the criteria set out in Part A of Annex IV. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  listing  the  genera  or  species  with  particular  importance  for  the 
sustainable development of agriculture in the Union. Those genera or species shall be 
listed in accordance with the criteria set out in Part B of Annex IV. 

3. 

4. 

5. 

6. 

EN 

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Article 57 
Registration of varieties provided with an officially recognised description 

1. 

A variety may be registered in a national variety register on the basis of an officially 
recognised description if one of the following conditions are complied with:  

(a) 

(b) 

in  case  the  variety  had  been  previously  not  registered  in  a  national  variety 
register  or  in  the  Union  variety  register  and  plant  reproductive  material 
belonging  to  that  variety  has  been  made  available  on  the  market  before  the 
entry into force of this Regulation;  

in  case  the  variety  had  been  previously  registered  in  any  national  variety 
register or in the Union variety register on the basis of a technical examination 
pursuant to Article 71, but has been deleted from those registers more than five 
years before the submission of the current application and would not fulfil the 
requirements laid down in Articles 60, 61 and 62 and, where applicable, Article 
58(1) and Article 59(1). 

2. 

In order to be registered on the basis of an officially recognised description, a variety 
shall comply, in addition to paragraph 1, with the following conditions:  

(a) 

(b) 

(c) 

it is produced in the region(s) of origin; 

it is not included in a national variety register or in the Union variety register, 
as a variety with an official description; 

it is not protected by a Union plant variety right as provided for in Article 62 of 
Council Regulation (EC) No 2100/94, or by a national plant variety right, and 
it is not the subject of a pending application for such a right.  

3. 

After the registration of a variety in a national variety register pursuant to paragraph 
2(a),  competent  authorities  may  approve  additional  region(s)  of  origin  for  that 
variety. 

4. 

The officially recognised description shall comply with the following requirements: 

(a) 

(b) 

it  is  based,  where  available,  on  information  from  plant  genetic  resources 
authorities  or  from  organisations  recognised  for  that  purpose  by  the  Member 
States; and 

its  accuracy  is  supported  by  the  results  of  previous  official  inspections  or 
unofficial examinations or knowledge gained from practical experience during 
cultivation, reproduction and use. 

Article 58 
Satisfactory value for cultivation and/or use 

1. 

2. 

For the purpose of paragraph 2(b) of Article 56, varieties shall be deemed to have a 
satisfactory value for cultivation and/or use if, compared to other varieties examined 
under  similar  agro-climatic  conditions  and  similar  production  systems,  their 
characteristics, taken as a whole, offer, at least as far as production in any region is 
concerned,  a  clear  improvement  either  for  cultivation  in  general  or  for  the  specific 
uses which can be made of the crops or the products derived therefrom.  

Member  States  shall  adopt  rules  concerning  the  examinations  to  determine  the 
satisfactory value for cultivation and/or use of the varieties to be registered in their 
national variety register. Those rules shall concern the characteristics of the varieties 
in one or more of the following areas: 

EN 

55 

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1. 

2. 

1. 

2. 

(a) 

(b) 

quality and agronomic characteristics, including yields; 

suitability  for  cultivation  in  resilience  and  low  input  production  systems, 
including for organic agricultural production. 

Each  Member  State  shall  publish  those  rules  and  notify  them  to  the  Agency,  the 
Commission and the other Member States. 

Article 59 
Sustainable value for cultivation and/or use 

For the purpose of paragraph 2(c) and paragraph 3(c) of Article 56, varieties shall be 
deemed to have a sustainable value for cultivation and/or use if, compared to other 
varieties  examined  under  similar  agro-climatic  conditions  and  similar  production 
systems, their characteristics, taken as a whole, offer, at least as far as susceptibility 
to pests, input of resources, susceptibility to undesirable substances or adaptation to 
divergent  agro-climatic  conditions  are  concerned,  a  clear  improvement  either  for 
cultivation in general or for the specific uses which can be made of the crops or the 
products derived there from. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out  rules  concerning  the  examinations  to  determine  the 
sustainable value for cultivation and/or use of the varieties. Those rules shall concern 
the characteristics of the varieties in one or more of the following areas: 

(a) 

resistance to pests;  

(b) 

reduced need for input of specific resources;  

(c) 

decreased content of undesirable substances; or  

(d) 

increased adaptation to divergent agro-climatic environment. 

Those  rules  shall  take  into  account,  where  applicable,  the  available  technical 
protocols. 

Article 60 
Distinctness 

For the purposes of the official description, referred to in point (a) of Article 56(2) 
and  (3),  a  variety  shall  be  deemed  to  be  distinct,  if  it  is  clearly  distinguishable,  by 
reference  to  the  expression  of  the  characteristics  that  results  from  a  particular 
genotype  or  combination  of  genotypes,  from  any  other  variety  whose  existence  is 
commonly known on the date of the application determined pursuant to Article 70.  

The existence of another variety, as referred to in paragraph 1, shall be deemed to be 
commonly known, if on the date of the application determined pursuant to Article 70 
one or more of the following conditions are complied with: 

(a) 

(b) 

that  variety  is  included  in  a  national  variety  register  or  in  a  Union  variety 
register; 

an application has been filed for registration of that variety in a national variety 
register  pursuant  to  Article  66,  or  in  the  Union  variety  register  pursuant  to 
Article  95(1),  or  for  the  granting  of  a  plant  variety  right  in  respect  of  that 
variety in the Union;  

EN 

56 

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(c) 

an official description of that variety has been produced in the Union, and the 
technical  examination  has  been  conducted  pursuant  to  the  provisions  of 
Article 69, Article 71 and, where applicable, Article 73 . 

3. 

Where  point  (c)  of  paragraph  2  applies,  the  person(s)  responsible  for  the  technical 
examinations  shall  make  available  to  the competent  authorities  and  the  Agency  the 
official description of the variety examined by them. 

Article 61 
Uniformity 

For the purposes of the official description, referred to in point (a) of Article 56(2) and (3), a 
variety shall be deemed to be uniform if, subject to the variation that may be expected from 
the particular features of its reproduction and type, it is sufficiently uniform in the expression 
of those characteristics which are included in the examination for distinctness, as well as in 
the expression of any other characteristics used for its official description. 

Article 62 
Stability 

For the purposes of the official description referred to in point (a) of Article 56(2) and (3), a 
variety  shall  be  deemed  to  be  stable  if  the  expression  of  those  characteristics  which  are 
included in the examination for distinctness, as well as any other characteristics used for the 
variety description, remains unchanged after repeated reproduction or, in the case of cycles of 
reproduction, at the end of each such cycle. 

Article 63 
Granted plant variety rights 

If a variety has been granted a plant variety right pursuant to Article 62 of Regulation (EC) 
No 2100/1994, or pursuant to the legislation of a Member State, that variety shall be deemed 
to be distinct, uniform and stable, for the purpose of the official description as referred to in 
point (a) of Article 56(2) and (3) and to have a suitable denomination for the purposes of point 
(a) of Article 56(1). 

Article 64 
Denomination of varieties 

1. 

For the purposes of point (a) of Article 56(1), the denomination of a variety shall not 
be deemed suitable if: 

(a) 

(b) 

(c) 

its  use  in  the  territory  of  the  Union  is  precluded  by  the  prior  right  of  a  third 
party; 

it  may  commonly  cause  its  users  difficulties  as  regards  recognition  or 
reproduction; 

it is identical to, or may be confused with, a variety denomination under which 
another  variety  of  the  same  or  of  a  closely  related  species  is  entered  in  a 
national  variety  register  or  in  the  Union  variety  register,  or  under  which 
material of another variety has been made available on the market in a Member 
State  or  in  a  Member  of  the  International  Union  for  the  Protection  of  New 
Varieties of Plants, unless that other variety no longer remains in existence and 
its denomination has acquired no special significance; 

EN 

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(d) 

(e) 

(f) 

it  is  identical  to,  or  may  be  confused  with,  other  designations  which  are 
commonly used for the making available on the market of goods or which have 
to be kept free pursuant to other Union legislation; 

it is liable to give offence in one of the Member States or is contrary to public 
order; 

it is liable to mislead or to cause confusion concerning the characteristics, the 
value or the identity of the variety, or the identity of the breeder. 

2. 

Without prejudice to paragraph 1, if a variety is already registered in other national 
variety  registers,  or  in  the  Union  variety  register,  the  denomination  shall  only  be 
deemed suitable if it is identical to that appearing in those registrations.  

3. 

Paragraph 2 shall not apply if: 

(a) 

(b) 

the  denomination  is  likely  to  mislead  or  cause  confusion  concerning  the 
relevant variety in one or more Member States; or 

the  rights  of  third  parties  impede  the  free  use  of  that  denomination  in 
connection with the variety in question. 

4. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out  specific  rules  concerning  the  suitability  of  variety 
denominations. Those rules may concern: 

(a) 

(b) 

their relation to denominations of trade marks; 

their  relation  to  geographical  indications  or  designations  of  origin  for 
agricultural products; 

(c)  written  consents  of  holders  of  prior  rights  to  remove  impediments  to  the 

suitability of a denomination; 

(d) 

specific  criteria  to  determine  whether  a  denomination  is  misleading  or 
confusing as referred to in paragraph 1(f); and 

(e) 

the use of a denomination in the form of a code. 

SECTION 2 
CLONES 

Article 65 
Registration requirements for clones 

1. 

A  clone  may  be  included  in  the  national  variety  register,  or  in  the  Union  variety 
register, only if it complies with the following requirements: 

(a) 

(b) 

it  belongs  to  genera  or  species  which  have  a  particular  value  for  particular 
market sectors and listed pursuant to paragraph 3; 

it  belongs  to  a  variety  registered  in  a  national  variety  register  pursuant  to 
Chapter IV or in the Union variety register pursuant to Chapter V;  

(c) 

it has been subject to genetic selection; 

(d) 

it bears a suitable denomination. 

2. 

For the purpose of establishing whether a denomination is suitable as referred to in 
paragraph  1(d)  of  this  Article,  the  provisions  of  Article  64  shall  apply  with  the 

EN 

58 

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3. 

4. 

1. 

2. 

1. 

necessary  modifications.  References  made  in  Article  64  to  varieties  shall  be 
construed as references to clones. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, listing the genera or species, the clones of which have a particular value 
for particular market sectors. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, setting out the following:  

(a) 

that clones belonging to particular genera or species shall be subject to sanitary 
selection  for  the  purpose  of  inclusion  in  a  national  variety  register  or  in  the 
Union variety register; and  

(b) 

the requirements for the sanitary selection referred to in point (a); 

CHAPTER IV 
National variety register procedures 

SECTION 1 
VARIETY REGISTRATION PROCEDURE 

Article 66 
Submission of applications 

Any person may submit to the competent authority an application for registration of a 
variety in the national variety register.  

The  application  referred  to  in  paragraph  1  shall  be  submitted  in  writing.  That 
submission may take place electronically. 

Article 67 
Content of applications 

The application for registration of a variety in a national variety register shall contain 
the following items: 

(a) 

(b) 

(c) 

a request for registration; 

the identification of the botanical taxon (genus or species) to which the variety 
belongs; 

the  reference  number  of  the  applicant,  where  applicable,  and  its  name  and 
address, or, where appropriate, the names and addresses of the joint applicants, 
and the credentials of any procedural representative; 

(d) 

a provisional denomination; 

(e) 

(f) 

(g) 

(h) 

the  name  and  address  of  the  person  responsible  for  the  maintenance  of  the 
variety, and, where applicable, the reference number of that person; 

a  description  of  the  main  characteristics  of  the  variety  and,  if  available,  a 
completed technical questionnaire; 

a description of the procedure of variety maintenance; 

the geographic origin of the variety; 

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(i) 

information  on  whether  the  variety  is  registered  in  another  national  variety 
register,  or  the  Union  variety  register,  and  on  whether  it  is  known  to  the 
applicant  that  an  application  for  registration  in  one  of  those  registers  is 
pending; 

(j)  where  the  variety  contains  or  consists  of  a  genetically  modified  organism, 
evidence  that  the  genetically  modified  organism  in  question  is  authorised  for 
cultivation  pursuant 
to  Directive  2001/18/EC  or  Regulation  (EC)  No 
1829/2003; 

(k)  where  the  application  is  based  on  an  officially  recognised  description  of  the 
variety,  a  file  containing  that  description  and  any  document  or  publication 
supporting it; 

(l) 

in the case of an application concerning varieties granted a plant variety right 
as referred to in Article 63, the proof that the variety is protected by such right, 
with the corresponding official description; 

(m)  where  applicable,  a  declaration  that  the  variety  has  satisfactory  value  for 
cultivation and/or a use as referred to in Article 58(1) and/or sustainable value 
for cultivation and/or use as referred to in Article 59(1). 

The  application  for  registration  of  a  variety  in  a  national  variety  register  shall  be 
accompanied by the submission of a sample of sufficient quality and quantity of the 
variety, as specified by the competent authority. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out  additional  items  to  be  included  in  the  application  for 
particular  genera  or  species,  in  relation  with  the  particular  features  of  the  varieties 
belonging to those genera or species.  

2. 

3. 

Article 68 
Application format 

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format  of  the  application 
referred  to  in  Article  66.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 141(3). 

Article 69 
Formal examination of application 

1. 

2. 

The competent authority shall register each application for registration in the national 
variety  register  it  receives,  and  shall  carry  out  the  formal  examination  of  that 
application.  The  formal  examination  of  the  application  shall  examine  whether  the 
application complies with: 

(a) 

the content requirements laid down in Article 67; and 

(b) 

the format adopted pursuant to Article 68. 

If the application does not comply with the requirements laid down in Article 67 or 
the  format  adopted  pursuant  to  Article  68,  the  competent  authority  shall  give  the 
applicant the possibility to make its application compliant within a given time. 

EN 

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   EN 

Article 70 
Date of application 

The date of application for registration shall be the date on which an application complying 
with  the  content  requirements  laid  down  in  Article  67  and  the  format  adopted  pursuant  to 
Article 68 was submitted to the competent authority. 

Article 71 
Technical examination  

1. 

Where, as a result of the formal examination, the application is found to comply with 
the content requirements referred to in Article 67 and the format adopted pursuant to 
Article 68, a technical examination of the variety shall be carried out for the purpose 
of establishing an official description. 

2. 

The technical examination referred to in paragraph 1 shall verify: 

3. 

4. 

5. 

1. 

(a) 

the  compliance  with  the  requirements  for  distinctiveness,  uniformity  and 
stability of the variety, as laid down in Articles 60, 61 and 62;  

(b)  where applicable, that the variety has a satisfactory value for cultivation and/or 
use,  according  to  Article  58(1)  and  a  sustainable  value  for  cultivation  and/or 
use according to Article 59(1). 

The  technical  examination  referred  to  in  paragraph  1  shall  be  carried  out  by  the 
competent authorities in accordance with the requirements referred to in Article 74. 

On  request  submitted  by  the  applicant  to  the  competent  authority,  the  technical 
examination, or part of it, may be carried out by the applicant, in accordance with the 
provisions of Article 73 and the requirements referred to in Article 74. 

In case an official description of the variety, produced by the Agency or a competent 
authority, is already available, the competent authority shall decide that the technical 
examination referred to in paragraph 1 is not necessary. 

By way of derogation from paragraph 4, the competent authority may decide that the 
technical examination referred to in paragraph 1 is necessary in the case of a variety 
the registration of which is requested pursuant to point (b) Article 57(1). 

Article 72 
Audit of the competent authority's premises and organisation 

The  competent  authority  may  carry  out  the  technical  examination  referred  to  in 
Article  71(1)  only  if  its  premises,  which  must  be  dedicated  to  this  purpose,  and  its 
organisation have been audited by the Agency.  

That  audit  shall  verify  whether  the  premises  and  the  organisation  of  the  competent 
authority are suitable for carrying out the technical examination as regards:  

(a) 

(b) 

compliance  with  the  requirements  for  distinctiveness,  uniformity  and  stability 
referred to in Articles 60, 61 and 62; and  

compliance with the requirements of a sustainable value for cultivation and/or 
use referred to in Article 59(1).  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, setting out the rules concerning the audit referred to in paragraph 1.  

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3. 

1. 

2. 

3. 

4. 

5. 

On the basis of the audit referred to in paragraph 1, the Agency may recommend to 
the  competent  authority,  if  appropriate,  actions  to  ensure  the  suitability  of  the 
premises and organisation of the competent authorities. Further to the audit referred 
to in paragraph 1, the Agency may carry out additional audits and, where applicable, 
recommend to the competent authorities corrective actions to ensure the suitability of 
their premises and organisation. 

Article 73 
Technical examination by the applicant 

The applicant may carry out the technical examination referred to in Article 71(1), or 
part of it, only if it has been authorised thereto by the competent authority. Technical 
examination  by  the  applicant  shall  be  carried  out  in  particular  premises,  which  are 
dedicated to this purpose. 

Prior  to  granting  the  authorisation  to  carry  out  the  technical  examination,  the 
competent  authority  shall  audit  the  premises  and  the  organisation  of  the  applicant. 
That  audit  shall  verify  whether  the  premises  and  organisation  are  suitable  for 
carrying out the technical examination as regards:  

(a) 

(b) 

(c) 

compliance  with  the  requirements  for  distinctiveness,  uniformity  and  stability 
referred to in Articles 60, 61 and 62; and  

compliance with the requirements of a satisfactory value for cultivation and/or 
use referred to in Article 58(1); 

compliance with the requirements of a sustainable value for cultivation and/or 
use referred to in Article 59(1).  

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, setting out the rules concerning the audit referred to in paragraph 2. 

On  the  basis  of  the  audit  referred  to  in  paragraph  1,  the  competent  authority  may 
recommend  to  the  applicant,  if  appropriate,  actions  to  ensure  the  suitability  of  the 
applicant’s premises and organisation. 

Further  to  the  authorisation  and  audit  referred  to  in  paragraph  1,  the  competent 
authority  may  carry  out  additional  audits  and,  where  applicable,  recommend  to  the 
applicant,  within  a  specific  period  of  time,  corrective  actions  concerning  the 
applicant’s premises and the organisation.  

In case the competent authority concludes that the applicant’s premises and organisation are 
not suitable, it may revoke or modify the authorisation referred to in paragraph 1. 

Article 74 
Additional rules on technical examination 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 140, supplementing the requirements on the technical examination laid down 
in Articles 71, 72 and 73. Those delegated acts may concern: 

(a) 

(b) 

qualification,  training  and  activities  of  staff  of  the  competent  authority,  or  of 
the  applicant,  for  the  purposes  of  the  technical  examination  referred  to  in 
Article 71(1);  

the  necessary  equipment, 
characteristics, necessary to carry out the technical examination; 

including 

laboratories  for  disease  resistance 

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(c) 

(d) 

(e) 

the  establishment  of  a  variety  reference  collection  to  assess  distinctness,  and 
the storage management of such reference collection;  

the establishment of quality management systems, including record of activities 
and protocols or guidelines, to be used for the technical examination; 

the  conduct  of  growing  trials  and  laboratory  tests  for  particular  genera  or 
species. 

Those  delegated  acts  shall  take  into  account  the  available  technical  and  scientific 
protocols. 

Where  no  requirements  have  been  adopted  pursuant  to  paragraph  1,  technical 
examinations shall be carried out in accordance with national protocols as regards the 
elements referred in points (a) to (e) of paragraph 1. 

Article 75 
Confidentiality 

Where, in the framework of the technical examination referred to in Article 71(1), an 
examination  of  the  genealogical  components  is  necessary,  the  results  of  that 
examination  and  the  description  of  the  genealogical  components  shall  be  treated  as 
confidential, if the applicant so requests. 

