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# 52013SC0162

**COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL On the production and making available on the market of plant reproductive material (plant reproductive material law) /\* SWD/2013/0162 final \*/**

  

Table
of contents

1. Procedural issues and consultation of interested
parties 3

1.1. Overview  3

1.2. Preparatory work  3

1.3. Consultations 4

1.4. Action Plan  5

1.5. Impact Assessment
Board  5

2. Problem definition. 8

2.1. Background  8

2.2. International
dimension  12

2.3. What are the issues
or problems that may require action?  13

2.4. Who is affected, in
what way and to what extent?  17

2.5. How would the
problems evolve, all things being equal?  17

2.6. Does the EU have
the right to act (subsidiarity)?  18

3. Objectives 20

3.1. Overall objectives 20

3.2. Specific objectives 20

3.3. Operational
objectives 21

4. Policy options 21

5. Analysis of impacts 30

6. Comparing the options 55

6.1. Comparing the options 55

6.2. Stakeholder
assessment of the options 59

6.3. Preferred option  61

7. Monitoring and evaluation. 66

Annex I: Glossary. 68

Annex II: History of the development of the PRM
legislation. 70

Annex III: Summary of the chronology of meetings 72

Annex IV: The International Framework of the PRM
Industry. 74

Annex V: List of stakeholders 78

Annex VI: Analysis of the public consultation. 92

Annex VII: Short description of the main features of
the PRM marketing legislation. 102

Annex VIII: Main features of the PRM marketing industry. 110

Annex IX: Selected data regarding the current EU common
catalogues for vegetable and field species 116

Annex X: Inspection costs for forest reproductive
material 124

Annex XI: Graphical
presentation of the five scenarios 130

Annex XII: Variety registration and seed certification
systems in major third countries 136

Annex XIII: Detailed presentation of the Measures
included in the preferred option. 141

Annex XIV: Cost structure of registration and
certification. 144

1.           Procedural issues and consultation of interested parties

1.1.        Overview

The revision of the Directives on the
marketing of plant reproductive material (PRM) is part of the 2012 Commission
Legislative and Work Programme and is included in the Commission strategy for
simplifying the EU legislation.

Plant reproductive material (PRM) is a
cornerstone input for agricultural, horticultural and forestal production and
it is the first link in the food and feed chain. Union legislation has been in
place since 1966 for cereal seed, beet seed, fodder plant seed, seed potatoes
and forest reproductive material. Later on, legislation was adopted for other
groups of plant species, for example material for the vegetative propagation of
the vine in 1968 to vegetable seed in 1970. A number of Directives were to a
large degree overhauled between 1998 and 2002. By 2011, PRM legislation has
grown to include around 90 legal acts. A full list of basic legal acts and a
short history of the legislation can be found in Annex II.

1.2.        Preparatory
work

The impact assessment builds on the results of the
evaluation of the European Union legislation on the marketing of seed and plant
propagating material (hereafter plant reproductive material, PRM) 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 and on a PRM certification study conducted by the
Commission's services. It also incorporates discussions with stakeholders, 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), an EU regulatory agency mandated to grant plant breeders’ rights
valid throughout the EU.

Key messages of the evaluation of the PRM legislation

Primary strengths:

·
Role of official authorities is considered
crucial by stakeholders in guaranteeing the equal access to all EU players onto
the PRM market

·
Evaluation of distinctness, uniformity and
stability (DUS) and the value for cultivation and use (VCU) are considered
essential and robust tools for conventional agriculture

·
Reasonable and proportionate costs linked to the
implementation of the legislation

·
The Common Catalogues on agricultural and
vegetable species are perceived as a powerful tool by private operators to
facilitate marketing of PRM

·
Provisions for certification have helped
European seed industry to become a world market leader

·
Alignment with international standards and
guidelines (i.e. OECD, ISTA, UPOV)

Areas for improvement

·
Room for cost reduction and increased efficiency

·
Complex legislation with lack of flexibility

·
Non-harmonised implementation in Member States

·
Niche and emerging markets are disadvantaged

The
respective documents related to the preparatory stages of the legislative
review can be found at http://ec.europa.eu/food/plant/propagation/evaluation/index\_en.htm.

1.3.        Consultations

Stakeholders
at various levels were first consulted in the context of the evaluation
conducted in 2007/2008. Following the evaluation,
internal consultations, discussions with Member states and further dialogues
with stakeholders were carried out. Annex III gives list of all the meetings.

1.3.1.
Internal consultation

Within the
Commission, internal consultation has been pursued through an Inter-Service
Steering Group (ISSG) set up in 2009. The ISSG was led by the
Directorate-General Health and Consumers, with the participation of DGs
Agriculture, Trade, Environment and the Secretariat General.

1.3.2. Member States consultation

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 by 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.

1.3.3. Stakeholder consultation

On 18 March 2009 an open conference on Ensuring
Seed Availability in the 21st Century was organised to present and discuss
the evaluation results with different stakeholders. Overall, stakeholders
supported the Commission's intention to revise the legislation.

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 more than 257 responses from a very wide range of stakeholder
groups. All replies to the questionnaire can be found in http://ec.europa.eu/food/plant/propagation/evaluation/options\_review\_legislation\_replies\_en.htm.
The results are summarised in section 6.2 and in more detail in Annex VI.

Main outcome of the stakeholder consultation

·
A majority of stakeholders support the continued
existence of the main pillars of variety registration and certification of lots
of listed species.

·
Competent authorities support the idea that the revised legislation should reflect a
combination of scenarios, combining obligatory variety registration and
certification of lots of listed species with more responsibilities for
operators, the introduction of cost recovery and a lighter system for
conservation varieties.

·
Breeders, suppliers and users of PRM support the maintenance of current technical provisions and accept
the idea that certain tasks should be shifted to operators under official
supervision. The concept of cost recovery is also accepted.

·
A majority of stakeholder groups mainly
interested in biodiversity issues support a liberalised and flexible system
with no obligatory variety registration and certification of lots.

·
Forest
stakeholders support the scenario with no changes
in the Directive on forest reproductive material.

1.4.        Action
Plan

Based on the evaluation
results and the stakeholder consultations, the Commission services presented a
PRM Action Plan (SEC(2009) 1272 final) on 2 October
2009, which was subsequently discussed with the Member States.

Main issues raised in the Action Plan

·
Single horizontal legal framework

·
Harmonised implementation of legislation in Member
States

·
Reduction of administrative burden and costs

·
Consistency with other EU policies:

·
Possible extension of the role of the CPVO

·
Enhancing the role of the Common Catalogue

·
Strengthening the EU role on international
standards

·
Setting structures for stakeholder involvement

1.5.        Impact
Assessment Board

The impact assessment report was submitted to the IA board
on 14 December 2011 and was formally presented on 18 January 2012. Following
this meeting the board issued on 20 January 2012 an opinion on the draft Impact
Assessment emphasising four main points to be addressed in the final version of
the report.

(1) Strengthen the evidence base of the
problem definition

·
The
problem definition in section 2.3. now more clearly describes which elements of
the current system are problematic and why amending the current legislation is
not sufficient;

·
The
problem definition now in more clarity explains how the current legislation
creates obstacles to a level playing field for all operators;

·
It is
stated in section 2.3. that the problem definition is based on the evaluation
and consultations with Member States' experts and stakeholders;

·
Section
2.5 emphasizes that a better implementation of the current legislation is not a
solution to the identified problems;

·
The
current market structure is described in the baseline scenario (section 5 –
Option 0) and in Annex VIII. The baseline scenario also contains detailed
descriptions of the different sub-sectors. Annex X provides details on
inspection in the FRM sector;

·
The
relevant elements of the EU Plant health Regime, links with the Official
Controls Regulation and the fact that GMOs are dealt with in a parallel legal
framework are mentioned at the end of section 2.1.

(2) Improve the intervention logic and
the presentation of the objectives

·
Problem
definition 2.3.4. shows which specific elements of the current legislation are
insufficient to promote sustainability and 2.3.5. demonstrates in detail the
obstacles that delay the flow of innovation to the market;

·
The report
now clearly demonstrates that the introduction of cost recovery regime does
constitute a proportionate measure (section 5: impact assessment of Option 1
and tables 3 and 4) and that it is an instrument to promote a level playing
field for all operators;

·
Section 4
lays out that the major trade-off is between transferring costs and tasks to
operators and the resulting flexibility;

·
The
description of each option is now accompanied by a text box outlining how the
options achieve the objectives (section 4).

(3) Better present the options
and their possible combinations

·
The
presentation of the policy options clarifies that simplification refers
exclusively to the legal structure (from 12 Directives to one Regulation) and
demonstrates that legal simplification and cost recovery are horizontal
provisions common to all options. The substantial differentiation of the
options is mainly based on the other instruments (see next point);

·
The first
paragraph of section 4 explains that options 1-4 were designed to reflect
internal consistency of the instruments mainly with respect to the flexibility
afforded to operators, while option 5 envisages a centralised, fully harmonised
system. It is emphasized that combinations are feasible if consistency is
respected;

·
The
preferred option is now presented in the same way as all the other options
(Section 6.2.), also stating which elements originate from which of the options
2, 4 and 5. A summary of the impacts of the preferred option is included as
well (Section 6.2.1). The preferred option is also included in the qualitative
comparison of all options in table.

(4) Present the expected
impacts in a more transparent way

·
In the
context of assessing the impacts of cost recovery a more detailed quantitative
analysis of costs and benefits was carried that also explicitly addresses the
different sectors (section 5: assessment of Option 1);

·
The impact
of cost recovery on SMEs and micro-enterprises is analysed in detail in the
assessment of option 1. Available, but incomplete, information from sectors other
than the sector of agricultural crops is taken into account. The analyses of
impacts of all other options explicitly take SMEs and micro-enterprises into
account where appropriate;

·
The
impacts on international competitiveness and trade flows are in detail dealt
with in the analysis of all options, but have particularly been strengthened in
Options 3 and 4;

·
The
employment impact is analysed separately for the private and public sector. Other
social impacts are analysed in a dedicated section for each option;

·
The fact
that GMOs are dealt with in a parallel legal framework is mentioned at the end
of section 2.1., where it is also stated that invasive alien species are
outside the scope of the PRM legislation. Environmental impacts are analysed
for each option, specifically agro-biodiversity: this analysis for option 3
shows specifically how VCU can have an impact of land use;

·
Available
quantitative information on costs, benefits and industry structure has been
taken into account in the analysis of all options, in particular in the
analysis of option 1. Available quantitative information on costs is summarised
in Annex XIV.

(D) Procedure and Presentation

·
The
analysis of the stakeholder survey is presented in Annexes V and VI. Responses
are analysed for different stakeholder groups. The report refers to stakeholder
opinions in several places (for example section 2.3.4). The report states that
stakeholder input has been relevant for identifying the options (section 4) and
emphasizes that the preferred option also strikes a balance between different
stakeholder groups (section 6.2.);

·
The IA
executive summary has been changed accordingly to reflect the changes of the
main report.

Following the resubmission the board issued on 29 March 2012
a further opinion on the draft Impact Assessment emphasising four issues to be
addressed in the final version of the report.

(1) Strengthen the evidence
base of the problem definition

·
Sections
2.3.1. – 2.3.5. now include several new footnotes that make specific references
to findings of the evaluation of the existing S&PM legislation

(2) Reformulating the
objectives to better address the issues raised in the problem definition and by
clarifying trade-offs

·
The
overall and specific objectives (Sections 3.1. and 3.2.) now correspond almost
exactly to the problems identified in Sections 2.3.1. – 2.3.5.

·
Trade-offs
are explicitly identified following the presentation of the policy objectives
in Sections 3.1. – 3.3.

·
In the
assessment of Option 1 it is now explicitly stated that cost recovery regime is
a proportionate measure in the light of the main objective.

(3) Improve the presentation
of impacts and the comparison of options

·
In Section
4 it is now spelled out in more detail which elements of the options are
compatible with each other and which elements are not.

·
In the
assessment of Option 2, point 3, data are presented that demonstrate the
potential cost savings for some sectors if official supervision of
certification is introduced.

·
The
comparison of the options now includes a summary graph that in a
semi-quantitative manner summarises the impacts of the initial and also the
preferred option.

(D) Procedure and presentation

·
Stakeholder
input has been frequently and constantly sought during the entire revision
process and has helped identifying problems, devising objectives and options
and assessing specific impacts. The objectives (see Section 3) thus also
reflect well the diversity of stakeholder attitudes. Stakeholder groupings are
presented in Annex V and opinions are summarised in detail in the newly added
Section 6.2.

2.           Problem definition

2.1.        Background

Plant
reproductive material is an input of fundamental importance for the
productivity, the diversity, and the quality of plant production and food. This
fact has been reflected in national legislation since the late 19th
century and in European legislation since the 1960s. Productivity is determined
by two basic elements. First, varieties of agricultural and horticultural crop
species and forest reproductive material shall be of good quality and
identifiable. This means that the plants show a strong and healthy growth, are
resistant or tolerant to attacks of some harmful organisms, and to adverse
environmental conditions and finally have the right characteristics for their intended
use. Wheat varieties, for instance, could be suitable for bread but not for
pasta, or exactly the opposite. Second, the PRM lots brought to the market
should be in a state so that growers have the best guarantee on the identity of
the material and that the plants are able to realise their good characteristics
when properly maintained after sowing or planting.

At the time
when the PRM EU legislation was first developed, its objective was to contribute
to improving the productivity of agriculture in order to ensure food security
in the EU, to improve the competitiveness of the related sectors and to play
part in the harmonisation of the legislation at EU level, leading to more open
markets. This policy has proved to be successful: the PRM sector in the EU is
diverse and competitive (see Annex VIII) and has developed into the world's
largest PRM exporter. But agricultural policy is no longer restricted to the
policy aims formulated in the 1960s. 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" of food crop production
in which yields are increased without adverse environmental impact and without
the cultivation of more land has become a central concern. PRM legislation is
critically important for reaching this aim as well.

The EU
legislation on the marketing of PRM is based on two main pillars, namely the
registration of varieties/material[1]
and the certification[2]
of individual PRM lots of plant species used for agriculture marketed in the EU
and identified in the Annex of the Directives ('EU listed species') or the
approval and registration of basic material and the traceability and quality
control of forest reproductive material. It consists of 12 basic Council
Directives and is structured into one horizontal Directive on the Common
Catalogue of varieties of agricultural plant species and 11 vertical Marketing
Directives, among which five seed Directives (fodder plant seed, cereal seed,
beet seed, seed of oil and fibre plants and vegetable seed[3]), three plant propagating material
Directives (vine propagating material[4],
seed potatoes, vegetable reproductive material other than seed) and three
Directives that cover both seed and propagating material (fruit plant propagating
material, ornamental plants and forest reproductive material[5]). Annex VII summarises the
processes of registration and certification and provides a tabular overview
over the current requirements for the different plant groups covered by the
legislation.

Community Plant Variety
Office (CPVO)[6]

To better appreciate the assessment of one of the
options developed here, it is also necessary to succinctly describe the present
role of the CPVO and to keep in mind the difference between plant variety
rights and plant variety marketing. CPVO manages the Union's intellectual property rights system for new plant varieties. After an application has been submitted, the CPVO
first studies the administrative file, including payment of fees, and whether
the variety is in fact novel with regard to previous marketing. If no formal
impediment is found for granting protection, the CPVO arranges for a technical
examination of the variety submitted. The purpose of
this examination is to ensure that the criteria of distinctness, uniformity,
and stability (DUS) are complied with. The technical examination is entrusted
to Member States competent bodies (examination offices) or carried out in
cooperation with third countries. They are conducted in accordance with
protocols established by the CPVO, based on UPOV guidelines, and are monitored
by its technical experts. In addition to the technical requirements, a variety
must be identified by a variety denomination, which is proposed by the
applicant in the form of a code or a “fancy” name. To be approved, a variety
denomination must fulfil several criteria that ensure clear and unambiguous
identification.

CPVO is currently only
responsible for the granting of intellectual property rights for plant
varieties – granting of this intellectual property right for a new
variety is entirely independent from the right to market the variety.

The current EU
PRM legislation sets out general principles that operators[7] need to comply with before reproductive
material of plant varieties can be marketed:

1. Plant
varieties should be listed in a national and then in the EU (Common) catalogues
(for agricultural and vegetable crops) to be marketed.[8] The purpose is to ensure that
the varieties are clearly identified. In order to be listed, it has to be
demonstrated that varieties are Distinct, Uniform and Stable (DUS) and that
variety denomination rules are observed. Moreover, varieties of agricultural
crop species must be tested for their Value for Cultivation and Use (VCU).[9] The tests should be conducted
as official examinations. The above general principles are not applicable to
ornamentals. The principles for forest reproductive material are based on
national registers of approved basic material.

2. Individual
lots of seed and plant propagating material are subject to a pre-market
certification system on the basis of official certification or certification
under official supervision of the competent authorities. However, for seed
potatoes and for the categories of pre-basic and basic seed only official
inspections shall be carried out.

The above
general principles are not applicable to ornamentals or vegetable standard
seeds, while for fruit plants EU mandatory rules will only apply as from 2012.

For forest
reproductive material the Member States shall, by an official control system
set up or approved by them, ensure that reproductive material from individual
units of approval or lots remains clearly identifiable through the entire
process from collection to delivery to the end user. Therefore a master
certificate is required, showing the unique register reference for all
reproductive material derived from approved basic material.

3. The more
recent Directives require the registration of suppliers, in particular because
most of the PRM concerned is brought to the market carrying a suppliers' label.

In the recent
years, to meet objectives such as preserving biodiversity, supporting in situ
conservation and the protection of natural environment, specific legislations
creating derogation for less stringent marketing requirement for so called
conservation and amateur varieties and preservation seed mixtures were
developed.[10]

The legislation
on PRM applies without prejudice to the provisions of Directive 2001/18/EC,
Regulation (EC) No 1829/2003 and Regulation (EC) No 1830/2003 concerning the
deliberate release into the environment, including cultivation, placing on the
market, traceability and labelling of GMOs.

As regards harmful
organisms, the so-called non-quarantine pests are listed together with other
certification requirements in the various PRM Directives. In addition the
Directive on seed potatoes list some quarantine pests which should today only
be listed under the umbrella of the Plant Health legislation.

The scope of
the new legislation should exclude from marketing authorisation material
belonging to plants which are injurious to plants exclusively through
competition for nutrients and/or ecological niche or allelopathy (invasive
alien species, IAS). With regard to IAS, the new legislation on PRM will apply
without prejudice to the EU 2020 Biodiversity Strategy adopted in May 2011.

Finally, the
enforcement of PRM legislation is currently not framed by a general legal
framework providing the competent authorities in the
Member States with a solid and comprehensive set of rules which affords them
the necessary powers and tools to deliver their enforcement duties in an
efficient and reliable fashion. In fact, official controls performed by
competent authorities to verify compliance with PRM legislation are not covered
at present by Regulation (EC) No 882/2004 governing official controls along the
food chain, nor do equivalent provisions exist for official controls for the
purpose of enforcing PRM legislation. The required official control system for
forest reproductive material is already set up by member states and may be
checked by the Commission. Nevertheless, a harmonised European approach is not
yet in place. This issue will be addressed in the context of the on-going
Impact Assessment for the review of the Regulation (EC) No 882/2004.

2.2.        International
dimension

The EU is the world's
largest exporter of PRM with an estimated export value of EUR 4.4 billion
representing roughly 60% of the total worldwide PRM export value of EUR 7.7
billion[11].
The high quality of European PRM is an asset in the global market – and an
asset for food security.

The legal
framework established in the EU has facilitated – if not enabled – this
development, but it needs to be underlined that rules and standards have been
established in a wider international context than the EU (see also Annex IV).
The EU is an active member in these international fora and EU rules have had
considerable influence on the elaboration of international rules and standards.
Internationally accepted standards for seed sampling and testing are developed
by the International Seed Testing Association (ISTA) and applied in the EU by
seed analysis laboratories. EU protocols for the technical examination of
varieties are based on test guidelines elaborated by UPOV experts (Union
Internationale pour le Protection des Obtentions Végétales); EU is member of
UPOV since July 2005. Varietal identity and purity standards for the
certification of PRM lots in view of their marketing are based on OECD (EU has
a status of participant) seed rules and forest reproductive material control, which are also open to non OECD countries, or on UNECE standards for
seed potatoes. The plant health legislation is framed in the wider context of
the International Plant Protection Convention (IPPC). In general, the EU
standards are in line with OECD standards, but not fully coherent with UNECE
standards on seed potatoes. The UNECE standard is an evolving framework, while
the EU Directive has not changed since its adoption. Regarding plant genetic
resources, the EU is a contracting party to the International Treaty for Plant
Genetic Resources for Food and Agriculture (ITPGRFA) since 2004.[12]

PRM which are
developed in Europe can later be exported, commercialized and grown in third
countries, in particular through the OECD seed scheme or OECD forest
reproductive material scheme, directly in similar agro-climatic conditions
areas or by being introduced to breeding programs. The rules which are
developed in the Union are following the principles of the international
standards in order to assure coherence with all countries following such
standards and to facilitate international trade. 67 countries are members of
the OECD seed schemes, including India, Argentina, Brazil; Senegal is candidate to one of the OECD seed schemes.

The revision of the
PRM legislation will continue to take into consideration the productivity in
the agricultural, horticultural, and forestal production and will strengthen
sustainability criteria in the variety registration process in order to adjust
production to major challenges such as climate change, food security and to
reinforce the link between breeders and user/farmer in the plant innovation
system. The control and certification system along the PRM production chain
will maintain the high quality of the material and continue to contribute to
food/feed safety and security. The rules on forest reproductive material
conform to the standard developed at OECD level which will be further used by
third countries for the production of tropical wood PRM.

The revision of the
PRM legislation also contributes to achieving the millennium goals, including
measures in favor of preservation of biodiversity through the facilitation of
market access for conservation varieties.

2.3.        What
are the issues or problems that may require action?

In line with the Europe 2020 Strategy and Commission SMART Regulation
policy[13]
aiming at simplifying and improving regulation and at
developing an economy based on knowledge and innovation,
it is necessary to review PRM legislation, streamline and remove overlaps to
ensure that it is consistent and does not create unnecessary burdens for
operators and citizens.

This is especially relevant due to the fact that the EU PRM
sector is not only the world's biggest exporter of seeds (net market value EUR
4.4 billion) but also has an average R&D/net sales
ratio of around 15% of its annual turnover (EUR 6.8 billion) in seed market.[14] Maintaining the comparative
advantage of the EU industry on the global market, while ensuring at the same
time innovation and diversity as crucial element, is therefore one main
objective of this review.

The external
evaluation carried out in 2007-2008 concluded that most of the stakeholders
consider that the EU's PRM legislation has been effective in achieving its
initial objectives and that free movement of marketed PRM is observed in the internal
market. However, the evaluation also highlighted a
number of problems regarding the application of the legislation in practice.
The five key problems, identified in the evaluation and through consultation
with member States' experts and stakeholders, form the basis of this
review.

2.3.1.
Complexity, rigidity and fragmentation of legislation and gaps

Driver: The
legislation is composed of 12 basic Directives and approximately 90 other legal
acts. The Directives have been developed over several decades and within
different political and scientific-technical contexts. Furthermore, the
alignment with other legislative acts that concern the sector also needs
improvement. The problems cannot be corrected by only amending the legislation.

Problem:

·
Understanding the requirements laid down in the
Directives and other legal acts in their entirety is not simple.[15] In some PRM sectors, the
operators must implement 2-3 Directives at the same time in order to fulfil
their obligations. There is also a lack of consistency, such as
cross-referencing to outdated legislation or concerning definitions and some
obligations.[16]
The current legislation is in a form of Directive
requiring national transposition. The Directives are implemented at different
points of times and give room for substantial differences in national
interpretation;[17]

·
Certain work-intensive parts of the
certification process (field inspections for pre-basic and basic seed, seed
potatoes, FRM) and the examinations for variety registration (DUS, VCU) can
only be carried out as official examinations. This may limit the flexibility of
operators to adapt to the more quickly changing demands of an increasingly
global market for PRM[18];

·
As regards variety registration, it is well known
in the sector that some Member States use much larger variety reference
collections than others[19]
and that there are considerable differences how extensively VCU tests are
carried out (criteria, testing, calculation of results, etc.)[20];

·
The current legislation gives the possibility
for additional national rules. For example, in the case of certification of
seed potatoes, different marketing categories exist in different Member States
leading to national systems taking precedence over the EU legislation and thus
undermining the internal market;

·
The current legislation does not contain a solid and comprehensive set of rules for competent authorities in the Member States performing official
controls and in the majority does not include the empowerment for the Commission
to audit/visit the Member States' control system;

·
There are currently no EU rules on fees for
variety registration or official controls including PRM certification;

·
The majority of the current Directives do not
require the registration of operators.

It therefore seems sensible to envisage a review of the PRM
legislation with a view to its simplification and increased consistency with
itself and with other legal acts that govern PRM marketing.