In  the  case  of  varieties  of  plant  reproductive  material  intended  exclusively  for  the 
production of agricultural raw materials for industrial purposes, and if so requested 
by the applicant, the results of the technical examination referred to in Article 71(1) 
and the intended uses of those varieties shall be treated as confidential. 

Article 76 
Provisional examination report and provisional official description 

Following  the  technical  examination  referred  to  in  Article  71(1),  the  competent 
authority shall produce a provisional examination report and, where it considers that 
the  distinctiveness,  uniformity  and  stability  requirements,  as  referred  to  in 
Articles 60,  61  and  62,  are  complied  with,  a  provisional  official  description  of  the 
variety on the basis of that report. 

The  provisional  examination  report  may  refer  to  findings  of  other  examination 
reports,  produced  on  the  relevant  variety,  by  the  competent  authority  concerned, 
other competent authorities or the Agency. 

The competent authority  shall  communicate  the provisional  examination  report  and 
the provisional official description of the variety to the applicant. 

Where the competent authority does not consider the examination report to constitute 
a  sufficient  basis  for  a  decision  on  the  registration  of  the  variety,  it  shall  provide  a 
complementary examination of its own motion, after consulting the applicant, or on 
request of the applicant. Any complementary examination carried out until a decision 
is  taken  pursuant  to  Article 79(1)  shall  be  considered  to  be  part  of  the  technical 
examination referred to in Article 71(1). 

2. 

1. 

2. 

1. 

2. 

3. 

4. 

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1. 

2. 

1. 

2. 

1. 

2. 

3. 

4. 

1. 

Article 77 
Examination report and official description 

After  having  given  the  applicant  an  opportunity  to  comment  on  the  provisional 
examination  report  and  the  provisional  official  description,  the  competent  authority 
shall establish a final examination report and a final official description. 

Competent  authorities  shall,  on  reasoned  request,  make  available  the  examination 
reports to third parties, subject to national or Union provisions on data protection and 
applicable rules on confidentiality.  

Article 78 
Examination of the denomination  

After the formal examination of the application referred to in Article 69, and prior to 
the registration of a variety in a national variety register pursuant to Article 79, the 
competent authority shall consult the Agency on the variety denomination proposed 
by the applicant. 

The  Agency  shall  submit  to  the  competent  authority  a  recommendation  on  the 
suitability of the variety denomination proposed by the applicant, in accordance with 
the  requirements  set  out  in  Article  64.  The  competent  authority  shall  inform  the 
applicant on that recommendation.  

Article 79 
Decision on registration 

If, on the basis of the procedure set out in Articles 66 to 78, it is concluded that the 
variety  complies  with  the  applicable  requirements  set  out  in  Article  56,  the 
competent  authority  shall  decide  to  register  the  variety  in  the  national  variety 
register. 

The  competent  authority  shall  adopt  a  decision  refusing  registration  in  the  national 
variety register if: 

(a) 

(b) 

it  establishes  that  the  applicable  requirements  set  out  in  Article  56,  are  not 
fulfilled; or 

the applicant has failed to comply with any obligations set out for it in Articles 
66 to 74. 

Decisions refusing the registration shall state the reasons justifying the refusal.  

The competent authority shall  communicate to the applicant a copy of the  decision 
referred to in paragraphs 1 and 2.  

Article 80 
Already registered varieties and clones 

By way of derogation from Articles 66 to 79, the competent authorities shall register 
in their national variety registers all varieties officially accepted or registered, before 
the entry into force of this Regulation, in the catalogues, lists or registers established 
by their Member States pursuant to Article 3 of Directive 2002/53/EC, Article 3(2) 
of  Directive  2002/55/EC,  Article  7(4)  of  Directive  2008/90/EC  and  Article  5  of 
Directive  68/193/EEC  and  all  clones  registered  pursuant  to  Article  5  of  Directive 
68/193/EEC,  Article  7(4)  of  Directive  2008/90/EC,  Chapter  II  of  Directive 

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2008/62/EC  and  Section  I  of  Chapter  II  and  Section  I  of  Chapter  III  of  Directive 
2009/145/EC. 

2. 

Varieties accepted in accordance with Article 3 of Directive 2008/62/EC and Article 
3(1) of Directive 2009/145/EC shall be registered in the national variety registers as 
varieties provided with an officially recognised description. 

Article 81 
New denomination after registration 

Where, after the registration of a variety, it is established by the competent authority that at 
the  time  of  the  registration  the  denomination  of  the  variety  was  not  suitable  within  the 
meaning of Article 64, the applicant shall submit an application for a new denomination. The 
competent authority shall decide on that application upon consultation with the Agency. The 
competent authority may permit the previous denomination to be used temporarily. 

SECTION 2 
REGISTRATION PERIOD AND VARIETY MAINTENANCE 

Article 82 
Validity period of the registration 

The validity period of the registration of a variety in a national variety register shall 
be 30 years. 

In the case of varieties consisting of, or containing, a genetically modified organism, 
the validity of the registration shall be limited to the period for which that genetically 
modified organism is authorised for cultivation pursuant to Directive 2001/18/EC or 
Regulation (EC) No 1829/2003. 

Article 83 
Duration of the renewal period 

The registration of a variety in a national variety register may be renewed for further 
periods of 30 years, in accordance with the procedure and the conditions laid down in 
Article 84. 

In the case of a variety consisting of or containing a genetically modified organism, 
the  renewal  shall  be  limited  to  the  period  for  which  that  genetically  modified 
organism  is  authorised  for  cultivation  pursuant  to  Directive  2001/18/EC  or 
Regulation (EC) No 1829/2003. 

Article 84 
Procedure and conditions for registration renewal 

Any  person  intending  to  renew  the  registration  of  a  variety  shall  submit  an 
application,  no  earlier  than  12  months,  and  no  later  than  six  months,  before  the 
expiration of the validity period as referred to in Article 82. 

The  application  shall  be  submitted  in  writing.  That  submission  may  take  place 
electronically.  It  shall  be  accompanied  by  evidence  showing  that  the  conditions  set 
out in paragraphs 3 and 4 are fulfilled. 

The renewal of the registration of a variety in a national variety register shall only be 
granted if the following conditions are met:  

1. 

2. 

1. 

2. 

1. 

2. 

3. 

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(a) 

(b) 

the  variety  continues  complying  with  the  requirements  of  Article  56,  and, 
where applicable of Article 57;  

the competent authority determines that a person is responsible for maintaining 
the variety in accordance with the provisions of Article 86. 

4. 

The competent authority may renew the registration of a variety in a national variety 
register, without an application for renewal being submitted pursuant to paragraphs 1 
and  2,  where  it  considers  that  the  renewal  of  that  registration  serves  sustainable 
agricultural  production  and  the  preservation  of  genetic  diversity,  and  that  the 
conditions of paragraph 3 are fulfilled. 

Article 85 
Deletion from national variety registers 

1. 

The  competent  authority  shall  decide  to  delete  a  variety  from  the  national  variety 
register, in the following cases: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

if the competent authority concludes, on the basis of any new evidence, that the 
requirements for registration, as set out in Article 56 are no longer fulfilled;  

if  a  request  to  delete  the  variety  from  the  national  variety  register  has  been 
submitted by the applicant; 

if  the  applicant  does  not  pay  the  annual  fee  pursuant  to  point  (d)  of  Article 
87(1)(e); 

if  the  person  responsible  for  the  maintenance  of  the  variety,  as  referred  to  in 
Article  86(1),  so  requests,  unless  maintenance  of  the  variety  is  assured  by 
another person; 

if the variety is no longer maintained pursuant to requirements of Article 86; 

if  the  variety  is  maintained  in  a  third  country,  that  third  country  has  not 
provided  assistance  on  the  controls  of  that  maintenance  pursuant  to  Article 
86(8); 

if  at  the  time  of  the  application,  false  or  fraudulent  data  were  supplied 
concerning the facts on the basis of which the registration was decided; 

if,  by  the  deadline  to  submit  an  application  for  renewal  referred  to  in  Article 
84(1),  the  applicant  has  not  submitted  such  an  application  and  the  validity 
period referred to in Article 82(1) has expired. 

On  request  by  the  applicant,  the  competent  authority  may  allow  a  variety  deleted 
from the national variety register in accordance to paragraph 1(b) to continue to be 
made available on the market until 30 June of the third year following the deletion 
from the register. 

That  request  shall  be  submitted  no  later  than  the  date  of  the  expiration  of  the 
registration period. 

After a variety is deleted from the national variety register, the competent authority 
shall submit a sample of that variety, and its description, to a gene bank dedicated to 
the conservation of genetic resources. 

2. 

3. 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

Article 86 
Variety maintenance 

Varieties registered in a national variety register shall be maintained by the applicant 
or  by  any  other  person  acting  in  mutual  agreement  with  the  applicant.  That  other 
person shall be notified by the applicant to the competent authority. 

Variety  maintenance  shall  take  place  in  accordance  with  accepted  practices 
concerning, as appropriate, genera, species or types of varieties.  

The  persons  referred  to  in  paragraph  1  shall  keep  records  concerning  the 
maintenance  of  the  variety.  It  shall  at  all  times  be  possible  for  the  competent 
authority to check the maintenance of the variety from those records. Those records 
shall  also  cover  the  production  of  pre-basic,  basic,  certified  and  standard  material, 
and the stages of production prior to pre-basic material. 

Varieties  provided  with  an  officially  recognised  description  shall  be  maintained  in 
their region(s) of origin. 

The  competent  authority  shall  carry  out  controls  on  the  manner  in  which  variety 
maintenance  is  carried  out  and  may,  to  this  purpose,  take  samples  of  the  varieties 
concerned. 

Where  a  competent  authority  finds  that  the  person  responsible  for  variety 
maintenance  does  not  comply  with  paragraphs  1  to  4,  it  shall  give  that  person  the 
opportunity to take corrective action. 

Where  variety  maintenance  takes  place  in  a  Member  State  other  than  the  Member 
State in whose national variety register the variety has been registered, the competent 
authorities of the two Member States concerned shall assist each other in the controls 
on variety maintenance. 

Where variety maintenance takes place in a third country, the competent authorities 
of the Member State in whose national variety register the variety has been registered 
concerned  shall  request  the  third  country's  authorities  assistance  in  the  controls  on 
variety maintenance. 

SECTION 3 
REGISTRATION FEES 

Article 87 
Registration fees 

1. 

The  competent  authorities  shall  charge  fees  to  recover  the  necessary  costs  incurred 
for the following actions: 

(a) 

(b) 

(c) 

(d) 

(e) 

the formal examination of the application referred to in Article 69; 

the  technical  examination  and  the  audits  referred  to  in  Article  71  and  Article 
73(1); 

the examination of the variety denomination referred to in Article 78; 

the  decision  on  registration  referred  to  in  Article  79,  and  any  administrative 
appeal lodged pursuant to national rules against that decision;  

the  inclusion  of  the  variety,  or  where  applicable  the  clone,  in  the  national 
variety register for each year of the duration of the registration;  

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2. 

3. 

1. 

2. 

1. 

2. 

3. 

(f) 

controls on the maintenance as referred to in Article 86(5). 

The actions referred to in paragraph 1 shall only be carried out on demand submitted 
by the applicant to the competent authority, and after the respective fees have been 
paid. The demand shall be deemed not to have been made, if the fees have not been 
paid  within  one  month  from  the  date  on  which  the  competent  authority  requested 
payment of the fees and indicated in that request the consequences of the failure to 
pay. 

The Commission shall be empowered to adopt delegated acts, in accordance with the 
procedure referred to in Article 140, setting out the specific cost items to be covered 
pursuant to paragraph 1(a) to (f). 

Article 88 
Fees for varieties provided with an officially recognised description 

In  the  case  of  varieties  provided  with  an  officially  recognised  description,  no  fees 
shall be charged for the actions referred to in point (e) of Article 87(1).  

In  the  case  of  varieties  provided  with  an  officially  recognised  description,  the 
competent authorities shall reduce the amount of the fee for the actions referred to in 
of  points  (a),  (c),  (d),  and  (f)  of  Article  87(1).  That  reduction  shall  take  place  in  a 
manner to ensure that the fee does not constitute a barrier to the registration of the 
variety concerned. 

Article 89 
Exemptions from the payment of registration fees  

Fees  provided  for  in  Article  87  and  88  shall  not  directly  or  indirectly  be  refunded, 
unless unduly collected.  

Applicants  employing  fewer  than  10  persons  and  whose  annual  turnover  or  annual 
balance  sheet  total  does  not  exceed  EUR  2  million  shall  be  exempted  from  the 
payment of the fees provided for in Article 87 and Article 88. 

The  costs  referred  to  in  Articles  87  and  88  shall  not  include  those  incurred  for  the 
performance of official controls on the applicants referred to in paragraph 2. 

SECTION 4 
REGISTRATION OF CLONES 

Article 90 
Applicable provisions 

1. 

For the registration of a clone in a national variety register, Sections 1, 2 and 3 shall 
apply with the necessary modifications, excluding the following provisions: 

(a) 

(b) 

(c) 

the provisions on the content of applications as set out in Article 67; 

the  provisions  referring  to  varieties  provided  with  officially  recognised 
descriptions; 

the  provisions  referring  to  varieties  with  sustainable  or  satisfactory  value  for 
cultivation and/or use. 

2. 

As regards the content of applications, Article 92 shall apply instead of Article 67. 

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Article 91 
References  

When applying Sections 1, 2 and 3 for the registration of a clone in a national variety register, 
references shall be construed as follows: 

(a) 

(b) 

(c) 

(d) 

references to varieties shall be construed as references to clones; 

references to Article 56 shall be construed as references to Article 65;  

references to the requirements set out in Articles 60, 61 and 62 shall be construed as 
references to requirements set out in Article 65(1)(b) and (3); 

references to Article 67, concerning the content of applications, shall be construed as 
references to Article 92. 

Article 92 
Content of applications 

1. 

The application for registration of a clone in a national variety register shall contain 
the following items: 

(a) 

a request for registration; 

(b) 

the identification of the variety to which the clone belongs; 

(c) 

the  name  and  address  of  the  applicant,  or,  where  appropriate,  the  joint 
applicants, and the credentials of any procedural representative; 

(d) 

a provisional denomination; 

(e) 

(f) 

(g) 

(h) 

(i) 

the  name  and  address  of  the  person  responsible  for  the  maintenance  of  the 
clone, and, where applicable, the reference number of that person; 

a  description  of  the  main  characteristics  of  the  clone  and,  if  available,  a 
completed technical questionnaire; 

the geographic origin of the clone; 

information  on  whether  the  clone  is  registered  in  another  national  variety 
register or Union variety register, and on whether it is known to the applicant 
that an application for registration of the clone in those registers is pending; 

in  the  case  of  a  clone  containing  or  consisting  of  a  genetically  modified 
organism,  evidence  that  the  genetically  modified  organism  in  question  is 
authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) 
No 1829/2003. 

2. 

The application for the registration of a clone in a national variety register shall be 
accompanied by the submission of a sample of sufficient quality and quantity of the 
clone. 

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CHAPTER V 
Procedures concerning the Union variety register 

SECTION 1 
SCOPE OF THE CHAPTER 

Article 93 
Relevant varieties and clones 

This Chapter shall apply to varieties and clones not registered in any national variety register 
pursuant to Article 79. 

SECTION 2 
REGISTRATION PROCEDURE 

Article 94 
Applicable provisions 

1. 

For  the  registration  of  a  variety  or  clone  in  the  Union  variety  register,  Chapter  IV 
shall apply with the necessary modifications, excluding the following provisions: 

2. 

3. 

(a) 

the provisions on the examination of denominations set out in Article 78; 

(b) 

the provisions on variety maintenance set out in Article 86; 

(c) 

(d) 

the  provisions  referring  to  varieties  provided  with  an  officially  recognised 
description; 

the provisions on exemptions from the payment of registration fees, set out in 
Article 89(2) and (3). 

For  the  examination  of  denominations,  for  variety  and  clone  maintenance  and  for 
exemptions from the payment of registration fees, Articles 95, 96 and 97 shall apply 
instead of the provisions referred to in paragraph 1(a), (b) and (d). 

When  applying  Chapter  IV  for  the  registration  of  a  variety  or  clone  in  the  Union 
variety register, references shall be construed as follows: 

(a) 

(b) 

references  to  the  competent  authority  shall  be  construed  as  references  to  the 
Agency;  

references  to  national  variety  registers  shall  be  construed  as  references  to  the 
Union variety register;  

(c) 

references to Article 78 shall be construed as references to Article 95; 

(d) 

references to Article 86 shall be construed as references to Article 96; 

(e) 

references to administrative appeal lodged pursuant to national rules against the 
respective decision shall be construed as references to the appeal referred to in 
Article 98.  

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Article 95 
Examination of the denomination 

After the formal examination of the application referred to in Article 69, as applied 
pursuant to Article 94, and before a variety or clone is registered in the Union variety 
register, the Agency shall examine the denomination of the variety or clone proposed 
by the applicant. 

The Agency shall decide on the suitability of the variety or clone denomination, in 
accordance with the requirements set out in Article 64. 

Article 96 
Maintenance of varieties and clones 

Varieties and clones registered in the Union variety register shall be maintained by 
the applicant, or by any other person acting in mutual agreement with the applicant. 
The other person shall be notified to the Agency. 

The  maintenance  shall  take  place  in  accordance  with  accepted  practices,  as 
appropriate per genera, species or types of varieties. 

The person referred to in paragraph 1 shall keep records concerning the maintenance 
of the variety or the clone. It shall at all times be possible for the Agency to check the 
maintenance of the variety or the clone from those records. Those records shall also 
cover the production of pre-basic, basic, certified and standard material, and stages of 
production prior to pre-basic material. 

The  Agency  shall  check  the  way  the  maintenance  is  carried  out  and  may,  to  this 
purpose, take samples of the varieties and the clones. 

The competent authorities of the Member State where the maintenance of the variety 
or  the  clone  concerned  takes  place,  shall  assist  the  Agency  as  regards  controls  on 
maintenance. 

In  case  the  Agency  finds  that  the  person  responsible  for  the  maintenance  does  not 
comply  with  the  provisions  of  paragraphs  1,  2  and  3,  it  shall  give  that  person  the 
opportunity to take corrective action. 

Article 97 
Amount of fees 

The Commission shall be empowered to adopt delegated acts, in accordance with the 
procedure referred to in Article 140, setting out the amount of the fees referred to in 
Article 87(1) as applied pursuant to Article 94. 

The level at which the fees are set pursuant to paragraph 1 shall reflect the principle 
of sound financial management to allow the Agency to maintain a balanced budget. 

1. 

2. 

1. 

2. 

3. 

4. 

5. 

6. 

1. 

2. 

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SECTION 3 
APPEALS 

Article 98 
Right of appeal 

An appeal shall lie from decisions of the Agency which have been taken pursuant to Section 
2.  It  shall  be  examined  by  the  Board  of  Appeal  of  the  Agency  referred  to  in  Article  46  of 
Regulation (EC) No 2100/1994. 

Article 99 
Provisions applicable to appeals  

1. 

2. 

Chapters V and VI of Part Four of Regulation (EC) No 2100/1994 shall apply, with 
the necessary modifications, to appeals referred to in Article 98. 

Notwithstanding paragraph 1 of this Article, the following provisions of Chapters V 
and  VI  of  Part  Four  of  Regulation  (EC)  No  2100/1994  shall  not  apply  to  appeals 
referred to in Article 98: 

(a)  Article 67 (1) and (3); 

(b)  Article 74; 

(c)  Article 80(5). 

Article100 
References  

For the purposes of Article 99(1), references contained in Chapters V and VI of Part Four of 
Regulation (EC) No 2100/1994 shall be construed as follows: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

the reference made in Article 68 to Article 82 shall be omitted; 

the reference made in Article 70(1) to "the body of the Office which has prepared the 
decision" shall be construed as a reference made to the Agency; 

the  reference  made  in  Article  76  to  the  "examination  made  pursuant  to  Articles  54 
and 55" shall  be construed  as a reference made to the technical examination of  the 
application for registration carried out by the Agency pursuant to this Regulation; 

the reference made in Article 78(3) and (4) to Article 90(2) shall be omitted; 

the  reference  made  in  Article  79  to  the "competent offices" shall be construed as a 
reference made to the competent authorities; 

the reference made in Article 80(1) to the "applicant for a Community plant variety 
right  or  the  holder"  shall  be  construed  as  a  reference  made  to  the  applicant  for 
registration; 

the reference made in Article 80(3) to the "time limits specified in Article 52 (2), (4) 
and (5) shall be omitted; 

the  reference  made  in  Article  81  to  the  "staff  of  the  Examination  Offices"  shall  be 
omitted. 

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CHAPTER VI 
Notification of varieties to the Union variety register 

Article 101 
Notification procedure 

Each  competent  authority  shall  notify  within  five  working  days  the  Agency  of  the 
application  for  registration  of  a  variety,  the  adoption  of  the  decision  referred  to  in 
Article  79,  the  new  denomination  after  registration  pursuant  to  Article  81,  the 
renewal  of  the  registration  pursuant  to  Article  83,  and  the  deletion  of  a  variety 
pursuant to Article 85.  

Each  competent authority shall notify the Agency of the  person responsible for the 
maintenance of the variety pursuant to Article 86. That notification shall take place 
within five working days from the date on which the competent authority has become 
aware of that person. 

The  Commission  shall  establish,  by  means  of  implementing  acts,  procedures  for 
submission of the notifications referred to in paragraph 1. Those implementing acts 
shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 141(3). 

CHAPTER VII 
Keeping and handling of information 

Article 102 
Documentation on the national variety registers and on the Union variety register 

The  competent  authority  shall  keep  a  file  on  each  variety  registered  in  the  national 
variety  register,  containing  the  official  description,  the  examination  report  and  any 
complementary examination report pursuant to Article 76. Where applicable, the file 
shall  only  contain  the  officially  recognised  description  of  the  variety,  and  the 
documents supporting that description. 

The Agency shall keep a file on each variety registered in the Union variety register, 
containing  the  official  description  and  the  examination  report  issued  pursuant  to 
Article 94(1).  

Article 103 
Access to information of the national variety registers 

Each  Member  State  shall  inform  the  other  Member  States,  the  Agency  and  the 
Commission on the access to its national variety register.  

By  31  March  of  each  year,  each  competent  authority  shall  notify  to  the  other 
competent  authorities  and  the  Commission  any  amendments  of  the  respective 
national variety registers which took place during the preceding year. 

Each  competent  authority  shall,  on  request,  make  available  to  another  competent 
authority, the Agency or the Commission: 

(a)  where  applicable,  the  examination  reports  of  varieties  registered  in  the 

respective national variety register, as referred to in Article 77(1); 

1. 

2. 

3. 

1. 

2. 

1. 

2. 

3. 

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(b)  where  applicable,  the  results  of  technical  examinations  referred  to  in  Article 

71(1); 

(c) 

the list of varieties for which an application for registration is pending; 

(d) 

any other information available in respect of registered or deleted varieties. 

The  competent  authority  shall  take  appropriate  measures  to  make  available  the 
information  contained  in  the  files  of  the  national  variety  register  to  any  person 
requesting  access  to  this  information.  This  provision  shall  not  apply  where  the 
information must be treated as confidential pursuant to Article 75. 

Article 104 
Access to information of the Union variety register 

The  Agency  shall  notify  the  competent  authorities  and  the  Commission  of  the 
information required to access the Union variety register. 

By 31 March of each year, the Agency shall notify the competent authorities and the 
Commission  of  any  amendments  of  the  Union  variety  register  made  during  the 
preceding year with regard to the varieties registered pursuant to Article 94(1). 

The  Agency  shall,  on  request,  and  with  regard  to  varieties  registered  in  the  Union 
variety register pursuant to Article 94(1), make available to a competent authority or 
the Commission: 

(a) 

the examination reports or the official description of the registered varieties; 

(b) 

the results of technical examinations; 

(c) 

the list of varieties for which applications for registration are pending; 

(d) 

any other information available in respect of registered or deleted varieties. 

The  Agency  shall  take  appropriate  measures  to  make  available  the  information 
contained in the files of the Union variety register to any person requesting access to 
that  information.  This  provision  shall  not  apply  where  the  information  must  be 
treated as confidential under Article 75. 

4. 

1. 

2. 

3. 

4. 

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PART IV 
PRODUCTION AND MAKING AVAILABLE ON THE 
MARKET OF FOREST REPRODUCTIVE MATERIAL 

TITLE I 
General provisions 

Article 105 
Scope 

This  Part  shall  apply  to  the  production  and  making  available  on  the  market,  of  forest 
reproductive material. 

1. 

For the purposes of this Part, the following definitions shall apply: 

Article 106 
Definitions 

(a) 

"basic  forest  material"  means  seed  source,  stand,  seed  orchard,  parents  of 
family, clone or clonal mixture; 

(b) 

"seed source" means trees within a delimited area from which seed is collected; 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

"stand" means a delineated population of trees possessing sufficient uniformity 
in composition; 

"seed  orchard"  means  a  plantation  of  selected  clones  or  families,  which  is 
isolated or managed so as to avoid or reduce pollination from outside sources, 
and managed to produce frequent, abundant and easily harvested crops of seed; 

"parents of family" means trees used to obtain progeny by controlled or open 
pollination  of  one  identified  parent  used  as  a  female,  with  the  pollen  of  one 
parent  (full-sibling)  or  a  number  of  identified  or  unidentified  parents  (half 
sibling); 

"clone"  means  group  of  individuals  (ramets)  derived  originally  from  a  single 
individual  (ortet)  by  vegetative  reproduction,  including  by  cuttings,  micro-
propagation, grafts, layers or divisions; 

"clonal mixture" means a mixture of identified clones in known proportions; 

''Autochthonous stand" or "autochthonous seed source" means a stand or seed 
source which:  

(i) 

has been continuously regenerated by natural regeneration; or  

(ii)  has  been regenerated  artificially  from  reproductive  material  collected  in 

the same stand or seed source; or  

(iii)  has  been regenerated  artificially  from  reproductive  material  collected  in 
stands  or  seed  sources,  within  the  close  proximity,  meeting  the 
description in points (i) and (ii); 

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(i) 

"Indigenous  stand"  or  'indigenous  seed  source'  means  a  stand  or  seed  source 
raised artificially from seed, the origin of which is situated in the same region 
of provenance; 

(j) 

"origin" means:  

(i) 

(ii) 

for an autochthonous stand or seed source – the place in which the trees 
are growing; 

for a non-autochthonous stand or seed source – the place from which the 
seed or plants were originally introduced; 

(k) 

"provenance" means the place in which any stand is growing;  

(l) 

"region of provenance" means, for a species or sub-species, the 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, and is 
delimited, where appropriate, by altitudinal boundaries; 

(m)  "category" means any of the following groupings of derived forest reproductive 

material: source-identified, selected, qualified or tested reproductive material;  

(n) 

(o) 

(p) 

"source-identified":  means  derived  from  basic  forest  material  which  may  be 
either a seed source or stand located within a single region of provenance; 

"selected":  means  derived  from  basic  forest  material  consisting  of  a  stand 
located  within  a  single  region  of  provenance  and  which  has  been 
phenotypically selected at the population level; 

"qualified":  means  derived  from  basic  forest  material  consisting  of  seed 
orchards,  parents  of  families,  clones  or  clonal  mixtures,  the  components  of 
which have been phenotypically selected at the individual level; 

(q) 

"tested":  means  derived  from  basic  forest  material  consisting  of  stands,  seed 
orchards, parents of families, clones or clonal mixtures of superior quality; 

(r) 

"planting stock" means one of the following:  

(i) 

plants raised from seed units;  

(ii)  plants raised from parts of plants; or  

(iii)  plants raised from natural regeneration(s); 

(s) 

(t) 

"seed  unit"  means  cones,  infructescences,  fruits  and  seeds  intended  for  the 
production of planting stock; 

"parts of plants" means stem cuttings, leaf cuttings and root cuttings, explants 
or  embryos  for  micro-propagation,  buds,  layers,  roots,  scions,  sets  and  any 
parts of a plant intended for the production of planting stock; 

(u) 

"area  of  utilisation"  means  the  area  where  the  forest  reproductive  material  is 
used for a specified purpose. 

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TITLE II 
Basic forest material 

Article 107 
Approval of basic forest material 

1. 

2. 

3. 

4. 

Basic forest material shall be approved by the competent authority for the production 
of the relevant categories of forest reproductive material if it meets the requirements 
set out in Annexes V, VI, VII or VIII.  

Each unit of approved basic forest material (hereinafter:  'unit of  approval')  shall be 
identified by a unique reference to the register referred to in Article 112(1). 

The approval shall be withdrawn, if the requirements referred to in paragraph 1 are 
no longer met. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  supplementing  the  requirements  set  out  in  point  3  of  Annex  VII 
concerning  clones,  and  point  4  of  Annex  VII  concerning  clonal  mixtures,  by 
determining  the  maximum  number  of  years  or  the  maximum  number  of  ramets  to 
which the approval of clones or clonal mixtures shall be restricted  

Article 108 
Provisional approval of basic forest material intended for the production of tested material 

1. 

Basic  forest  material  intended  for  the  production  of  forest  reproductive  material 
under  the  'tested'  category,  whose  compliance  with  the  requirements  referred  to  in 
Article  107(1)  has  not  been  established,  may  provisionally  be  approved  by  the 
competent  authorities  for  a  maximum  period  of  ten  years,  provided  that  it  can  be 
assumed that the basic forest material will, when tests have been completed, satisfy 
the  requirements  for  approval.  That  assumption  shall  be  based  on  the  provisional 
results of the genetic evaluation or comparative tests referred to in Annex VIII. 

2. 

The  provisional  approval  referred  to  in  paragraph  1  may  cover  all  or  part  of  the 
territory of the Member Stated concerned.  

Article 109 
Post approval inspections 

After the approval referred to in Articles 107 and 108, basic forest material intended for the 
production of forest reproductive material under the selected, qualified and tested categories 
shall  be  re-inspected  by  the  competent  authority  at  regular  intervals  to  confirm  compliance 
with those Articles.  

Article 110 
Demarcation of regions of provenance 

1. 

2. 

The  Member  States  shall  demarcate  the  regions  of  provenance  of  basic  forest 
material consisting of stands or seed sources and intended for the production of forest 
reproductive material under the ‘source-identified’ and ‘selected’ categories. 

Member  States  shall  draw  up  and  publish  maps  showing  the  demarcations  of  the 
regions of provenance. Those maps shall be communicated to the Commission and 
other Member States. 

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Article 111 
Notification of the intention to collect approved basic forest material 

The  professional  operators  shall  inform  the  competent  authorities  in  due  time  about  their 
intention to collect material from approved basic forest material. 

Article 112 
National register and national list of approved basic forest material 

1. 

2. 

3. 

Member States shall establish a national register of basic forest material approved on 
their  territory  pursuant  to  Article  107  and  Article  108.  That  register  shall  contain 
information  concerning  the  unit  of  approval  together  with  its  unique  register 
reference. 

Each  Member  State  shall  establish,  publish  and  update  a  summary  of  the  national 
register in the form of a national list.  

The national list referred to in paragraph 2 shall be drawn up in a common form. It 
shall  enumerate  each  unit  of  approval.  However,  for  basic  forest  material  intended 
for the categories 'source-identified- and 'selected', a further summarisation based on 
regions of provenance shall be permitted. 

4. 

The national list referred to in paragraph 2 shall contain the following details: 

(a) 

botanical name; 

(b) 

category for the production of which the basic forest material is intended; 

(c) 

(d) 

(e) 

(f) 

purpose  of  the  forest  reproductive  material  which  will  derive  from  the  basic 
forest material; 

type  of  basic  forest  material  (seed  source,  stand,  seed  orchard,  parents  of 
family, clone or clonal mixture); 

register  reference  to  the  unit  of  approval  or,  where  appropriate,  summary 
thereof or identity code of the region of provenance; 

location:  a  short  name,  if  appropriate,  and  any  of  the  following  sets  of 
particulars: 

(i) 

(ii) 

for basic forest material intended for production of the ‘source-identified’ 
category, region of provenance and geographical position defined by the 
latitudinal and longitudinal range; 

for  basic  forest  material  intended  for  production  of  the  ‘selected’ 
category, the region of provenance and the geographical position defined 
by latitude and longitude or the latitudinal and longitudinal range; 

(iii)  for  basic  forest  material  intended  for  production  of  the  ‘qualified’ 
category,  the  exact  geographical  position(s)  where  the  basic  material  is 
maintained; 

(iv)  for basic forest material intended for production of the ‘tested’ category, 
the exact geographical position(s) where the basic material is maintained; 

(g) 

(h) 

altitude or altitudinal range; 

area: the size of a seed source(s), stand(s) or seed orchard(s); 

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(i) 

the  basic  material 

is  autochthonous/indigenous,  non 
origin:  whether 
is  unknown.  For  non-
autochthonous/non-indigenous  or 
autochthonous/non-indigenous  basic  material,  the  origin  shall  be  stated  if 
known; 

the  origin 

if 

5. 

1. 

2. 

3. 

4. 

(j) 

in the case of basic forest material intended for the ‘tested’ category, whether it 
is genetically modified. 

The Commission shall, by means of implementing acts, adopt the common form in 
which  national  lists  shall  be  established,  as  referred  to  in  paragraph  3.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 141(3). 

Article 113 
Union List of Approved Basic Forest Material  

Member  States  shall  notify  to  the  Agency,  the  Commission  and  the  other  Member 
States the national list referred to in Article 112(2) and any of its updates within five 
working days. 

On  the  basis  of  the  national  lists  notified  by  each  Member  State,  the  Agency  shall 
establish, publish and update a register entitled ‘Union List of Approved Basic Forest 
Material for the Production of Forest Reproductive Material'. 

The  Agency  shall  include  in  that  register  all  elements  of  the  Community  List  of 
Approved  Basic  Material  for  the  Production  of  Forest  Reproductive  Material 
published pursuant to Article 11(1) of Directive 1999/105/EC. 

That  Union  list  shall  reflect  the  details  contained  in  the  national  lists  referred  to  in 
Article  112  and  indicate  the  area  of  utilisation,  and  any  authorisations  granted 
pursuant to Article 128. 

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format  of  the 
notification referred to in paragraph 1 and of the register referred to in paragraph 2. 
Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 141(3).  

TITLE III 
Making available on the market of material derived from basic 
forest material 

Article 114 
Scope 

This  title  shall  apply  to  the  making  available  on  the  market  of  forest  reproductive  material 
derived from basic forest material. 

CHAPTER I 
List of requirements 

Article 115 
Requirements for making available on the market of forest reproductive material 

Forest reproductive material may only be made available on the market if it complies with: 

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(a) 

(b) 

(c) 

(d) 

the registration requirements set out in Chapter II; 

the quality requirements set out in Chapter III for the relevant category; 

the handling requirements set out in Chapter IV; 

the certification and identification requirements set out in Chapter V. 

CHAPTER II 
Registration requirements 

Article 116 
Forest reproductive material derived from basic forest material registered in a national 
register 

Forest reproductive material may be made available on the market only if it is derived from 
approved basic forest material registered in a national register pursuant to Article 112(1) and 
approved for the relevant category pursuant to Title II. 

CHAPTER III 
Quality requirements 

Article 117 
Quality requirements 

1. 

2. 

3. 

4. 

5. 

6. 

Forest  reproductive  material  shall  be  made  available  on  the  market  under  the 
categories ‘source-identified’, ‘selected’, ‘qualified’ or ‘tested’. 

Forest reproductive material belonging to the species and artificial hybrids listed in 
Annex  IX  may  not  be  made  available  on  the  market  under  the  source  identified 
category  if  it  is  has  been  obtained  from  vegetative  reproduction  of  other  forest 
reproductive material. 

Forest  reproductive  material  belonging  to  the  artificial  hybrids  listed  in  Annex  IX 
shall only be made available under the categories ‘selected’, ‘qualified’ or ‘tested’.  

Forest reproductive material belonging to the species and artificial hybrids listed in 
Annex IX may only be made available on the market under ‘selected’ category if it 
has been mass propagated from seeds 

Notwithstanding  paragraphs  1  and  2,  forest  reproductive  material  belonging  to  the 
species and artificial hybrids listed in Annex IX, which consists wholly or partly of 
genetically modified organisms may only be made available on the market under the 
‘tested’ category. 

The  types  of  basic  forest  material  which  shall  be  used  for  the  production  of  the 
various  categories  of  forest  reproductive  material  belonging  to  the  species  and 
artificial hybrids listed in Annex IX are set out in Annex X. 

Article 118 
Additional requirements for certain forms of forest reproductive material 

Forest reproductive material belonging to the species and artificial hybrids listed in Annex IX 
and referred to in Annex XI may only be made available on the market if it meets the quality 
requirements set out in Annex XI, in addition to those applicable pursuant to Article 117. 

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Article 119 
Additional requirements for certain parts of plants and planting stock 

The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, 
setting  out  quality  requirements  for  making  available  on  the  market  specific  parts  of  plants 
and  planting  stock  of  species  and  artificial  hybrids  listed  in  Annex  IX,  supplementing  the 
requirements referred to in Articles 117 and 118. Those requirements shall take into account 
the development of scientific and technical knowledge. 

CHAPTER IV 
Handling requirements 

Article 120 
Lots 

1. 

2. 

Forest  reproductive  material  shall,  during  all  stages  of  production,  be  kept  in 
separated lots by reference to individual units of approval from which it derives.  

Forest reproductive material shall be made available on the market in lots. 

Article 121 
Packaging of seed units 

Seed units shall be made available on the market only in sealed packages. The sealing device 
shall be such that it will become unserviceable when the package is opened. 

CHAPTER V  
Certification and identification requirements  

Article 122 
Master certificate 

1. 

2. 

3. 

4. 

5. 

After harvesting, a master certificate showing the reference of the register referred to 
in point (e) of Article 112(4) shall be issued by the competent authority for all forest 
reproductive material derived from approved forest basic material.  

The master certificate shall contain the relevant information set out, as applicable, in 
Part A, Part B and Part C of Annex XII. 

For  subsequent  vegetative  reproduction  in  accordance  with  Article  117(2),  a  new 
master certificate shall be issued. 

Where  mixing  takes  place  in  accordance  with Article 126(1), (2), (3) or (5), a new 
master certificate, or other document, identifying the previous master certificates of 
the material composing the mixture shall be issued. 

The Commission shall determine, by means of implementing acts, the model of the 
format  of  the  master  certificate  as  referred  to  in  paragraph  1.  Those  implementing 
acts  shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 141(3). 

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Article 123 
Identification of lots  

1. 

2. 

Each lot shall remain clearly identifiable through the entire process from collection 
to delivery to the end user. 