2.3.2.
High level of administrative burden in particular for public authorities

Driver: Public competent authorities are to a
high degree involved in variety registration and in the certification of PRM
lots brought to the market, as the required tests and examinations (DUS, VCU)
are currently nearly exclusivley carried out by the authorities.

Problem: As Member State national budgets are
under strong pressure and the need to prioritise resources is becoming more and
more severe, it seems pertinent to consider the possibility to reduce the level
of public resources required by PRM legislation.[21]

The system therefore needs to become more
efficient and less burdensome. It should be examined whether, and if so to what
extent, certain tasks could or should be assigned to the private sector or can
be shared between Member States while ensuring that the quality of the marketed
PRMs remains at least as high as under the current regime and that the
operational capacity of SMEs is not compromised.

2.3.3.
Non-harmonised implementation of the current legislation

Driver: The evaluation of the current regime found that implementation of
the legislation in the Member States varies significantly. There are currently
no rules for fees at EU level for public services rendered to private
operators, and therefore there is no harmonised framework for costs and
responsibility sharing. Some Member States recover the whole cost of technical
examination of varieties and of certification from the producer, some only
recover a part.

Furthermore,
the variety examination procedures and associated costs can vary considerably
from Member State to Member State.[22]
For certification, additional or stricter national requirements for national
production are applied in several Member States.

Problem:
This lack of harmonisation causes obstacles to the establishment of a level
playing field for all operators in the internal market. While costs for
registration and certification amount to no more than 3% of the annual market
value of agricultural seed crops[23],
the burden for public services is quite significant in some Member States: in Germany and France annual costs for registration and certification are approximately EUR 26 Mio and
EUR 24 Mio, respectively. However, in Germany only around 50% of these costs
are recovered, while in France 67% of registration costs and 97% of
certification costs are recovered (see Annex XIV). The 'user pays' principle is
not evenly applied across all Member States.

2.3.4. Weaknesses concerning
horizontal coordination with recent EU strategies concerning biodiversity, sustainability
and climate change

Driver: For
historical reasons, the current system is mainly focused on the improvement of
productivity of agricultural crops and for all listed species to a certain
extent on the resistance to biotic and abiotic stress and diversification of
uses, in addition to the harmonisation of the market.

Problem: The
evaluation stressed that although productivity is still an important factor for
the development of new varieties, other aspects have gained in importance.[24] In the
past decade the need for "greening" of the Common Agricultural Policy
(CAP) has emerged and policy objectives related to sustainability, biodiversity
protection and climate change have gained importance in addition to food
security (including feed) and food safety. Specific
products such as old varieties or minor crops are increasing their market
share. Breeders and competent authorities in some Member States have taken
these developments proactively into account, but efforts should be spread over
the entire EU. For low-input agriculture the rules are seen to be far too
strict and costly. Certain stakeholders are stating that the less stringent
requirements developed in the recent years in the EU for conservation and
amateur varieties are still too restrictive, burdensome and costly.[25] Basic
Council Directives 66/402/EEC and 2002/55/EC stipulate limitation to
region of origin for conservation varieties and appropriate quantitative
restrictions. Some stakeholder groups are strongly against both these
stipulations, while others are adamant that no changes should be considered.

2.3.5.
Removing obstacles to quick market access of innovations

Driver: The
registration process of varieties is a heavy procedure requiring time,
technical knowledge and staff both at the level of competent authorities and
operators’ in order to fulfil the registration criteria. Rules governing the
variety registration process can place a series of small obstacles in the way
to market access, which in their combination can delay the flow of innovations
to the market.

Problem:

·
As part of the registration process, Member
States’ notifications are to be transferred to the EU Common Catalogue. Some
Member States only report national registrations twice per year for transfer to
the EU Common Catalogue. At the EU level, depending on the time of the year,
the administrative procedure concerning the transfer of varieties to the Common
Catalogues (Official Journal) takes roughly 8 weeks;

Member States may have limited resources for
growing trials for variety testing. Therefore in some Member States the
number of applications in certain species per year are limited;
Strict deadlines for submission of application
and material;
Number of years required for the technical
examination varies between Member States;
Breeders have to accept the practical conditions
for testing (e.g. locations of fields) in the examination office, which
might be suboptimal for variety in question;

·
For a new type of variety the development of the
necessary testing protocols can take several years.

In addition, variety registration
procedures put a high burden on competent authorities. This is amplified by the
difficult current economic environment which leads to a reduced availability of
public funds: the consultation process demonstrated that a number of Member
States are under pressure to reduce staff and to close some testing stations.
The current administrative procedures might delay the flow of innovation onto
the market.

2.4.        Who
is affected, in what way and to what extent?

-           Member State authorities: financial and staff resources are under severe pressure and it
becomes increasingly difficult for competent authorities to fulfil the
obligations laid down in the legislation;

-           Breeders of
varieties, as changes in the legislation may affect their right to
commercialise the products of their breeding activity, taking into account that
breeding activities represent at least 10 years of work, and the cost of doing
so;

-           PRM
suppliers, if quality requirements for lots brought to the market would be
altered or if costs of certification would be transferred more systematically
to the private sector operators;

-           PRM users,
as a revision of the legal framework with regard to minimum conditions for PRM
marketing could affect the availability, quality and the cost of PRM brought to
the market;

-           Consumers
of produced commodities, because PRM is a primary input of any agricultural,
horticultural or forestal production and as such the changes felt by PRM users
will be reflected in the availability, quality and costs of the commodities (food)
offered to the final consumers;

-           PRM
suppliers, agricultural stakeholders and consumers outside the EU, because, as
the EU is the world leader in PRM production and export, changes to the EU PRM
marketing legislation will have consequences worldwide. EU has an important
role to play in global food security and thus in avoiding food crises.

2.5.        How
would the problems evolve, all things being equal?

The current provisions on variety
registration only allow examinations by official authorities and do not allow
examinations to be carried out by private operators. As regards certification,
the current legislation caters for a possibility in certain cases to transfer
part of the work related to certification of lots of PRM to the industry
through a system of certification under official supervision. However,
limitations of the legislation do not allow certain plant species (e.g.
potatoes) and categories of seed (pre-basic and basic) to fully benefit from
officially supervised examination. This will in particular have an impact on
big companies and competitive, innovative SMEs in big Member States, which are
limited in their room to operate. If no action was taken, the shortcomings of
the system will grow and become an increasingly larger burden for both official
authorities and business with consequences for competitiveness, adaptation to
market demands as well as export capacities vis-à-vis to non EU competitors.

The provisions contained in the EU PRM
marketing legislation on registration of varieties and on certification of
individual PRM lots are strict. This could become more problematic given the
current financial situation as in today's global market operators need to react
quickly to market demands and opportunities. The current variety registration
system can be improved with a view to support innovation. These improvements
are needed to ensure quick access to the market for new improved varieties,
especially those giving a higher and more regular yield on the same land
surface with less need for irrigation, fertilisers or pesticides. Developments
in plant breeding have contributed significantly to yield increases, but with
regard to the European strategy to further reduce the use of plant protection
products and fertilisers, plant breeding efforts will have to be strengthened
in order to be able to take such requirements into consideration.

Furthermore, discrepancies with regard to
technical examinations and evaluations in the context of registration and certification
would continue to exist across the Member States. This would prove
disadvantageous to some operators and may continue to be an obstacle to the
establishment of a level playing field in the internal market.

Finally, the
complexity and fragmentation of the existing legislation is likely to
perpetuate existing uncertainties and discrepancies in its implementation. This
would further maintain or aggravate current difficulties of national
authorities and operators. In addition, without amending legislation, the
possibility to move more technical requirements to the implementing measures
and thus the increase in flexibility of the legislation would be lost.

As regards the
current legislation on conservation varieties, the strict requirements for
variety testing, restriction to production in region of origin and quantitative
restrictions might compromise achievement of the aim of conservation of
agro-biodiversity in situ. Therefore there are few opportunities for the growth
and expansion of this sector.

No synergies
with the Plant Health Law concerning the plant health checks that are part of
the PRM certification process or integration of general principles concerning
official controls embedded in Regulation (EC) n°882/2004 would be obtained.

2.6.        Does the EU have the right to act (subsidiarity)?

2.6.1. Right of the EU to act (Treaty basis)

The PRM legislative framework is based on
the Treaty on the Functioning of the European Union (TFEU) Article 43
(ex-Article 37) 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. 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.

Article 114 provides
the legal basis for the establishment and functioning of the internal market
and the approximation of provisions laid down by the law, regulation or
administrative actions in this respect.

Article 191 states
as the objectives of EU environment policy the preservation of the environment,
the prudent and rational use of natural resources as well as promoting measures
at international level to deal with environmental problems.

2.6.2.
Necessity for the EU to act

The introduction of the EU framework
legislation on the marketing of PRM in the sixties has been a major contributor
to the creation of an internal market. As confirmed in stakeholder
consultation, performed as part of the current systems evaluation, a large
majority of the respondents believe that the EU rules on marketing of PRM have
had a positive impact on free movement, availability and quality of PRM
on the EU market and have thus facilitated trade within the EU. If there was no action at EU level, 27 systems
instead of one would be in place. This would put obstacles to the movement of
PRM on the internal market and increase the financial burden associated with
the necessary controls on health and quality of PRM.

International standards or recommendations
have been established not only for PRM quality (OECD, UNECE, ISTA) but also for
plant health (IPPC, WTO/SPS agreement) which require an adequate transposition
in all EU27 Member states. In order to avoid a more non harmonised
implementation of EU rules on the internal market, a common EU framework
is the most appropriate approach.

2.6.3. Added value

A common legislative framework adds weight
to EU positions and approaches for addressing issues of PRM on the global
level, notably in international agreements.

At the same time, transparent and reliable
rules ensuring the highest product quality are of particular relevance
to the EU PRM industry in its role as the largest exporter in the world. The
competitive advantage of EU exporters relies heavily on the high quality of its
products.

Certification and
marketing of PRM relies on a system of pre-market authorisation, such as DUS-
and VCU-evaluation for variety registration and field inspection and sampling
of PRM production as well as approved basic material and traceability of forest
reproductive material. These are performed by national authorities, but in line
with a 'one key, several doors' principle, are valid in all EU27 Member
states. This ensures the quality of EU products while safeguarding open and
fair competition on the Single market, and facilitating the marketing of
innovative products. A certain margin for higher efficiency herein is possible
with the introduction of the possibility for direct EU-wide authorisations by
CVPO.

2.6.4 Proportionality

With a view to ensuring proportionality of measures,
notably reducing administrative burden for Member States and private actors,
the system of pre-market control must take into consideration the freedom and
economic viability of stakeholders as well as SME and micro-entities regarding
the more specific parts of the PRM market. Varieties of common knowledge,
conservation or amateur varieties help to ensure access of growers, including
amateur gardeners, to PRM of varieties that would not pass modern variety
evaluation. Conservation varieties could play an important role in maintaining
resilient systems in agriculture production and genetic diversity at the field
level. Smart growth is fostered by specifically focusing on niche markets (e.g.
old varieties), such as in allowing simplified market access for specific
varieties and PRM.

2.6.5 Citizens' and Human Rights

Provide Member States' competent authorities with efficient tools
for the performance of official controls and, consequently, allow for a more efficient use of national control
resources in line with the principles of equity and fairness and in full
compliance with the Charter of Fundamental Rights of the EU, in particular the
right to protection of personal data and the right to an effective remedy.

3.           Objectives

3.1.        Overall objectives

·
To assure the health and high quality of PRM;

·
To provide a single and harmonised regulatory framework
which is supportive for innovation and the competitiveness of the European PRM
industry;

·
To support sustainable production, biodiversity
protection, adaptation to climate change and to contribute
to food security and poverty alleviation.

3.2.        Specific objectives

·
To ensure a level playing field across the EU
through simplified, clarified and harmonised basic rules on fundamental
principles presented in an improved legal form;

·
To reduce unnecessary costs and administrative
burden and to increase flexibility for operators without compromising the
general policy objectives;

·
To align PRM legislation with other recent Union
strategies (plant health law, official controls regulation, agriculture,
biodiversity, food security, climate change, bio-based economy);

·
To foster innovation in plant breeding,
especially in SMEs, in order to improve PRM users’ choice and access to a wide
diversity of plant varieties adapted to conditions in Europe.

3.3.        Operational objectives

·
To provide a simplified legal framework for
marketing of PRM – “PRM Law” - with the establishment of simplified, more
flexible and proportionate procedures;

·
To promote a more harmonised implementation of
legislation throughout the EU by audits and training;

·
To foster innovation by increasing the
timeliness and level of information provided in the Common Catalogue;

·
To enhance market transparency and improve
traceability through the registration of operators.

The objectives also reflect the diversity of opinions and aims among
stakeholder groups in the PRM sector (see Annexes V and VI). Attempting to
realise all these objectives simultaneously is constrained by a number of
potential trade-offs between or even within objectives: (1)
Transferring tasks to the private sector and broadening the scope of official
supervision may have an impact on the health and quality of PRM; (2) the
reduction of costs for competent authorities and the transfer of tasks to the
private sector may burden in particular SMEs that may not be able to bear the
additional costs or to carry out the tasks themselves; (3) Breeding for
sustainability traits of crops (drought resistance etc.) may compromise yield
increases.

4.           Policy options

Based on the evaluation, on internal
discussions and on discussions with Member States' experts and various
stakeholder groups, a number of policy options were developed.

The problem
definition identified the following main axes along which the system has to
change in order to be fit for the new economic, environmental, social, and
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,

(iii) Horizontal coordination with recent, already adopted EU
policies.

Various
measures – increased flexibility, deregulation or centralisation – are explored
for improving the efficiency of the system, while maintaining the assurances
for high quality PRM, competitiveness and addressing new challenges such as
hold of loss of biodiversity. These measures have been translated into the
content of the options as regards the main instruments of the legislation:
registration of varieties/material, certification, registration of operators
and conservation varieties.

The preparatory
work for the Impact Assessment identified 5 options that address all or most of
the identified problems and are characterised by internal consistency,
especially with respect to the level of responsibility sharing between private
and public actors and the obligatory or voluntary nature of instruments such as
registration or certification. The options were chosen so that, for example,
responsibility sharing between operators and competent authorities or
deregulation extends to all main instruments of the legislation and are not
arbitrarily restricted to certain instruments. Option 5 (centralisation) is
compatible with increased flexibility of operators concerning certification,
but is more limiting concerning variety registration. Option 5 is by and large
incompatible with deregulation. It should be noted that simplification of the legal architecture (replacing 12 Directives
by one Regulation) and cost recovery are constant for all options and
compatible with deregulation, increased flexibility and centralisation.

In the various
options, issues concerning 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 PRM market.

Specific attention is given to the trade-off
between transferring operational work and maintenance of PRM quality

A graphical presentation of the five
options can be found in Annex XI. A detailed quantitative analysis of
stakeholder attitudes towards the options can be found in Annex VI.

Option 1 - Cost recovery: No change to technical
provisions and allocation of tasks but complete recovery of registration and
certification costs by competent authorities

Cost recovery and the simplification of the basic legal acts (replacing 12 Directives by
one Regulation) are horizontal provisions common to all options.

Option 1 does not foresee any changes to
the technical provisions of the current legislation or to the allocation of
responsibilities for the implementation and the control of the implementation
of the legislation. The registration and certification systems will continue to
exist as they are for the same plant species. The involvement of public
authorities in the management of the system is not changed. The only change
with potential significant impacts consists in a recovery from the
stakeholders of costs incurred by the competent authorities in all the Member
States. This will be achieved via the introduction of a mandatory fee system or
any other way of authorities' compensation. Currently there is a wide
divergence in the extent to which this is done in the Member States.

Option 2 - Co-system: No change to technical
provisions but certain tasks performed by industry under official supervision;
improved coherence between the PHR and PMR regimes

Cost recovery and the simplification of the basic legal acts (replacing 12 Directives by
one Regulation) are horizontal provisions common to all options.

This option foresees the shifting of
certain tasks and responsibilities from the competent authorities to the
private sector. As a result, the system focuses more on process- than on product-control.

1. Registration
of varieties and material

Variety registration continues to be obligatory
for crops covered by EU legislation.  However, more responsibilities will be
given to industry to carry out DUS and VCU evaluations subject to validation
and audit by the competent authorities. For VCU evaluation harmonised and more
detailed EU criteria will be developed on the basis of the requirements set up
in the Member States. Official examination shall remain possible on request. Provisions
related to variety denomination and the management of the Common Catalogues
will remain unchanged. In this option all administrative tasks at EU level will
be attributed to the Community Plant Variety Office (CPVO).

2. Certification/inspection
of PRM

The certification
requirements for lots of PRM remain unchanged. However, as a standard
procedure, the PRM certification is carried out by the operator under
supervision of the competent authority. On request of the operator
certification under official examination is still possible. Marketing of lots
of PRM covered by a suppliers' label equally remains unchanged. Pests currently
regulated under the PRM will be listed under PHL; definitions and provisions
between PHL and PRM Law will be aligned. This should allow removing any
obstacles for combine health inspections under the two regimes.

3. Registration
of operators

In a context where a more significant role
is given to the industry, all operators (breeders,
growers, suppliers) are registered, allowing a monitoring of their activities and facilitating traceability in case of identified problems. This registration will be valid both for the EU plant health regime
and for the PRM marketing legislation and implemented through a shared register
to reduce burden.

4. Approach
to conservation varieties/amateur varieties/niche markets

This approach is not changed. Specific
provisions continue to apply for conservation varieties and landraces of
agricultural crops, for vegetable varieties, mixtures of fodder plant seed and
for forest reproductive material intended for gene conservation purposes.

Option 3 - Deregulation: VCU-evaluation and official
certification are optional. Harmonised tests are developed. Reallocation of
tasks as under option 2

Cost recovery and the simplification of the basic legal acts (replacing 12 Directives by
one Regulation) are horizontal provisions common to all options.

In this option, tasks and responsibilities
are not only shifted from the competent authorities to the private sector, but
also reduced: VCU-evaluation and official certification are no
longer legal requirements. Furthermore, ornamentals
will no longer fall within the scope of the PRM marketing legislation and
therefore will be totally deregulated.

1. Registration
of varieties and material

DUS-test for variety registration continues
to be compulsory for the crops regulated by the EU legislation, and the
verification of compliance with the requirements will be passed to industry as
in option 2.

VCU-evaluation for agricultural crops will
no longer be a legal requirement. It is the responsibility of plant breeders to
provide information on the value of varieties. For the sake of transparency,
harmonised evaluation methods will be developed at EU level. In this option,
all administrative tasks at the EU level related to variety registration,
including the checking of variety denomination, will be attributed to the CPVO.

2. Certification/inspection
of PRM

All lots of PRM are marketed solely on the
basis of a suppliers' label (i.e. no pre-market inspection but only marketing
controls carried out by consumer protection services), and there is no
obligation to certify. Certification of lots will only be done for PRM lots
intended for export. However, lots under suppliers' label will need to meet
certain minimum criteria, which are set at the EU level. As it is envisaged to
include PRM under the scope of the new Regulation on official controls along
the food chain (see the related IA), marketing controls will be carried out in
accordance with the latter framework, in particular following the principle of
risk based controls.

3. Registration
of operators

In a context where a more significant role
is given to the industry, all operators (breeders,
growers, suppliers) are registered, allowing a monitoring of their activities and facilitating traceability in case of identified problems. This registration will be valid both for the EU plant health regime
and for the PRM marketing legislation and implemented through a shared register
to reduce burden.

4. Approach
to conservation varieties/amateur varieties/niche markets

This approach is not changed. Specific
provisions on less stringent requirements continue to apply for conservation
varieties and landraces of agricultural crops, for vegetable varieties,
mixtures of fodder plant seed and for forest reproductive material intended for
gene conservation purposes.

Option 4 - Enhanced flexibility system: Mandatory basic provisions for registration
with a voluntary level of higher assurance for registration and certification

Cost recovery and the simplification of the basic legal acts (replacing 12 Directives by
one Regulation) are horizontal provisions common to all options

This option envisages a substantial
flexibility regarding the allocation of tasks and responsibilities among the
actors. The system can thus be process- or product-centred, depending on the
priorities of the operators. Furthermore, basic general
EU criteria with regard to plant health and fitness for purpose, as well as for
traceability/labelling, will apply to all PRM brought to the market.

A dual system is put in place allowing a
broader choice for operators: (i) official description of the variety and a
right for certification and (ii) official recognised description provided by
the operator and no right for certification.

1. Registration
of varieties and material

All varieties and material of specified crops
(in principle those covered by the current EU marketing Directives with a closed
list of species) will be registered in national and subsequently in EU
catalogues, which will be composed of two sections. For both sections, the variety
description should be based on criteria complying with CPVO and UPOV rules. All
administrative tasks at the EU level related to variety registration will be
attributed to the CPVO.

Section 1 will
comprise "officially tested" varieties that have been tested and
described officially or under official supervision. Technical examination will include
DUS, mandatory VCU criteria (sustainability of resistance/tolerance to pests,
adaptation to the physical environment and sustainability criteria such as
sensitivity to input level or plant competitiveness) and denomination. Only
varieties that are listed in this part of the catalogues will have the right to
certification.

Section 2 will comprise "not
officially tested" varieties that are registered on the basis of an
accepted harmonised description of the variety prepared by the applicant,
including the denomination – this amounts to an "officially recognized
description". Competent authorities will only be responsible for checking
the denomination and registration and for controls of material present on the market,
focussing on labelling in particular. Varieties in this category will not have
the right for certification because the authorities, in the absence of
officially verified and accepted results of identity testing (official
examinations), cannot certify the identity of individual PRM lots.

2. Certification
of PRM

Certification of certain species is no
longer an obligation, but is converted into a right that only the officially tested
varieties can have. Obligatory certification of PRM could be maintained for
crops that cause specific risks in terms of plant health or other aspects with
societal relevance such as possible content of toxic substances, sustainability
of production, food security. In case of no certification, competent
authorities will only carry out marketing controls, possibly under the new Regulation
on official controls along the food chain (see Scenario 3, point 2).

3. Registration
of operators

In a context where a more significant role
is given to the industry, all operators (breeders,
growers, suppliers) are registered, allowing a monitoring of their activities and facilitating traceability in case of identified problems. This registration will be valid both for the EU plant health regime
and for the PRM marketing legislation and implemented through a shared register
to reduce burden.

4. Approach on conservation varieties/amateur varieties/niche
markets

The marketing of conservation or certain
"niche market" varieties is liberalised. As there is no obligatory technical
examination of varieties and no obligatory certification of PRM, the marketing
of conservation varieties or "niche market" varieties can take place
under the provisions of the regime for non-tested varieties. Suppliers whose PRM
lots hold no particular plant health risk (in line with priorities to be set by
a revised EU plant health legislation).

Option 5 - Centralisation: Centralised EU registration procedure
with CPVO managing and making final decisions, and fully harmonised
certification requirements; improved coherence between the PHR and PMR regimes

Cost recovery and the simplification of the basic legal acts (replacing 12 Directives by
one Regulation) are horizontal provisions common to all options.

In this option, registration is centralised
at the CPVO, while some other tasks and responsibilities can be allocated to
the private sector. Variety registration and PRM certification, where
applicable, will remain mandatory for crops covered by the existing EU
legislation and detailed technical requirements will be defined in the
legislation.

1. Registration of varieties and material

The CPVO will
be mandated to coordinate and decide on variety registration, covering both
technical examination (DUS and VCU) as well as variety denomination.
Applications for registration of new varieties will be sent directly to CPVO. In
addition, this would allow breeders to obtain in the
same office the intellectual property title and the authorisation for marketing
("one key, 27 locks").

The EU catalogue(s)
will be published online, and will be continuously updated. To make them more
informative, they will contain hyperlinks leading to standardised descriptions
of the registered varieties, including possible relevant data related to food
safety aspects.

National
catalogues may still coexist alongside the EU (Common) catalogue(s). They could
contain additional VCU information that has been validated at national level or
play a role for species that are not covered by the EU marketing legislation.

2. Certification
of PRM

The
certification requirements for lots of PRM remain unchanged. However, as a
standard procedure, the control of compliance with the criteria for PRM
marketing is carried out by the operator under supervision of the competent
authority. On request of the operator certification under official examination is
still possible. Possible stricter requirements of the Member States that apply
to their domestic production will be subject to approval at EU level. Pests
currently regulated under the PRM will be listed under PHL; definitions and
provisions between PHL and PRM Law will be aligned. This should allow removing
obstacles for combine health inspections under the two regimes. The Union
system of comparative tests and trials – which have not been carried out since
2008 – will be replaced by “Reference Certification Centres”. These centres
will have the task to develop and share best practices, carry out comparative
tests and trials, carry out studies in support of policy development and to
disseminate knowledge of PRM certification. This all should contribute to the
health and quality of PRM and to the development and harmonisation of PRM
certification in the Union.