Each  lot  of  forest  reproductive  material  shall  be  identified  by  the  following 
information: 

(a) 

the master certificate code and number; 

(b) 

the botanical name; 

(c) 

the category of forest reproductive material;  

(d) 

the purpose; 

(e) 

the  type  of  basic  forest  material  from  which  the  forest  reproductive  material 
derives  (seed  source,  stand,  seed  orchard,  parents  or  family,  clone  or  clonal 
mixture); 

(f) 

the register reference of the basic forest material or identity code of the region 
of provenance of the basic forest material; 

(g)  whether the basic forest material, from which the forest reproductive material 
derives, is autochthonous or indigenous, non-autochthonous or non-indigenous, 
or whether its origin is unknown; 

(h) 

in the case of seed units, the year of ripening; 

(i) 

(j) 

the age of planting stock, of seedlings or of cuttings;  

the type of planting stock (whether undercuts, transplants or containerised); 

(k)  where applicable, the fact that it is genetically modified; 

(l)  where applicable, the fact that it has been vegetatively reproduced. 

Article 124 
Labelling 

1. 

Each  lot  shall  be  accompanied  by  a  label  produced  by  the  professional  operator 
(hereinafter  'operator's  label').  The  operator's  label  shall  contain,  in  addition  to  the 
information required under Article 123, the following information: 

(a) 

the master certificate number(s) issued under Article 122(1) or the reference to 
the other document available according to Article 122(4); 

(b) 

the reference number, where applicable, and the name of professional operator; 

(c) 

(d) 

the quantity supplied; 

in the case of forest reproductive material of the ‘tested’ category derived from 
basic forest material which is provisionally approved under Article 108(1), the 
words ‘provisionally approved’. 

2. 

In the case of seeds, the operator's label shall also include the following information:  

(a) 

(b) 

the percentage by weight of pure seed, other seed and inert matter;  

the germination rate of the pure seed, or, where germination rate is impossible 
or  impractical  to  assess,  the  viability  percentage  assessed  by  reference  to  a 
specified method; 

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(c) 

(d) 

the weight of 1 000 pure seeds; 

the number of germinable seeds per kilogram of product made available on the 
market  as  seed,  or,  where  the  number  of  germinable  seeds  is  impossible  or 
impractical to assess, the number of viable seeds per kilogram. 

3. 

4. 

The  colour  of  the  operator's  label  shall  be  yellow  in  the  case  of  ‘source-identified’ 
reproductive  material,  green  in  the  case  of  ‘selected’  reproductive  material,  pink  in 
the  case  of  ‘qualified’  reproductive  material  and  blue  in  the  case  of  ‘tested’ 
reproductive material. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  140,  setting  out  the  conditions  under  which  the  operator's  label  shall  be 
supplemented  by  another  document  produced  by  the  professional  operator.  Those 
delegated acts shall determine the information items to be included in that document.  

Article 125 
Labelling of forest reproductive material belonging to Populus spp. species 

In the case of Populus spp., parts of plants shall only be made available on the market if the 
Union  classification  number  according  to  point  2(b)  of  Annex  XI,  Part  C  is  given  on  the 
operator's label. 

1. 

2. 

3. 

4. 

5. 

6. 

Article 126 
Mixtures of forest reproductive material 

Mixtures of forest reproductive material shall be produced and made available on the 
market in accordance with the provisions of this Article. 

Mixing  of  forest  reproductive  material  derived  from  two  or  more  units  of  approval 
within  the  ‘source-identified’  category  or  within  the  ‘selected’  category  may  take 
place if the units of approval are located in the same region of provenance. 

When forest reproductive material derived from different seed sources and stands is 
mixed  pursuant  to  paragraph  2  within  the  ‘source-identified’  category,  the  new 
combined lot shall be certified as ‘reproductive material derived from a seed source’. 

When  forest  reproductive  material  derived  from  non-autochthonous  or  non-
indigenous  basic  forest  material  is  mixed  pursuant  to  paragraph  2  with  forest 
reproductive material derived from basic forest material of unknown origin, the new 
combined lot shall be certified as being ‘of unknown origin’. 

When  mixing  takes  place  in  accordance  with  paragraph  4,  the  identity  code  of  the 
region of provenance may not be substituted for the register reference as provided for 
in Article 123(f). 

Mixing  of  forest  reproductive  material  derived  from  a  single  unit  of  approval  from 
different years of ripening may take place provided that the actual years of ripening 
and proportion of material from each year are recorded by the professional operator. 

Article 127 
Amendments to Annexes V to XII 

The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, 
amending Annexes V to XII. Those amendments shall take into account the development of 
scientific or technical knowledge and economic data. 

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TITLE IV 
Derogations 

Article 128 
More stringent requirements and prohibitions 

1. 

The Commission may, by means of implementing acts, authorise Member States: 

(a) 

(b) 

to  adopt  more  stringent  quality  requirements  than  those  referred  to  in  Article 
117 and 118; and 

to  prohibit  the  making  available  on  the  market  with  a  view  to  seeding  or 
planting in all or part of its territory of specified forest reproductive material.  

The prohibition referred to in point(b) may be restricted to making available on the 
market to the end users only. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 141(3).  

2. 

In  order  to  obtain  the  authorisation  referred  to  in  paragraph  1(a)  and  (b),  Member 
States shall submit to the Commission a request setting out: 

(a) 

(b) 

draft provisions concerning the proposed requirements or prohibitions; 

a  justification  on  the  necessity  and  proportionality  of  such  requirements  or 
prohibitions;  

(c)  whether the proposed requirements or prohibitions would be permanent or for a 

specified period. 

3. 

The  authorisation  referred  to  in  paragraph  1  shall  be  granted  if  the  following 
conditions are fulfilled: 

(a) 

the implementation of the restrictions or prohibitions referred to in paragraph 1, 
ensures  improvement  of  the  quality  of  the  forest  reproductive  material 
concerned, protection of the environment or conservation of genetic resources; 
and 

(b) 

the  restrictions  or  prohibitions  referred  to  in  paragraph  1  are  necessary  and 
proportionate to their objective. 

4. 

The authorisation referred to in paragraph 1 shall be granted on the basis of: 

(a) 

evidence relating to the region of provenance or the origin of the material, and 
documentation  showing  the  differences  in  the  respective  climatic  and 
ecological data; or 

(b)  known results of trials, scientific research, or the results obtained from forestry 
practice  concerning  survival  and  development  of  planting  stock,  including 
growth, in relation to morphological and physiological characteristics. 

Article 129 
Temporary difficulties in supply 

1. 

In order to remove temporary difficulties in the general supply of forest reproductive 
material that may occur in a Member State, the competent authority of the Member 
State  concerned  may  authorise  the  making  available  on  the  market  of  forest 

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reproductive material belonging to the species and artificial hybrids listed in Annex 
IX  with  reduced  requirements,  compared  to  the  requirements  of  Articles  117  and, 
where applicable, Article 118 and Article 119. 

That authorisation shall be granted, on the basis of a reasoned request submitted by 
the professional operator concerned, for a specific period of time.  

The label of the forest reproductive material made available on the market pursuant 
to  this  paragraph  shall  be  brown.  It  shall  state  that  the  forest  reproductive  material 
complies with lower quality requirements than those referred to in Articles 117 and, 
where applicable, Article 118 and Article 119. 

Member  States  shall  notify  the  Commission  and  the  other  Member  States  of  each 
authorisation granted pursuant to this paragraph. 

The  Commission  may,  by  means  of  implementing  acts,  require  a  Member  State  to 
repeal or amend an authorisation granted pursuant to paragraph 1, if it concludes that 
that  authorisation  is  unnecessary  or  not  proportionate  to  the  objective  of  removing 
the temporary difficulties in the general supply of forest reproductive material. Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 141(3). 

2. 

Article 130 
Seed made rapidly available on the market 

In  order  to  make  seed  of  the  current  season's  crop  rapidly  available,  forest  reproductive 
material  may  be  made  available  on  the  market  as  far  as  to  the  first  buyer,  without  the 
information  on  germination  or  viability  being  included  on  the  operator's  label  pursuant  to 
Article  124(2)(b)  and  (d).  The  information  referred  to  in  Article  124(2)(b)  and  (d)  shall  be 
provided by the professional operator as soon as possible. 

1. 

2. 

1. 

Article 131 
Exemption for small quantities 

In the case of seed made available on the market in small quantities, the information 
requirements  concerning  germination  or  viability  as  laid  down  in  Article  124(2)(b) 
and (d) shall not apply.  

The Commission shall be empowered to adopt delegated acts, in accordance with the 
Article  140,  setting  out  the  maximum  size  of  the  small  quantities  referred  to  in 
paragraph  1  for  particular  categories  or  species  of  forest  reproductive  material  to 
ensure that the exemption of paragraph 1 is applied in a proportionate manner.  

Article 132 
Emergency measures 

Where it is evident that forest reproductive material is likely to constitute a serious 
risk to human, animal and plant health or the environment, and that such risk cannot 
be  contained  satisfactorily  by  means  of  measures  taken  by  the  Member  State(s) 
concerned, the Commission on its own initiative or at the request of a Member State, 
shall  without  delay  take  any  appropriate  interim  emergency  measures,  including 
measures  restricting  or  prohibiting  the  making  available  on  the  market  of  the  plant 
reproductive  material  concerned,  depending  on  the  gravity  of  the  situation.  Those 

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2. 

3. 

4. 

1. 

2. 

1. 

measures  shall  be  adopted  by  means  of  implementing  acts  in  accordance  with  the 
examination procedure referred to in Article 141(3). 

On duly justified imperative grounds of urgency to address a serious risk to human 
health,  the  Commission  shall  adopt  immediately  applicable  implementing  acts  in 
accordance with the procedure referred to in Article 141(4). 

Where  a  Member  State  officially  informed  the  Commission  of  the  need  to  take 
emergency  measures  and  the  Commission  has  not  acted  in  accordance  with 
paragraph  1,  the  Member  State  concerned  may  adopt  any  appropriate  interim 
emergency  measures,  restricting  or  prohibiting,  within  its  territory,  the  making 
available on the market of the forest reproductive material concerned, depending on 
the gravity of the situation. It shall immediately inform the other Member States and 
the Commission thereof, stating the grounds for its decision. The Commission may 
adopt implementing acts requiring the Member State to amend or repeal the national 
interim  emergency  measures.  Those  implementing  acts  shall  be  adopted  in 
accordance  with  the  examination  procedure  referred  to  in  Article  141(3).  The 
Member State may maintain its national interim emergency measures until the date 
of application of the implementing acts referred to in this paragraph.  

This  Article  shall  apply  without  prejudice  to  any  measures  adopted  pursuant  to 
Article  23(2)  of  Directive  2001/18/EC  or  Article  34  of  Regulation  (EC)  No 
1829/2003  prohibiting  or  restricting  the  cultivation  of  genetically  modified 
organisms. 

Article 133 
Temporary experiments 

The Commission may decide, by means of implementing acts, to organise temporary 
experiments  in  order  to  identify  improved  alternatives  to  any  provisions  set  out  in 
Articles  107,  117  and,  where  applicable,  Article  118  and  Article  119.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 141(3). 

The implementing acts referred to in paragraph 1 shall identify the genera or species 
concerned, the conditions of the experiment per genera or species, the duration of the 
experiments,  and  the  monitoring  and  reporting  obligations  of  the  participating 
Member  States.  They  shall  take  into  account  the  evolution  of  techniques  for 
reproduction, production and control of the concerned material.  

The duration of an experiment shall not exceed seven years. 

Article 134 
Less stringent requirements to conserve genetic resources 

Member States may adopt requirements less stringent than those set out in Articles 
107,  117  and,  where  applicable,  Article  118  and  Article  119,  in  the  interest  of 
conservation and sustainable use of forest genetic resources. In doing so, they shall 
consider  the  need  of  producing  and  making  available  on  the  market  forest 
reproductive material which is naturally adapted to the local and regional conditions 
and threatened by genetic erosion.  

Member  States  shall  submit  to  the  Commission  and  the  other  Member  States  a 
reasoned notification of those measures.  

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2. 

The  Commission  may,  by  means  of  implementing  acts,  require  a  Member  State  to 
repeal  or  amend  the  measures  referred  to  in  paragraph  1,  if  it  concludes  that  those 
measures are not necessary or not proportionate to the objective of conservation and 
sustainable use of forest genetic resources. Those implementing acts shall be adopted 
in accordance with the examination procedure referred to in Article 141(3). 

TITLE V 
Fees  

Article 135 
Registration and certification fees 

1. 

Competent authorities shall charge fees for the following actions: 

2. 

3. 

1. 

2. 

3. 

(a) 

registration of approved basic forest material pursuant to Article 112; and 

(b) 

issuance of a master certificate pursuant to Article 122.  

The actions referred to in paragraph 1 shall only be carried out on demand submitted 
by the professional operator to the competent authority. The demand shall be deemed 
not to have been made if the fees have not been paid within one month from the date 
on which the competent authority requested payment of the fees and indicated in that 
request the consequences of the failure to pay. 

The Commission shall be empowered to adopt delegated acts, in accordance with the 
procedure referred to in Article 140, setting out the specific cost items to be covered 
pursuant to paragraph 1(a) and (b).  

Article 136 
Exemptions from the payment of registration fees 

Fees provided for in Article 135(1) shall not directly or indirectly be refunded, unless 
unduly collected.  

Applicants  employing  fewer  than  10  persons  and  whose  annual  turnover  or  annual 
balance  sheet  total  does  not  exceed  EUR  2  million  shall  be  exempted  from  the 
payment of the fees provided for in Article 135(1). 

The  costs  referred  to  in  Article  135(3)  shall  not  include  those  incurred  for  the 
registration of approved basic forest material and the issuance of a master certificate 
referred to in paragraph 2. 

TITLE VI 
Imports from and exports of forest reproductive material to third 
countries 

Article 137 
Imports on the basis of Union equivalence 

1. 

Forest  reproductive  material  may  be  imported  from  third  countries  only  if  it  is 
established,  pursuant  to  Article  138,  that  it  fulfils  requirements  equivalent  to  those 
applicable  to  forest  reproductive  material  produced,  and  made  available  on  the 
market in the Union. 

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2. 

3. 

1. 

2. 

3. 

1. 

2. 

3. 

Where seed and planting stock are imported into the Union, the professional operator 
importing  that  forest  reproductive  material  shall  inform  the  respective  competent 
authority in advance of the import. 

Imported  forest  reproductive  material  shall  be  accompanied  by  a  master  certificate, 
or an official certificate, issued by the third country of origin, and records containing 
details of that material provided by the professional operator in that third country. 

Article 138 
Commission Decision on equivalence  

The  Commission  may  decide,  by  means  of  implementing  acts,  whether  forest 
reproductive  material  of  specific  genera,  species  οr  categories  produced  in  a  third 
country, or particular areas of a third country, fulfils requirements equivalent to those 
applicable to forest reproductive material produced and made available on the market 
in the Union, on the basis of:  

(a) 

a thorough examination of information and data provided by the third country 
concerned pursuant to Article 124(1) of Regulation (EU) No …/… [Office of 
Publications, please insert number of Regulation on Official Controls]; and 

(b)  where  appropriate,  the  satisfactory  outcome  of  a  control  performed  in 
accordance  with  Article  119(1)  of  Regulation  (EU)  No  …/…  [Office  of 
Publications, please insert number of Regulation on Official Controls]; 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 141(3). 

When  adopting  the  decisions  referred  to  in  paragraph  1,  the  Commission  shall 
consider  whether  the  systems  for  approval  and  registration  of  basic  forest  material 
and  subsequent  production  of  forest  reproductive  material  from  that  basic  forest 
material  applied  in  the  third  country  concerned  afford  the  same  assurance  as  those 
provided for in Articles 107 and 117, and, where applicable, Article 118 and Article 
119, for the 'source identified', 'selected', 'qualified' and 'tested' categories. 

For the purpose of adopting the decisions referred to in paragraph 1, the Commission 
may  apply  the  provisions  of  Article  71  of  Regulation  (EU)  No  …/…  [Office  of 
Publication, please insert number of Regulation on Official Controls] concerning the 
approval of pre-export controls carried out by third countries. 

Article 139 
Export from the Union  

Where the export of forest reproductive material to a third country is governed by an 
agreement with that third country, that export shall comply with that agreement.  

Where the export of forest reproductive material to a third country is not governed by 
an agreement with that country, that export shall  take place in  accordance with the 
rules  of  the  third  country  into  which  that  forest  reproductive  material  is  to  be 
exported.  

Where  the  export  of  forest  reproductive  material  to  a  third  country  is  neither 
governed by an agreement with a third country nor by the rules of the third country 
into  which  that  forest  reproductive  material  is  to  be  exported,  the  requirements  for 
production  and  making  available  on  the  market  of  forest  reproductive  within  the 
Union territory, as set out in Articles 105 to 134, shall apply.  

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PART V 
PROCEDURAL PROVISIONS 

Article 140 
Delegated acts 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

The  delegation  of  power  referred  to  in  Articles  11(3),  13(3),  14(3),  15(5),  16(2), 
17(4),  18(4),  18(6),  20(4),  21(5),  23(3),  30(4),  32(1),  33(3),  34(6),  36(4),  38(4), 
39(3), 44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67(2), 72(2), 74(1), 119, 124(4), 127, 
131(2)  and  135(4)  and  138(1)  shall  be  conferred  on  the  Commission  for  an 
indeterminate period of time from the date of the entry into force of this Regulation. 

The  delegation  of  power  referred  to  in  Articles  11(3),  13(3),  14(3),  15(5),  16(2), 
17(4),  18(4),  18(6),  20(4),  21(5),  23(3),  30(4),  32(1),  33(3),  34(6),  36(4),  38(4), 
39(3), 44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67(2), 72(2), 74(1), 119, 124(4), 127, 
131(2), 135(4) and 138(1) may be revoked at any time by the European Parliament or 
by  the  Council.  A  decision  of  revocation  shall  put  an  end  to  the  delegation  of  the 
power specified in that decision. It shall take effect the day following the publication 
of  the  decision  in  the  official  Journal  of  the  European  Union  or  at  a  later  date 
specified therein. It shall not affect the validity of any delegated acts already in force. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

A delegated act adopted pursuant to Articles 11(3), 13(3), 14(3), 15(5), 16(2), 17(4), 
18(4),  18(6),  20(4),  21(5),  23(3),  30(4),  32(1),  33(3),  34(6),  36(4),  38(4),  39(3), 
44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67(2), 72(2), 74(1), 119, 124(4), 127, 131(2) 
135(4)  and  138(1)  shall  enter  into  force  only  if  no  objection  has  been  expressed 
either by the European Parliament or the Council within a period of two months of 
notification of that act to the European Parliament and the Council or if, before the 
expiry of that period, the European Parliament and the Council have both informed 
the  Commission  that  they  will  not  object.  That  period  shall  be  extended  by  two 
months at the initiative of the European Parliament or the Council. 

Article 141 
Committee procedure 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Plants,  Animals, 
Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council. That committee shall be a committee within 
the meaning of Regulation (EU) No 182/2011.  

Where  reference  is  made  to  this  paragraph,  Article  4  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  the  opinion  of  the  committee  is  to  be  obtained  by  written  procedure,  that 
procedure shall be terminated without result when, within the time-limit for delivery 
of  the  opinion,  the  chair  of  the  committee  so  decides  or  a  simple  majority  of 
committee members so request. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

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3. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  the  opinion  of  the  committee  is  to  be  obtained  by  written  procedure,  that 
procedure shall be terminated without result when, within the time-limit for delivery 
of  the  opinion,  the  chair  of  the  committee  so  decides  or  a  simple  majority  of 
committee members so request. 

4. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU)  No 
182/2011, in conjunction with Article 5 thereof shall apply. 

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PART VI 
FINAL PROVISIONS 

Article 142 
Amendment of Regulation (EC) No 2100/94 

Regulation (EC) No 2100/94 is amended as follows: 

(1) 

Article 4 is replaced by the following: 

'Article 4 
Union Agency 

1. 

For purposes of the implementation of this Regulation, a European Agency on 
Plant Varieties, hereinafter referred to as 'Agency', is hereby established. 

2. 

The Agency shall carry out the following tasks:  

(a) 

(b) 

to offer recommendations on variety denominations, where requested so 
pursuant to Article 50(2) and 78(2) of Regulation (EU) No …/… [Office 
of Publications, please insert number of this Regulation];  

to  promote  and  coordinate  development  of  uniform 
technical 
examination of varieties, including development of protocols, carried out 
pursuant to Article 71 and, where applicable, the acts adopted pursuant to 
Article  74  of  Regulation  (EU)  No  …/…  [Office  of  Publications,  please 
insert number of this Regulation] 

(c) 

to carry out audits of competent authorities, including their premises and 
organisation of work, carrying out technical examinations, as referred to 
in Article 72 of the PRM Regulation;  

(d) 

to offer, and participate in offering, training in its area of mission; 

(e) 

(f) 

(g) 

(h) 

(i) 

to  provide  technical  support  to  the  Commission  in  the  areas  within  its 
mission; 

to commission studies necessary for the accomplishment of its mission;  

to search for, collect, collate, analyse and summarise technical data in the 
fields within its mission; 

to  ensure  that  the  public  and  interested  parties  receive  rapid,  reliable, 
objective and comprehensible information in the fields within its mission; 

to  provide  technical  assistance,  when  requested  to  do  so  by  the 
Commission, with a view to improving cooperation between the Union, 
applicant countries, international organisations and third countries, in the 
fields within its mission; 

(j) 

to  establish,  publish  and  update  a  database  on  reference  collections  of 
varieties.' 

3. 

The  Agency  shall  also  manage  and  support  the  Union  variety  register, 
established in accordance with Article 52 of Regulation (EU) No …/… [Office 
of  Publications,  please  insert  number  of  this  Regulation].  It  shall  implement 
the  procedure  for  the  registration  of  varieties  in  the  Union  variety  register  in 

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accordance with Chapter V of Title IV of Regulation (EU) No …/… [Office of 
Publications, please insert number of this Regulation]'. 

(2) 

The following Article 4a is inserted: 

'Article 4a 
References to the Community Plant Variety Office (Office) 

References  made  in  this  Regulation  to  the  Office  and  references  made  in  Union 
legislation to the Community Plant Variety Office shall be construed as references to 
the European Agency on Plant Varieties established by Article 4.' 

Article 143 
Penalties 

The Member States shall lay down the rules on penalties applicable to infringements of this 
Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are  implemented.  The 
penalties provided for must be effective, proportionate and dissuasive. 

The Member States shall notify those provisions to the Commission within one year after the 
entry into force of this Regulation and shall notify without delay any subsequent amendments 
of those provisions. 

Article 144 
Repeals  

1. 

2. 

1. 

The acts referred to in Annex XIII are hereby repealed. 

References  to  the  repealed  acts  shall  be  construed  as  references  to  this  Regulation 
and shall be read in accordance with the correlation table in Annex XIV. 

Article 145 
Transitional Provisions 

Member States shall, by [Office of Publications, please insert date of application of 
this  Regulation],  review  the  measures  adopted  pursuant  to  Article  5  of  Directive 
66/401/EEC,  Article  5  of  Directive  66/402/EEC,  Article  4(1)  of  Directive 
68/193/EEC, Article 7 of Directive 2002/54/EC, Article 24 of Directive 2002/55/EC, 
Article 5 of 2002/56/EC and Article 7 of 2002/57/EC, and take one of the following 
actions: 

(a) 

(b) 

repeal those measures; or 

amend those measures to comply with the applicable Union legislation on the 
plant reproductive material concerned. 

2. 

Member States shall notify to the Commission and the other Member States:  

(a) 

all  measures  adopted  pursuant  to  the  Directives  referred  to  in  paragraph  1  by 
[Office  of  Publications,  please  insert  date  of  application  of  this  Regulation]; 
and  

(b) 

any action taken pursuant to points (a) or (b) of paragraph (1). 

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Article 146 
Entry into force 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

It  shall  apply  from  [Office  of  Publications  please  insert  date  counting  36  months  from  the 
entry into force]. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President

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ANNEX I 

GENERA AND SPECIES AS REFERRED TO IN ARTICLE 11 

Abies alba Mill. 

Abies cephalonica Loudon 

Abies grandis Lindl. 

Abies pinsapo Boiss. 

Acer platanoides L. 

Acer pseudoplatanus L. 

Agrostis canina L.  

Agrostis capillaris L.  

Agrostis gigantea Roth.  

Agrostis stolonifera L.  

Allium cepa L.  

Allium fistulosum L. 

Allium porrum L.  

Allium sativum L.  

Allium schoenoprasum L.  

Alnus glutinosa Gaertn. 

Alnus incana Moench. 

Alopecurus pratensis L.  

Anthriscus cerefolium (L.) Hoffm.  

Apium graveolens L.  

Arachis hypogaea L.  

Arrhenatherum elatius (L.) P. Beauv. ex J. Presl & C. Presl.  

Asparagus officinalis L. 

Avena nuda L.  

Avena sativa L.(including A. byzantina K. Koch) 

Avena strigosa Schreb.  

Beta vulgaris L. 

Betula pendula Roth. 

Betula pubescens Ehrh. 

Brassica juncea (L.) Czern.  

Brassica napus L. 

Brassica nigra (L.) W.D.J. Koch  

Brassica oleracea L.  

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Brassica rapa L. 

Bromus catharticus Vahl  

Bromus sitchensis Trin.  

Cannabis sativa L. 

Capsicum annuum L. 

Carpinus betulus L. 

Carthamus tinctorius L. 

Carum carvi L.  

Castanea sativa Mill. 

Castanea Mill. (rootstocks) 

Cedrus atlantica (Endl) Manetti ex Carr. 

Cedrus libani A. Richard 

Cichorium endivia L. 

Cichorium intybus L.  

Citrullus lanatus (Thunb.) Matsum. & Nakai  

Citrus L. 

Corylus avellana L. 

Corylus L. (rootstocks) 

Cucumis melo L.  

Cucumis sativus L. 

Cucurbita maxima Duchesne 

Cucurbita pepo L. 

Cydonia oblonga Mill. 

Cynara cardunculus L. 

Cynodon dactylon (L.) Pers.  

Dactylis glomerata L.  

Daucus carota L. 

Fagus sylvatica L. 

Festuca arundinacea Schreb.  

Festuca filiformis Pourr.  

Festuca ovina L.  

Festuca pratensis Huds.  

Festuca rubra L.  

Festuca trachyphylla (Hack.) Krajina 

xFestulolium Asch. et Graebn. 

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Ficus carica L. 

Foeniculum vulgare Mill.  

Fortunella Swingle 

Fragaria L. 

Fraxinus angustifolia Vahl. 

Fraxinus excelsior L. 

Galega orientalis Lam.  

Glycine max (L.) Merrill  

Gossypium L. 

Hedysarum coronarium L.  

Helianthus annuus L. 

Hordeum vulgare L. 

Juglans regia L. 

Juglans L. (rootstocks) 

Lactuca sativa L.  

Larix decidua Mill. 

Larix kaempferi (Lamb.) Carr. 

Larix sibirica Ledeb. 

Larix x eurolepis Henry 

Linum usitatissimum L.  

Lolium × boucheanum Kunth  

Lolium multiflorum Lam.  

Lolium perenne L.  

Lotus corniculatus L. 

Lupinus albus L. 

Lupinus angustifolius L. 

Lupinus luteus L. 

Malus domestica Borkh. 

Malus Mill. (rootstocks) 

Medicago lupulina L.  

Medicago sativa L. 

Medicago × varia T. Martyn  

Olea europaea L. 

Onobrychis viciifolia Scop. 

Oryza sativa L. 

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Papaver somniferum L.  

Petroselinum crispum (Mill.) Nyman ex A. W. Hill  

Phacelia tanacetifolia Benth.  

Phalaris aquatica L. 

Phalaris canariensis L.  

Phaseolus coccineus L. 

Phaseolus vulgaris L. 

Phleum nodosum L. (formerly Phleum bertolonii DC.) 

Phleum pratense L. 

Picea abies (L.) H. Karst. 

Picea sitchensis (Bong.) Carr. 

Pinus brutia Ten. 

Pinus canariensis C. Smith 

Pinus cembra L. 

Pinus contorta Douglas ex Loud. 

Pinus halepensis Mill. 

Pinus leucodermis Antoine 

Pinus nigra Arnold 

Pinus pinaster Aiton 

Pinus pinea L. 

Pinus radiata D. Don 

Pinus sylvestris L. 

Pistacia vera L. 

Pistacia L. (rootstocks) 

Pisum sativum L.  

Poa annua L. 

Poa nemoralis L. 

Poa palustris L. 

Poa pratensis L. 

Poa trivialis L. 

Poncirus Raf. 

Populus spp. and artificial hybrids between those species 

Prunus amygdalus Batsch  

Prunus armeniaca L. 

Prunus avium (L.) L. 

EN 

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   EN 

Prunus cerasus L. 

Prunus domestica L. 

Prunus persica (L.) Batsch 

Prunus salicina Lindley 

Prunus L. (rootstocks) 

Pseudotsuga menziesii (Mirb.) Franco 

Pyrus communis L.  

Pyrus L. (rootstocks) 

Quercus cerris L. 

Quercus ilex L. 

Quercus petraea (Matt.) Liebl. 

Quercus pubescens Willd. 

Quercus robur L. 

Quercus rubra L. 

Quercus suber L. 

Raphanus sativus L.  

Rheum rhabarbarum L.  

Ribes L. 

Robinia pseudoacacia L. 

Rubus L. 

Scorzonera hispanica L. 

Secale cereale L.  

Sicyos angulatus L. (rootstocks) 

Sinapis alba L.  

Solanum lycopersicum Lam. (formerly Lycopersicon esculentum Mill.)  

Solanum lycopersicum Lam.x Solanum spp. (rootstocks) 

Solanum melongena L.  

Solanum tuberosum L.  

Sorghum bicolor (L.) Moench  

Sorghum bicolor (L.) Moench × Sorghum sudanense (Piper) Stapf.  

Sorghum sudanense (Piper) Stapf  

Spinacia oleracea L. 

Tilia cordata Mill. 

Tilia platyphyllos Scop. 

Trifolium alexandrinum L.  

EN 

98 

   EN 

Trifolium hybridum L.  

Trifolium incarnatum L.  

Trifolium pratense L. 

Trifolium repens L. 

Trifolium resupinatum L.  

Trigonella foenum-graecum L. 

Trisetum flavescens (L.) P. Beauv.  

xTriticosecale Wittm. ex A. Camus  

Triticum aestivum L. 

Triticum durum Desf.  

Triticum spelta L. 

Vaccinium L. 

Valerianella locusta (L.) Laterr. 

Vicia faba L.  

Vicia pannonica Crantz  

Vicia sativa L. 

Vicia villosa Roth. 

Vitis L. 

Zea mays L. 

EN 

99 

   EN 

ANNEX II 

REQUIREMENTS FOR PRE-BASIC, BASIC, CERTIFIED AND STANDARD 
MATERIAL, AND ELEMENTS FOR THE ADOPTION OF THOSE 
REQUIREMENTS 

PART A 

REQUIREMENTS FOR THE PRODUCTION OF PLANT REPRODUCTIVE MATERIAL AS REFERRED 
TO IN ARTICLE 16(2)  

The following requirements for fields and crops shall apply, depending on the characteristics 
of each genus or species: 

1. 

Sowing or planting: 

(a) 

the  identity  of  the  plant  reproductive  material,  including  where  applicable 
mother  plants,  shall  be  determined  to  ensure  the  traceability  of  the  plant 
reproductive  material.  The  label  of  the  material  or  the  records  on  the  mother 
plant shall be kept. 

(b) 

the material shall be planted and /or sowed in a way that there is:  

(i) 

sufficient  distance  from  pollen  sources  of  the  same  species  and/or  the 
same  varieties,  according  to  isolation  rules  per  botanical  characteristics 
and  breeding  techniques,  to  ensure  protection  from  any  undesirable 
foreign pollination and to avoid cross pollination with other crops; 

(ii) 

an  appropriate  source  and  level  of  pollination  to  ensure  the  subsequent 
reproduction; 

(iii)  an  appropriate  rotation  (previous  cropping  and  duration  between 

cropping period with the same species) to avoid impurities; 

appropriate attention shall be paid to the machines and any equipment used to 
ensure  absence  of  weed  or  other  species  which  are  difficult  to  distinguish  at 
seed level in laboratory tests; 

the material shall be sown and planted in a manner to ensure that the presence 
of Union quality pests or their vectors, as listed in an implementing act adopted 
in  accordance  with  Article  37(2)  of  Regulation  EU  (No)  …/…  (Office  of 
Publications,  please  insert  number  of  Regulation  on  protective  measures 
against pests of plants), complies with the provisions of that act. 

(c) 

(d) 

2. 

Cultivation: 

(a)  Off-types  shall  be  absent  to  ensure  varietal  identity  and  purity,  and  efficient 
production.  Where  this  is  not  possible  due  to  the  characteristics  of  the  plant 
reproductive material concerned, they shall be present up to the lowest possible 
level.  

In  case  of  presence  of  off-types  or  other  plant  species,  appropriate  treatment 
and/or elimination shall be applied to ensure varietal identity and purity. 

(b)  Mother plants shall be treated or excluded as a source of reproductive material 

in case of positive test results or visual symptoms of pests or defects. 

(c)  Harvesting: 

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The  plant  reproductive  material  shall  be  harvested  in  bulk  or  as  individual 
plants,  as  appropriate  to  ensure  the  identity  and  purity  of  the  harvested 
material. 

(d)  Maintenance: 

Plant reproductive material, including where applicable mother plants, shall be 
maintained  in  a  way  to  ensure  the  identity  of  the  variety.  That  maintenance 
shall  be  based  on  the  official  description  or  the  officially  recognised 
description of the variety.  

(e)  Union quality pests 

The plant reproductive material shall be cultivated in a manner to ensure that 
the presence of Union quality pests, as listed pursuant to the implementing act 
referred  to  in  Article  37(2)  of  Regulation  (EU)  No  …/…  (Office  of 
Publications,  please  insert  number  of  Regulation  on  protective  measures 
against  pests  of  plants),  in  that  plant  reproductive  material  complies  with  the 
provisions of that act. 

(f)  Where  appropriate,  the  cultivation  of  plant  reproductive  material  shall  take 
place separately from the cultivation of material belonging to the same genera 
or species for food or feed purposes, to ensure health of the material concerned. 

(g)  Where applicable, micro-propagation may also be used for the reproduction of 

plant reproductive material. 

PART B 

REQUIREMENTS FOR THE QUALITY OF PLANT REPRODUCTIVE MATERIAL REFERRED TO IN 
ARTICLE 16(2)  

Plant  reproductive  material  shall  fulfil  one  or  more  of  the  following  quality  requirements, 
depending on the characteristics of each genus or species: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

it  shall  have  minimum  germination  to  allow  an  appropriate  number  of  plant  per 
square meter (m2 ) after sowing, and consequently to secure the yield and quality of 
the production; 

it  shall  have  a  maximum  content  of  hard  seed  to  allow  an  appropriate  number  of 
plant per square metre (m2); 

it shall have minimum purity to secure the highest level of varietal identity; 

it  shall  have  maximum  moisture  content  to  ensure  the  preservation  of  the  material 
during processing, storage and making available on the market; 

it  shall  have  maximum  content  of  plant  reproductive  material  of  other  genera  or 
species to ensure the lowest presence of undesirable plants in the lot; 

it  shall  have  minimum  vigour,  defined  dimension,  and  specific  grading,  to  ensure 
appropriateness  of  the  material and  sufficient homogeneity  of the  lot for sowing or 
planting; 

it shall have maximum presence of earth or extraneous matter to prevent fraudulent 
practices and technical impurities; 

it shall be free from specific defects and damages to ensure quality and health of the 
material; 

EN 

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   EN 

(i) 

the  presence  of  Union  quality  pests,  as  listed  pursuant  to  the  implementing  act 
referred  to  in  Article  37(2)  of  Regulation  (EU)  No  […]  on  protective  measures 
against pests, in plant reproductive material shall comply with the provisions of that 
act.  

PART C 

REQUIREMENTS  FOR  THE  CERTIFICATION  OF  PLANT  REPRODUCTIVE  MATERIAL  AS 
INDICATED IN ARTICLE 20(1)  

A. 

Frequency and methods of field inspections  

The  frequency  of  inspections  and  the  relevant  growth  stage(s)  of  the  plant 
reproductive  material  for  inspections  shall  ensure  efficient  observations  and 
inspections. 

The methods for inspections shall be such ensure the reliability of the observations. 

Where applicable, the mother plants shall be inspected, at least by visual inspection, 
at the most appropriate period(s) of the year to check the presence of pests or their 
vectors  

The mother plants shall be maintained in all phases of cultivation under conditions to 
enable  the  production  of  plant  reproductive  material  and  permit  the  verification  of 
the identity based on the description of the variety.  

Inspections  shall  concern,  where  appropriate,  compliance  with  the  rules  set  out 
pursuant Article 37(2) of Regulation (EU) No …/… [Office of Publications, please 
insert  number  of  Regulation  on  protective  measures  against  plants]  concerning  the 
presence of quality pests on the plant reproductive material concerned. The quality of 
soil,  substrates,  mother  plants  and  the  immediate  environment  shall  be  checked  to 
avoid presence of pests or their vectors. 

B. 

Sampling and testing 

1. 

The sampling method shall fulfil the following requirements:  

(a) 

the  sample  to  be  drawn  from  a  lot  shall  have  the  appropriate  minimum 
weight for determining content of certain weeds, to ensure representative 
sampling  and  suitable  size  for  the  analysis  of  the  material  to  assess 
whether the quality requirements have been fulfilled. 

(b) 

the intensity of sampling, the equipment of sampling, and methods to be 
used, shall ensure that reliable samples are collected for testing. 

Testing  shall  be  carried  out  in  accordance  with  methods,  equipment  and 
growing media established per species, as well as per reference collection for 
purity  analysis,  to  ensure  that  the  quality  requirements  have  been  fulfilled. 
Testing shall include, where appropriate, retesting of germination rate to ensure 
the adequate germination after a certain period or mixing of plant reproductive 
material. 

Inspections shall concern, where appropriate, compliance with the rules set out 
pursuant  Article  37(2)  of  Regulation  (EU)  No  …/…  [Office  of  Publications, 
please  insert  number  of  Regulation  on  protective  measures  against  plants] 
concerning  the  presence  of  quality  pests  on  the  plant  reproductive  material 
concerned.  The  quality  of  soil,  substrates,  mother  plans  and  the  immediate 
environment shall be checked to avoid presence of pests or their vectors. 

2. 

3. 

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   EN 

PART D 

ELEMENTS  FOR  THE  ADOPTION  OF  THE  REQUIREMENTS  FOR  THE  PRODUCTION  AND 
QUALITY  OF  PLANT  REPRODUCTIVE  MATERIAL  REFERRED  TO  IN  ARTICLE  16(2),  AND  FOR 
THE  CERTIFICATION  OF  PLANT  REPRODUCTIVE  MATERIAL  AS  REFERRED  TO  IN  ARTICLE 
20(1)  

The  production  and  quality  requirements  referred  to  in  Parts  A  and  B,  and  the  certification 
schemes referred to in Part C, may be laid down per one or more of the following elements:  

(a) 

(b) 

(c) 

genera,  species,  categories,  and  sub-divisions  inside  the  category,  including 
generations; 

the types of variety or plant reproductive material (heterogeneous material or niche 
market material), including intraspecific or interspecific hybrids; 

the  specific  uses  of  the  genera,  species,  or  types  of  plant  reproductive  material 
concerned; 

(d) 

type of reproduction. 