3. Registration
of operators

In a context where a more significant role
is given to the industry, all operators (breeders,
growers, suppliers) are registered, allowing a monitoring of their activities and facilitating traceability in case of identified problems. This registration will be valid both for the EU plant health regime
and for the PRM marketing legislation and implemented through a shared register
to reduce burden.

4. Approach
on conservation varieties/amateur varieties/ niche markets

Conservation varieties have a strong link
with their region of origin and should be evaluated in that same region for
their contribution to agro-biodiversity. This evaluation should be carried out
on the basis of harmonised criteria. Deviations from the normal regime ought to
be kept to an absolute minimum.

Discarded options

The following option was also considered
but given its incompatibility with the objectives of the revision it has been
excluded at an early stage and not been analysed in detail.

Abolishing
the EU legislation on PRM marketing

Variety registration and seed certification
schemes have a long history in Europe: in the Netherlands, government seed
testing services were already offered in 1877, in Germany a seed certification
programme was established in the late 19th century[26] and Sweden created an official
system in 1888.[27]
Variety registration developed in the early 20th century; Germany
passed the first seed law that included variety registration in 1929.

The development of some type of regulatory
system concerning PRM is predicated on the fact that any inadequacies
concerning identity of or quality in purchased seed are difficult or impossible
for the farmer to recognise. Due to long production circles, this issue is also
crucial for forestry. Regulation is best seen as a response to insufficient
information in a market, which may limit transactions. In these cases a third
party helps ensure that adequate information is available to guide market
transactions or to enforce standards of public safety. Abolishing the current
EU-wide legislation on PRM marketing would most likely not lead to a complete
disappearance some form of variety registration or of certification of seed as
the transparency of the market has to be maintained. A complete replacement of
the current well-functioning official system by a similar, but private system
thus does not appear to be an efficient course of action. If these private
schemes were mainly run on a national level, new problems may well arise as can
be illustrated using the example of certification.

In the absence of any EU regulations
concerning PRM marketing, the principle of free movement of goods has still to
be respected. At intra-EU level, the private sector certification schemes would
most likely not be identical. This would lead to a lack of transparency, making
choice for farmers more difficult. As the PRM industry would have to take
account of diverging rules and required specifications depending on the
customer to whom and the Member State in which they sell their products, this would
have a strong negative impact on the administrative burden for the industry and
consequently, on its competitiveness. In the absence of mandatory minimum
standards, part of the operators may seek to gain a part of the market through
low prices based on the reduction of production costs. This could ultimately
affect agricultural production and productivity as well as forestry. This
option could also increase the risk of spreading plant pests. On the whole, it
is considered that this option will not contribute to the achievement of the
overall objectives.

In the absence of any EU regulations
concerning PRM marketing, trade with third countries will only be regulated in
line with the OECD rules and internationally recognised rules on seed testing.
This entails that Member States will have to maintain a system of
certification. This implies furthermore, that the EU equivalence system would
have to be abolished as it would represent a technical trade barrier within the
WTO system.

As one underlying objective of the review
is the reduction of cost and administrative burden, possible options that would
lay down stricter rules, such as centralising certification or a full VCU evaluation
for all groups of plant species, were discarded.

5.           Analysis of impacts

Option
0 - Baseline

Structure
and dynamics of the sector

In 2009 – 2010,
the EU commercial seed market has reached a value of
approximately EUR 6.8 billion and it thus represents more than 20% of the total
worldwide market for commercial seed. There is still an important potential on
the international market for improved seed; an annual growth rate of about 5%
for field crops at global level can be expected. The value of the PRM market
other than agricultural seed is approximately an additional EUR 6-7 billion.

The PRM
industry is very dynamic. Traditionally, the seed markets were national markets
with quite a low volume of international exchanges. This has changed
dramatically in the past 20 years. The industry has undergone considerable
consolidation and continues to evolve. This sector now comprises a complex and
dynamic network of ownerships (partial and complete), joint ventures,
partnerships or strategic alliances.[28]

The situation
in old Member States can be characterized as follows: a large proportion of
SMEs with a high R&D rate, strong interlinkages and production for the
global market. The situation in the new Member States is still quite different:
breeding of new varieties is still largely done by public bodies, but SMEs are
in charge of seed multiplication and sales. Therefore, companies in the new
Member States such as Poland, Hungary and Romania are not research intensive
and a large proportion are likely seed multipliers or seed traders. Annex IX
shows on the basis of variety registration data from the Common Catalogue the
still significant differences between some selected old and new Member States
in terms of new varieties registered and the provenance of variety maintainers.

Situation in specific subsectors

Vegetable
seeds are mainly multiplied outside the EU in a
wide range of countries in which labour costs are lower than in the EU. The
produced seeds are shipped to the EU, mainly to the Netherlands, for treating,
sampling and packaging and re-exported to their final destination in the EU or
outside the EU. The production has a value of about EUR 1 billion. Main
producers are FR, IT, NL, HU DK, PL. The five biggest companies have 95% of the
seed market.

In the EU, forest nursery activities are linked to
reforestation and afforestation, which could concern forested area,
agricultural land (agricultural abandonment of marginal area), creation/renovation
of hedges or agro-forestry. European forests serve different aims: economical (raw
materials like sawn wood for construction purposes or furniture, pulpwood for cellulose,
insulation, packaging, paper and source of renewable energy), environmental
(e.g. protection against soil erosion, avalanche control, regulation of streams
and rivers, CO2 capture) and societal (e.g. recreation, employment
in rural areas).

Regarding the
control of nursery activities, registration of new selected seed stands and qualified
seed orchards, deliverance of Master certificates, responsibility is at the
level of the competent authority in the Member States. Generally, there are two
different competent authorities for plant health control and PRM control,
except in few Member States (FR, IE). Regarding the practical modalities of
control and the costs involved, the situation is very diverse among the Member
States as is shown in Annex X.

The existing
legal framework for forest reproductive material is accepted and supported by
all stakeholder groups.

The
propagating material of fruit plants is produced in
all EU countries, but the largest quantity of the propagating material marketed
in the Union is produced in specialised areas concentrated in few countries
(ES, IT, NL, FR, PT, UK and HU). The production of propagating material is held
by a large number of suppliers accredited by the responsible official bodies of
the Member States. Only a low number of suppliers have a large business
specialised in fruit plant propagating material breeding or reproduction. Some
suppliers are specialised in the production of particular material e.g. stone
fruits, citrus fruit or apple trees only. In some cases the same company is
involved in production of fruit plants and ornamental plants propagating
material, it is accredited as supplier for fruit plants and registered as
supplier for ornamental plants. In other cases the production of propagating
material is a part of other farming business. Basic research is still generally
carried out by universities or other public Research Institutes.

DG SANCO
consolidated some key figures in 2007-08 and concluded that more than 12,000
enterprises are involved in production of fruit plants in the EU; and about 90%
of them are small to medium enterprises frequently based in rural areas where
alternative business is not possible. The estimated value of this business was
estimated at about EUR 2.5 billion.

The EU is world leader in the market for vine nursery
products, with an annual output of 360 million cuttings. The steady decline
in prices for cuttings on the world market and stronger competition from other
producer countries has resulted over recent years in an exponential increase in
the number of nursery closures in Europe and has plunged the entire sector into
crisis. In Italy, for instance, it is estimated that in 2009 the market for
cuttings has shrunk by 30 %, and up to 60 % in areas experiencing severe
difficulties. In France, over the past three years alone, 130 of the country's
830 vine nurseries have closed down owing to the collapse in market prices for
cuttings, which have fallen well below production costs.

Implementation
costs of the legislation

The current cost of implementing the
variety registration provisions amounts to approximately EUR 55-60 Mio per year
in the EU according to information provided by Member States.[29] DUS and VCU account for 45%
and 55% of the cost, respectively (see also Annex XIV).

The cost of certification is more difficult
to estimate since in a number of Member States staff involved in certification
is also involved in plant health inspections, and it is not straightforward to
assign costs.

From information provided by Member States
(evaluation of 2007/2008 and certification questionnaire) it is estimated that
the expenditure by Member States' authorities on certification of PRM are in
the range of EUR 73-79 Mio.[30]
Seed lot sampling and analysis represents more than 50% of the total
certification costs, while field inspection costs represent in between 20-30%
on average (Annex XIV). For agricultural and vegetable crops the 2007/2008
evaluation calculated an approximate combined cost for variety registration and
certification incurred by competent authorities of just under EUR 120 Mio and
that across the EU approximately 60% of these costs are recovered. These
figures serve as a basis for the analysis of the costs in the other options.
Table 1 and 2 provide information on the current distribution of variety
registration and seed certification costs between public and private bodies in
the Member States. Annex XIV provides further information on the cost structure
of registration and certification for Member States for which detailed
information could be gathered during the evaluation.

Controls for the possible presence of harmful organisms (HO)
at growing stage and in lots of PRM brought to the market are an important cost
factor and an integration of plant health and certification inspection schemes
could lead to some cost savings. This possibility is analysed in options 2 and
5.

Table 1 – Current
distribution of seed registration costs between public and private bodies in
the MS

MS || Transfer of Registration costs || Additional information

AT || ||

BE || Yes || Partial transfer of costs  (around 50% of DUS and VCU costs)

BG\* || || No transfer of DUS costs, partial transfer of VCU costs

CY || Yes || Partial transfer of costs  (around 50% of DUS and VCU costs)

CZ || Yes || Partial transfer of costs  (between 70% and 80% of DUS and VCU costs)

DE || Yes || Partial transfer of costs (around 50% of DUS and VCU costs)

DK || Yes || Full transfer of DUS and VCU costs (100%)

EE || Yes || Full transfer of DUS and VCU costs (100%)

ES || Yes || Partial transfer of costs

FI || Yes || Full transfer of DUS and VCU costs (100%)

FR || Yes || Around 2/3 of DUS and VCU costs are transferred to the industry)

GR || Yes ||

HU || No ||

IE || No ||

IT || Yes || Full transfer of DUS and VCU costs (100%)

LT || No ||

LU || Yes || Partial transfer of costs

LV || No ||

MT || No ||

NL || Yes || Full transfer of DUS and VCU costs (100%)

PL || Yes || Partial transfer of costs (around 25 to 30% of DUS and VCU costs)

PT || Yes || Partial transfer of costs

RO\* || No ||

SE || Yes || Full transfer of DUS and VCU costs (100%)

SI || || Almost no DUS testing performed in Slovenia, around 70% of VCU costs are transferred

SK || Yes || Partial transfer of costs (around 70% of VCU costs)

UK || Yes || Full transfer of DUS and VCU costs (100%)

Source:
compiled on the basis of the data provided in the qualitative and the cost
questionnaire. \* Information received from these Member States leads to the
conclusion that by now full (BG) or at least partial (RO) cost recovery is in
place.

Table 2 – Current distribution of seed
certification costs between public and private bodies in the Member States

MS || Certification costs are transferred to industry || Additional information

AT || Yes || Partial transfer of costs

BE || Yes || 30% of costs are transferred to the industry

BG || Yes || Partial transfer of costs

CY || Yes || Partial transfer of costs

CZ || Yes || Partial transfer of costs

DE || Yes || Between 30% and 70% depending on the Federal Land concerned

DK || Yes || Full transfer of costs (100%)

EE || Yes || Partial transfer of costs

ES || Yes || Partial transfer of costs

FI || Yes || Full transfer of costs (100%)

FR || Yes || 97% for seed, 65% for vine

GR || Yes || The fee = (reference price) x (certified quantity) x 3%. The rate of the reference price is fluctuating between the farmer’s price and the final selling price of the seed.

HU || Yes || Full transfer of costs (100%)

IE || Yes || Partial transfer of costs

IT || Yes || Full transfer of costs (100%)

LT || Yes || 8% is financed by private sector

LU || Certification is mostly financed by national authorities

LV || Yes || Partial transfer of costs

MT || No ||

NL || Yes || Full transfer of costs (100%)

PL || Yes || Full transfer of costs (100%)

PT || Yes || Full transfer of costs (100%)

RO || Yes ||

SE || Yes || Full transfer of costs (100%)

SI || Yes ||

SK || Yes ||

UK || Yes || 70-80 of costs transferred to the industry and target of 100%

Source: compiled on the base of the answers provided to the cost
questionnaire and by official authorities to the preliminary questionnaire.

Rating of impacts

To facilitate comparisons between options,
impacts have been rated:

0 || No or neutral impact || 0 || No or neutral impact

+ || Small positive impact || - || Small negative impact

++ || Significant  positive impact || -- || Significant negative impact

Option
1 - Cost recovery: No change to technical provisions but complete recovery of
registration and certification costs by competent authorities

Under this option, the impacts of the
horizontal measures (cost recovery, the simplification of the basic legal acts and the registration of
operators) are assessed. The current situation concerning the distribution of
costs between the public and the private sector are shown in tables 1 and 2.

1. Impact
on health and quality of PRM

No significant impacts compared to the
baseline are expected on health and quality of PRM.

2. Impact
on employment and jobs

Employment in the public sector might
escape some of the cuts that would be necessary under the budgetary austerity
measures if there is no change in the system. No noticeable effects on the
private sector are expected.

3. Impact
on administrative burden for authorities and private sector operators

The main instruments having impacts in
these respects will be legal simplification and cost recovery. No additional costs are expected from the simplification and harmonisation
of the legislation. Benefits are expected as legislation will become far less
complex and fragmented and as all technical measures laid down by the existing
basic legislation will be transferred to specific implementing acts. Member
States save costs as they do not have to transpose EU legislation into national
law. Increased flexibility for the management of technical implementing acts is
expected both by official bodies and suppliers. Costs will decrease for
competent authorities in those Member States that so far have not implemented
cost recovery and the extra resources will help to maintain the pool of
expertise in the public services which will secure their functioning in the
future. Costs will increase to a small extent for operators in those Member
States. The impacts on the private sector can be considered in more detail for
the different sectors:

Agricultural
seed crops:

With an estimated cost for variety
registration and certification of up to 3%[31]
of the market value of the agricultural seed crops, the introduction of cost
recovery is unlikely to have a direct impact on the competition of between PRM
companies from different Member States – especially as at least 60% of these
costs are already recovered across the EU. Two factors
have to be considered in order to judge the impact of cost recovery on the PRM
industry: the ability to absorb extra cost and the specific impact on SMEs and
micro-enterprises. The PRM industry as a whole is one of the most research
intensive industries having an average R&D/net sale ratio of 15% and thus
can be expected to have the financial capability to absorb the costs for
registration and certification.

Annex VIII shows that the largest numbers
of SMEs are found in three Member States: Hungary, Poland and Romania.
Approximately 4900 companies are located in these three Member States and more
than 90% of these companies are SMEs. However, these three Member States
already have cost recovery for seed certification. Variety registration costs
are not recovered in Hungary and partially recovered in Romania[32] and Poland. Thus, a large
majority of SMEs and micro-enterprises in the EU are already operating under
cost recovery regimes for seed certification (which accounts for approximately
57% of the implementation costs of the PRM legislation). If cost recovery were
to be extended to all Member States for both variety registration and seed
certification, only a small increase of costs amounting to less than 1% of the
market value of the agricultural seed crops (taking into account the already
recovered share of the total costs) would have to be borne by operators that
develop and register new varieties. It has also to be taken into account that a
large share of the SMEs and micro-enterprises in the new Member States are seed
multipliers and seed traders[33]
and are not involved in breeding new varieties. Therefore, they are not
registering new varieties to a significant extent.

Vegetables:

Vegetable varieties only undergo DUS, but
no VCU and certification is not compulsory. The main producers of vegetable
seed and propagating material are the Netherlands and France, two countries in
which cost recovery for DUS is already in force. The impact of cost recovery on
this sector will therefore be minimal.

Fruit
propagating material:

Many of the enterprises active in this
sector are small or micro-enterprises located in disadvantaged areas. In
addition, it has to be taken into account that variety registration may very
well be more expensive than for agricultural seed crops on which the estimate
of 1.3% is based on. DUS for fruit propagating material takes at least 4 years
and thus could be approximately 30% more expensive. Detailed information
concerning cost recovery in this sector is not available, but on the basis of
available general information from the Member States and information from
experts, it can be assumed that at least partial cost recovery already exists
in the major countries producing fruit plant propagating material. The effects
of introducing cost recovery are most likely moderate to low.

Forest
reproductive material:

Forests are atypical compared to the other
sectors in their multifunctionality (including public goods such as recreation,
cultural identity or environmental protection) and the long-term perspectives
concerning these functions. This explains and also justifies the current strong
involvement of public authorities in breeding, growing and certification. Annex
X shows the practical modalities and costs involved in control of FRM, but
detailed data on potentially specific cost recovery regimes for this sector are
not available.

Vine reproductive material:

The problems
facing vine nurseries have their root cause not in the marketing Directives.
The 1999 reform of the common market organisation (CMO) for wine strengthened
the goal of achieving a better balance between supply and demand on the
Community market, giving producers the chance to bring production into line
with a market demanding higher quality and to allow the sector to become
competitive in the long term by financing the restructuring of a large part of
present vineyards. This reform proved insufficient to reduce wine surpluses and
considerable sums still had to be spent on disposing of them. The reform
adopted by the EU in 2008 has the goals of making EU wine producers even more
competitive, making the market-management rules simpler, clearer and more
effective – to achieve a better balance between supply and demand and to preserve
the best traditions of European wine. After 2015, current EU restrictions on
planting vines will be lifted, enabling competitive producers to increase
production.

Detailed data for cost
recovery in this sector are not available, but assuming that practices are
similar to other sectors, cost recovery will not have a significant impact, but
rather help to maintain the system to control the strict quality requirements
demanded of planting material.

·
Table 3  Potential impact of requiring MS to achieve cost
recovery on registration[34]

|| HU || IE || LT || LV || MT || BE || CY || DE || PL || ES\* || GR\* || LU\* || PT\* || CZ || FR || RO\*\* || SI || SK || BG\*\* || DK || EE || FI || IT || NL || SE || UK || AT

High impact || || || || || || || || || || || || || || || || || || || || || || || || || || ||

Medium impact || || || || || || || || || || || || || || || || || || || || || || || || || || ||

Low impact || || || || || || || || || || || || || || || || || || || || || || || || || || ||

No impact || || || || || || || || || || || || || || || || || || || || || || || || || || ||

High impact:
currently no cost recovery; medium impact: currently 50% cost recovery; low
impact: 50% < current cost recovery < 100% and no impact: currently cost
recovery.

\* These Member
States only stated that they achieve partial cost recovery without providing a
number.

\*\* The situation
in BG and RO appears to have changed since the evaluation was carried out in
2007. Information received from those Member States lead to the conclusion that
cost recovery is in place in BG and at least partial recovery in RO.

·
Table 4  Potential impact of requiring MS to achieve cost
recovery on certification

|| MT || LT || LU || AT || BG || CY || CZ || EE || ES || GR || IE || LV || BE || DE || UK || FR || DK || FI || HU || IT || NL || PL || PT || RO || SE || SI || SK

High impact || || || || || || || || || || || || || || || || || || || || || || || || || || ||

Medium impact || || || || || || || || || || || || || || || || || || || || || || || || || || ||

Low impact || || || || || || || || || || || || || || || || || || || || || || || || || || ||

No impact || || || || || || || || || || || || || || || || || || || || || || || || || || ||

Data received
from ESA (personal communication) on the situation of micro-enterprises, SMEs
and large companies in the some European countries where the seed sector is
relatively important, show that the proportion of micro enterprises ranges from
around 48% in France, 68% in Italy, 82% in Hungary to up to 95% in Poland. The micro-enterprises
are mainly involved in seed production and marketing.

Today in
France, Italy and Poland the principle of cost recovery for variety registration
and seed certification is already in place and applied to all types of
companies and is not of major concern for the majority of stakeholders. In
Hungary, cost recovery only applies to seed certification.

In the sector of fruit, forest and vine
nurseries, the percentage of small enterprises is even higher.[35] The exemption of these sectors
from the scope of the Regulation is not in coherence with the global request of
nursery growers to increase the quality of the material in order to provide
high quality material and remain competitive at global level.

Regarding a
general exemption of micro-enterprises from the scope of the new Regulation, it
will result in an exemption of 95% of the businesses in Poland and of 50% in
France.

The cost recovery
principle will not affect SMEs and micro-enterprises to a significant extent
because this principle is already realised in a majority of Member States and offers
benefits to these enterprises as it ensures the continuation of access to
official services needed for marketing. Furthermore, operators active along the
food chain share with competent authorities the responsibility of preventing
that unsafe or unfit products enter the market. They are the first
beneficiaries of the added value produced by an efficient control system and
are thus called upon to finance the official control system through the payment
of a fee which allows the competent authorities to recover its control costs. Introducing
a cost recovery regime is a proportionate measure as it does not unduly burden
SMEs and because it contributes significantly to achieving the objective of
assuring the health and quality of PRM.

The general
principle of proportionality will apply in the new PRM legislation also in a
different sense: for species such as those from the ornamental sector or non-listed
species (not important with regard to EU agricultural production and food
quality), obligations will be limited to registration of professional operators
and minimum labelling requirement affixed by the operators.

The review of
PRM legislation is also linked to the review of plant health Regulation
(Directive 2000/29) and control in the food chain (Regulation No. 882/2004)
where the issue of SMEs and exempting small or micro enterprises from the scope
of the legislation will also be addressed.

4. Impact on competitiveness and trade

The major positive impact of cost recovery
consists in establishing a level playing field for all operators in the
internal market. This should improve competitiveness and trade in the EU.

5. Impact
on innovation and research

No significant impacts on innovation and
research are expected, as the R&D budgets are far larger than the
additional costs incurred through cost recovery.

6. Environmental
impact

No environmental impacts are expected
compared to the baseline

7. Social impact

No social impacts are expected compared to
the baseline

Summary
of the key impacts under option 1

Areas || Impacts

Impact on health and quality of PRM || 0

Impact on employment and jobs in the public and private sector || 0

Impact on administrative burden and costs for authorities || + (in few MS ++)

Impact on administrative burden and costs for private sector operators || - (in few MS --)

Impact on competitiveness and trade || +

Impact on innovation and research || 0

Environmental impact || 0

Social impacts || 0

Option
2 - Co-system: No change to technical provisions but certain tasks performed by
industry under official supervision; improved coherence between the PHR and PMR
regimes

1. Impact
on health and quality of PRM

Transferring the legal requirements for
registration to industry should not have a major negative impact on the health
of PRM. With regard to the certification of PRM, Member States that are already
using certification under official supervision (11 Member States in 2007) did
not consider that widening the possibility to certify PRM “under official
supervision” to all categories of PRM and to all agricultural species would
lead to a general reduction of the health and quality of PRM lots of
agricultural crops on the market. Propagating material will run the highest
health risk, rather than true seeds, because this technique of reproduction
could transfer more possible pests and diseases to the daughter generations.

Improving the
coherence between the PHR and PMR regimes will make it easier to change the
status of regulated harmful organisms from territorial (quarantine) to
marketing (quality). This will improve the flexibility and adaptability of both
legal regimes to changes in threats to PRMs. Further alignments of definitions
and provisions of the EU plant health and PRM regimes can remove obstacles for
Member States to combine health inspections under the two regimes and reduce
burden. Where consignments require a plant passport and a certification label,
the competent authorities shall issue a single document. This would allow for a
reduction of operator costs up to EUR 0.7 Mio per year.[36]

2. Impact
on employment and jobs

Between 1300 and 1500 employees work on
variety registration in official bodies in the EU. The results of the variety
registration study indicate that 60% of the registration costs are in fact
labour costs. If the practical work for variety registration were fully
transferred to the private sector stakeholders, it could result in redundancies
in Member States' competent authorities. Technical examination of the identity
of varieties would then be limited to the work done for that share of varieties
checked in the system of official supervision of variety evaluation activities
and in the context of post-controls on lots of PRM present on the market. In
terms of jobs, a certain share of those related to variety evaluation in the
public sector might disappear, but part of the staff could potentially be
recruited by private companies, to take advantage of their specialised
expertise. This might lead to a limited increase in employment in the private
sector. However, the principle of cost recovery will contribute to the
maintenance of the appropriate level of expertise in competent authorities.

As for the certification of individual lots
of PRM, in the current system of examination under official supervision the
authorities have to inspect only 5% of the fields and lots, meaning that there
could be a significant reduction in staff numbers. Some major PRM producing
Member States already implement examination under official supervision for
agricultural crops other than seed potatoes, and there the number of jobs lost
in the competent authorities would probably be fairly limited.[37] As roughly half of PRM produced
in the EU is intended for export to third countries, official certification or
certification under official supervision will still have to be carried out for
these lots of PRM. A rough estimate is that no more than 600-700 public sector jobs
might be lost.

Part of the redundant staff may be
recruited by the private sector, as it will have to control their products more
thoroughly, being ultimately responsible for the PRM lots brought to the
market.

3. Impact
on administrative burden for authorities and private sector operators

The administrative burden related to the
registration of varieties is estimated to be 55 to 60 Mio Euro per year, while
the cost of the certification regime is estimated to be EUR 73-79 Mio.[38] As explained earlier, moving
the inspection task to the private sector should reduce this burden
significantly. The industry, however, will be required to maintain records of
their variety and certification procedures. Already now, mostly large companies
in the sector perform a considerable number of inspections as part of their
quality assurance schemes. According to the variety registration study,[39] private companies could do the
work at lower cost. It is therefore expected that the majority of these costs
can be absorbed by businesses under normal business practices (business as
usual) and that the additional cost will not be significant. Therefore, passing
the task of inspections from the Member State authorities to the sector will
lead to only a limited increase of workload for the private sector. Moreover,
the sector has pointed at the importance of enhanced flexibility, timeliness
and cost savings offered by examination under official supervision.

Estimating cost savings for certification under official supervision

During official certification, work that is carried in the context
of companies' quality assurance schemes is to some extent or even completely
duplicated. The following examples of seed potato and cereal certification
provide an estimate of the costs that could be saved if official supervision of
certification for these crops would be introduced.

Estimation of costs and possible savings in the seed potato sector[40]:

The total EU market of seed potatoes is approximately 2.5 Mio tons
of which 400 000 tons is exported to third countries. Seed lot testing is done
both by official inspection authorities and seed companies which means a
potential 100% duplication of work.

Exports (400 000 tons) are tested in lots of 25 tons: this means
that a total of 16 000 inspections take place every year. Assuming inspection
costs of EUR 50[41]
this amounts to a total cost of EUR 800 000.

Seed potatoes for the internal market (2.1 Million tons) are tested
in lots of 100 tons: this means that 21 000 inspections take place per year.
Again assuming that costs per inspection are EUR 50, the total inspection
effort amounts to a cost of EUR 1.0 Mio. The total cost of duplicated
activities during certification is thus EUR 1.8 Mio. Under official
supervision, 5% of lots are checked by the competent authorities. This means
that approximately EUR 1.7 Mio (≈ 2% of total certification costs) could
be saved in the seed potato sector alone by avoiding duplicated work under a
system of official supervision of certification.

Estimation of costs and possible savings for a company in the cereal
sector[42]:

A large seed company produces approximately 10 000 lots of basic and
pre-basic and 20 000 lots of certified cereal seeds each year. Official
supervision for certified cereal seed is already in place. Field inspections
cost approximately EUR 11 per visit – both if done by company staff or the
competent authorities – and lot inspections EUR 35 if carried out by the
company and EUR 65 if carried out by the competent authorities. If official
supervision of the certification of pre-basic and basic seed was introduced and
assuming complete duplication of quality assurance work and official inspection
and that on average 2 field visits are carried out, the company could save in
the order of 0.95\*10 000 \* EUR 87 = EUR 826 500 per year.

It is very difficult to generalise these calculations to the entire
European cereal sector as internal costs for companies and costs of inspections
will differ substantially between Member States.

The impacts of registration of operators
will not be significant as PRM operators are to a large majority covered by the
register envisaged under the new plant health legislation.

4. Impact on competitiveness and trade

Registration tests require staff with a
high level of specialised technical skills. It is possible that only a small part
of the breeding industry would be interested in performing registration tests
themselves, namely bigger companies (10% of companies) that breed several crops
and that can afford specialised staff, and some smaller companies which have
become acknowledged specialists in a very limited number of crops. As already
today major companies are carrying out variety evaluation work themselves, in
particular for big volume crops, such a shift would allow them to act faster
and more efficient, without increasing their costs. This would enhance their
competitiveness.

A
significant number of companies in the sector are SMEs that do not necessarily
have the facilities to do the necessary technical examinations. These companies
would need to outsource this work to the private sector or to facilities run by
competent authorities. The aim is to provide flexibility for all operators to
carry out some tasks directly if they wish to do so, but the continued
existence of public services is also guaranteed, so that SMEs and
micro-enterprises can have technical examinations and inspections carried out
by competent authorities.

There is also the risk that staff cuts in
public facilities and a lower amount of technical examination/inspection work
results in an erosion of skills and knowledge in the public sector. But the
cost recovery principle for the services provided should counterbalance this
tendency and help to maintaining the necessary level of staffing and expertise.

The currently available opportunities for
performing certification under official supervision are not widely taken up in
the Member States, in part because in many Member States the cost of
certification is not recovered from the private sector. In Member States where
already now the costs are fully recovered, the reduction of costs for producers
of PRM will be limited, but it will result in a definite improvement of
flexibility in their operations, and therefore most of them would benefit from
a widened certification under official supervision, regardless of the size of
their enterprise.

The increased flexibility envisaged in this
option will also help to maintain the competitiveness of European companies on
the global market.

The forestry sector faces some specific
challenges that need to be considered separately. This sector is characterised
by a strong involvement of the public sector. This involvement is justified by
the long-term perspective of forestry and by the multifunctional role of
forests – they not only serve economic purposes, but also contribute to several
public goods such as environmental protection, cultural identity or recreation.
Due to the particular conditions of forests and
forestry, a specific approach has to be taken for forest reproductive material. Official examination of FRM is therefore a justifiable approach to
ensure the long-term achievement of all these goals.

5. Impact
on innovation and research

A transfer of tasks related to technical
examination for variety registration could improve the knowledge and efficiency
at the level of breeders to recognize and develop the varieties with the best
commercial potential. This should have a positive impact on innovation and
research.

However, a full transfer of the work and
the associated costs of variety registration could have negative impacts on
breeding activities in minor crops, which are normally only produced by small
companies for national or regional markets. Requirements differ according to
species and so does size of the markets. For example, the evaluation of fodder
varieties is 3 to 4 times more expensive than evaluating cereal varieties; less
money is made with fodder plant seed but there is also less competition in the
EU market. There is a possibility that this option would benefit more the
breeding of major crops which generate higher income. Based on the observation
that cost recovery is done in approximately half of the Member States (see
table 3), this could in the end have a small impact on breeding
activities for less profitable species such as fodder plants and other minor
crops. Breeding of small crops will not be abandoned because of variety
registration cost but due to R&D investment. Once again the cost recovery
principle could, to some extent, contribute to maintaining expertise or
reorienting the activity at the level of competent authorities towards these
crops.

6. Environmental
impact

Under this regime, other possible impacts
such as a shift to or away from varieties that can be grown in a more
sustainable manner with less inputs (mainly pesticides, fertilisers and
irrigation) are minor because the regime does not contain decisive elements to
steer such evolutions. As outlined above, for the small crops there is a risk
of less breeding of new varieties and a gradual abandoning of such crops by the
PRM users, thus reducing biodiversity.

7. Social Impact

No
negative social impact is expected. The allocation of more responsibilities to
private operators will maintain staff and raise the skill level in PRM
companies that are mainly located in rural areas.

Summary
of the key impacts under option 2

Areas || Impacts

Impact on health and quality of PRM || 0

Impact on employment and jobs in the public and private sector || - (in the public sector) + (in the private sector)

Impact on administrative burden and costs for authorities || ++

Impact on administrative burden and costs for private sector operators || - (more reporting obligation but less financial cost)

Impact on competitiveness and trade || +

Impact on innovation and research || +

Environmental impact || -

Social impact || +

Option
3 - Deregulation: VCU-evaluation and official certification are optional.
Harmonised tests are developed. Reallocation of tasks as under option 2

1. Impact
on health and quality of PRM

In this option, VCU-evaluation and
certification would no longer be obligatory for any PRM. In the short term no
significant effect is expected, but medium- to long-term effects on both
quality and health are likely.

The modern food system is made up of a series
of highly integrated chains that extend from farm to fork. Varieties are bred
for very specific uses and the buyers that purchase from farmers have to be
completely certain that they receive the variety with the expected
characteristics. Farmers in turn have to be sure that they receive the PRM
variety in guaranteed purity and quality to satisfy the demands of their
customers. Official or officially supervised VCU evaluation provides PRM users
with important information on the characteristics and quality of a variety and
helps to ensure maximum transparency of information. VCU thus contributes to
the functioning of a specialised and differentiated market. For vegetables used
by agri-food industries, there are traditionally close links between breeders,
growers and buyers who maintain a quality system and no VCU is carried out and
it is not sought after. For most agricultural crops such strong links do not
exist and thus VCU is likely to remain important.

In the medium and long term abandoning the
possibility of health evaluation for variety registration of agricultural crops
could potentially lead to varieties with lower pest resistance or quality and
lowered food safety due to the fact that proper verification of the health
status will entirely depend on the quality of the inspection work done by the
operator. To the extent that the official authorities maintain a credible
system of general monitoring this should not lead to increased risks for health
of PRM in the Union. However, if official authorities seldom carry out e.g.
field inspections for certification, there is a large risk that essential
skills are lost. There could be a risk for the quality of certain groups of
PRM.

Under this option, ornamentals are no
longer covered under EU legislation. This will negatively affect the identity
and health of the material on the market. Due to a different approach for FRM,
there will be no effect on FRM under this option.

2. Impact
on employment and jobs

Between 1300 and 1500 employees work in
official bodies on variety registration in the EU Member States. Approximately
half of this personnel works on VCU (performance) evaluation, posts that are at
risk of becoming redundant. Moreover, identity evaluation would pass to the
private sector and the role of the official/competent authorities would be to
test a fraction (about 5%) of the varieties submitted for registration,
together with identity tests and samples drawn from the market in the context
of general monitoring. As a consequence up to 1300 competent authority posts
for the technical examination of varieties could be lost. Companies might carry
out additional work on the performance of their varieties and recruit staff
from the public sector but it is unlikely that it would absorb more than a few
hundred posts. This would lead to only a small direct increase in employment in
the private sector. However, after a variety has been registered,
recommendation trials are carried out in public, semi-public or private
structures that assist PRM users and distributors in their choice. Some of the
staff that was previously involved in VCU-evaluation is likely to be involved
in recommendation trials as well. Furthermore, these trials will gain in
importance if mandatory VCU is abolished. The principle of cost recovery will
guarantee that expertise will be maintained in competent authorities to carry
out the necessary tasks. Abolishing VCU could have serious consequences for
SMEs that develop varieties of agricultural crops. VCU presently serves as a
quality assurance that ensures that small and large companies can compete on a
comparatively equal footing – VCU provides the buyer with unbiased information
on the performance of a variety. The success of a variety on the market is
therefore not mainly dependent on the marketing power of an operator. If this
source of information were no longer available, SMEs would most likely not be
able to be competitive.

Abolishing certification increases the risk
that some activities, especially seed multiplication for agricultural seeds
will be relocated to non-EU countries as already is the case for vegetable seed
(as the EU equivalence system cannot be maintained). This could lead to
considerable job losses in this part of the PRM industry (see section 4 below).

Certification costs in EU are estimated at EUR
73-79 Mio which corresponds to roughly 2000 jobs[43] which potentially could become
mobile as there will be a continued need for certification of PRM lots intended
for export to third countries. Given the fact that up to half of the production
of PRM is intended for export,[44]
this exported share will continue to have to be certified. If this is done
under official supervision only 5% (currently applied percentage) need official
examination. In any case, a generalised shift to certification under official
supervision could make redundant up to 1500 or even 1600 posts. Certification
duplicates to a good extent work done by the PRM suppliers, and hence the
transfer of practical inspection work to the suppliers will not create a lot of
new jobs in the private sector.

At EU level, in total up to 2900 jobs might
be lost in authorities that are
competent for variety registration and PRM certification.

3. Impact
on administrative burden for authorities and private sector operators

According to the variety registration
study,[45]
completely removing official performance
examination(VCU) for agricultural crops in the EU would save about EUR 23 Mio
for private operators and for public authorities combined.

However, the study also indicated that most
Member States would prefer to continue having VCU on a voluntary basis on their
territory, and therefore abandoning VCU as a mandatory element of the EU
legislation would only save between EUR 2.3 to 11.5 Mio as a direct impact (10
– 50% of actual VCU cost) depending on the cost recovery in Member States.

In practice, companies will continue with a
limited type of VCU-evaluation in their testing programs as this provides basic
information needed during their breeding and selection cycle. In addition,
voluntary, but well-established and stable post registration networks,
consisting of public, semi-public and private facilities, exist in a number of
Member States. The costs for these services cannot be established as they form
part of the business cost of private operators and are not based on obligations
stemming from EU legislation.

4. Impact on competitiveness and trade

The costs saved by abandoning
VCU-evaluation and official certification could lower the production costs of
PRM, and hence have a positive impact on competitiveness, markets, trade and
investment flows. VCU is not a statutory requirement in several important Third
country competitors on the global seed market (e.g. USA, New Zealand,
Australia), but it has to be noted that similar examinations are still carried
out widely in these countries (see Annex XII). In addition, more varieties
would more quickly enter the market, as fewer varieties would be eliminated by
VCU-evaluation. This elimination rate is currently up to 50 – 60% in Denmark or
80 – 90% in Germany. As a consequence, the resources invested in those
varieties could be recovered via marketing. This option may therefore increase
competition on the EU market which could be to the benefit of PRM users
(increased choice, less expensive varieties). On the other hand this implies
that varieties with low performance might be placed on the market and micro and
small enterprises with less marketing staff will be disadvantaged.

Abolishing certification would, however,
have significant effects on trade with Third countries. In this case, EU equivalence
cannot be maintained and trade with third countries would have to be based on
compliance with OECD seed schemes and internationally recognised rules on seed
testing. Such a situation is likely to significantly increase trade flows into
the EU and competitive pressure on the EU PRM industry and also decrease the
quality of PRM.

SMEs will be disadvantaged as VCU is
abolished, which serves as unbiased information for users independent of market
power of the seller. No supplementary measures are planned for micro
enterprises and SMEs.

5. Impact
on innovation and research

Money saved on expenses for VCU and
official certification could potentially be directed to breeding programmes but
may also be invested in internal certification procedures, VCU evaluation or
marketing. Also, more varieties will be brought to the market as none will be
eliminated by poor VCU. The positive effects from this option are likely to be
seen over the long term rather than immediately.

6. Environmental
impact

This option may contribute to increasing
agricultural biodiversity if more varieties are placed on the market but there
is the risk that this promise is not fulfilled if varieties are not further
developed after few years of production. Abandoning VCU-evaluation and tests for
disease resistance, which are part of it, could lead to less resistant
varieties being marketed that need more interventions using plant protection
products, which is inconsistent with EU strategy to reduce pesticide use. In
addition, yield evaluation which is part of VCU will not continue to be
performed and consequently agricultural productivity for crops like wheat,
maize, potato will no longer be guaranteed to the farmer and could have an
impact of land tenure. Certification also assures the purity (seeds of other
plant species) of PRM lots entering the market. Higher impurity levels and
especially the deregulation of ornamentals may increase the risk of invasive
alien species (IAS) gaining a foothold in the EU.

VCU can embody both private and public aims.
The "Cultivation"-part of VCU could, for example, employ criteria
that support the sustainability of agriculture, that reflect the practices of
low-input agriculture and that demonstrate how resilient varieties are to the
consequences of climate change. The "Use"-part of VCU presently comprises
of course many elements that are mainly of interest for industrial or final
consumers. The “Use”-part can, nonetheless, also reflect public goods. For
example, low-glucosinate cultivars of rapeseed are bred to decrease the
toxicity of animal feedstuffs (feed safety). Maize varieties are developed that
have high conversion efficiencies as animal feed and thus contribute to energy
and land-use efficiency of agriculture. Linoleic or high oleic varieties of
sunflowers are another example of the use of specific varieties that also
contribute to public goods, in this case public health. A complete abandoning
of VCU would thus make it difficult to steer agriculture towards more
sustainability.

7. Social
impact

Abolishing VCU and certification will most
likely threaten SMEs and lead to the erosion of skilled jobs in disadvantaged
rural areas.

Summary
of the key impacts under option 3

Areas || Impacts

Impact on health and quality of PRM || --

Impact on employment and jobs in the public and private sector || --

Impact on administrative burden and costs for authorities || ++

Impact on administrative burden and costs for private sector operators || ++

Impact on competitiveness and trade || -

Impact on innovation and research || +

Environmental impact || -

Social impact || --

Option
4 - Enhanced flexibility system:
Mandatory basic provisions for registration with a voluntary level of higher
assurance for registration and certification

1. Impact on health and quality of PRM

Officially tested varieties (registration)
are by and large tested as they are currently done (sustainability criteria
are, though, included now in VCU-evaluation). For not officially tested
varieties, not undergoing official technical examination, part of which is for
pest resistance/tolerance, there would be a risk in the long term that varietal
identity on the market and characteristics such as disease resistance etc. are
not maintained.

As there is no obligatory certification for
any of the two groups of varieties, proper verification of properties such as
varietal purity, seed of other species, germination rate and health status of
lots that are marketed with an operators' label will entirely depend on the
quality of the inspection work done by the operator. To the extent that the
official authorities maintain a credible system of general monitoring, this
should not lead to increased risks for plant health and quality in the Union,
especially for reproductive material. For certified lots there would not be any
impact as compared to the current situation.

2. Impact
on employment and jobs

As there is no obligatory official
technical examination for the registration of varieties, theoretically a
substantial part of the 1500 competent authority jobs involved with variety
registration could be lost if all varieties would in the future be marketed as
not officially tested varieties (some variety identification work would remain
in the context of testing of PRM samples taken on the market and for exports as
variety registration is also a precondition for certification for exports).
However, based on consultation with stakeholders, this assessment is considered
to be an overestimate. On average, the number of
varieties with EU variety rights protection is roughly 30-35 % of the number of
newly registered varieties in the common catalogues. Holders of variety-rights
that seek for legal protection will most likely also accept the additional cost
of the official performance evaluation in order to have access to the category
of officially tested varieties and to be eligible for certification which is a
normal precondition for export of PRM to third countries. Taking into account
the two elements above, this would mean that a significant part of the jobs in
the public authorities are likely to be maintained. However, if the technical
examination of varieties would be done under official supervision, this would
end up in far fewer jobs being maintained, with accordingly more jobs created
in the private sector.

Abolishing certification increases the risk
that some activities, especially seed multiplication for agricultural seeds
will be relocated to non-EU countries as already is the case for vegetable seed
(as the EU equivalence system cannot be maintained). This could lead to
considerable job losses in this part of the PRM industry (see section 4 below).

Certification costs in EU are estimated at EUR
73-79 Mio which corresponds to roughly 2000 jobs[46]. These could potentially be
lost if there is no obligatory certification. Given the expected dominant
position of officially tested varieties and taking into account the certification
requirements for certain export markets, it could be assumed that some PRM lots
of these officially tested varieties will normally be submitted to
certification, especially for species which are internationally trade such as
maize (less the case with wheat). As a consequence, certification would
probably be done on far more than 30% of the lots on the market and this means
that a good part of the jobs associated with certification would be kept. Here
too, a full shift to certification under official supervision could sharply
reduce the number of public sector jobs that are saved while at the same time
only a small number of private sector jobs are created.

The flexibility with regard to ‘not
officially tested varieties’ will decrease the level of technical requirements
for variety description provided by micro-enterprise to competent authority.

3. Impact
on administrative burden for authorities and private sector operators

As there is no obligatory official
technical examination for registration, in theory 90% of 55-EUR 60 Mio could be
saved, since authorities would merely have a light administrative burden in
registering or listing varieties. However, again based on the assumption that
30-35% of the varieties would be officially tested varieties, the costs will be
in the order of EUR 40 Mio per year. These costs will be fully recovered from
or directly borne by the private operators.

Assuming a comparable situation for certification
of PRM lots, if in future about one third of the lots will be certified,
savings on PRM certification would be roughly EUR 50 Mio. A higher percentage
of lots offered for certification would reduce the amounts saved. Again, these
costs will be fully recovered and borne by the private operators.

Not officially tested varieties would
constitute a ‘low-burden” group that could be interesting in particular for
conservation varieties and other varieties with limited marketing potential. It should allow access to the market of varieties of interest for
conservation and other varieties that are expected to have only a local
importance. For such varieties, full technical examination and certification
would be a disproportionate cost when set out against the potential marketing
opportunities. However, this reduction of administrative burden could lead to
an expansion of this market. If breeders and PRM suppliers would use this at
too large a scale as an outlet for new varieties with less potential, they would
risk compromising the profitability of the markets for their top varieties. Due
to a different approach for FRM, there will be no effect on FRM under this
option.

4. Impact on competitiveness and trade

As there is no obligatory official
technical examination for registration and no obligatory official
certification, this enhanced flexibility ought to allow a more rapid market
access for new, not officially tested varieties. In particular, the operators
producing specific PRM for regional and local markets would benefit from this
opportunity, even though this forms a very small part of the volume of PRM
produced in the EU. For officially tested varieties there would not be any
significant change compared to the present situation. Given the fact that the two
markets of registered and unregistered varieties can be expected not to be to a
significant degree in direct competition with each other, the impact on the
sector is likely to be low. Also, unregistered varieties are mostly brought to
the market by micro and small enterprises, while seeds for export and
wide-spread commercial cultivation are drawn from the highly concentrated six
global seed companies.

Abolishing certification would, however,
have significant effects on trade with Third countries. In this case, EU
equivalence cannot be maintained and trade with third countries would have to
be based on compliance with OECD seed schemes and internationally recognised
rules on seed testing. Such a situation is likely to significantly increase
trade flows into the EU and competitive pressure on the EU PRM industry and
also decrease the quality of PRM.

A diversity of operators, especially SME and
micro-entities active in niche markets, are bound to benefit from the increased
freedom to act. On the other hand, this option offers good opportunities to
support sustainable agriculture and agro-biodiversity as the registration of
conservation/amateur varieties is administratively simplified and should
bolster market access in this area.

5. Impact
on innovation and research

A double effect is anticipated. The
enhanced flexibility should allow a more rapid and less costly access to the
market for new, but not always improved varieties. The industry will be
stimulated to focus its research on the sustainability of the new varieties as
under this option sustainability criteria will be a mandatory element of VCU of
officially tested varieties.

6. Environmental
impact

Not officially tested varieties, but with
an officially recognised description provided by the operator, are intended in
the first place to serve the interest of the conservation of biodiversity. It
should allow access to the market of varieties of interest for conservation and
other varieties that are well adapted to local conditions and that are expected
to have only local importance. It seems likely that overall more varieties will
be cultivated under this option and that therefore a positive effect on
agro-biodiversity can be expected. The charts below show that the introduction
of conservation varieties of agricultural crops and amateur varieties for
vegetables has been successful.

.

Officially tested varieties should
constitute the bulk of the varieties. Here too, a positive effect is expected
as varieties in this group will have undergone a screening for their
sustainability profile. This new approach on VCU is in line with the
Commission's approach to pesticides[47].
Annex III (1) to that Directive recommends to use, where appropriate,
resistant/tolerant cultivars and standard/certified seed and planting material.
To implement this provision, users of PRM should dispose of the proper
information. Official or officially supervised sustainability evaluation would
appear to be the best and probably the least costly guarantee that PRM users
indeed receive this information.

7. Social
impact

A positive social impact is expected concerning new
operators which are involved in landraces/conservation varieties at local level
and try to develop local markets in order to respond to consumer request for
traditional local food.

Summary
of the key impacts under option 4

Areas || Impacts

Impact on health and quality of PRM || -

Impact on employment and jobs in the public and private sector || -

Impact on administrative burden and costs for authorities || ++

Impact on administrative burden and costs for private sector operators || ++

Impact on competitiveness and trade || +

Impact on innovation and research || +

Environmental impact || +

Social impact || +

Option
5 - Centralisation: Centralised EU registration procedure with CPVO managing
and making final decisions, and fully harmonised certification requirements;
improved coherence between PHR and PMR regimes

1. Impact
on health and quality of PRM

As for registration, the assessment of the
description (DUS) of varieties will be centralised by CPVO and carried out in national
testing stations, following audits carried out by CPVO.[48] This should result in an
improved reliability of variety descriptions, including qualifications of the
performance criteria of varieties placed on the EU market.

Concerning certification, the reduction of
possibilities for more stringent requirements for national production should
result in a better harmonisation and improved transparency. Introducing
“Reference Certification Centres” will contribute to the harmonisation and
dissemination of best practices and thus increase the overall quality of PRM
certification in the Union.

Improving the coherence between the PHR and
PMR regimes will lead to the same impacts as analysed in option 2 above.

2. Impact
on employment and jobs

The effect of centralised variety
registration is difficult to calculate as it depends on how many of the
currently operating testing stations (just over 500 testing locations) with
their 1500 employees would continue their activities after CPVO audits. For jobs
on certification no significant impact is expected.