EN 

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   EN 

ANNEX III 

PART A 

CONTENT OF OFFICIAL LABEL AND OPERATOR'S LABEL AS REFERRED TO IN ARTICLE 21(1) 

The official label and operator's label shall contain the following: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

(m) 

(n) 

the botanical name, or names in case of mixture, of the plant species concerned, in 
roman characters; 

the common name, or names in case of mixture, of the plant species concerned in one 
of the official Union languages; 
the  two-letter  code  indicated  in  norm  ISO  3166-1  alpha  222  for  the  Member  State 
and,  where  appropriate,  the  name  or  acronym  of  the  respective  competent 
authority(ies) with which the professional operator is registered;  

the registration number of the registered professional operator or, in absence of such 
number, the name and address of the operator; 

the lot number of the plant reproductive material concerned, and, where relevant, a 
reference to a unique traceability data carrier, such as bar code, hologram or chip; 

the indication of the denomination of the variety or variety denominations in case of 
mixture components, when making available on the market in reference to varieties; 

the indication 'EU rules and standards'; 

references to the country of production or countries in case of mixture, with the two 
letter code referred to in point (c); 

references  to  declared  number  of  seeds,  rootstocks  or  other  units  of  reproductive 
material, or, where applicable, the net or gross weight; 

indications  concerning  category  of  plant  reproductive  material  and,  where 
appropriate, sub-divisions of categories; 

references  to  month  and  year  of  labelling  or  references  to  month  and  year  of  last 
sampling; 

the  indication,  where  appropriate,  that  the  plant  reproductive  material  belongs  to  a 
variety  with  officially  recognised  description  only,  and  indication  of  the  region  of 
origin of that variety; 

the indication, where appropriate, that the respective plant reproductive material is a 
clone or rootstock; 

the  indication,  where  applicable, that the plant reproductive material consists of, or 
contains, genetically modified organisms. 

22 

ISO 3166-1:2006, Codes for the representation of names  of countries and their subdivisions – Part 1: 
Country codes. International Organization for Standardization, Geneva. 

EN 

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   EN 

                                                 
PART B 

INFORMATION TO BE CONTAINED IN THE LABEL FOR GENERA OR SPECIES OTHER THAN THE 
SPECIES LISTED IN ANNEX I, AS REFERRED TO IN ARTICLE 47 

The label shall contain the following: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

the species, indicated with the botanical name and in roman characters; 

the common name in one of the official languages of the Union; 

the  denomination  of  the  variety,  if  the  plant  reproductive  material  is  respectively 
made available on the market with reference to a variety;  

the name and address of the professional operator, and its registration number; 

the reference number of the lot given by the operator; 

declared  number  of  seeds,  rootstocks  or  other  units  of  reproductive  material,  or, 
where applicable, the net or gross weight; 

the indication 'EU quality'; 

the date of the issuance of the label; 

in  the  case  of  import  from  third  countries,  indication  of  the  country  of  harvesting, 
with the two letter code as referred to in point (h) of Part A; 

the place of production; 

where  applicable,  the  indication  that  the  respective  plant  reproductive  material 
belongs  to  a  clone  or  rootstock,  and  the  denomination  of  the  variety  to  which  that 
clone or rootstock may belong to; 

where  plant  reproductive  material  is  produced  and  made  available  on  the  market 
together with forest reproductive material, the respective label of plant reproductive 
material shall indicate 'not for forestry purposes'. 

EN 

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ANNEX IV 

PART A 

CRITERIA FOR GENERA OR SPECIES WITH SATISFACTORY VALUE FOR CULTIVATION AND/OR 
USE  

The requirements set out in Article 58(2) on satisfactory value for cultivation and/or use shall 
apply to genera and species which comply with one or more of the following criteria: 

(a) 

(b) 

(c) 

they are of vital importance for food and feed security;  

they  are  of  vital  importance  for  food  processing,  feed  processing  or  industrial 
processing; 

they  are  of  vital  importance  for  resilience  and  low-input  agriculture,  including 
organic agricultural production. 

PART B 

CRITERIA  FOR  GENERA  OR  SPECIES  WITH  SUSTAINABLE  VALUE  FOR  CULTIVATION  AND/OR 
USE  

The  requirements  set  out  Article  59(1)  on  sustainable  value  for  cultivation  and/or  use  shall 
apply to genera and species which comply with one or more of the following criteria: 

(a) 

(b) 

(c) 

(d) 

they are substantially susceptible to pests;  

they are subject to particular requirements concerning efficiency of resources;  

they are susceptible to the presence of undesirable substances;  

they are susceptible to adaptation to diverse agro-climatic conditions.  

EN 

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ANNEX V 

REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR 
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE 
CERTIFIED AS ‘SOURCE-IDENTIFIED’ 

1. 

2. 

The basic material shall be as seed source or stand located within a single Region of 
Provenance. A formal inspection must be made where the material is destined for a 
specific forestry purpose. 

The Region of Provenance and the location and the altitude or altitudinal range of the 
place(s)  where  the  reproductive  material  is  collected  must  be  stated  by  the 
professional operator concerned to the competent authority. It must be stated whether 
the basic material is: 

(a) 

(b) 

autochthonous or non-autochthonous or the origin is unknown; or 

indigenous  or  non-indigenous  or  the  origin  is  unknown.  In  the  case  of  non-
autochthonous  or  non-indigenous  basic  material  the  origin  must  be  stated  if 
known. 

EN 

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ANNEX VI 

REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR 
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE 
CERTIFIED AS ‘SELECTED’ 

General: The stand will be judged with respect to the specific stated purpose for which the 
reproductive material will be intended and due importance shall be given to requirements 1- 9, 
depending  on  the  specific  purpose.  The  criteria  used  for  the  selection  of  the  forest 
reproductive  material  and  the  purpose  of  that  material  shall  be  indicated  in  the  National 
Register. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

Origin:  It  must  be  determined  either  by  historical  evidence  or  other  appropriate 
means  whether  the  stand  is  autochthonous/indigenous,  non-autochthonous/non-
indigenous  or  the  origin  is  unknown  and  for  non-autochthonous/  non-indigenous 
basic material the origin must be stated if known. 

Isolation: Stands must be situated at a sufficient distance from poor stands, including 
non-autochthonous/nonindigenous or of unknown origin, of the same species or from 
stands  of  a  related  species  or  variety  which  can  form  hybrids  with  the  species  in 
question. 

Effective Size of the Population: Stands must consist of one or more groups of trees 
well  distributed  and  sufficiently  numerous  to  ensure  adequate  inter-pollination.  To 
avoid  the  unfavourable  effects  of  inbreeding,  selected  stands  shall  consist  of  a 
sufficient number and density of individuals on a given area. 

Age  and  Development:  Stands  must  consist  of  trees  of  such  an  age  or  stage  of 
development that the criteria given for the selection can be clearly judged. 

Uniformity:  Stands  must  show  a  normal  degree  of  individual  variation  in 
morphological characters. Where necessary, inferior trees shall be removed. 

Adaptedness:  Adaptation  to  the  ecological  conditions  prevailing  in  the  Region  of 
Provenance must be evident. 

Volume production: For the approval of selected stands volume production of wood 
must  normally  be  superior  to  the  accepted  mean  under  similar  ecological  and 
management conditions. 

Wood Quality: The quality of the wood shall be taken into account. 

Form or Growth Habit: Trees in stands must show particularly good morphological 
features,  including  straightness  and  circularity  of  stem,  favourable  branching  habit, 
small size of branches and good natural pruning. In addition, the proportion of forked 
trees and those showing spiral grain must be low. 

EN 

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ANNEX VII 

REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR 
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE 
CERTIFIED AS ‘QUALIFIED’ 

1. 

Seed Orchards 

(a)  The type, objective, crossing design and field layout, components, isolation and 
location  and  any  changes  of  these  must  be  approved  and  registered  with  the 
competent authority; 

(b)  The  component  clones  or  families  shall  be  selected  for  their  outstanding 
characters and special consideration shall be given to the requirements 4, 6, 7, 
8, 9 and 10 of Annex III; 

(c)  The component clones or families shall be planted or shall have been planted 
according to a plan which has been approved by the competent authority and 
established in such a way that each component can be identified; 

(d)  Thinning  carried  out  in  seed  orchards  shall  be  described  together  with  the 
selection  criteria  used  for  such  thinning  and  registered  with  the  competent 
authority; 

(e)  The seed orchards shall be managed and seed harvested in such a way that the 
objectives of the orchards are attained. In the case of a seed orchard intended 
for  the  production  of  an  artificial  hybrid,  the  percentage  of  hybrids  in  the 
reproductive material must be determined by a verification test. 

2. 

Parents of Family(ies) 

(a)  The parents shall be selected for their outstanding characters and in accordance 
with  the  requirements  4,  6,  7,  8,  9  and  10  of  Annex  III,  or  selected  for  their 
combining ability; 

(b)  The  objective,  crossing  design  and  pollination  system,  components,  isolation 
and  location  and  any  significant  changes  of  these  must  be  approved  and 
registered with the competent authority; 

(c)  The  identity,  number  and  proportion  of  the  parents  in  a  mixture  must  be 

approved and registered with the competent authority; 

(d) 

In  the  case  of  parents  intended  for  the  production  of  an  artificial  hybrid,  the 
percentage  of  hybrids  in  the  reproductive  material  must  be  determined  by  a 
verification test. 

3. 

Clones 

(a)  Clones shall be identifiable by distinctive characters which have been approved 

and registered with the competent authority; 

(b)  The value of individual clones shall be established by experience or have been 

demonstrated by sufficiently prolonged experimentation; 

(c)  Ortets used for the production of clones shall be selected for their outstanding 
characters  and  in  accordance  with  the  requirements  4,  6,  7,  8,  9  and  10  of 
Annex III. 

EN 

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4. 

Clonal Mixtures 

(a)  Clonal mixture shall meet the requirements in points 3(a), 3(b) and 3(c); 

(b)  The identity, number and proportion of the component clones of a mixture, and 
the  selection  method  and  foundation  stock  must  be  approved  and  registered 
with  the  competent  authority.  Each  mixture  must  contain  sufficient  genetic 
diversity. 

EN 

110 

   EN 

ANNEX VIII 

REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR 
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE 
CERTIFIED AS ‘TESTED’ 

1. 

REQUIREMENTS FOR ALL TESTS 

(a)  General 

The basic material must satisfy the applicable requirements in Annex V or VI. 

Tests  set  up  for  the  approval  of  basic  material  are  to  be  prepared,  laid  out, 
conducted  and  their  results  interpreted  in  accordance  with  internationally 
recognised procedures. For comparative tests, the forest reproductive material 
under  test  must  be  compared  with  one  or  preferably  several  approved  or  pre-
chosen standards. 

(b)  Characters to be examined 

(i)  Tests must be designed to assess specified characters and these must be 

indicated for each test; 

(ii)  Weight shall be given to adaptation, growth, biotic and abiotic factors of 
importance. In addition, other characters, considered important in view of 
the  intended  specific  purpose,  shall  be  evaluated  in  relation  to  the 
ecological conditions of the region in which the test is carried out. 

(c)  Documentation 

Records must describe the test sites, including location, climate, soil, past use, 
establishment, management  and  any  damage due to abiotic/biotic factors, and 
be available to the competent authority. Age of the material and results at the 
time of the evaluation must be recorded with the competent authority. 

(d)  Setting up the tests 

(i)  Each  sample  of  reproductive  material  shall  be  raised,  planted  and 

managed in an identical way as far as the types of plant material permit; 

(ii)  Each  experiment  must  be  established  in  a  valid  statistical  design  with  a 
sufficient  number  of  trees  in  order  that  the  individual  characteristics  of 
each component under examination can be evaluated. 

(e)  Analysis and validity of results 

(i)  The  data  from  experiments  must  be  analysed  using  internationally 
recognised statistical methods and the results presented for each character 
examined; 

(ii)  The methodology used for the test and the detailed results obtained shall 

be made freely available; 

(iii)  A  statement  of  the  suggested  region  of  probable  adaptation  within  the 
country in which the test was carried out and characteristics which might 
limit its usefulness must also be given; 

(iv)  If during tests it is proved that the reproductive material does not possess 
at  least  the  characteristics  of  the  basic  material,  then  such  reproductive 
material shall be eliminated. 

EN 

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2. 

REQUIREMENTS FOR GENETIC EVALUATION OF COMPONENTS OF BASIC MATERIAL 

(a)  The components of the following basic material may be genetically evaluated: 

seed orchards, parents of family(ies), clones and clonal mixtures. 

(b)  Documentation 

The  following  additional  documentation  is  required  for  approval  of  the  basic 
material: 

(i)  The identity, origin and pedigree of the evaluated components; 

(ii)  The crossing design used to produce the reproductive material used in the 

evaluation tests. 

(c)  Test procedures 

The following requirements must be met: 

(i)  The genetic value of each component must be estimated in two or more 
evaluation  test-sites,  at  least  one  of  which  must  be  in  an  environment 
relevant to the suggested use of the reproductive material; 

(ii)  The  estimated  superiority  of  the  reproductive  material  to  be  marketed 
shall  be  calculated  on  the  basis  of  these  genetic  values  and  the  specific 
crossing design; 

(iii)  Evaluation  tests  and  genetic  calculations  must  be  approved  by  the 

competent authority. 

(d) 

Interpretation 

(i)  The estimated superiority of the reproductive material shall be calculated 

against a reference population for a character or set of characters; 

(ii) 

It shall be stated whether the estimated genetic value of the reproductive 
material  is  inferior  to  the  reference  population  for  any  important 
character. 

3. 

REQUIREMENTS FOR COMPARATIVE TESTING OF REPRODUCTIVE MATERIAL 

(a)  Sampling of the reproductive material 

(i)  The sample of the reproductive material for comparative testing must be 
truly  representative  of  the  reproductive  material  derived  from  the  basic 
material to be approved; 

(ii)  Sexually produced reproductive material for comparative testing shall be: 

harvested  in  years  of  good  flowering  and  good  fruit/seed  production; 
artificial pollination may be utilised, 

harvested  by  methods  that  ensure  that  the  samples  obtained  are 
representative. 

EN 

112 

   EN 

(b)  Standards 

(i)  The performance of standards used for comparative purposes in the tests 
shall if possible have been known over a sufficiently long period in the 
region  in  which  the  test  is  to  be  carried  out.  The  standards  represent 
material that has been shown useful for forestry at the time that the test 
starts, and in ecological conditions for which it is proposed to certify the 
material.  They  shall  come  as  far  as  possible  from  stands  selected 
according  to  the  criteria  in  Annex  III  or  from  basic  material  officially 
approved for production of tested material; 

(ii)  For comparative testing of artificial hybrids, both parent species must, if 

possible, be included among the standards; 

(iii)  Whenever possible several standards are to be used. When necessary and 
justified, standards may be replaced by the most suitable of the material 
under test or the mean of the components of the test; 

(iv)  The same standards will be used in all tests over as wide a range of site 

conditions as possible. 

(c) 

Interpretation 

(i)  A  statistically  significant  superiority  as  compared  with  the  standards 

must be demonstrated for at least one important character; 

(ii) 

It  will  be  clearly  reported  if  there  are  any  characters  of  economic  or 
environmental importance which show significantly inferior results to the 
standards  and  their  effects  must  be  compensated  for  by  favourable 
characters. 

4. 

CONDITIONAL APPROVAL 

Preliminary  assessment  of  young  trials  may  be  the  basis  for  conditional  approval. 
Claims  of  superiority  based  on  an  early  assessment  must  be  re-examined  at  a 
maximum interval of ten years. 

5. 

EARLY TESTS 

Nursery,  greenhouse  and  laboratory  tests  may  be  accepted  by  the  competent 
authority for conditional approval or for final approval if it can be shown that there is 
a  close  correlation  between  the  measured  trait  and  the  characters  which  would 
normally be assessed in forest field tests. Other characters to be tested must meet the 
requirements set out in paragraph 3.  

EN 

113 

   EN 

ANNEX IX 

LIST OF TREE SPECIES AND ARTIFICIAL HYBRIDS 

Abies alba Mill. 

Abies cephalonica Loud. 

Abies grandis Lindl. 

Abies pinsapo Boiss. 

Acer platanoides L. 

Acer pseudoplatanus L. 

Alnus glutinosa Gaertn. 

Alnus incana Moench. 

Betula pendula Roth. 

Betula pubescens Ehrh. 

Carpinus betulus L. 

Castanea sativa Mill. 

Cedrus atlantica Carr. 

Cedrus libani A. Richard 

Fagus sylvatica L. 

Fraxinus angustifolia Vahl. 

Fraxinus excelsior L. 

Larix decidua Mill. 

Larix x eurolepis Henry 

Larix kaempferi Carr. 

Larix sibirica Ledeb. 

Picea abies Karst. 

Picea sitchensis Carr. 

Pinus brutia Ten. 

Pinus canariensis C. Smith 

Pinus cembra L. 

Pinus contorta Loud. 

Pinus halepensis Mill. 

Pinus leucodermis Antoine 

Pinus nigra Arnold 

Pinus pinaster Ait. 

Pinus pinea L. 

Pinus radiata D. Don 

EN 

114 

   EN 

 
Pinus sylvestris L. 

Populus spp. and artificial hybrids between those species 

Prunus avium L. 

Pseudotsuga menziesii Franco 

Quercus cerris L. 

Quercus ilex L. 

Quercus petraea Liebl. 

Quercus pubescens Willd. 

Quercus robur L. 

Quercus rubra L. 

Quercus suber L. 

Robinia pseudoacacia L. 

Tilia cordata Mill. 

Tilia platyphyllos Scop. 

EN 

115 

   EN 

ANNEX X 

CATEGORIES UNDER WHICH REPRODUCTIVE MATERIAL FROM THE 
DIFFERENT TYPES OF BASIC MATERIAL MAY BE MADE AVAILABLE ON THE 
MARKET 

Type of basic 
material 

Seed Source 

Stand 

Seed Orchard 

Parents of 
Family(ies) 

Clone 

Clonal Mixture 

Category of forest reproductive material 
(Label colour if colours label or document used) 

Source identified 
(Yellow) 

Selected 
(Green) 

Qualified 
(Pink) 

Tested 
(Blue) 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

EN 

116 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX XI 

PART A 
Requirements to be met by fruit and seed lots of the species listed in Annex IX 

1. 

2. 

Fruit and seed lots of the species listed in Annex IX may not be marketed unless the 
fruit or seed lot reaches a minimum species purity level of 99 %. 

Notwithstanding the provisions of paragraph 1, in the case of closely related species 
in  Annex  IX,  excluding  artificial  hybrids,  the  species  purity  of  the  fruit  or  seed  lot 
shall be stated if it does not reach 99 %. 

PART B 
Requirements to be met by parts of plants of the species and artificial hybrids listed in 
Annex IX 

Parts  of  plants  of  the  species  and  artificial  hybrids  listed  in  Annex  IX  shall  be  of  fair 
marketable  quality.  Fair  marketable  quality  shall  be  determined  by  reference  to  general 
characteristics, health and appropriate size. In the case of Populus spp. it may be stated that 
the additional requirements set out in Part C are met. 

PART C 
Requirements for external quality standards for Populus spp. propagated by stem 
cuttings or sets 

1. 

Stem cuttings 

a. 

Stem  cuttings  shall  not  be  considered  to  be  of  fair  marketable  quality,  within 
the meaning of Part B, if any of the following defects exist:  

(i) 

their wood is more than two years old; 

(ii) 

they have less than two well formed buds; 

(iii) 

they are affected by necroses; 

(iv) 

they show signs of desiccation, overheating, mould or decay. 

b.  Minimum dimensions for stem cuttings 

- 

- 

minimum length: 20 cm, 

minimum top diameter: 

Class EC 1: 8 mm 

Class EC 2: 10 mm. 

2. 

Sets 

a. 

Sets  shall  not  be  considered  to  be  of  fair  marketable  quality  if  any  of  the 
following defects exist: 

(i) 

their wood is more than three years old; 

(ii) 

they have less than five well formed buds; 

(iii) 

they are affected by necroses; 

(iv) 

they show signs of desiccation, overheating, mould or decay; 

(v) 

they have injuries other than pruning cuts; 

(vi) 

they have multiple stems; 

EN 

117 

   EN 

 
(vii)  they have excessive stem curvature. 

b. 

Size classes for sets 

Class 

Non-Mediterranean regions 

N1 

N2 

Mediterranean regions 

S1 

S2 

Minimum diameter at mid-
length 
(mm) 

Minimum height 
(m) 

6 

15 

25 

30 

1,50 

3,00 

3,00 

4,00 

PART D 
Requirements to be met by planting stock of the species and artificial hybrids listed in 
Annex IX 

The  planting  stock  shall  be  of  fair  marketable  quality.  Fair  marketable  quality  shall  be 
determined by reference to general characteristics, health, vitality and physiological quality. 

PART E 
Requirements to be met by planting stock to be marketed to the end-user in regions 
having a Mediterranean climate 

Planting stock shall not be marketed unless 95 % of each lot is of fair marketable quality. 

1. 

Planting stock shall not be considered to be of fair marketable quality if any of the 
following deficits exist: 

(a) 

injuries other than pruning cuts or injuries due to damage when lifting; 

(b) 

lack of buds with the potential to form a leading shoot; 

(c)  multiple stems; 

(d)  deformed root system; 

(e) 

(f) 

signs of desiccation, overheating, mould or decay; 

the plants are not well balanced. 

EN 

118 

   EN 

 
 
 
 
2. 

Size of the plants 

Species 

Maximum age 
(years) 

Minimum 
height 
(cm) 

Maximum 
height 
(cm) 

Minimum root 
collar diameter 
(mm) 

25 

40 

25 

35 

15 

20 

30 

45 

30 

40 

30 

50 

60 

2 

3 

2 

3 

2 

3 

2 

3 

3 

4 

2 

3 

3 

8 

12 

8 

10 

8 

10 

7 

15 

10 

15 

8 

15 

13 

Pinus halepensis 

Pinus leucodermis 

Pinus nigra 

Pinus pinaster 

Pinus pinea 

Quercus ilex 

Quercus suber 

1 

2 

1 

2 

1 

2 

1 

2 

1 

2 

1 

2 

1 

3. 

Size of the container, where used 

Species 

Minimum volume 
of the container 
(cm³) 

Pinus pinaster 
Other species 

120 
200 

EN 

119 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX XII 

PART A 
Information to be included in the master certificate of identity for reproductive material 
derived from seed sources and stands 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

Title  with  the  text  'Issued  in  accordance  with  Regulation  EU  (No)  …/…  [Office  of 
Publications, please insert number of this Regulation]' 

Member State 

Number of certificate and code of Member State 

The  following  indication:  'It  is  certified  that  the  forest  reproductive  material 
described  below  has  been  produced:  (a)  in  accordance  with  Regulation  EU  (No) 
…/…  [Office  of  Publications,  please  insert  number  of  this  Regulation]';  (b)  under 
transitional arrangements.' 

Botanical name 

Nature of forest reproductive material (seed unit, part of plants or planting stock) 

Category of forest reproductive material (source identified, selected or tested) 

Type of basic material (seed source or stand) 

Purpose 

National register reference or identity of basic material in national register 

The  indication  'autochthonous',  'non-autochthnonous',  'indigenous',  'non-indigenous' 
or 'unknown' 

Origin of basic material (for non-autochthonous/non-indigenous material, if known) 

Member State and region of provenance of basic material 

Altitude or altitudinal range of site of basic material 

Year in which seeds ripened 

Quantity of forest reproductive material 

Indication  whether  the  material  covered  by  this  certificate  is  the  result  of  a 
subdivision  of  a  larger  lot  covered  by  a  previous  Union  certificate,  and,  where 
applicable, indication of previous certificate number or quantity in initial lot 

Length of time in nursery 

Indication on whether there has been subsequent vegetative reproduction of material 
derived from seed 

Other relevant information 

Name and address of professional operator 

Name and address of competent authority 

Stamp of competent authority and date 

EN 

120 

   EN 

PART B 
Information to be included in the master certificate of identity for reproductive material 
derived from seed orchards or parents of family(ies) 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

24. 

Title  with  the  text  'Issued  in  accordance  with  Regulation  EU  (No)  …/…  [Office  of 
Publications, please insert number of this Regulation] 

Member State 

Number of certificate and code of Member State 

The  following  indication:  'It  is  certified  that  the  forest  reproductive  material 
described  below  has  been  produced:  (a)  in  accordance  with  Regulation  EU  (No) 
…/…  [Office  of  Publications,  please  insert  number  of  this  Regulation]';  (b)  under 
transitional arrangements.'' 

Botanical name 

Nature of basic material (as mentioned in the catalogue) 

Nature of forest reproductive material (seed unit, part of parts or planting stock) 

Category of forest reproductive material (qualified or tested) 

Type of basic material (seed orchard or parents of family(ies) 

Purpose 

National register reference or identity of basic material in the national register 

Where  appropriate,  indication  'autochthonous',  'non-autochthonous',  'indigenous', 
'non-indigenous' or 'unknown' 

Origin of basic material (for non-autochthonous/non-indigenous material, if known) 

Member State and region of provenance or location of basic material 

Indication whether seed is derived from open pollination, supplemental pollination or 
controlled pollination 

Year in which seed ripened 

Quantity of forest reproductive material 

Indication  whether  the  material  covered  by  the  certificate  is  the  result  of  a 
subdivision of a larger lot covered by a previous Union certificate (with reference to 
previous certificate number and quantity in initial lot) 

Length of time in nursery 

Number of components represented, including indication of families and clones) 

Altitude or altitudinal range of site of basic material 

Indication whether genetic modification has been used in the production of the basic 
material 

For  forest  reproductive  material  derived  from  parents  or  family(ies),  indication  on 
crossing design and range of percentage composition of component families 

Indication  whether  there  has  been  subsequent  vegetative  reproduction  of  material 
derived  from  seed,  including  indication  of  method  of  reproduction  and  number  of 
cycles of reproduction 

25. 

Indication 'other relevant information' 

EN 

121 

   EN 

26. 

27. 

28. 

29. 

Name and address of the professional operator 

Name and address of the competent authority 

Stamp of competent authority and date 

Name and signature of responsible officer 

EN 

122 

   EN 

PART C 
Information to be included in the master certificate of identity for reproductive material 
derived from clones and clonal mixtures 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

24. 

25. 

Title  with  the  text  'Issued  in  accordance  with  Regulation  EU  (No)  …/…  [Office  of 
Publications, please insert number of this Regulation] 

Member State 

Number of certificate and code of Member State 

The  following  indication:  'It  is  certified  that  the  forest  reproductive  material 
described  below  has  been  produced:  (a)  in  accordance  with  Regulation  EU  (No) 
…/…  [Office  of  Publications,  please  insert  number  of  this  Regulation]';  (b)  under 
transitional arrangements.' 

Botanical name  

Name of clone or clonal mixture 

Nature of forest reproductive material (part of plants or planting stock) 

Category of forest reproductive material (qualified or tested) 

Type of basic material (clones or clonal mixtures) 

Purpose 

National register reference or identity of basic material in the national register 

Where appropriate, the indication 'autochthonous', 'non-autochthonous', 'indigenous', 
'non-indigenous' or 'unknown' 

Origin of basic material (for non-autochthonous/non-indigenous material, if known) 

Member State and region of provenance or location of basic material 

Indication whether the seed derives from open pollination, supplemental pollination 
or controlled pollination 

Year in which seeds ripened 

Quantity of forest reproductive material 

Indication  whether  the  material  covered  by  this  certificate  is  the  result  of  a 
subdivision  of  a  larger  lot  covered  by  a  previous  Union  certificate,  and,  where 
applicable, indication of previous certificate number or quantity in initial lot 

Length of time in nursery 

Altitude or altitudinal range of site of basic material 

Indication whether genetic modification has been used in the production of the basic 
material 

Where forest reproductive material derives from parents of family(ies), indication of 
crossing design and range of percentage composition of component families 

Indication on whether there has been subsequent vegetative reproduction of material 
derived from seed 

Indication 'Other relevant information' 

Name and address of professional operator 

EN 

123 

   EN 

26. 

27. 

Name and address of competent authority 

Stamp of competent authority and date 

EN 

124 

   EN 

ANNEX XIII 

REPEALED ACTS AS REFERRED TO IN ARTICLE 144 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

Directive 66/401/EEC 

Directive 66/402/EEC 

Directive 68/193/EEC 

Directive 98/56/EC 

Directive 1999/105/EC 

Directive 2002/53/EC 

Directive 2002/54/EC 

Directive 2002/55/EC 

Directive 2002/56/EC 

Directive 2002/57/EC 

Directive 2008/72/EC 

Directive 2008/90/EC 

EN 

125 

   EN 

 
ANNEX XIV 
CORRELATION TABLES 

1. 

Council Directive 66/401/EEC 

Council Directive 66/401/EEC 

This Regulation 

Regulation 
(EU) No 
…/…. (Office 
of 
Publication, 
please insert 
number of 
Regulation on 
Official 
Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1 

Article 1a 

Article 2(1), point A 

Article 1 

Article 3, Article 2 

Article 11(1), (2) 

Article 2(1), points B, C, D, E 

Article 16(2), Article 20(2) 

Article 2(1), points F, G 

Article 2(1a) 

Article 2(1b) 

Article 2(1d) 

Article 2(2) 

Article 2(3), (4) 

Article 3(1) 

Article 3(1a) 

Article 3(2) 

Article 3(3) 

Article 3(4) 

Article 3a 

Article 4(a) 

Article 4(b) 

Article 4a(1), first subparagraph 

Article 18(5) 

Article 11(3) 

─ 

─ 

─ 

Article 20(2), Article 24 

Article 12(1) 

─ 

Article 12(2) 

Article 12(3) 

Article 16(3) 

Article 12(1) 

Article 38 

Article 39 

Article 2 

Article 4a(1), second subparagraph 

Article 4 

Article 4a(2) 

Article 4a(3) 

Article 5 

Article 5a 

Article 6 

Article 7 

Article 8(1) 

Article 8(2) 

Article 9 

─ 

─ 

Article 40 

Article 20(2) 

Article 75 

Article 20(2), Article 24 

Article 17(1) 

Article 17(4), Article 18(5) 

Article 18 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

EN 

126 

   EN 

 
 
 
 
 
 
 
 
 
 
Article 10 

Article 10a 

Article 10b 

Article 10c 

Article 10d 

Article 11 

Article 11a 

Article 12 

Article 13 

Article 13a 

Article 14(1) 

Article 14(1a) 

Article 14a 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19(1) 

Article 19(2) 

Article 20 

Article 21 

Article 21a 

Article 22 

Article 23 

Article 23a 

Article 24 

Article 19, Article 21(1) 

Article 18(5) 

Article 18(5) 

Article 18(5) 

Article 18(4) 

Article 19(4), (5) 

Article 21(1) 

Article 21(6) 

Article 32, Article 33 

Article 42 

Article 4 

Article 40 

Article 20(2), Article 21 

Article 38 

Article 44 

Article 35, Article 37 

Article 46 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Article 8 

─ 

Article 93 

Article 141 

Article 16(2) 

Article 16(2), Article 20(2) 

Article 12(4), point (a) 

Article 145(1), (2) 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

2. 

Council Directive 66/402/EEC 

Council Directive 66/402/EEC 

This Regulation 

Regulation (EU) 
No …/…. (Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls) 

Regulation (EU) 
No …/… (Office 
of Publication, 
please insert 
number of 
Regulation on 
protective 
measures against 
pests of plants) 

Article 1 

Article 1a 

Article 2(1), point A 

Article 1 

Article 3, Article 2 

Article 11(1), (2) 

─ 

─ 

─ 

─ 

─ 

─ 

EN 

127 

   EN 

 
 
 
Article 2(1), point B  

Article 10(1) 

Article 2(1), points C, Ca, D, E, F, G, 
H 

Article  16(2),  Article  20(2)
Article 11(3) 

Article 2(1a) 

Article 2(1b) 

Article 2(1c) 

Article 2(1e) 

Article 2(2) 

Article 16(2), Article 20(2) 

─ 

─ 

Article 16(2), Article 20(2) 

Article 20(2), Article 24 

Article 2(3), (4) 

Article 12(1), (2) 

Article 3(1) 

Article 3(2) 

Article 3(3) 

Article 3a 

Article 16(2) 

Article 20(2) 

Article 12(1) 

Article 38 

Article 4(1), first subparagraph (a) 

Article 39 

Article 4(1), first subparagraph (b) 

Article 39 

─ 

─ 
─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Article 4(1), second subparagraph 

Article 20(c) 

Article 4(4) 

Article 4a(1), first subparagraph 

Article 4a(1), second subparagraph 

Article 4a(2) 

Article 4a(3) 

Article 5 

Article 5a 

Article 6 

Article 7 

Article 8(1) 

Article 8(2) 

Article 9 

Article 10 

Article 10a 

Article 11 

Article 11a 

Article 12 

Article 13 

Article 13a 

Article 14(1) 

Article 14(1a) 

Article 14a 

Article 15 

Article 16 

Article 2 

Article 4 

─ 

─ 

Article 40 

Article 20(2) 

Article 75 

Article 20(2), Article 24 

Article 17(1) 

Article 17(4), Article 18(5) 

Article 18 

Article 19, Article 21(1) 

Article 18(5) 

Article 19(4), (5) 

Article 21(1) 

Article 21(6) 

Article 32, Article 33 

Article 42 

Article 4 

Article 40 

Article 20(2), Article 21 

Article 38 

Article 44 

Article 35, Article 37 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 
─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

EN 

128 

   EN 

 
 
 
 
 
 
Article 17 

Article 18 

Article 19(1) 

Article 19(2) 

Article 20 

Article 21 

Article 46 

─ 

─ 

─ 

Article 141 

Article 16(2), Article 20(2) 

Article 21a, Article 21b 

Article 12(4), point (a) 

Article 22 

Article 22a 

Article 23 

Article 23a 

Article 24 

Article 57 

Article 145(1), (2) 

─ 

─ 

3. 

Council Directive 68/193/EEC 

Council Directive 68/193/EEC 

This Regulation 

─ 

Article 8 

─ 

Article 93 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Regulation (EU) 
No …/…. (Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1 

Article 2(1) 

Article 2(2) 

Article 3(1) 

Article 3(2) 

Article 1 

Article 3 

─ 

Article 12(1), (2) 

─ 

Article  3(3),  first  subparagraph, 
points  (a)  and  (b)  and  second 
subparagraph 

Article  3(3),  first  subparagraph, 
point (c) 

Article 

12(1), 

(2)

Article 12(4), point (a) 

Article 3(3), third subparagraph 

Article 4 

Article 3(4) 

Article 3(5) 

Article 4 

Article 5(1) 

Article 5(2) 

Article 5(3) 

Article 5a 

Article 5b(1) 

Article 5b(2) 

EN 

Article 16(2) 

Article 12(1), (2) 

Article 40 

Article 51 

Article 14(1) 

Article 15(1), Article 51 

Article 56(2), point (a) 

Article 60 

Article 61 

129 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
Article 5b(3) 

Article 

Article 62 

5ba 

Article  4,  Article  56(1), 
point (b) 

Article 5c 

Article 4 

Article 5d(1), (2) 

Article 71, Article 74 

Article 5d(3) 

Article 5e(1) 

Article 64(2) 

Article 85(1) 

Article 5e(2), first sentence 

Article 103(3) 

Article 5e(2), second sentence 

Article 52 

Article 5f 

Article 5g 

Article 7 

Article 8(1) 

Article 8(2) 

Article 9 

Article 10(1) 

Article 10(2) 

Article 10(3) 

Article 10(4) 

Article 10(5) 

Article 10(6) 

Article 10a 

Article 11(1) 

Article 11(2) 

Article 12 

Article 12a 

Article 13 

Article 14 

Article 14a 

Article 15(1) 

Article 15(2) 

Article 16 

Article 16a 

Article 16b 

Article 17 

Article 17a 

Article 18 

Article 18a 

Article18b 

Article 19 

Article 53(1), point (h) 

Article 86 

Article 17(1) 

Article 18(1), (2), (3), (4) 

Article 18(5) 

Article 18 

Article 19(1), Article 22 

Article 17(2), Article 29(2) 

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Article 21(4) 

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Article 21(1) 

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Article 45 

Article 4 

Article 4 

Article 38 

Article 35, Article 36 

Article 42 

Article 46 

Article 44 

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Article 141 

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130 

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Article 20 

Article 145 

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4. 

Council Directive 98/56/EC 

Council Directive 98/56/EC 

This Regulation 

Regulation (EU) No 
…/…. (Office of 
Publication, please 
insert number of 
Regulation on 
Official Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1(1) 

Article 1(2), (3) 

Article 2 

Article 3 

Article 4 

Article 5(1) 

Article 5(2) 

Article 5(3), (4) 

Article 5(5) 

Article 6 

Article 7(1) 

Article 7(2) 

Article 7(3) 

Article 7(4) 

Article 8(1) 

Article 1 

Article 2 

Article 3 

Article 6 

Article 4 

Article 16(2), Article 48(1) 

Article 64(1) 

Article 16(2) 

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Article 5 

Article 7 

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Article 8 

─ 

Article 17, Article 48(2) 

Article 8(2), (3) 

Article 19(4), Article 49 

Article 8(4) 

Article 9(1) 

Article 9(2) 

Article 9(3) 

Article 9(4) 

Article 10 

Article 11(1) 

Article 11(2) 

Article 11(3) 

Article 11(4) 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

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Article 50 

Article 50(2), Article 64(4) 

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Article 35, Article 37 

Article 44 

Article 43 

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Article 8 

Article 64(1) 

Article 93 

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   EN 

 
 
Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 141 

Article 141 

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Article 145 

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5. 