3. Impact on administrative burden on
public authorities and on businesses

The administrative burden for industry would
be lowered, as repetition of work on variety registration and on protection of
plant variety rights will be avoided (some operators might, though, continue to
apply in several Member States to be on the national list for marketing
reasons). There will only be one single EU variety registration system instead
of 27 national variety registration organisations, even though the evaluation
work as before will be done in entrusted testing stations across the EU. An
example from Annex XIV shows what kind of savings might be possible. In Germany
and France annual DUS costs are EUR 6.7 Mio and EUR 5.2 Mio, respectively. If
testing stations in the same agro-ecological regions cooperated, the number of
stations could be reduced. The maximum cost reduction would be in the order of
EUR 3-4 Mio if the number of test locations could be cut by half. In addition,
a centralised management by CPVO of the collections for
variety comparison held in the testing stations (reference collections) may
reduce the cost of variety evaluation as this element accounts for 6 to 30% of
the evaluation costs (based on information provided by four Member States).
This saving, however, has to be balanced against the costs of running,
coordinating and maintaining the databases of reference collections which would
entail considerable IT and staff investment at the CPVO and this will be
reflected in increased fees for operators. This option also reduces the
administrative burden for the Member States and thus saves costs. With an
estimated overhead for administrative costs of 10% of the registration costs in
the Member States the total savings at Member State level could be around EUR 5.5
to 6 Mio. The work at CPVO level will be increased (direct application, audit,
and harmonisation of DUS) and will result with more reporting obligations on
public authorities (CPVO audit of national examination offices) but in the
meantime it will increase the level of harmonisation of technical requirements
in the internal market.

The establishment of Union Certification
Reference Centres, training in the context of the Better Training for Safer
Food-initiative, the development of communication and information tools and
studies in support of policy development will cost EUR 2.3 Mio per year. At
least 85% of these costs will be borne by the Commission. The benefits are expected
to be significant as comparative tests and trials are carried out, harmonised
best practices established and disseminated and staff continuously trained.

In addition, the possibility is offered to
all operators to make a single application at the CPVO in order to receive
plant variety registration and/or plant variety protection; this will simplify
especially the work of SMEs. Due to a different approach for FRM, there will be
no effect on FRM under this option.

4. Impact on competitiveness and trade

A centralised uniform EU variety
registration system for the internal market improves transparency and it
ensures a truly level playing field for all operators. Concentration
of all variety registration tasks in CPVO facilitates work for breeders. Trade
will benefit from increased transparency and harmonisation. However, language
barriers might discourage some breeders and micro-enterprises and SMEs from
seeking registration at the CPVO and a distant, centralised authority might
have difficulties judging the value of small and regional crops.

5. Impact
on innovation and research

Uniform and harmonised EU rules and systems
of variety registration support the access of new varieties to the market, and
thus innovation and research.

6. Environmental
impact

As outlined under health, new provisions
might lead to better reassurance on the intrinsic health profile of varieties.
Access to the market for varieties that draw their main interest from their
contribution to biodiversity or that have enhanced qualities in respect of
sustainability will not change as compared to the current situation.

7. Social
impact

No social impact is expected concerning this option.

Summary of the key impacts under option 5

Areas || Impacts

Impact on health and quality of PRM || 0

Impact on employment and jobs in the public and private sector || -

Impact on administrative burden and costs for authorities || +

Impact on administrative burden and costs for private sector operators || ++

Impact on competitiveness and trade || ++

Impact on innovation and research || +

Environmental impact || 0

Social impact || 0

6.           Comparing the options

The revision of the existing legislation
aims at achieving the objectives identified in the 'Action Plan' of 2009 which
are reflected in the objectives of this IA. Thus, all five options are being
assessed against their potential to achieve these objectives.

6.1.        Comparing
the options

Drawing from the impact assessment of each
of the five options, the two summary tables below and the graph provide an
overall comparison (1) in terms of achieving the objectives, (2) terms of
effectiveness, efficiency and coherence with overarching EU objectives,
strategies and priorities and (3) semi-quantitatively in terms of aggregated
and weighted impacts.

The summary table below provides an overall
comparison of options in terms of achieving the objectives of the review.

|| || Option 1 || Option 2 || Option 3 || Option 4 || Option 5 || Preferred Option

Overall objectives || To assure the health and high quality of PRM || 0 || 0 || − − || − || 0 || 0

To provide a single and harmonised regulatory framework which is supportive for innovation and the competitiveness of the European PRM industry || + || + || + || ++ || ++ || ++

To support sustainable production, biodiversity protection, adaptation to climate change and to contribute to food security and poverty alleviation || 0 || 0 || − || ++ || 0 || ++

Specific objectives || To ensure a level playing field across the EU through simplified, clarified and harmonised basic rules on fundamental principles presented in an improved legal form || + || + || + || + || ++ || ++

To reduce unnecessary costs and administrative burden and for public authorities and increase flexibility for operators without compromising the general policy objectives || + || ++ || + || ++ || ++ || ++

To foster innovation in plant breeding, especially in SMEs, in order to improve PRM users’ choice and access to a wide diversity of plant varieties adapted to conditions in Europe || 0 || + || 0 || ++ || ++ || ++

To align PRM legislation with other recent Union strategies (agriculture, biodiversity, food security, climate change, bio-based economy) || 0 || 0 || − || + || 0 || +

Operational objectives || To provide a simplified legal framework for marketing of PRM – “PRM Law” - with the establishment of simplified, more flexible and proportionate procedures || 0 || ++ || ++ || ++ || ++ || ++

To promote a more harmonised implementation of legislation throughout the EU by audits and training || 0 || 0 || 0 || 0 || ++ || ++

To foster innovation by increasing the timeliness and level of information provided in the Common Catalogue || 0 || 0 || 0 || 0 || ++ || ++

To enhance market transparency and improve traceability through the registration of operators || 0 || ++ || ++ || + || ++ || ++

Legend:

0  no change with
the baseline option          +  minor positive effect       ++   significant
positive effect               −  minor negative effect         − − significant negative
effect

Criteria || Option 1 || Option 2 || Option 3 || Option 4 || Option 5 || Preferred option

Effectiveness || The health and quality of PRM will remain high, while a more level playing field is established. There are no strong incentives to steer innovation towards environmental and sustainability aims. 0 || The health and quality of PRM will remain high, while a more level playing field is established. There are no clear incentives to steer breeding activities and innovation towards more sustainability. + || Health and quality of PRM might become compromised in the long term. Innovation is supported and agricultural biodiversity might increase, but both effects might not be persistent. − || The health and quality of some PRM might become compromised in the long term. The option offers incentives for breeding new varieties and the pursuit of environmental and sustainability aims. 0 || The health and quality of PRM will remain high, while a more level playing field is established. Strong support for innovations in conventional breeding but lack of incentives for breeding for sustainable agriculture 0 || The health and quality of PRM will remain high, while a more level playing field is established. The option offers incentives for breeding new varieties and the pursuit of environmental and sustainability aims and strong support for innovations in conventional breeding. +

Efficiency || Public financial burden is reduced, but no possibility for private operators to achieve efficiency gains through taking over responsibilities from the public sector − || As many tasks as possible are transferred to industry and cost recovery is implemented. This will lead to more efficient implementation of the legislation and the reduction of financial and administrative burden. ++ || This option will lead to large cost saving for CAs and for operators as most obligations are abolished. However, many new non-EU competitors will be able to enter the market and economic activities can be relocated to non EU-countries. − − || This option will lead to large costs savings, while leaving to operators the possibility to seek added official quality assurance. However, many new non-EU competitors will be able to enter the market and economic activities can be relocated to non EU-countries. − || This option leads to a highly efficient system as most technical aspects are harmonised and centralised. The speed of market access of new, improved varieties will be increased. ++ || As many tasks as possible are transferred to industry and cost recovery is implemented leading to more efficient implementation of the legislation and the reduction of financial and administrative burden. Technical harmonisation through CPVO involvement also increases efficiency. ++

Coherence with EU objectives || Achieves the goal of a single legislative framework but the lack of flexibility means it is less likely to achieve the operational objectives and is less able to be adapted to changing circumstances in the future. − || Offers a coherent framework that can achieve many of the operational objectives. The option lacks clear means to adapt to the development of PMR to the needs of sustainability and other environmental goals. 0 || The option offers a maximally flexible system that could have unintended consequences for plant health and the environment that are not in line with the objectives. − − || This option offers a flexible system that can achieve the operational objectives of CAs and most stakeholder groups. ++ || Offers a maximally coherent framework that can achieve many of the operational objectives. The option lacks clear means to adapt to the development of PMR to the needs of sustainability and other environmental goals. 0 || Offers a balance between a coherent system and flexibility. The system will guarantee high quality of PRM and competitive advantage on the internal and the world markets, while possible derogations in addition will support diversity of SMEs, sustainability and biodiversity. ++

The data summarised in this graph are based
on the qualitatively ranked impacts of section 5. Each “-“ is given a score of
-1, each “+” a score of 1, a “0” is given a score of 0. The scores for each
option are added up and furthermore the standard deviation s of the
scores for each option is calculated. The sum of the scores for each option is
then weighted by the inverse of the squared standard deviation (1/s2)
of the scores. This weighting operation favours risk-aversion: options that
have a high standard deviation of scores (i.e. both high and low impacts) are
discounted more strongly than options with more even impacts.

6.2.        Stakeholder
assessment of the options

For this purpose we divided the
participants of the web-based survey into five groups and quantitatively assessed
the position of each group to each option. The analysis is summarised below and
is in more detailed presented in Annex VI.

(1) Competent authorities and ministries

64% of
competent authorities consider that scenario 1 is slightly beneficial or
neutral, 24% that it is rather negative or very
negative and 12% that they don’t know. 62% of competent authorities consider
that scenario 2 is slightly beneficial or fairly beneficial, 10%
that it is neutral, 24% that it is rather negative or very negative and 4% that
they don’t know. All other scenarios are rated by the majority as rather to
very negative. It was noticeable that competent authorities involved
specifically in the FRM sector consider that the scenario ‘’no change’’
is the most appropriate one. Accordingly it was decided to group them with the
other FRM suppliers and users in order to create a more homogenous group.

(2) PRM Breeders and suppliers (PRM
B&S)

77% of PRM
B&S consider that the scenario 2 is slightly beneficial or fairly
beneficial. 18% consider that it is rather negative
or very negative, 2% that it is neutral and 3% that they don’t know. 44% of PRM
B&S consider that the scenario 5 is slightly beneficial or neutral,
30% that it is rather negative or very negative and 26 % that they don’t know.
All other scenarios are rated as rather to very negative by the majority in
this group. The representation of PRM B&S involved in fruit or vine
reproductive material was very low (3 of 60).

(3) Stakeholder groups mainly interested
in biodiversity issues

54% of participants from this group
consider that the scenario 4 is slightly beneficial or very beneficial, 33% that it is rather negative or very negative and 13% that they
don’t know. All other scenarios are rated as rather to very negative by the
majority in this group.

(4) Users,
farmer growers, technical institutes

69% of this
stakeholder group consider that scenario 1 is slightly beneficial or neutral, 27% that it is rather negative or very
negative and 4% that they don’t know. 80% consider scenario 2 as
fairly beneficial or slightly beneficial, 8% as neutral, 8% as rather
negative or very negative and 4% that they don’t know. 46% consider scenario
5 as slightly negative, 23% as neutral, 11% as slightly beneficial and
12% that they don’t know.

This group is characterized by a strong
opposition to options 3 and 4.

(5) FRM

This stakeholder group opposed all
scenarios and stated that the option "no change" was not sufficiently
assessed. Members from this often mention, that agriculture and forestry are
different and that within the information provided, FRM was not specifically
mentioned. Due to the missing information, some stakeholders couldn't decide
among the options and have proposed to keep the existing legislation.

The analysis of the questionnaires also
shows that a majority of stakeholders prefer a new option which combines
elements from the options analysed in the Impact Assessment. Competent
authorities mainly support the idea that the revised legislation should
reflect a combination of scenarios (64%), with a large majority supporting the
inclusion of elements from option 2 (64%) and 30% for the inclusion of elements
from scenarios 4 and 5. 22% support the inclusion of the element of cost
recovery. 18% espouse inclusion of elements from scenario 3. PRM Breeders
and suppliers strongly back a combination of scenarios (74%), with
56% for taking up elements from option 2 and 39% for elements from scenario 5.
A minority supports the introduction of elements from scenario 4 (14%),
scenario 1 (8%) and scenario 3 (6%). A majority of stakeholder groups mainly
interested in biodiversity issues supports the idea that the revised
legislation should reflect combination of scenarios (54%). These groups mainly
state that the scenario 4 should be the basis for the revision. A minority
support the introduction of elements from scenario 3 (8%). Users of PRM
strongly support the idea that the revision should reflect a combination of
scenarios (96%). They mainly state that scenario 2 should be the basis for the
revised legislation (89%). 27% consider that the revised legislation could also
include the element of cost recovery and some centralization for DUS (23%). A
minority supports the introduction of elements from scenario 4 (8%). Forest
stakeholders support the scenario with no changes in the Directive on FRM.

No stakeholder provided details of entirely
new elements that should be considered in the options.

6.3.        Preferred
option

As none of the five options delivered an
optimal balance between efficiency of the system, the quality assurance of the
PRM, the maintenance of competitiveness and the issue of biodiversity, and in
line with a majority of stakeholders a preferred option, combining positive
elements of the initial options while maintaining as much choice and
flexibility as possible for operators, was designed and selected in the end. An
exhaustive presentation of the preferred option is in Annex XIII.

Option
6 – Preferred Option

The preferred option takes up elements from
options 2, 4 and 5. This combination aims at striking a balance between
flexibility for 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 the products. A balance is also achieved between the interests of
different stakeholder groups (see Annex VI). It includes the horizontal
principles of simplification of the PRM legal architecture, transparency and
cost recovery. Furthermore, basic general EU criteria with regard to plant health
and fitness for purpose, as well as for traceability/labelling, will apply to
all PRM brought to the market.

1.
Registration of varieties and material

·
Technical examinations can be carried out under
official supervision. On request of the operator official technical examination
is still possible.

·
All varieties and material of specified crops
(in principle those covered by the current EU marketing Directives with a
closed list of species) will be registered in national or directly at the CPVO and
subsequently entered into the EU plant variety registers, which will be
composed of two sections. Administrative tasks at the EU level related to
variety registration for e.g. vegetables (because no VCU is required) could be carried
out by the CPVO. The CPVO will also play a more central role by centralising
all information on the reference collections that are held in the various
testing stations in the Member States; the CPVO audits the national examination
offices which in turn allow private-sector testing stations to carry out
technical examination; the CPVO shall take an increased role in the practical
arrangements for the publication of the EU common catalogues. The CPVO will verify
variety denominations for all applications (from option 5) at national or EU
level.

·
Section 1 of the variety register will comprise
"officially tested" varieties that have been tested officially or
under official supervision. Technical examination will include DUS, mandatory
VCU criteria (for agricultural crops) and variety denomination will be checked
by CPVO. VCU criteria shall principally reflect public goods and become a “VCU
for sustainability and health”. VCU shall be harmonised as much as possible
across agro-ecological regions and continuously improved as much as possible to
take care of any evolution of public and private needs. Varieties that are
listed in this part of the catalogues could undergo certification (from option
2). Provenances and clones of forest reproductive material are identified on
the basis of the criteria as currently applicable for such material and have a
specific chapter in the catalogues of officially tested varieties.

·
Section 2 of the variety register will comprise
"not officially tested" varieties that are registered on the basis of
description of the variety prepared by the applicant, including the
denomination, accepted by the competent authority – this amounts to an
"officially recognized description". VCU-evaluation is not required
for this category of PRM. Competent authorities will only be responsible for checking
the denomination and registration and for controls of material present on the market,
focussing on labelling in particular. Varieties in this category cannot undergo
certification because the authorities, in the absence of officially verified
and accepted results of an official variety description, cannot certify the
identity of individual PRM lots (from option 4).

·
At the EU level, a high level group including
all relevant stakeholders shall be established for further policy guidance on
registration issue.

·
All non-listed species, which should include
ornamentals, must fulfil certain minimum conditions in order to be marketed
(labelling obligations and a provision of 'fitness for use').

2. Certification
of PRM

The
certification requirements for lots of PRM remain unchanged for varieties and
material from section 1 of the catalogue. However, as a standard procedure, the
control of compliance with the criteria for PRM marketing is carried out by the
operator under supervision of the competent authority. On request of the
operator certification under official examination is still possible. Marketing
of lots of PRM covered by a suppliers' label equally remains unchanged. Pests currently
regulated under the PRM will be listed under PHL, however the certification
procedure will continued to be used for the inspection; in this regard,
definitions and provisions between PHL and PRM Law will be aligned. This should
allow removing obstacles for combine health inspections under the two regimes.
“Reference Certification Centres” shall be established to develop, harmonise
and disseminate best practices in PRM certification.

3. Registration
of operators

In a context where a more significant role
is given to the industry, all operators (breeders,
growers, suppliers) are registered, allowing a monitoring of their activities and facilitating traceability in case of identified problems. This registration will be valid both for the EU plant health regime
and for the PRM marketing legislation and implemented through a shared register
to reduce burden (common to all options).

4. Approach on conservation varieties/amateur varieties/niche
markets

The requirements for the marketing of
conservation or certain "niche market" varieties will be adapted. As
there is no obligatory technical examination of varieties and no obligatory
certification of PRM, the marketing of conservation varieties or "niche
market" varieties can take place under the provisions of the regime for
non-officially tested varieties with the instrument of an officially recognised
description based on current and/or historical information available on the
variety.

5. Forest reproductive material

Following the Impact Assessment and the stakeholder
consultation the basic approach on FRM identification and certification will
not be changed and official controls will be maintained. A separate chapter in
the proposed Regulation is dedicated to FRM.

6.2.1. Analysis of impacts of the
preferred option

The impact on health and quality of
PRM will be absent or
negligible. Officially tested varieties are tested as they currently
are, with further emphasis on resistance/tolerance to biotic and abiotic
stress, while not officially tested varieties will not be tested for
pest/resistance or tolerance. These varieties will, however, only have a small
share in the total market for PRM. Certification will remain obligatory for the
same species as currently is the case and thus no negative impact is expected.
Introducing minimum requirements for non-listed species will improve the
quality of this group of species. Including ornamentals in this group will
ensure a minimum quality for this group of plant species. The impact on
employment and jobs can be significant in the public sector as tasks
are transferred to the private sector. For registration this loss could be
significant, but it can be expected that a proportion of that highly
specialised staff could be recruited by private operators. As for the certification
of individual lots of PRM, the analysis from option 2 is relevant here. A rough
estimate is that no more than 600-700 public sector jobs concerned with
certification might be lost, but that part of the redundant staff may be
recruited by the private sector. Nevertheless, appropriate levels of staff and
expertise will have to be maintained because public services shall remain
available. The impact on administrative burden and costs will be
most noticeable for competent authorities, which will recover fully the costs
for services offered and transfer responsibilities to the private sector.
Larger operators already to a great extent have the resources to carry out
these tasks and will most likely be able to carry them out in a more efficient
manner. The possibility of directly registering varieties of some species at
the CPVO will also lower administrative burden for operators. The new approach
of enabling the marketing of new varieties directly at the stage of national
register will save time and allow quicker market access. This and the transfer
of tasks to operators will increase their operating flexibility and thus have a
positive impact on competitiveness on the global market place. The
analysis of option 2 showed, using the example of the potato and the cereal
sector, that official supervision of certification tasks can lead to
considerable costs savings for companies. The maintenance of VCU for
officially tested varieties for certain groups of species will also contribute
to maintain an open competition in the Internal Market as large companies and
SMEs will compete mainly based on the quality of their products. Trade
with Third countries will not be particularly affected by this option, but the
rules that remain in place (DUS, VCU, certification) will guarantee that
European PRM companies will compete with high-quality and traceable products. With
regard to micro and small companies, the option
will have rules for providing public services for variety registration and PRM
certification; it will also provide flexibility with regard to ‘officially
recognised description’. The increased flexibility of operators should help to
accelerate the market access of new, improved varieties. Adapted VCU-criteria
("sustainable VCU") will simulate the industry to focus development
of varieties into new directions and thus foster innovation and research.
This option will also have a positive environmental impact. The
instrument of not officially tested varieties will serve the interest of the
conservation of agrobiodiversity. "Sustainable VCU" will support the
trend to develop agricultural practices more robust to climate change and less
reliant on pesticides and fertilisers. The social impact is also assessed as
positive as a high-skill PRM industry will be maintained in disadvantaged rural
areas.

Summary of
the key impacts under the preferred option

Areas || Impacts

Preferred option

Impact on health and quality of PRM || 0

Impact on employment (private and public sector) || 0(-)

Impact on administrative burden and costs for authorities || ++

Impact on administrative burden and costs for private sector operators || +

Impact on competitiveness and trade || +

Impact on innovation and research || +

Environmental impact || ++

Social impacts || +

The preferred option thus leads to legal architecture based
on a simplified and harmonized unitary legal base with two pillars describing
the provisions for listed (tested and non-tested) and non-listed species.

Regulation on the marketing of plant reproductive material Horizontal provisions: · Cost recovery of activities carried out by competent authorities · Possibility of official supervision for all activities carried out by operators · Official register of operators ||

►Level playing field for operators in all Member States ||

Provisions for EU listed species · Registration of varieties o Official description § DUS § VCU (e.g. specific crops such as agricultural crops) o Officially recognized description for conservation varieties e.g. \* o Suitable denomination · PRM Certification o Category (pre-basic, basic, certified) o Post-certification controls o Official label · Extended mandate of CPVO o Possible direct registration for certain species o Harmonization of DUS testing among MS o Mandatory requirement for denomination checking o Audit of national and private examination offices · Listed species defined in Annex 1 · Standard marketing category for varieties of listed species o with operator’s label o free from harmful organisms This pillar guarantees legal security for operators and consumers, high quality of PRM and competitive advantage on the internal and the world markets. \*Derogations on the basis of public goods and biodiversity conservation (officially recognized description) || Minimum provisions for non-listed species · Free from harmful organisms and defects, satisfactory vigor and germination (where appropriate) · Traceability of material and records of production keeping by the operators · If marketed as a variety: sufficient identity and purity and denomination · Operator’s label All species not listed in Annex 1 or for ornamental use This pillar allows minor crops or crops with particular uses access to specific or small market segments. At the same time a level playing field is established with minimum obligations ensuring traceability, health and information to the consumer. This pillar also supports diversity of SMEs, sustainability and biodiversity.

7.           Monitoring and evaluation

The general
monitoring of the legislation on marketing PRM will be carried out according to
the principles of the Regulation 882/2004 on official controls on feed and food
where the Commission (Food and Veterinary Office, FVO) controls the enforcement
of the legislation in the Member States by audits.

The monitoring of
the impact and effectiveness of the PRM legislation at EU level will be
required not only to assess the correct implementation but also to propose
further action or redirection of the measures, if necessary.

Two sets of
indicators will be needed, the first one for the overall monitoring of the PRM
sector and the second one for assessing the effect of the measures introduced
with the revision of the legislation with regard to the objectives.

|| Indicators

1. Overall monitoring of the PRM sector

Variety registration || Number, list of species concerned and evolution

|| Number of variety applications / species, MS and evolution

|| Number of varieties registered / species, MS and evolution

|| Number of varieties withdrawn from the EU register and evolution

|| Number of maintainers / group of species, MS and evolution

PRM quality control (health and quality) || Number and list of species concerned by this legislation and evolution

|| Amount of PRM yearly inspected / groups of species and evolution

|| Amount of PRM yearly finally certified / groups of species and evolution

|| Number, type, quantity of PRM not satisfying EU rules (post control evaluation) / MS and evolution

|| Number and type of derogations requested per MS for material not satisfying EU requirements and evolution

Market || Internal PRM market per species/group of species, type of material (certified or under the  responsibility of supplier's) (ha, EUR), per MS and evolution

|| Import, export (quantity/value) per group of species and MS and evolution

|| EU equivalence for PRM import

2. Assessment of the specific objectives of the revised legislation

2.1 Effectiveness of the system

|| Number of complaints and requests for clarifications received from stakeholders, MS

|| Number of notification received from Member States on national measures and national implementation

|| Functional register of operators and evolution.

|| Results of CPVO audits of national examination centres for variety registration and harmonised DUS protocol

|| Results of FVO audits on implementation of the legislation in the MS and PRM official control by competent authorities

|| Number of cases of developing information tools in the Member States concerning the implementation of the new Regulation

|| Number of studies conducted for the preparation and development of Union legislation in the field of plant reproductive material

2.2 Reduction of administrative burden and costs and introduction of flexibility

Variety registration || Application: Number, Time needed, cost recovery for variety registration per group of species and MS and evolution

|| PRM companies with a focus on SMEs applying for new varieties or for withdrawing the existing ones : Number, type, evolution

|| Number of varieties registered with an ‘officially recognised description’

|| Number of direct applications to CPVO and evolution

PRM quality control (health and quality) || % of certification under official supervision compared to official certification in the Member States (ha, type of companies especially SMEs) and evolution

|| Cost recovery for PRM quality control

|| Number of Union certification reference centres established

|| Number of comparative tests and trials carried out

|| Number of cases of amendments to legislation or establishment of protocols to improve the methodology of certification

2.3 Alignment of  PRM legislation with other recent Union strategies (biodiversity, CAP, climate change, bio-based economy) and proportionate rules

|| Number, quantity of conservation varieties/landraces/amateur varieties and of minor species listed per MS and evolution

|| Number, quantity of conservation varieties/landraces/amateur varieties and of minor species marketed per MS and evolution

|| Number of species concerned and evolution

|| Harmonised criteria for variety registration (e.g. sustainable VCU)

              ANNEX
I: GLOSSARY

AOA: area of adaptation

AOSCA: Association of Official Seed
Certifying Agencies

CA: certifying agency

CMO: Common Market Organisation

CPVO: Community Plant Variety Office

DG: Directorate General

DUS: distinctness, uniformity, stability

ESA: European Seed Association

EU: European Union

FVO: Food and Veterinary Office

GATT: General Agreement on Tariffs and
Trade

GMO: genetically modified organism

HO: harmful organisms

IAS: Invasive alien species

IPPC: International Plant Protection
Convention

ISF: International Seed Federation

ISSG: inter-service steering group

OECD: Organisation for Economic
Co-operation and Development

PRM: Plant Reproductive Material

R&D: Research and Development

SME: small and medium-sized enterprises

SPS: sanitary and phytosanitary measures

PRM: Plant reproductive material

UNECE: United Nations Economic Commission
for Europe

UPOV: International Union for the
protection of new varieties of plants

USD: US dollar

USDA: United States Department of
Agriculture

VCU: value for cultivation and use

WTO: World Trade Organisation

              ANNEX
II: HISTORY OF THE DEVELOPMENT OF PRM LEGISLATION

PRM Marketing Directives have existed since
the mid 1960s. They comprise of one horizontal Directive on the Common
Catalogue of Varieties and 11 vertical Directives dealing with specific plant
groups:

Council Directive 2002/53/EC on the common catalogue of varieties of agricultural plant species

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 2002/54/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 2008/72/EC 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

Council Directive 1999/105/EC on the marketing of
forest reproductive material

The majority of Council Directives for the
marketing of PRM have first been issued between 1966 and 1971. Some Directives
are more recent, such as the Council Directive for the marketing of vegetable
propagating material and planting material other than seed and the one for the
marketing of ornamentals.

These original Directives have been updated
both frequently and substantially, creating the need for clarity and
transparency. In some cases, such as the Directive on the Common Catalogue,
this has been pursued in the current versions. In other cases, for example the
Directives on fodder plant seed and cereal seed, the original Directives are
still in force although these have been subject to a large number of
amendments.

The SLIM initiative launched by the
Commission in 1996 has led to the recasting of the Council Directive on the
marketing of ornamental plants in 1998 as well as to the “2002” Directives
(2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC) that are
codifications of pre-existing Directives. Directives 66/401/EEC and 66/402/EEC
were not included in this SLIM initiative as some amendments were on-going at
the time when the Directives were recast or codified.

As a follow-up to the OECD revision of its
trade scheme for forest reproductive material in the mid-1990s, the EU
undertook to renew its old Directive so that there would be only one set of
definitions and rules for marketing of FRM. The new Directive 1999/105/EC has
standards that reflect the increase in Member States since 1966, for example in
the number of species covered.

A more recent change was the adoption of
Council Directive 2008/90/EC on
the marketing of fruit plant propagating material and fruit plants intended for
fruit production. The
Commission has recently also developed specific legislation on conservation
varieties so that varieties of agricultural and vegetable crops, which may be
threatened by genetic erosion and which are adapted to regional and local
conditions, may be marketed under certain derogatory rules. Directive
2008/62/EC provides that agricultural landraces and varieties which are
naturally adapted to the local and regional conditions (conservation varieties)
can be placed on the catalogues without official examination, once they meet
some minimum standards. Directive 2009/145/EC foresees less stringent
requirements as regards the acceptance of the varieties and the marketing of
the seed for the vegetable landraces and varieties which have been
traditionally grown in particular localities and regions (conservation
varieties) and vegetable varieties with no intrinsic value for commercial crop
production but developed for growing under particular conditions. Equally,
conservation and preservation of natural environment of species-rich grassland
has gained importance. Directive 2010/60/EU provides for less stringent rules
which are necessary to allow the marketing of fodder plant seed mixtures as
'preservation seed mixtures'.

              ANNEX
III: SUMMARY OF THE CHRONOLOGY OF MEETINGS

No. || Action || Date

(1) Conference on Seed Availability in the 21st Century        || 18 March 2009

(2) Council WP on Agricultural Questions (Plant Breeder Rights/Seeds and Propagating Material) || 1.1.        2 October 2009

(3) Sanco Advisory Group, WG 'Seeds and Propagating Material' || 30 November 2009

(4) Commission Inter-Service Steering Group || 26 January 2010

(5) Commission Horizontal WG of MS experts || 9 February 2010

(6) Council WP on Agricultural Questions (Plant Breeder Rights/Seeds and Propagating Material) || 12 March 2011

(7) Sanco Advisory Group, WG 'Seeds and Propagating Material' || 15 April 2010

(8) Commission Horizontal WG of MS experts || 3 May 2010

(9) Commission Inter-Service Steering Group || 11 May 2010

(10) Commission Inter-Service Steering Group || 3 June 2010

(11) Commission Inter-Service Steering Group || 15 September 2010

(12) Commission Horizontal WG of MS experts || 30 September – 1 October 2010

(13) Commission Horizontal WG of MS experts || 8 October 2010

(14) Commission Inter-Service Steering Group || 26 October 2010

(15) Sanco Advisory Group, WG 'Seeds and Propagating Material' || 23 November 2010

(16) Commission Horizontal WG of MS experts || 13 December 2010

(17) Commission Horizontal WG of MS experts || 11 April 2011

(18) Web-based stakeholder survey || 19 April – 30 May 2011

(19) 1. Council WP on Agricultural Questions (Seed and Propagating Material) || 27th April 2011

(20) TF 1 (General requirements), TF 2 (Registration of varieties), TF 3 (Marketing requirements and controls) under Hungarian Presidency || 24 May 2011

(21) Commission Horizontal WG of MS experts || 30 – 31 May 2011

(22) TF 4 (material with spec. significance for biodiversity, spec. marketing requirements) under Hungarian Presidency || 1 June 2011

(23) Council WP Agricultural Questions (Seeds and Propagating Material/Plant Breeders Rights)  || 17 June 2011

(24) TF 3 (controls) under Polish Presidency || 19 July 2011

(25) Commission Inter-Service Steering Group || 11 November 2011

(26) Council WP Agricultural Questions (Seeds and Propagating Material/Plant Breeders Rights)  || 12 October 2011

              Annex
IV: The International Framework of the PRM Industry

OECD Seed Schemes

Since 1958, the OECD Seed schemes are open to OECD countries as well as other U.N. Members. 58 countries participate, including EU Member States and the US, Canada, Australia, New Zealand, Japan, Russia, Ukraine, Argentina, Brazil, Egypt, India and Iran. The OECD seed certification is applied to varieties which have obtained satisfactory results by official tests (including comparative field tests) in at least one participating country. The tests must also establish that the varieties have an acceptable value in at least one country. The varieties are notified by National Designated Authorities (NDA) and published in official lists: the annual OECD list of varieties eligible for certification includes about 43.000 varieties from 200 species and 400.000tons/year. The schemes deal with the following groups of species: Grasses and Legumes, Crucifers and other Oil or Fibre species, Cereals, Maize and Sorghum, Beet, Subterranean clover, Vegetables. All schemes aim at seed certification; the Vegetable Scheme provides also for "Standard Seed" which are not certified but only controlled. The schemes ensure the varietal identity and purity of the seed through appropriate harmonised requirements and controls throughout the cropping, seed processing and international recognised OECD labels (varietal identity and purity): generation control (pre-basic, basic and certified seed), isolation distances, purity standards, field inspections, lot sampling, post-control plots, compulsory official laboratory analysis for each certified seed lot. OECD certification provides for official recognition of seed with guaranteed varietal identity and purity, thus facilitating international trade and contributing to the removal of technical trade barriers. In order to become member, the basic requirement are the following :  § National seed law providing a framework for variety registration and seed certification, § National list of plant varieties § Effective national system for seed control and certification § Seed analyses laboratories working with ISTA or equivalent standards for seed testing § Post-control field test to check the varietal purity of basic and certified seeds

OECD scheme for the control of forest reproductive material moving in international trade

The scheme defines four categories of forest reproductive material recognised for certification: (i) source-identified material (minimum standard); (ii) material from selected stands located in well-delimited regions of provenance; (iii) material from untested seed orchards which can produce seed of improved quality; (iv) tested material that is genetically improved. The scheme is open to OECD Members as well as to other States. Today 25 participating countries implement the Scheme, including tropical countries which are developing their seed exchange for reforestation purposes. Seeds and plants are produced and officially controlled according to common harmonised procedures. All categories included, the participating countries approved to date 253 tree species eligible for OECD certification of reproductive material, with a total area of 13.6 million hectares.

ISTA International Seed Testing Association

Founded in 1924, with the aim to develop and publish standard procedures in the field of seed testing, ISTA is an independent association and acts free from economic interest. Currently its membership consists of 201 member laboratories, 52 personal members and 42 associate members, from 79 countries around the world (seed scientists and analysts from universities, research centres and governmental, private and company seed testing laboratories). 120 of the ISTA Member Laboratories are accredited by ISTA and entitled to issue ISTA international seed analyses certificates for international trade of quality seed. Research, training and publishing are conducted including cooperation with related organisations such as OECD, ISO, and many others. ISTA produces internationally agreed rules for seed sampling and testing, accredits laboratories, promotes research, provides international seed analysis certificates and training, and disseminates knowledge in seed science and technology. This facilitates seed trading nationally and internationally, and also contributes to food security. The ISTA International Rules for Seed Testing guarantee worldwide annually updated, harmonised, uniform, seed testing methods. The ISTA Accreditation Programme (1995) includes Accreditation Standard, Proficiency Testing Programme and Auditing Programme. 17 Technical Committees are responsible for the development of new methodologies for seed testing, including bulking and sampling, flower seed testing, forest tree and shrub seed, germination, GMO, moisture, nomenclature, seed health, proficiency testing, purity, rules, statistics, seed storage, Tetrazolium, and vigour.

IPPC International Plant Protection Convention

The International Plant Protection Convention (IPPC) is an international plant health agreement, established in 1952, that aims to protect cultivated and wild plants by preventing the introduction and spread of pests and to promote appropriate measures for their control. In applying phytosanitary measures, contracting parties have obligations to comply with the Convention principles of necessity, technical justification and transparency. IPPC began with 12 countries and measures for grapevine Phylloxera. Today 177 contracting party are signatories to the Convention. Each contracting party has a National Plant Protection Organization (NPPO) and an Official IPPC contact point. Nine Regional Plant Protection Organizations (RPPOs) were established to coordinate NPPOs on a regional level. The Secretariat is provided by the FAO. Within the context of the WTO (Sanitary and Phytosanitary Measures SPS Agreement), the IPPC role is to encourage international harmonization and elaborate international standards to ensure that phytosanitary measures are not used as unjustified barriers to trade. In 2005, the entry into force of the new revised IPPC-Agreement emphasizes cooperation and information exchanges toward the objective of global harmonization. In addition to describing national plant protection responsibilities, it also addresses important elements of international cooperation for the protection of plant health and the establishment and use of International Standards for Phytosanitary Measures (ISPMs). Some ISPMs concern the production and trade of PRM, such as: ISPM 07: 2011 Phytosanitary certification system ISPM 11: 2004 Pest risk analysis for quarantine pests, including analysis of environmental risks and living modified organisms ISPM 15: 2009 Regulation of wood packaging material in international trade ISPM 21: 2004 Pest risk analysis for regulated non-quarantine pests ISPM 33: 2010 Pest free potato micropropagative material, minitubers for international trade. ISPM 36: 2012 Integrated measures for plants for planting (excluding seed)

United Nations Economic Commission for Europe (UNECE) Standard for Seed Potato

Work on the UNECE Standard for Seed Potatoes began in 1958. The first version of the standard was adopted by the Working Party in 1963 at its 16th session. It sets common terminology and minimum commercial quality requirements for the certification of high-quality seed intended for marketing internationally. It is a unique international frame of reference, covering all aspects related to seed-potato certification: (a) varietal identity and purity; (b) genealogy and traceability; (c) diseases and pests; (d) external quality; (e) sizing; and (f) labelling. The requirements are set for three categories of seed potatoes: pre-basic, basic and certified, in descending order of quality. Within these categories and classes, countries producing seed potatoes are free to create national classes that are subject to specific national requirements. The Designated Authority is responsible for the maintenance of classification data to provide traceability. Varieties are accepted for trade according to the Standard only if an official description and a reference sample are available from the Designated Authority. The variety should be distinct, uniform and stable (DUS) and have a denomination so that it can be identified. The Standard prescribes rules on packaging, sealing and labelling to ensure the identity of the seed. It also provides guidelines for comparative trials of plants grown from seed potatoes sampled from marketed lots. A List of Diseases and Pests, containing a basic description of each disease with illustrative photographs and their status in certification, supplements the Standard.

World trade organisation and TBT

The WTO agreements cover goods, services and intellectual property. They spell out the principles of liberalisation, and the permitted exceptions. As tariff barriers are eliminated, non-tariff barriers, such as technical barriers, become possible significant obstacles to international trade. Technical regulations, standards, conformity assessment procedures are important, but they vary from country to country due to climatic conditions or cultural, socio-economic or geographical factors; they make life difficult for producers and exporters. They are necessary for environmental protection, safety, product quality, national security and to consumer information. If the standards are set arbitrarily, they could be used as an excuse for protectionism or market distortions. Standards can become obstacles to trade. The Technical Barriers to Trade Agreement (TBT) is part of WTO agreements and tries to ensure that regulations, standards, testing and certification procedures do not create unnecessary obstacles. However, the agreement also recognizes countries’ rights to adopt the standards they consider appropriate — for example, for human, animal or plant life or health, for the protection of the environment or to meet other consumer interests. The TBT agreement states that the procedures used to decide whether a product conforms with relevant standards have to be fair and equitable. It discourages any methods that would give domestically produced goods an unfair advantage. The agreement also encourages countries to recognize each other’s procedures for assessing whether a product conforms. Without recognition, products might have to be tested twice, first by the exporting country and then by the importing country.

              Annex
V: List of stakeholders

The following
European stakeholders’ organisations and individuals have participated in the
Internet consultation. In order to be able to carry out the data analysis
reported in Annex VI, the stakeholders were divided in 5 groups, as follow:

Ministries and competent authorities

EU || AGES / BAES || AT || Austrian Agency for Health and Food Safety (AGES / BAES)

|| AGES / FOFS || AT || Austrian Agency for Health and Food Safety / Federal Office for Food Safety

|| Lebensministerium || AT || Federal Ministry Agriculture, Forestry, Environment and Water Management

|| DGARNE || BE || DG for Agriculture, Natural Resources and Environment

|| DGARNE - SPW || BE || Direction of Quality – Dep. Development - General operational Directorate of Agriculture, natural Resources and Environment - Public Service of Wallonia

|| CRAW || BE || Centre Wallon de Recherches agronomiques + CRAW Département Productions et Filières - Unité Stratégies Phytotechniques

|| LV-vlaanderen || BE || Flemish authority: Agency for Agriculture and Fishery

|| MOA - DA || CY || Ministry of agriculture, natural resources and environment, department of agriculture, plant health and quality control section, plant propagating material

|| MOA-DA-Seed control || CY || Ministry of Agriculture, Natural Resources, Environment – Dep. Agriculture

|| UKZUZ || CZ || Central Institute for Supervising and Testing in Agriculture

|| BSA || DE || Federal Min. Agriculture Food, Consumer Protection - Plant Variety Office

|| JKI || DE || Institute for Breeding Research on Agricultural Crops, Horticultural & Fruit Crops, Plant Health of the Julius Kühn-Institute

|| LFL-Bayern || DE || Bayerische Landesanstalt für Landwirtschaft

|| LLH-Hessen || DE || Landesbetrieb Landwirtschaft Hessen

|| LWK-Niedersachen || DE || Landwirtschaftskammer Niedersachsen

|| LWK-NRW || DE || Landwirtschaftskammer Nordrhein-Westfalen

|| SMUL-SACHSEN || DE || Sächsisches Landesamt für Landwirtschaft, Umwelt und Geologie

|| || DK || Danish Plant Directorate

|| || EE || Ministry of Agriculture

|| OEVV || ES || Plant variety office – Ministerio de Medio Ambiente, Medio Rural y Marino

|| EVIRA || FI || Finnish Food Safety Authority Evira

|| MMM || FI || Ministry of Agriculture – Seed + Fruit and ornamental propagating material

|| MAAPRAT || FR || Ministère de l’Agriculture

|| GEVES || FR || Groupe d'Etude et de contrôle des Variétés Et des Semences

|| CTPS || FR || Comté Technique Permanent pour la Sélection (fodder crops, protein crop, vine, President)

|| SOC France || FR || Service Officiel de Contrôle et de certification des semences et plants

|| IFV || FR || Institut français de la vigne et du vin

|| MIN AGRIC || GR || Ministry Agriculture, Rural Development, Food - Directorate of Inputs for Crop Production

|| MGSZH || HU || Central Agricultural Office + CAO - Directorate of Plant Production and Horticulture

|| Min. agriculture || IE || Department of Agriculture, Fisheries and Food

|| COSVIR IX || IT || Ministero delle politiche agricole alimentari e forestali

|| COSVIR XI || IT || Ministero delle politiche agricole alimentari e forestali - Servizio fitosanitario

|| INRAN-ENSE || IT || INRAN-ENSE

|| VATZUM || LT || State Plant Service – ministry of Agriculture

|| ASTA || LU || Administration des Services Techniques de l’Agriculture

|| MRRA – SPMU || MT || Plant Health Directorate within the Ministry for Resources and Rural Affairs

|| MINLNV || NL || Ministry of Economics, Agriculture and Innovation - Netherlands

|| NAK || NL || Dutch General Inspection Service for agricultural seeds and seed potatoes

|| MINROL || PL || Ministry of Agriculture and Rural Development

|| COBORU || PL || Research Centre for Cultivar Testing

|| INCS || RO || Ministry of Agriculture and Rural Development

|| || RO || Territorial Inspection for quality SPM

|| JORDBRUKSVERKET || SE || Swedish board of agriculture

|| SLU || SE || Sveriges Lantbruksuniversitet

|| UKSUP || SK || Central Controlling and Testing Institute in Agriculture (2 answers)

|| DEFRA-FERA || UK || Food and environment research agency

Non EU || || NO || Norwegian Food Safety Authority

Breeding / supplier companies / associations / suppliers PRM

EU organisation

EU || ESA || BE || European Seed Association || Breeders / suppliers PRM

|| AOHE || FR || Association des Obtenteurs Horticoles Européens || Breeders PRM

Others

|| Monsanto || BE || Monsanto  Europe || Breeder / supplier PRM

|| Pioneer || BE || Pioneer Hi-Bred International || Breeder / supplier PRM

|| GWPPPDT-UPR || BE || Groupement Wallon Producteurs de Plants de Pommes de Terre || Breeders / suppliers PRM

|| CMMSSA || CZ || Czech Seed trade association || Breeders / suppliers PRM

|| || DE || Bundesverband Deutscher Saatguterzeuger E.V. || Breeders PRM

|| APVD || DK || Association of Plant Variety Owners in Denmark || Breeders PRM

|| Seed Council || DK || Danish seed Council || Breeders / suppliers / users PRM

|| DLF Trifolium || DK || || Breeders PRM

|| Dansk gartneri || DK || Danish Horticulture || Breeder / supplier PRM

|| ANOVE || ES || Spanish Association of plant breeders || Breeders PRM

|| JOVEGA || ES || Jõgeva plant Breeding Institute || Breeders PRM

|| FSTA || FI || Finnish Seed Traders Association || Suppliers PRM

|| Boreal || FI || Boreal Plant Breeding Ltd || Breeder PRM

|| Siemen Forelia || FI || || Supplier PRM

|| GNIS || FR || Groupement National Interprofessionnel des Semences et Plants || Breeders / suppliers PRM

|| FEDEPOM || FR || Association (Potatoes) || Breeders / suppliers PRM

|| FNPPPT || FR || Fédération Nationale Producteurs de Plants de Pommes de Terre || Breeders / suppliers PRM

|| FNPSMS || FR || Fédération nationale production de semences de maïs et de sorgho || Breeders / suppliers PRM

|| UFS || FR || Union Française des Semencier || Breeders / suppliers PRM

|| INRA || FR || Institut National de la Recherche Agronomique || Reseach / plant breeding PRM

|| Agri Obtentions || FR || || Breeder / supplier PRM

|| CLAUSE SA || FR || || Breeder / supplier PRM

|| Belloy Semences || FR || || Breeder / supplier PRM

|| DE SANGOSSE || FR || || Supplier PRM

|| EMC2 || FR || || Supplier PRM

|| EURALIS || FR || EURALIS SEMENCES + Groupe EURALIS || Breeder / supplier PRM

|| INVIVO || FR || || Breeder / supplier PRM

|| JOUFFRAY-DRILLAUD SA || FR || || Breeder / supplier PRM

|| Laboulet Semences || FR || || Breeder / supplier PRM

|| Limagrain group || FR || || Breeder / supplier PRM

|| Mercier Frères Sarl || FR || (vine nurseries) || Breeder / supplier PRM

|| NORIAP cooperative || FR || || Supplier PRM

|| Pépinières du Valois || FR || (Fruit reproductive material) || Breeder / supplier PRM

|| RAGT Semences || FR || || Breeder / supplier PRM

|| UNEAL SCA || FR || || Supplier PRM

|| Semences Vertes || FR || || Supplier PRM

|| Semlin || FR || Syndicat établissements multiplicateurs de semences de lin textile || Suppliers PRM

|| Terre de Lin || FR || || Breeder / supplier / User PRM

|| TOP Semences || FR || Seed company || supplier PRM

|| UNISIGMA || FR || || Breeder PRM

|| AHPB || HU || Association of Hungarian Plant Breeders || Breeders PRM

|| VSZT || HU || Hungarian Seed Association || Breeders / suppliers PRM

|| ASSOSEMENTI || IT || Associazione Italiana Sementi || Breeders / suppliers PRM

|| COVI || IT || COVI CONSORZIO ORTOVIVAISTI ITALIANI || Supplier PRM

|| || LV || Latvian Seed Association || Breeders / suppliers PRM

|| KAVB || NL || KAVB - Royal General Bulbgrowers' Association || Breeders / suppliers PRM

|| NAO || NL || Nederlandse Aardappel Organisatie (potato merchants) || Suppliers PRM

|| PLANTUM || NL || Dutch Seed association (ornamentals, vegetable seeds, agricultural crops, vegetable plants and strawberry.) || Breeders / suppliers PRM

|| Nickerson Zwaan || NL || || Breeder / supplier PRM

|| Rijk Zwaan || NL || || Breeder / supplier PRM

|| Syngenta Seeds || NL || || Breeder / supplier PRM

|| AGRICO U.A. || NL || ||

|| SPS-AGRO || PL || Association of Polish Nurseries (fruit reproductive material) || Suppliers PRM

|| AMSEM || RO || Association of Breeders, Producers and Traders PRM || Breeders / suppliers PRM

|| SVUF || SE || Swedish seed trade association || Breeders / suppliers PRM

|| Lindbloms Frö || SE || || Breeder / supplier PRM

|| SWSEED || SE || Lantmännen SW Seed AB || Breeder / supplier PRM

|| SASTAB || SK || Slovak Association of Seed Traders and Breeders || Breeders / suppliers PRM

|| HORDEUM s.r.o. || SK || || Breeder / supplier PRM

|| ZELSEED || SK || || Breeder / supplier PRM

|| BSPB || UK || British Society of Plant Breeders Ltd. || Breeders PRM

|| AIC || UK || Agricultural Industries Confederation Ltd. ||

|| J. Hutton Institute || UK || Fruit breeder || Breeder PRM

Non EU || || USA || New World Seeds & Tubers || Breeder / supplier PRM

User of PRM / Seed growers / technical institutes

EU organisation

EU || Copa-Cogeca || BE || European farmers – European agri-cooperatives || Seed growers / Users PRM

|| || BE || EUROPEAN FLOUR MILLERS || Users PRM

|| ESGG || FR || European Seed Growers' Group || Seed growers

|| C.I.B.E. || BE || International Confederation of European Beet Growers || Users PRM