Council Directive 1999/105/EC 

Council Directive 1999/105/EC 

This Regulation 

Regulation (EU) 
No …/…. (Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1 

Article 2 

Article 3(1) 

Article 3(2) 

Article 105 

Article 106 

Article 119 

Article 4 

Article 3(3), first subparagraph 

Article 105, Article 3(9) 

Article 3(3), second subparagraph  

Article 8(4) 

Article 3(4) 

Article 4(1) 

Article 4(2) 

Article 4(3), point (a) 

Article 4(3), point (b) 

Article 4(4) 

Article 4(5) 

Article 5 

Article 6(1) 

Article 6(2) 

Article 139 

Article 114 

Article 107(1), (2) 

Article 107(3) 

Article 109 

Article 134 

Article 108 

Article 4 

Article 115, point (b) 

Article 117(5) 

Article 6(3), first subparagraph 

Article 118 

Article 6(3), second subparagraph 

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Article 6(4) 

Article 6(5) 

Article 6(6) 

Article 6(7) 

Article 6(8) 

Article 7 

Article 8 

Article 9 

EN 

Article 5 

Article 2, point (a) 

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Article 134 

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Article 128 

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Article 110 

132 

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Article 10 

Article 11 

Article 12 

Article 13(1) 

Article 13(2) 

Article 13(3) 

Article 112 

Article 113 

Article 122 

Article 123 

Article 117(2) 

Article 126 

Article 14(1), (2) 

Article 124(1), (2) 

Article 14(3) 

Article 14(4) 

Article 14(5) 

Article 14(6) 

Article 14(7) 

Article 15 

Article 16(1) 

Article 16(2) 

Article 16(3), (4), (5) 

Article 16(6) 

Article 17(1) 

Article 17(2) 

Article 17(3) 

Article 17(4) 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

Article 31 

Article 130 

Article 131 

Article 125 

Article 124(3) 

Article 4 

Article 121 

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Article 128 

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Article 128(1), point (b) 

Article 129 

Article 137, Article 138 

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Article 133 

Article 4 

Article 127 

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Article 141 

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Article 144 

Article 145(1), (2) 

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Article 100(1) 

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133 

   EN 

 
6. 

Council Directive 2002/54/EC 

Council Directive 2002/54/EC 

This Regulation 

Regulation 
(EU) No …/…. 
(Office of 
Publication, 
please insert 
number of 
Regulation on 
Official 
Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1, first subparagraph 

Article 1 

Article 1, second subparagraph 

Article 46 

Article 2(1) 

Article 2(2) 

Article 2(3)(A) 

Article 2(3)(B) 

Article 2(4) 

Article 3(1) 

Article 3(2) 

Article 4 

Article 3, Article 10 

Article 20(2) 

Article 20(2), Article 23 

Article 20(2), Article 143 

Article 24 

Article 12(1), (2) 

Article 20(2) 

Article 12(1) 

Article  5,  first  subparagraph,  point 
(a) 

Article 

Article  5,  first  subparagraph,  point 
(b) 

Article 

Article 5, second subparagraph 

Article 5, third subparagraph 

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37

39

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Article 100 

Article 6(1), first subparagraph, point 
(a) 

Article  2,  points  (a)  and  (b)

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Article 6(1), first subparagraph, point 
(b) 

Article 

Article 6(1), second subparagraph 

Article 4 

34(1)

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Article 6(2) 

Article 6(3) 

Article 7 

Article 8 

Article 9(1) 

Article 9(1a) 

Article 9(1b) 

Article 9(2) 

Article 10(1) 

Article 10(2) 

Article 11(1) 

Article 11(2) 

Article 34(6) 

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Article 40 

Article 75(1) 

Article 20(2), Article 24 

Article 23(1) 

Article 23(1), point (a) 

Article 20(2) 

Article 17(1) 

Article 17(4) 

Article 18 

Article 18(4) 

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Article 11(3) 

Article 12(a) 

Article 12(b) 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22(1) 

Article 22(2) 

Article 22(3) 

Article 23 

Article 24 

Article 25(1) 

Article 25(2) 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30(1), point (a) 

Article 18(5) 

Article 19, Article 21 

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Article 18(5) 

Article 18(5) 

Article 18 

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Article 21(1) 

Article 21(6) 

Article 42 

Article 4 

Article 16(2) 

Article 38(1) 

Article 38(6) 

Article 44(2), point (b)(iii) 

Article 44 

Article 37 

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Article 16(3) 

Article 141 

Article 4 

Article 16(2) 

Article 30(1), point (b) 

Article 12(4), point (a) 

Article 30(1), point (c) 

Article 30(2) 

Article 30A 

Article 31 

Article 32 

Article 33 

Article 34 

Article 35 

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Article 145(1) 

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135 

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7. 

Council Directive 2002/55/EC 

Council Directive 2002/55/EC 

This Regulation 

Regulation (EU) 
No …/…. (Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1, first subparagraph 

Article 1 

Article 1, second subparagraph 

Article 46 

Article 2(1), point (a) 

Article 2(1), point (b) 

Article 2(1), point (c) 

Article 2(1), point (d) 

Article 2(1), point (e) 

Article 3(5) 

Article 11(2) 

Article 10(7) 

Article 10(8) 

Article 10(9) 

Article 2(1), point (f) 

─ 

Article 2(1), point (g) 

Article 2(2) 

Article 2(3) 

Article 2(4) 

Article 3(1) 

Article 3(2) 

Article 3(3) 

Article 3(4) 

Article 4(1) 

Article 4(2), (3) 

Article 4(4) 

Article 5(1) 

Article 5(2) 

Article 5(3) 

Article 6 

Article 7(1) 

Article 7(2) 

Article 7(3) 

Article 7(4), (5) 

Article 8 

Article 9(1) 

Article 9(2), (3) 

Article 9(4) 

Article 9(5) 

Article 18(5) 

Article 11(3) 

Article 53(1), point (i) 

Article 20(2), Article 24(4) 

Article 14(1) 

Article 51 

Article 52 

Article 14(1) 

Article 56(2), point (a) 

Article 4 

Article 57 

Article 60 

Article 61 

Article 62 

Article 14(1) 

Article 71 

Article 74 

Article 75 

Article 4 

Article 66, Article 67 

Article 51, Article 86 

Article 64 

Article 102(1) 

Article 53(1), point (h) 

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Article 9(6) 

Article 10(1), (2), (3), (4) 

Article 10(5) 

Article 11 

Article 12(1) 

Article 12(2) 

Article 12(3) 

Article 13(1) 

Article 13(2) 

Article 13(3) 

Article 13(4) 

Article 14(1), (2) 

Article 15(1) 

Article 15(2) 

Article 15(3) 

Article 16(1) 

Article 

Article 17 

Article 18 

Article 19 

Article 20(1), (2), (3) 

Article 20(4) 

Article 21 

Article 22(a) 

Article 22(b) 

Article 23(1), point (a) 

Article 23(1), point (b) 

Article 23(2) 

Article 23(3) 

Article 24 

Article 25(1) 

Article 25(1a) 

Article 25(1b) 

Article 25(2) 

Article 26(1) 

Article 26(2) 

Article 26(3) 

Article 27 

Article 28(1) 

Article 64(1) 

Article 103 

Article 76(3), (4) 

Article 86 

Article 82 

Article 83 

Article 84(4) 

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Article 85(1) 

Article 81 

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Article 85(1) 

Article 85(1) 

Article 85(2) 

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Article 4 

16(2) 

Article  4,  Article  56(1), 
point (c) 

Article 52, Article 53 

Article 41 

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Article 12 

Article 20(2) 

Article 2 

Article 37 

Article 39 

Article 2 

Article 34(1) 

Article 34(6) 

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Article 40 

Article 16(2), Article 20(2) 

Article 23(1) 

Article 23(1), point (a) 

Article 20(2) 

Article 17(1) 

Article 18(5) 

Article 32(1) 

Article 18 

Article 19(1), Article 21 

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Article 28(2) 

Article 28(3) 

Article 28(4) 

Article 29 

Article 30 

Article 31 

Article 32 

Article 33 

Article 34(1) 

Article 34(2) 

Article 35 

Article 36(1) 

Article 36(2) 

Article 36(3) 

Article 37 

Article 38 

Article 39 

Article 40 

Article 41 

Article 42 

Article 43 

Article 44 

Article 45 

Article 46 

Article 47 

Article 48 

Article 48(1)(b) 

Article 49 

Article 50 

Article 51 

Article 52 

Article 53 

Article 18(5) 

Article 19(4) 

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Article 18(5) 

Article 21(5) 

Article 21(1) 

Article 21(6) 

Article 42 

Article 4 

Article 12(1), (2) 

Article 20(2), Article 21(1) 

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Article 19(1), (2) 

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Article 44 

Article 35, Article 37 

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Article 30 

Article 20(2), Article 28 

Article 31 

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Article 14(4), Article 56 

Article 16(2), Article 20(2) 

Article 141 

Article 4 

Article 32, Article 33 

Article 12(4), point (a) 

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Article 144 

Article 145(1), (2) 

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8. 

Council Directive 2002/56/EC 

Council Directive 2002/56/EC 

This Regulation 

Regulation (EU) 
No …/…. (Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1, first subparagraph 

Article 1 

Article 1, second subparagraph 

Article 46 

Article 2 

Article 3 

Article 3(1), first sentence 

Article 12(1), Article 16(2) 

Article 3(1), second sentence 

Article 3(1), third sentence 

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─ 

Article 3(2), (3), (4) 

Article 4 

Article 5 

Article 16(2) 

Article 12(1) 

Article 40 

Article 6(1), first subparagraph 

Article 2 

Article 6(1), second subparagraph 

Article 4 

Article 6(2) 

Article 6(3) 

Article 7 

Article 8 

Article 9 

Article 10(1) 

Article 10(2) 

Article 10(3) 

Article 11(1) 

Article 11(2) 

Article 12(1) 

Article 12(2) 

Article 12(3) 

Article 13(1) 

Article 13(2) 

Article 14 

Article 15 

Article 16 

Article 17(1) 

Article 17(2), first sentence 

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Article 20(2) 

Article 16(2) 

Article 16(2) 

Article 16(2) 

Article 17(4) 

Article 17(4) 

Article 17, Article 18 

Article 18(5) 

Article 18(2), (4) 

Article 18(4) 

Article 18(5) 

Article 19(3), Article 21 

Article 18(5) 

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Article 21(1) 

Article 21(6) 

Article 4 

Article 40 

Article 17(2), second sentence 

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EN 

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Article 18 

Article 19 

Article 20 

Article 21 

Article 22(1) 

Article 22(2) 

Article 22(3) 

Article 23(1) 

Article 23(2) 

Article 24 

Article 25 

Article 26 

Article 27(1), point (a) 

Article 16(2) 

Article 42 

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Article 44 

Article 35, Article 37 

Article 34 

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─ 

Article 45 

Article 16(2) 

Article 141 

Article 4 

Article 16(2) 

Article 27(1), point (b) 

Article 12(4), point (a) 

Article 27(1), point (c) 

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Article 27(2) 

Article 28 

Article 29 

Article 30 

Article 31 

Article 16(2) 

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Article 144 

Article 145(1) 

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9. 

Council Directive 2002/57/EC 

Council Directive 2002/57/EC 

This Regulation 

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Article 93 

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Regulation 
(EU) No 
…/…. (Office 
of 
Publication, 
please insert 
number of 
Regulation on 
Official 
Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1, first subparagraph 

Article 1 

Article 1, second subparagraph 

Article 46 

Article 2(1)(a) 

Article 2(1)(b) 

Article 3, Article 10 

Article 11(1), (2), (4) 

Article 2(1)(c), (d), (e), (f), (g), (h), (i), 
(j), (k) 

Article 16, Article 20 

Article 2(2) 

Article 11(3) 

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140 

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Article 2(3) 

Article 2(3a) 

Article 2(4)(a) 

Article 2(4)(b) 

Article 2(5) 

Article 2(6) 

Article 3(1), (2), (3) 

Article 3(4) 

Article 4 

Article 5, first subparagraph (a) 

Article 5, first subparagrpah (b) 

Article 5, second subparagraph 

Article 5, third subparagraph 

Article  6(1),  first  subparagraph,  point 
(a) 

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Article 16(2) 

Article 20(2) 

Article 20(2) 

Article 20(2) 

Article 12(3) 

Article 16(3) 

Article 12(1) 

Article 37 

Article 39 

Article 44 

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Article 

Article 6, first subparagraph, point (b) 

Article 

Article 6(1), second subparagraph 

Article 6(2) 

Article 6(3) 

Article 7 

Article 8 

Article 9 

Article 10(1) 

Article 10(2) 

Article 11 

Article 12(1) 

Article 12(2) 

Article 12(3) 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 19a 

Article 20 

Article 34 

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Article 40 

Article 75(1) 

Article 20(2) 

Article 17(1), Article 18(1) 

Article 18(5) 

Article 18 

Article 19(1), Article 20(1) 

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Article 21(5), point (g) 

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Article 21(1) 

Article 21(6) 

Article 42 

Article 4 

Article 20(2) 

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Article 20(2) 

Article 42 

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Article 100(1) 

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Article 21(1) 

Article 21(2) 

Article 21(3) 

Article 22(1) 

Article 22(2) 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27(1), point (a) 

Article 27(1), point (b) 

Article 27(1), point (c) 

Article 27(2) 

Article 28 

Article 29 

Article 30 

Article 31 

Article 32 

Article 33 

Article 37 

Article 19 

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Article 20(2) 

Article 141 

Article 4 

Article 16(2) 

Article 12(4), point (a) 

─ 

Article 57(2) 

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─ 

─ 

Article 144 

Article 145 

Article 145 

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─ 

─ 

─ 

─ 

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─ 

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10. 

Council Directive 2008/90/EC 

Council Directive 2008/90/EC 

This Regulation 

Regulation (EU) No 
…/…. (Office of 
Publication, please insert 
number of Regulation on 
Official Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1(1) 

Article 1(2) 

Article 1(3) 

Article 1(4) 

Article 2 

Article 3(1) 

Article 3(2) 

Article 3(3) 

Article 3(4) 

Article 4 

Article 5 

Article 6(1) 

Article 1 

Article 11(2) 

Article 4 

Article 46 

Article 3 

Article 12(1) 

Article 4 

Article 4 

Article 2 

Article 16, Article 20 

Article 5 

Article 7 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

EN 

142 

   EN 

 
 
 
 
 
 
 
Article 6(2) 

Article 6(3) 

Article 6(4) 

Article 7(1) 

Article 
subparagraph 

─ 

Article 8 

─ 

Article 14, Article 50(1) 

7(2), 

first 

Article  14,  Article  50(1)

Article 
subparagraph 

7(2), 

second 

Article  12(4),  point  (a)

Article 7(3) 

Article 7(4) 

Article 7(5) 

Article 7(6) 

Article 8(1) 

Article 8(2) 

Article 50(2) 

Article 57 

Article 56  

Article 51, Article 52 

Article 17(1) 

Article 17(2) 

Article 9(1), point (a) 

Article 19 (4), (5) 

Article 9(1), point (b) 

Article 19 (1), (2) 

Article 9(1), second 
subparagraph 

Article 9(2) 

Article 9(3) 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14(1) 

Article 14(2) 

Article 14(3) 

Article 14(4) 

Article 

Article 

Article 14(7) 

Article 15 

Article 16 

Article 17(1) 

Article 17(2) 

Article 18 

Article 21(5) 

─ 

Article 21(1)  

─ 

Article 37 

Article 44 

─ 

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─ 

─ 

─ 

14(5) 

14(6) 

Article 4 

Article 40 

Article 11(3) 

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─ 

─ 

─  

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Article  8  and  Article  20, 
point (b) 

Article 13(1) 

Article 93 

Article 93(3), point (d) 

Article 93(3), point (b) 

Article 
(a)(ii)(b) 

Article 
(a)(ii)(b) 

161, 

point 

161, 

point 

Article 93 

Article 115 

Article 118 

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─ 

Article 9(1) 

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EN 

143 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 141 

─ 

─ 

Article 144 

Article 145 (1), (2) 
 ─ 

─ 

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11. 

Council Directive 2002/53/EC 

Council Directive 2002/53/EC 

This Regulation 

Regulation (EU) No …/…. 
(Office of Publication, 
please insert number of 
Regulation on Official 
Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1(1) 

Article 1(2) 

Article 1(3) 

Article 2 

Article 3(1) 

Article 3(2) 

Article 3(3) 

Article 4(1) 

Article 4(2) 

Article 4(3) 

Article 4(4), (5) 

Article 4(6) 

Article 5(1) 

Article 5(2) 

Article 5(3) 

Article 5(4) 

Article 6 

Article 7(1) 

Article 7(2) 

Article 7(3) 

Article 7(4) 

Article 7(5) 

Article 8 

Article 9(1) 

Article 9(2), (3) 

Article 52(1) 

Article 52(1), point (b) 

Article 46 

─ 

Article 51 

Article 56(3), (4) 

Article 4 

Article 56 

Article 56(2) 

─ 

Article 4 

Article 57 

Article 60 

Article 61 

Article 62 

Article 58 

Article 4 

Article 71 

Article 74 

Article 75 

Article 4 

Article 4 

Article 67(1), point (i) 

Article 53(1) 

Article 64 

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─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

EN 

144 

   EN 

 
Article 9(4) 

Article 9(5) 

Article 9(6) 

Article 102(1) 

Article 53(1), point (g) 

Article 64(1) 

Article 10(1), (2), (3), (4) 

Article 103 

Article 10(5) 

Article 11 

Article 12(1) 

Article 12(2) 

Article 12(3) 

Article 13(1) 

Article 13(2) 

Article 13(3) 

Article 13(4) 

Article 14 

Article 15 

Article 16(1) 

Article 16(2) 

Article 17 

Article 18 

Article 19 

Article 76(3) 

Article 86 

Article 82 

Article 83(1), Article 84 

Article 84(4) 

─ 

Article 85(1) 

Article 81 

─ 

Article 85 

Article 85 

Article 4 

Article 4, Article 85(1) 

Article 52, Article 55 

Article 45, Article 85(1)  

Article 84(4) 

Article 20(1) 

─ 

Article  20(2)and  20(3),  point 
(a) 

Article 57 

Article 20(3), point (b) 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

─ 

─ 

Article 44 

Article 141 

─ 

─ 

Article 144 

Article 145(1), (2) 

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EN 

145 

   EN 

 
 
 
 
 
 
 
 
12. 

Council Directive 2008/72/EC 

Council Directive 2008/72/EC 

This Regulation 

Regulation (EU) No 
…/…. (Office of 
Publication, please 
insert number of 
Regulation on 
Official Controls) 

Regulation (EU) No 
…/… (Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants) 

Article 1(1) 

Article 1(2) 

Article 1(3) 

Article 2 

Article 3 

Article 4 

Article 5(1) 

Article 5(2) 

Article 5(3) 

Article 5(4) 

Article 6(1) 

Article 6(2) 

Article 6(3) 

Article 6(4) 

Article 7 

Article 8(1) 

Article 1 

Article 11(1), (2), (4) 

Article 11(3) 

Article 46 

Article 3, Article 10 

Article 16(2) 

Article 6 

Article 7, Article 8 

─ 

─ 

Article 5 

─ 

─ 

Article 24 

─ 

Article 5 

Article 8(2), points (a) and (b) 

Article 2 

Article 8(2), point (c) 

Article 12(4), point a 

Article 8(3) 

Article 9(1), (2) 

Article 9(3) 

Article 10(1) 

Article 10(2) 

Article 10(3) 

─ 

Article 14(1) 

Article 52 

Article 17(1) 

Article 17(2) 

─ 

Article 11(1), first subparagraph 

Article 17(1), Article 28 

Article 
subparagraph 

11(1), 

Article 11(2) 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

second 

─ 

─ 

─ 

Article 35, Article 37 

Article 4 

Article 4, Article 40 

Article 43, Article 44 

146 

EN 

─ 

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─ 

─ 

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─ 

─ 

─ 

Article 36 

─ 

─ 

Article 115 

─ 

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─ 

─ 

Article 8 

─ 

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─ 

Article 9, Article 15 

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Article 64 

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─ 

─ 

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─ 

─ 

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   EN 

 
 
 
 
 
Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23(1) 

Article 23(2) 

Article 24 

Article 25 

Article 26 

Article 27 

Article 24 

─ 

Article 8, Article 13 

Article 20 

Article 20, point (d) 

─ 

─ 

Article 141 

─ 

─ 

Article 4 

─ 

Article 144 

Article 145(1), (2) 

─ 

Article 93 

─ 

─ 

Article 8 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

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─ 

─ 

EN 

147 

   EN