Others

EU || LK-OE || AT || Landwirtschaftskammer Österreich || Users PRM

|| IRBAB || BE || Institut Royal Belge pour l'amélioration de la betterave - IRBAB-KBIVB asbl ||

|| AKCR || CZ || Agrarian Chamber || Users PRM

|| WVZ || DE || Wirtschaftliche Vereinigung Zucker- WVZ || Users PRM

|| Dansk planteskole || DK || Danish Nursery sector || User PRM

|| || DK || The Knowledge centre for Agriculture, Plant production ||

|| MTK-agriculture || FI || Central Union of Agricultural Producers and Forest Owners (MTK), Agriculture Group || Users PRM

|| ARVALIS || FR || Institut du vegetal || Users PRM

|| AGPB || FR || Association générale des producteurs de blé et autres céréales || Users PRM

|| AGPL || FR || Association générale des producteurs de lin || Users PRM

|| AGPM || FR || Association générale des producteurs de maïs || Users PRM

|| BNIC || FR || Bureau National Interprofessionnel du Cognac || Users, Suppliers, Breeders

|| Capseine || FR || || Seed growers

|| CETIOM || FR || Centre technique des oléagineux métropolitains || Users PRM

|| Champagne Céréales || FR || Champagne Céréales || Users PRM

|| CFSI || FR || Comité français de la semoulerie industrielle || Users PRM

|| CGB || FR || Confédération générale des betteraves || Users PRM

|| FNAMS || FR || Fédération Nationale Agriculteurs Multiplicateurs de Semences || Seed growers

|| FNPC || FR || Federation Nationale des Producteurs de Chanvre || Users PRM

|| SFG || FR || Société Française des Gazons - SFG ||

|| TOULEMONDE FRERES Sarl || FR || || Users PRM (Fruit)

|| USRTL || FR || Union syndicale des rouisseurs teilleurs de lin || Users PRM

|| || NL || Agriculture and horticulture Organisation – section trees and perenials ||

|| NFU || UK || National Farmers Union || Users PRM

|| || UK || Pre Basic Growers Association (seed potatoes) || Users, Suppliers PRM

Non EU || Felleskjøpet Agri || NO || || User PRM

Others (biodiversity, conservation varieties, organic farming…)

EU organisation

EU || ECVC || BE || European Coordination Via Campesina || Users, Suppliers, breeders PRM

|| IFOAM EU || BE || International Federation of Organic Agriculture Movements || Conservation varieties

|| ECOPB || DE || European Consortium for Organic Plant Breeding || Breeder PRM (biodiversity)

Others

EU || Arche Noah || AT || Verein, Austrian Seed Savers Association || NGO (Breeder, supplier, user)

|| ARGE Streuobst || AT || Österreichische Arbeitsgemeinschaft zur Förderung des Streuobstbaues und zur Erhaltung obstgenetischer Ressourcen || User PRM (biodiversity)

|| ASBL Terre potagère || BE || Association || Supplier PRM (biodiversity)

|| thevegetablegarden || BE || || Conservation varieties

|| VELT || BE || || Supplier & consumer (biodiversity)

|| SAVE || DE || SAVE-Foundation || Conservation varieties

|| VERN e.V || DE || Verein zur Erhaltung und Rekultivierung von Nutzpflanzen in Brandenburg || NGO (old varieties)

|| ABDP || DE || Association of biodynamic plant breeders eV || Breeder / supplier PRM

|| || DE || Bingenheimer Saatgut AG || Breeders / suppliers PRM (organic farming)

|| Frøsamlerne || DK || Danish Seed Savers Association "Frøsamlerne" - NGO dealing with variety conservation and biodiversity || NGO (biodiversity)

|| Confederation paysanne || FR || Agricultural Union || Breeder, supplier, User PRM

|| KOKOPELLI || FR || Association || Breeder / supplier PRM

|| ITAB || FR || Technical Institute for Organic Farming || Technical institute

|| OKOFORRAS || HU || Ökoforrás (Eco-resources) Foundation || Conservation varieties

|| || IE || Eco Committee of Cork Monthly Meeting of the Religious Society of Friends in Ireland || Conservation varieties

|| || IE || Irish Seed Savers Association || Supplier & consumer (Conservation varieties)

|| Mullingar Educate together NS || IE || || Consumers (biodiversity)

|| AIAB || IT || Associazione Italiana per l’Agricoltura Biologica) || Biodiversity

|| Bifurcated Carrots || NL || || NGO (seed network)

|| Fritidsodlingens Riksorganisation || SE || || Consumers (gardeners)

|| Röttle natur och kultur || SE || || Biodiversity

Non EU || Portage Perennials || CA || || Consumer (biodiversity)

|| FNI || NO || Fridtjof Nansen Institute || Research institute (biodiversity)

|| || Forestry / Nurseries ||

Competent authorities || || ||

BFW || AT || Federal Forest Office – FRM || CA

SPW-DGO3-DNF || BE || Service public de Wallonie - Département Nature & Forest - Comptoir Forestier || CA

MMM || FI || Ministry of Agriculture and Forestry, Department of Forestry || CA

Min. Agriculture || IE || Forest Service, Department of Agriculture, Fisheries and Food || CA

SKOGSSTYRELEN || SE || Swedish forest agency || CA

NLC || SK || National forest centre || CA

EU organisation

EFNA || UK || European Forest Nursery Association ||

Nordic Forestry || BE || Bureau of Nordic Family Forestry || User

Others

Bosgroep || BE || Bosgroep Zuidwest Brabant vzw  (advice to forest owner) || Advice

IBGE || BE || Brussels Institute for Management of the Environment - Division Nature, Water and Forest - Forestry Department || Supplier

SPW || BE || Department of nature and forest in Wallonia || User

SRFB || BE || Société royale forestière de Belgique || User, breeder, supplier

DGARNE DNF || BE || Nature and Forest Administration of Walloon Region || User

UCL || BE || Université Catholique de Louvain - Earth and Life Institute - Environmental sciences Laboratory of forest sciences || User

Vallée du Chavan || BE || Groupement forestier || User

Scaldéen sprl || BE || Groupement Forestier || User

Forest Life SCA || BE || || User

|| BE || Nanson A.( former responsible for the regulations of Control of FRM) Aigret G., Serstevens A., Bastin H., Baudry O., Blondel N., Bonte F., Charmetant C., Coquelet L., Corriat J., d’Aspremont Lynden F.-R., De Lannoy, De La Vallée F., De La Vallée P., De Le Court E., De Le Court J.-C., De Le Court J-F, De Lichtervelde F. de Radzitzky J., de Radzitzky P., du Parc P., Delogne J.-F., Dessain H., Egefim, Evrad D., Gobbe V., Indivision Arnould - Vandeputte, Iweins de Wavrans F., Jugnot V., Mestdagh G., Rondia G., Simon N., Sonnet J., Sosson C, Tennstedt L.-M.,.Vincent A., Wootwood || Users

FD-MOA || CY || Department of Forests || Supplier

NST || DK || Danish nature Agency (tree) || User, breeder, supplier

MTK-forestry || FI || Central Union of Agricultural Producers and Forest Owners (MTK), Forestry Group || Users

|| FI || Union of Forest Owners West Finland || User

|| FI || Finnish Forest Research Institute (2 answers) || Research

ERTI || HU || Forest Research Institute || Research

LTO || NL || Agriculture and Horticulture Organisation Netherlands section Trees and perennials || Supplier, breeder, user

LRF || SE || Federation of Swedish Family Forest Owners ||

SODRA || SE || Southern Swedish Forest Owners Association || Supplier, breeder, user

|| SE || Foreningen Sveriges Skogsplantproducenter (Swedish Forest Nursery Association) || Supplier

|| SK || Federal Forest Office - Forest Reproductive Material || Breeder / Supplier

CONFOR || UK || Confederation of Forest Industries, Nursery Producers Group ||

Individual

Consumer || FR || Coquin P., Dano C., François Rose Marie., Le Hingrat Y., André V.

Seed grower || FR || Vitu M.

Consumer || SE || A. Truedsson

Consumer || SK || Schnorrer M., Majdekova, Kása S.

Consumer || ? || Anonymous

              ANNEX
VI: ANALYSIS OF THE PUBLIC CONSULTATION

I. Overall analysis

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 more than 257 responses from a
very wide range of stakeholder groups. All replies to the questionnaire can be found
with the following link:

http://ec.europa.eu/food/plant/propagation/evaluation/options\_review\_legislation\_replies\_en.htm.

1- Response profile

Stakeholders from 27 countries have
answered to the web based consultation, including from 24 Member States
(Bulgaria, Portugal and Slovenia did not answer). Canada, the US and Norway
also have provided answers. 2/3 of answers were coming from 6 countries:
Belgium, France (20-25%), Germany, Sweden, Finland and the Netherlands (between
4-6%).

Table V.1: Response profile

Competent authorities ||

Certification || 19.4%

Variety registration || 16.7%

S&PM: ||

Breeders || 25.5 %

Suppliers || 28.9 %

Users of S&PM || 32.7%

User for raw material || 4.9 %

Final Consumer || 8.4%

Type of organisation ||

SME || 6.1%

National companies || 10.7%

International companies || 8.4%

International organisations || 6.1%

Others || 28.5%

The questionnaire authorised multiple
answer with regard to the activities (e.g. breeders and suppliers), and thus
the percentages do not add up exactly to 100%.

2- Problem
definition

64% of the stakeholders consider that the
problems were not defined correctly and that issues such as genetic
improvement, productivity, competitiveness, global food security, adaptation to
climate change, biotechnology, agro-environmental adaptation, biodiversity
(minor crop and old varieties), niche markets, national stricter rules or no
common solutions for all PRM were not sufficiently addressed.

71.9% of the stakeholders considered that
the scenarios were not defined correctly and that certain scenarios were
overlooked. Therefore, a majority of stakeholders (between 54 and 96% depending
on activity and sector, with the exception of FRM where stakeholders are in
favour of keeping the status quo) proposed that a combination of scenario
should be developed. 79.5% feel that certain scenarios are unrealistic.

There was a majority of 57.4% to discard
the baseline scenario ‘’no change’’ and the extreme scenario ‘’abolishment of
S&PM Regulation’’.

Table V.2: Prioritisation of objectives

Priority objectives || 1 || 2 || 3 || 4 || 5 || N/A

Ensure availability of healthy high quality seed and propagating material

|| 37% || 23% || 9% || 8% || 3% || 21%

Secure the functioning of the internal market for seed and propagating material

|| 21% || 19% || 14% || 11% || 15% || 20%

Empower users by informing them about seed and propagating material

|| 2% || 13% || 14% || 32% || 17% || 22%

Contribute to improve biodiversity, sustainability and favour innovation

|| 21% || 12% || 25% || 11% || 11% || 19%

Promote plant health and support agriculture, horticulture and forestry

|| 7% || 15% || 17% || 14% || 28% || 18%

The analysis of the answer of stakeholders
on the priority objectives shows that:

·
37% of stakeholders consider that ‘’ensuring availability
of healthy high quality seed and propagating material’’ is the first priority
and remains valid in 2011 and 60% that it is a priority 1 or 2.

·
40% consider that ‘’securing the functioning of
the internal market for S&PM’’ is a first or second priority.

·
25% of stakeholders consider that ‘’contributing
to improve biodiversity, sustainability and innovation’’ is a medium priority
objective while 21% consider this to be of a high priority. This is reflected
in the discussion where some stakeholders consider that the issue is already
addressed while some others state that there is a definite need to do more in
this field.

·
Around 50% consider that ‘’empowering users by
informing them about S&PM’’ has a lower priority.

·
Only 7% of stakeholders consider that the
objective ‘’promoting plant health and support agriculture, horticulture and
forestry’’ is a first priority and 28% state that it has a low priority. This
might be explained by the fact that plant health for S&PM is already
addressed in the first priority through the terminology ‘’healthy high quality
seed’’ and that the securing of the Internal market covers the principle of
support for agriculture, horticulture and forestry.

3-
Assessment of options

76.9% of stakeholders considered that the
impacts of each option were not correctly analysed and that certain impacts
have been overlooked or underestimated. This stakeholder view is, however,
based on a preliminary assessment of the impacts in the “Options &
Analysis”-paper.

Some stakeholders judge that the impacts on
the various sectors of PRM (agricultural crops, vegetable, fruit, and vine or
forest material) were not sufficiently addressed in the options which were
described as very general and even simplistic.

Specific questions related to Forest
Reproductive Material are not adequately taken into consideration and the
related plant health issue neither (seed potato, fruit and vine materials).

Certain stakeholders believe that the
impact of the transfer of cost to the private sector has been underestimated.
Others consider that the issue of biodiversity is underestimated.

Several stakeholders consider that the
issue of warranty of quality of PRM to users has been underestimated.

Table V.3: Stakeholders'
support to specific options or combination of options

1 || 2 || 3 || 4 || 5 || Combination of scenarios || Scenario with new features || N/A

3.1% || 7.3% || 2.7% || 6.5% || 8.0% || 28.5% || 44.2% || 6.9%

44.2% are in favour of a new scenario
with new features. 28.5% of the stakeholders support the idea that the
preferred option for the review of the PRM legislation should be a combination
of options.

Regarding the options which would best meet
the objectives of the review, only 16 stakeholders provided an answer.
‘’Green’’ stakeholders (37.5% of respondents answering this question, but only
2.3% of all respondents) considered that option 4 will meet them, while other
groups shared the opinion that a combination of option or a scenario with new
features (12.5%+37.5% of respondents answering this question, but only 3.1% of
all respondents) will meet the objectives.

II. Analysis of the consultation according to sectoral
stakeholder groupings

This section presents an overview of the
positions taken by sectoral stakeholder groupings and the competent authorities
of the Member States in reply to the consultations. The Commission has
attempted to summarise these positions as accurately as possible.

1.
Opinions concerning the proposed scenarios

The public
consultation was based on the five scenarios presented in detail in this Impact
Assessment and the discarded options of "No change" and
"abolishment".

Discarded options ||

SCENARIO 1 "Cost Recovery": || Complete recovery of variety registration and PRM certification costs by competent authorities

SCENARIO 2 "Co-system": || Limited flexibility for operators: technical examination for variety registration and PRM certification can be carried out by the operator under official supervision.

SCENARIO 3 "Deregulation" || Complete flexibility by deregulation: only DUS tests are mandatory and made under official supervision. VCU tests are optional. PRM certification applies only to exports.

SCENARIO 4 ‘’Enhanced flexibility’’ || Dual system: one for officially tested varieties (DUS, VCU) and one for non-officially tested varieties. Certification is limited to officially tested varieties.

SCENARIO 5: ‘’Centralisation’’ || CPVO will be given the mandate for variety registration. No change for certification (scenario 2).

Stakeholders,
including competent authorities, from 24 EU Member States (no responses from
Bulgaria, Portugal and Slovenia) took part. Six countries accounted for two
thirds of the responses:

France (more than 25% of all responses)
Belgium (25% of the responses, including 40 responses from the
Belgium forest sector)
Germany, Finland, Netherlands and Sweden.

Five responses
came from third countries: Norway (3 – competent authority, user of PRM and
research institute), Canada (1 – user of PRM), USA (1 – breeder and PRM
supplier).

North American
(US and Canada) stakeholders reject all scenarios; Norwegian stakeholders
consider the scenarios 1 and 5 as very negative and have a range of views on
the other scenarios.

For the
following analysis, stakeholders were divided into categories:

Competent authorities and ministries: 25% of responses;
Breeders and PRM suppliers: 30%;
Users of PRM;

-
non FRM: 13%;

-
Users of PRM emphasizing biodiversity issues:
12%;

FRM : 15%

Competent authorities (excluding FRM)

Scenarios || Discarded options || 1 || 2 || 3 || 4 || 5

CA || disregarded || Slightly beneficial or neutral || Slightly beneficial || Rather negative || Rather negative || Rather negative

Discarded options

66% of
competent authorities (excluding FRM) consider that the assessment of the
discarded options was sufficient and consequently disregarded these two
options.

Scenario 1

64% of competent authorities judged scenario
1 to be slightly beneficial or neutral, 24%
consider it to be rather negative or very negative and 12% state that they
don’t know.

Scenario 2

62% of competent authorities judged scenario
2 to be slightly beneficial or fairly beneficial, 10% consider it to be neutral, 24% as rather negative or very
negative and 4% state that they don’t know.

Scenario 3

76% of competent authorities judged scenario
3 as rather negative or very negative. 12%
consider it to be slightly beneficial or fairly beneficial, 6% as neutral and
6% state that they don’t know.

Scenario 4

72% of competent authorities judge scenario
4 as rather negative or very negative. 12%
consider it is slightly beneficial or fairly beneficial, 10% as neutral and 6%
state that they don’t know.

Scenario 5

68% of competent authorities judge scenario
5 as rather negative or very negative. 14%
consider it to be slightly beneficial or fairly beneficial, 14% that it is
neutral and 4% state that they don’t know.

It is noticeable that competent
authorities involved specifically in the FRM-sector judge the discarded
scenario ‘’no change’’ to be the most appropriate.

PRM Breeders and suppliers (PRM B&S)

Scenarios || Discarded options || 1 || 2 || 3 || 4 || 5

Breeders and PRM suppliers (PRM B&S) || disregarded || Rather negative || Slightly beneficial || Very negative || Rather negative || Slightly beneficial or neutral

Discarded
options

81% of PRM B&S consider that
the assessment of the discarded scenario ‘’no change’’ or ‘’abolishment’’ was
sufficient and consequently disregarded these two options.

Scenario 1

65% of PRM B&S consider scenario
1 to be rather negative or very negative, 20%
state that it is slightly beneficial or fairly beneficial, 6% that it is
neutral and 9% that they don’t know.

Scenario 2

77% of PRM B&S judge scenario 2
to be slightly beneficial or fairly beneficial. 18%
state that it is rather negative or very negative, 2% that it is neutral and 3%
that they don’t know.

Scenario 3

84% of PRM B&S consider scenario
3 to be rather negative or very negative and 8%
state that it is slightly beneficial or fairly beneficial, 5% that it is
neutral and 3% that they don’t know.

Scenario 4

80% of PRM B&S consider that scenario
4 is rather negative or very negative and 15%
state that it is slightly beneficial or fairly beneficial, 2% that it is
neutral and 3% that they don’t know.

Scenario 5

44% of PRM B&S consider that scenario
5 is slightly beneficial or neutral, 30% state
that it is rather negative or very negative and 26 % that they don’t know.

It was conspicuous that the representation
of PRM B&S involved in fruit or vine reproductive material is very low (3
between 60). It is thus not possible to arrive at strong conclusions concerning
these sectors.

Stakeholder
groups mainly interested by biodiversity issues

Scenarios || Discarded options || 1 || 2 || 3 || 4 || 5

Stakeholders || disregarded || Very negative || Rather negative || Rather negative || Slightly beneficial || Very negative

Discarded
options

65% of this group answered that the assessment of the discarded scenarios was sufficient.
30% responded that the disregarded options ‘’no change’’ or ‘’abolishment’’
were not sufficiently assessed.

Scenario 1

75% of respondents from this
stakeholder group consider scenario 1 to be very negative, 8% state that
is neutral, 4% that it is slightly
beneficial and 13% that they don’t know.

Scenario 2

75% consider scenario 2 to be
rather negative or very negative, 8% state that it
is neutral and 17% that they don’t know.

Scenario 3

62% consider scenario 3 to be
rather negative or very negative, 8% state
that is neutral, 17% that it is slightly beneficial or fairly beneficial and
13% that they don’t know.

Scenario 4

54% of PRM B&S consider scenario
4 to be slightly beneficial or very beneficial,
33% state that it is rather negative or very negative and 13% that they don’t
know.

Scenario 5

75% of PRM B&S consider scenario
5 to be very negative, 8% state that it is
neutral and 17% that they don’t know.

This stakeholder group is generally
critical to very critical concerning the various scenarios. Only scenario 4
(58%) is judged to provide some benefits concerning the question of
biodiversity.

Users (non-FRM, also including
technical institutes)

Scenarios || 0 || 1 || 2 || 3 || 4 || 5

Stakeholders || Disregarded || Slightly beneficial or neutral || Slightly beneficial || Very negative || Very negative || Neutral or rather negative

Discarded options

61% of this group respond that the
assessment of the discarded options ‘’no change’’ or ‘’abolishment’’ was
sufficient and consequently disregarded these two options.

Scenario 1

69% consider scenario 1 to be
slightly beneficial or neutral, 27% state that it
is rather negative or very negative and 4% that they don’t know.

Scenario 2

80% consider scenario 2 to be
fairly beneficial or slightly beneficial, 8% state
that it is neutral, 8 % that it is rather negative or very negative and
4% that they don’t know.

Scenario 3

100% consider scenario 3 to be very
negative.

Scenario 4

100% consider scenario 4 to be very negative.

Scenario 5

46% consider scenario 5 to be
slightly negative, 23% state that it is neutral,
11% that it is slightly beneficial and 12% that they don’t know.

This stakeholder group is characterized by
a common view on scenarios 3 and 4 stating that those two scenarios are very
negative for the future of the PRM sector.

Forest reproductive material

Within the FRM sector, forest owners can
be supplier and users at the same time. Due to the fact that public owned
forests are common in Europe, sometimes the competent authorities can also be
user and supplier. Therefore all participants in the public consultation
involved with forestry were treated as one stakeholder group.

Scenarios || 0 || 1 || 2 || 3 || 4 || 5

Stakeholders || Not sufficiently assessed || No opinion || Very negative || Very negative || Very negative || Very negative

Discarded options

2/3 of this group answered that the
disregarded scenarios were not sufficiently assessed.

Scenario 1

46% of the group state that they don’t
know how to assess the possible impact of scenario 1. 23% consider that
it would be negative, 19 % answer that the scenario would have a positive
impact, 12% consider it as neutral.

Scenario 2

69% of the group consider scenario 2
to be rather negative or very negative, 23% don't know how to assess it and 8%
answer that it is neutral.

Scenario 3

69% of the group consider scenario 3
to be rather negative or very negative, 23% don't know how to assess it and 8%
answer that it is neutral.

Scenario 4

58% of the group consider scenario 4
to be rather negative or very negative, 27% don't know how to assess it, 11%
answer that it is positive and 4% consider it as neutral.

Scenario 5

61% of the group consider scenario 5
to be rather negative or very negative and 27% don't know how to assess it,
7.7% answer that it is neutral and 4% that it is positive.

This group is opposed to all options. It
is often mentioned, that agriculture and forestry are different and that FRM
was not specifically mentioned in the Option & Analysis Paper provided. Due
to this, some stakeholders from this sector couldn't decide yet and have
proposed to keep the existing legislation.

2.
Opinions concerning the proposed objectives

Obj. 1. Ensure availability of healthy high quality seed and
propagating material;

Obj. 2. Secure the functioning of the internal market for seed and
propagating material;

Obj. 3. Empower users by informing them about seed and propagating
material;

Obj. 4. Contribute to improving biodiversity, sustainability and
favour innovation;

Obj. 5. Promote plant health and support agriculture, horticulture
and forestry

Objectives || Obj.1 || Obj. 2 || Obj. 3 || Obj. 4 || Obj. 5

Priorities for competent authorities || 1 || 2 || 4 || 3 || 3

Priorities for breeders and PRM suppliers || 1 || 2 || 3 || 2 || 3

Biodiversity stakeholders || 2 || 4 || 2 || 1 || 3

PRM users, PRM growers || 1 || 3 || 3 || 2 || 3

Forestry group || 1 || 2 || 4 || 2 || 3

This table shows that for four stakeholder
groups, except the biodiversity group, the objective of ‘’ensuring availability
of healthy high quality seed and propagating material’’ is the first priority.
The biodiversity group puts objective 4 first, but responds that the objective
of ‘’ensuring availability of healthy high quality seed and propagating
material’’ is the second priority.

For competent authorities, breeders and
suppliers and forestry stakeholders, the second most important objective is to
‘’secure the functioning of the internal market for PRM’’.

It is noticeable that the objective of
improving ‘’biodiversity and innovation’’ is also an important concern of
nearly all stakeholder groups.

              ANNEX
VII: SHORT DESCRIPTION OF THE MAIN FEATURES OF THE PRM MARKETING LEGISLATION

Distinctness, Uniformity, Stability (DUS)

A variety shall be regarded as distinct if it is clearly
distinguishable on one or more important characteristics from any other variety
known in the Union. The characteristics of a variety must be capable of precise
recognition and precise definition.

A variety shall be regarded as sufficiently uniform if, apart from a
very few aberrations, the plants of which it is composed are, account being
taken of the distinctive features of the reproductive systems of the plants,
similar or genetically identical as regards the characteristics, taken as a
whole, which are considered for this purpose.

A variety shall be regarded as stable if, after successive propagation
or multiplications or at the end of each cycle, it remains true to the
description of its essential characteristics.

For the official examination of a variety the CPVO- or UPOV- or
national protocols are used.

Value for cultivation and use (VCU)

The value of a variety for cultivation and
use shall be regarded as satisfactory if, compared to other varieties accepted
in the catalogue of the Member State in question, its qualities, taken as a
whole, offer, at least as far as production in any given region is concerned, a
clear improvement either for cultivation or as regards the uses which can be
made of the crops or the products derived there from. Where other, superior
characteristics are present, individual inferior characteristics may be
disregarded. The characteristics to be considered are the value for cultivation
(being yield, resistance to harmful organisms and behaviour with respect to
factors in the physical environment) and the value for use (quality
characteristics).

Protocols and testing procedures for the
four characteristics are developed on a national level.

Certification/controls on lots of PRM

Quality and health of lots of PRM on the market are
guaranteed by issuing of a label, which stands for a statement that the lot
concerned complies with the EU requirements applicable to the species and the
category under which the lot is placed on the market.

For nearly all agricultural crops marketing
is only possible in the categories of certified material or higher. It also
implies that the label is an official label issued following an official
examination of the field production and the lot or an examination under
official supervision. This examination involves controls during the growing
period of the PRM crop, examination at the stage of the preparation of the lot
itself and sampling followed by laboratory testing.

Besides official certification labels, the
guarantee can be based on the basis of a suppliers' label which is issued by
the supplier himself, on the basis of his own verification of the compliance of
the lots with the applicable standards. The only official controls on such lots
are the post-controls on samples drawn from PRM that is present on the market.
One of the consequences is that the official services can only verify
compliance with the standards applicable to the lot itself.

The various steps in the variety registration and certification
processes are shown in the following flowchart

Figure 1. Registration of varieties and
certification/inspection of PRM lots for marketing

EU system for PRM marketing[49]

Step 1: Registration of varieties

1.1 Applicant
submits an application and a sample to the national competent authority

1.2 Competent
authority performs technical examination:

- distinctness,
uniformity, stability (DUS) for all varieties, (at least over 2 growing
seasons)

- value for cultivation
and use (VCU) as additional tests for agricultural crops

- suitability of
the proposed variety name

 if all
criteria are met

1.3 Competent
authority registers the variety in its national catalogue or list

For agricultural and vegetable crops, the variety is
eligible for marketing in the Member State, for other crops marketing in the
entire EU is permitted

1.4 The competent
authority notifies the Commission of the registration of varieties of
agricultural and vegetable crops

1.5 The EU includes
the agricultural and vegetable varieties in a common catalogue

The variety of agricultural and vegetable
crops is eligible for marketing throughout the EU

Step 2: Inspections/certification of lots of PRM

Marketing of
lots covered by an official certification label

2.1.1 Supplier
submits an application to the competent authority

2.1.2 Authority performs inspections on
growing seed crop and on lots prepared for marketing, including sampling and
laboratory testing. Under certain conditions inspections may be done by the
supplier under official supervision

 if all criteria[50]
are met

2.1.3
Certification label issued

 lot eligible for marketing

2.1.4 Competent
authority performs random post-control on lots of PRM on the market

Marketing
covered by a suppliers' label[51]

2.2.1 Supplier
performs inspections on his seed crop and on lots prepared for marketing

 if all criteria are met

2.2.2 Suppliers'
document issued

 lot eligible for marketing throughout EU

Current system on market access of
varieties/material: registration and certification of all varieties/materials
of plant reproductive material (PRM) of plant species regulated in the EU

Groups of plant species || Agricultural crops: seed of fodder, cereal, beet, oil and fibre plants, potatoes || Vegetable seed and propagating material || Fruit and vine propagating material and plants || Forestry reproductive material || Ornamental seed and propagating material

Registration of varieties or materials · Application is done by breeders § Purpose:  marketing of better varieties, with clearly identified characteristics. § The varieties are registered in catalogues (for agricultural and vegetables crops) or lists for fruits and vines. § The acceptance for registration is subject to examination of varieties for identity and performance as well as of denomination checking.

|| Registration of varieties in the MS (DUS examination for identity and VCU examination for performance, denomination checking) EU marketing through publication in the EU Common Catalogues || Registration of varieties in the MS (DUS examination for identity, only industrial chicory  VCU testing) EU marketing through publication in the EU Common Catalogues || Registration of varieties in the MS (DUS examination) EU marketing through publication in the national list, notification of information to the EU list || Official approval of basic material on the basis of its provenance  EU marketing through publication of basic material in the national list and notification of information to the EU list || No variety registration procedure: Can be marketed if  plant variety rights protection  or officially registered or commonly known or on suppliers list in the MS

Derogations to above  || Grasses for non-fodder use: no VCU testing For registration of conservation varieties in the MS and EU Common Catalogues: less stringent DUS testing and no VCU testing Preservation seed mixtures approved on basis of origin in the MS Derogative pre-authorisation marketing regime for tests and trials on farms with quantitative restrictions in the MS: 'not- yet listed varieties' || For registration of conservation varieties and amateur varieties the MS and EU Common Catalogues: less stringent DUS testing and no VCU testing || Possibility for less stringent derogative rules for varieties in the interest to preserve genetic diversity exists. || ||

Category/ S&PM || Agricultural crops: seed of fodder, cereal, beet, oil and fibre plants, potatoes || Vegetable seed and propagating material || Fruit and vine propagating material and plants || Forestry reproductive material || Ornamental seed and plant propagating material

Certification/inspection of  S&PM lots   · Purpose: ensure the presence of good quality and healthy lots on the market · Is subject to inspections done by national competent authorities or by the supplier under official supervision on growing seed crops and on lots prepared for marketing, including sampling and laboratory testing. Following these tests that explore various criteria such as: identity, purity, quality, plant health) certification label is issued.

(1)  Certification   PRM before marketing by official authority only || Marketing categories of pre-basic and basic seed (field inspection), seed potatoes || || Fruit: Marketing categories of pre-basic,  basic, certified Vine: Marketing categories of initial, basic seed, certified seed || Different marketing categories under which different types of basic material may be marketed.  Certification for derivation of approved basic material ('master certificate'). Official control system in the MS. ||

(2) In addition to (1): possibility for  certification under official supervision || Marketing categories of certified seed and commercial seed (fodder, oil &fibre plants) || Seed: marketing categories of pre-basic, basic seed and certified seed || || ||

(3) Marketing controls only (post-controls) || Small packages of beet seed and fodder plant seed || Seed: marketing category standard seed (verification) PM: self controls, MS supervision & controls of producers, small packages || Fruit: marketing category CAC Vine: marketing category standard || Re-inspected at regular intervals || No marketing categories, general quality requirements, random checks

              ANNEX
VIII: MAIN FEATURES OF THE PRM MARKETING INDUSTRY

EU production and trade in true seed

The European Seed Association (ESA)
estimates that in 2009-2010 the EU commercial seed market has reached a value
of approximately EUR 6.8 billion and that it represents more than 20% of the
total worldwide market for commercial seed. The EU seed markets for cereals and
pulses are estimated at EUR 2.5 billion, maize at EUR 1.6 billion seed potatoes
at EUR 900 Mio, vegetables at about EUR 1 billion, while oil and fiber plants,
sugar beet and grasses are respectively from EUR 200 to 300 Mio each.

The EU is the largest exporter with an
estimated export value of EUR 4.4 billion representing roughly 60% of the total
worldwide export value of EUR 7.7 billion. The EU became a net exporter of
planting seeds in 2002/2003, and its trade surplus has gradually increased
since then.

Statistics produced by
ISF (update
August 2010 – ISF will not accept any responsibility for the use of their
statistics by others)

|| Value of domestic seed market (in US mio $ at 1€ = 1.4 US $ || Export (includes EU destinations - in US mio $ at 1€ = 1.4 US $) || Import (includes EU origin - in US mio $ at 1€ = 1.4 US $)

Country || Agricultural + Vegetable crops || Agricultural seed || Vegetable seed || Agricultural seed || Vegetable seed

Belgium || 185 || 160 || 4 || 160 || 31

Bulgaria || 120 || 18 || 5 || 60 || 7

Czech Republic || 300 || 41 || 4 || 56 || 6

Denmark || 165 || 168 || 55 || 54 || 15

Germany || 1950 || 458 || 48 || 457 || 72

France || 2370 || 884 || 278 || 590 || 107

Estonia || n.a. || n.a. || n.a. || n.a. || n.a.

Greece || 240 || 11 || 2 || 63 || 24

Spain || 450 || 62 || 47 || 198 || 198

Ireland || 80 || 4 || 0 || 16 || 5

Italy || 715 || 123 || 94 || 186 || 162

Latvia || || 0 || 2 || 8 ||

Lithuania || || 6 || 1 || 17 || 3

Luxemburg || || 4 || 0 || ||

Hungary || 300 || 221 || 14 || 84 || 17

Cyprus || n.a. || n.a. || n.a. || n.a. || n.a.

Malta || n.a. || n.a. || n.a. || n.a. || n.a.

Netherlands || 317 || 241 || 1058 || 282 || 310

Austria || 150 || 115 || 3 || 91 || 14

Poland || 260 || 39 || 4 || 78 || 44

Portugal || 80 || 4 || 6 || 56 || 20

Romania || 220 || 86 || 0 || 124 || 14

Slovak Republic || 110 || 38 || 0 || 50 || 3

Slovenia || 40 || 5 || 3 || 15 || 5

Finland || 160 || || || 12 || 7

Sweden || 240 || 31 || 4 || 44 || 9

UK || 400 || 40 || 21 || 126 || 73

n.a.: information not
available

NB: The commercial world
seed market for 2009-10 is assessed at approx. 42 billion US $

Seed production in EU 27
Member State for the most important agricultural crops

Wheat seed is produced on 420 000 ha.
France is the biggest producer (82 000 ha) followed by Germany, the Czech
Republic, Hungary and the UK. Italy has the first place with durum wheat seed
production. Romania and Spain are also big cereal seed producers. Barley accounts
for 300 000 ha, where Germany (38 000 ha), France (36 000 ha), Denmark (33 000
ha) and the Czech Republic (30 000 ha) are the biggest producers.

France and Germany are the two main
producers of oilseed rape in the EU. In the last years production of rapeseed
for sowing was increased due to the demand for rapeseed as a supply stock for
biodiesel. Due to the very high multiplication factor, the number of hectares
of seed production remains fairly limited.

Maize seeds are grown on 140 000 ha. The
largest maize seed producers are France, Hungary and Romania.

Sugar beet seed is grown on 126 815 ha.
France and Italy are the largest producers in the Union.

Grass seed production in the EU occupies
207 000 ha. Denmark is the largest producer of grass seeds with about 72 000
ha, followed by Germany (29 350 ha), France (20 500 ha), and the Czech Republic
(16 700 ha) and the Netherlands (15 900 ha). All other Member States together
produce grass seeds on 52 550 ha.

Vegetable seeds are mainly multiplied outside the EU in a wide range of countries
in which labour costs are lower than in the EU. The produced seeds are shipped
to the EU, mainly to the Netherlands, for treating, sampling and packaging and
re-exported to their final destination in the EU or outside the EU. Vegetable
production in the EU has a value of EUR 27 bn, where five Member States (IT,
ES, RO, FR and PL) together represent more than 50% of the production. The
vegetable seed production has a value of about EUR 1 billion. Main producers
are FR, IT, NL, HU DK and PL. The five biggest companies have 95% of the seed
market.

Seed potato production occupies around
90.000 ha in Europe; four main countries are the largest producers: The
Netherlands (34.000ha), Germany and the United Kingdom (around 16.000 ha each),
France (14.000ha).

The
major players in the seed market

For several decades after plant breeding
emerged as a recognized field of science in the late 19th century,
almost all plant breeding activities took place in public institutes. Breeding
activities gradually shifted to the private sector during the 20th
century. This may explain why plant breeders (public first and then public
& private) have been involved to a large extent in the development of
national regulatory frameworks.

The seed industry matured due to the
introduction of hybrids, especially hybrid maize in North America, hybrid sugar
beet in Europe, and hybrid vegetables in South East Asia and intellectual
protection (plant breeder’s right). In North America and Europe, the hybrid
seed industry grew from regionally based family businesses. The profitability
of hybrids far outstripped that of non-hybrid open pollinated seeds. This has led
to eventual consolidation in the industry and the dominance of several key
companies in particular crops. In the 1970s, high margins attracted the
attention of several agrochemical companies, waiting to exploit possible
synergies of the seed business with their own line of business (e.g. the
acquisition of Northrup King (USA) by Sandoz (Switzerland).

The emergence of biotechnology in
agriculture in the 1980s has led to a complete reorganization of the sector.
Today, leading seed groups are largely owned or allied with the world leading
chemical/plant protection companies. Consolidation through mergers and
acquisitions took place in major field crops, and is currently on-going in the
vegetable sector. Chemicals companies’ interests in investing in biotech are
linked to the fact that many pesticides used in agriculture may be replaced by
transgenic crops that have a biologically inbuilt resistance.

In the top ten of the biggest seed
companies at global level, five are Europe-based companies, four of which are
from EU Member States.

The structure of the EU seed companies

The number of seed companies in the EU is
estimated at 6,797[52]
and includes breeding companies, seed producers and seed traders. About 6,580
out of 6,797 companies are based in ten Member States.

In Poland and Romania, there are a large
number of companies (around 2,000) and in Hungary around 800. The next position
occupies the United Kingdom with 600, followed by a group of 5 countries
(Italy, France, Slovakia, Germany, Netherlands) with a number between 120 and
350 companies. In the other member States, the number is lower than 60
companies.

This highlights that the three Member
States with the highest number of seed companies are Eastern countries;
respectively Poland, Romania and Hungary. However, the size of seed companies
in these countries is small with most of them (> 90%) being SMEs.

The total
employment is estimated at about 50,000 employees with about 80% of the number
of employees in the top ten Member States demonstrating that PRM sector is
concentrated in a limited number of Member States. The main countries with
regards to employment in the private seed sector are first France followed by
Romania, Netherlands, Poland, Germany and Italy.

The combination of number of companies and
seed employees shows that consolidation in France and the Netherlands is
important. The number of companies is quite small but the number of employees is
rather high.

The percentage of micro and small
enterprises per Member States is not known and is difficult to calculate as
many collaborations and agreements exist between companies across Member States.
Data regarding ESA membership (European Seed Association) show that around 15
individual members are medium or large companies and the others are small
companies. A majority of small or micro enterprises are participating in the
work of ESA through their membership in national associations (e.g. the French
seed association has 130 members, the Dutch seed association 300). It can be
concluded that, overall, the number of SMEs is quite high, especially in the
EU12 new Member States. As consolidation is still on-going in these Member
States, it can be estimated that the percentage of SMEs in the PRM sector in
these Member States and then at the EU level will decrease in the future.
Additionally, these figures do not distinguish between plant breeding
activities and seed multiplication activities.

Another point of consideration is the
correlation between the public breeding efforts and the number of SME. Indeed
when national plant breeding efforts on a given crop are dominated by public
activities (e.g. fruit plants and vine in the EU, all crops in Poland, marginal
crops in several EU12 new Member States, etc. ) varieties bred by these public
institutes are marketed by SMEs in charge of seed production and sales. Some
interviewees indicated that when plant breeding is privatised the number of
seed companies is decreasing.

The structure of the R&D efforts (plant
breeding) is presenting a quite different pattern as most of the plant breeding
activities are located in the EU15 old Member States, mainly in France, Germany
and Netherlands (more than 100 breeding stations, more than 2000 employees in
R&D in each country), followed by Italy and Spain (more than 50 stations
and around 700-800 employees each). In the new member States, the number of
private breeding stations is quite important in Hungary, Romania (around 50) and
in Poland (more than 25) but with different figures with regards to R&D
employees: around 200 in Hungary, 600 in Poland and more than 1000 in Romania
where the labour cost is cheaper. In the other Member states the number of
breeding stations is lower than 20 with less than 300 employees in R&D.

The importance of individual Member State's
effort in plant breeding by private actors can be estimated by calculating the
ratio between the number of R&D employees/number of total seed employees.
This shows that German companies are conducting half of their activities for
research and half for seed production while French companies, even if they are
very active in breeding (comparable date to Germany), are more involved in seed
production.

In the last 40 years, the commercial seed
industry has transformed dramatically. It has shifted from a competitive sector
of agribusiness, composed primarily of small, family-owned firms, to an
industry by transnational corporations, powerful family-owned firms,
cooperatively owned companies. This transformation is now nearly complete for
key commodity crop seeds but is still on-going in EU12 new Member States and in
the EU-wide vegetable sector. These corporations entered the industry by
acquiring numerous smaller seed companies and by merging with large
competitors. The hybrid seed corn industry, which emerged in the 1930s in the
US with the advent of high-yielding hybrid varieties, was the first to consolidate
in the EU in early 1990s. This process accelerated in the US due to enforcement
of Intellectual Protection systems, which attracted chemical and oil companies
to add to their portfolio of agricultural inputs. The decade of the 1990s saw
numerous mergers between pharmaceutical and chemical companies, in order to
take advantage of potential synergies. These new conglomerations were described
as life science companies due to their focus on biotechnologies. By 2009, six
companies with chemical and/or pharmaceutical company roots remained dominant
in the seed industry. In parallel to this evolution, changes of ownership in
original farmer-owned supply cooperatives have led to the appearance of
cooperatively owned global seed companies (e.g. Limagrain, Svalöf Weibull, etc.).
Both the fruit and the wine sectors are energized by public R&D efforts.

The hundreds of transactions and business
collaborations that have reshaped the industry in recent years challenge the simplistic
notion of a division of the sector between SMEs and multinationals. It is almost
impossible to map the structure of the industry as the number of collaboration agreements
between companies is extremely important and quite often small seed companies
may have access to varieties coming from medium size companies for seed
production and marketing on a given market.

Most of the interviewees and respondents to
the qualitative survey consider that consolidation will continue at a rapid
pace.

In the last 40
years, the commercial seed industry has transformed dramatically. It has
shifted from a competitive sector of agribusiness, composed primarily of small,
family-owned firms, to an industry dominated by a small number of transnational
corporations. This transformation is now nearly complete for key commodity crop
seeds but is still ongoing in EU12 Member States and in the EU-wide vegetable
sector. These corporations entered the industry by acquiring numerous smaller
seed companies and by merging with large competitors. The hybrid seed corn
industry, which emerged in the 1930s in the US with the advent of high-yielding
hybrid varieties, was the first to consolidate in the EU in early 1990’s. This
process accelerated in the US due to enforcement of Intellectual Protection
systems, which attracted the entrance of chemical and oil companies to add to
their portfolio of agricultural inputs. The decade of the 1990s saw numerous
mergers between pharmaceutical and chemical companies, in order to take
advantages of potential synergies. These new conglomerations were described as
life science companies due to their focus on biotechnologies. By 2009, six
companies with chemical and/or pharmaceutical company roots remained dominant
in the seed industry. In parallel to this evolution, changes of ownership in
original farmer-owned supply cooperatives have led to the appearance of
cooperatively owned global seed companies (e.g. Limagrain, Svalof Weibull, etc.).
Both the fruit and the wine sectors are energized by public R&D efforts.

The hundreds of
transactions and business collaborations that have reshaped the industry in
recent years challenge the simplistic notion of a division of the sector
between SMEs and multinationals. It is almost impossible to map the structure
of the industry as the number of collaboration agreements between companies is
extremely important and quite often small seed companies may have access to
varieties coming from medium size companies for seed production and marketing
on a given market.

Most of the
interviewees and respondents to the qualitative survey consider that
consolidation will continue at a rapid pace.

Plant propagating material sectors (vine, ornamentals, fruit plants,
and forest)

Data and
statistics regarding the vine, fruit plants and the forestry sectors are hardly
available as no consolidated sources of relevant data have been identified for
the EU market. In most Member States, activities related to certification of
plant propagating material of these three sectors is organised at regional
level or by different organisations so that the statistics are not consolidated
at national level. One example illustrating the difficulty to collect
information in these sectors is that it took the Commission more than one year
to get reliable data on the fruit plants sector during the preparatory work on
the revision of Directive 92/34/EC.

However, some
basic data have been collected during this study:

·
Regarding the tree seed market, the French
forestry experts interviewed during the study indicated that for example, the
seed forestry market value is, on average, not higher than EURO 2 Mio per year
in France. The International Seed Federation provided some data on
import/export of tree and shrub planting seed that show that seed trade is very
low in this sector.

·
For the fruit plants market, DG SANCO
consolidated some key figures in 2007-08 and concluded that more than 12000
enterprises are involved in production of fruit plants in the EU; and about 90%
of them are small to medium enterprises frequently based in rural areas where
alternative business is not possible. The estimated value of this business was
estimated at about EURO 2.5 billion.

The difficulty
in collecting market figures for these plant propagating material sectors is
also certainly linked to the fact that certification is not mandatory for all
species and that breeding of the majority of these species is done by public
institutes.

Summary

As demonstrated by the information above, the
European PRM sector is characterized by a large segmentation (from
national SMEs involved in cereals or ornamentals only to international
companies with a multi-crops approach).

PRM is not one sector but several
sectors in constant evolution, which are becoming
more and more specific in terms of type of products, type and number of actors,
competitiveness, product life cycle, R&D efforts, added value and return on
investment.

The leading Europe-based seed companies are
Syngenta and Limagrain and they are, like the major American companies
mentioned above, operating worldwide.

We can observe two major groups of
breeders:

·
SMEs that breed for their local/national markets
and develop partnerships with foreign seed partners for the purpose of
testing/positioning and, when relevant, for the marketing of their existing
cultivars in other countries characterized by specific growing conditions
(breed locally - test globally);

·
Larger companies whose breeding strategies aim
at a European and/or a global scale (e.g. maize) and consist of breeding for a
given Area Of Adaptation (AOA), which could be defined as an area where
agro-climatic and plant growing conditions are uniform (breed globally – test
locally).

              Annex
IX: Selected data regarding the current EU common catalogues for vegetable and
field species

Figure 1: Number of registered agricultural
varieties per Member State

Figure 1 shows that the three main
countries with regard to registration of agricultural varieties, i.e. Italy,
France and Germany, each 3000 or more varieties on their national catalogue.
Then 7 Member States (new or old ones) follow which have on their national list
between 1000-1500 varieties, followed by another 4 with numbers of varieties
ranging from 500-1000. The common catalogue lists also varieties from Iceland,
Norway and Switzerland.

These data can be compared to the utilised agricultural area
(UAA)[53].
In France, the UAA covers 27.1 million ha (16% of the total UAA of the EU27),
followed by Spain with 23.8 million ha (14.0%), Germany 16.7 million ha (10%),
the United Kingdom 15.9 million ha (10%), Poland 14.4 million ha (8.5%), Romania
13.3 million ha (7.8%) and Italy 12.9 million ha (7.6%). These seven Member
States accounted for almost three quarters of the utilised agricultural area in
the EU27 in 2010 (see the figure below).

Figure 2: Utilised agricultural
area in the EU Member States

Figures 1 and 2 show that more breeding companies are
registering their varieties in Italy even though Italy is not the biggest
agricultural country in terms of UAA. This could be partially explained by the
diversity of agro-ecological situations and smaller costs for registration.

The situation in Romania can be understood by its relatively
recent status as EU Member State. The big difference between the importance of
variety registration in the Netherlands and other smaller Member States could
be linked to important knowledge of this country with regards to technical
examination (plant variety protection) and the number of seed companies based
there (NL is the leading EU seed exporting country). Regarding the number of varieties
listed in Slovakia, it could be link to a smaller cost for registration.

Figure 3: Number of agricultural
varieties added per Member State in 2011

Regarding the most recent variety
additions, Germany has registered fewer varieties than other large Member
States such as Italy and France, while Slovakia and United Kingdom have been
quite active compared to Germany.

Figure 4:
Number of registered vegetable varieties per Member State

Figure 5: Number of vegetable varieties
added per Member State in 2011

These two figures show the predominance of
the Netherlands with regard to registration of vegetable varieties (8500);
followed by France, Spain and Italy which have on their national catalogues
between 1600 and 2600 varieties. 8 countries have less than 60 vegetable
varieties on their list and 6 have no varieties.

Figure 6:
Number of maintainers for agricultural varieties in national lists

This figure shows that the number of
maintainers of agricultural varieties by Member States mirrors the general
situation with regard to variety registration. In countries where there is a
significant number of varieties registered, they is also a high number of
maintainers.

The following figures give indications on
some national situations in order to see the origin of the varieties by
studying the responsible maintainers.

For
agricultural crops:

Figure 7: Number and provenance of maintainers in the Slovakian
national list

In Slovakia,
170 maintainers are listed. 80% of maintainers are coming from other countries,
mainly from 3 EU Member States (48%): Italy, France and the Czech Republic.
National maintainers represent 10%, which means that foreign operators are very
interested in registering their varieties in Slovakia.

Figure 8: Number and provenance of maintainers in the Romanian
national list

In Romania, 81 maintainers are listed.
Local maintainers represent 35%. Maintainers coming from France and Germany
represent around 30%. This figure indicates that a lot of local operators are
active on this market.

Figure 9: Number and provenance of maintainers in the Polish
national list

In Poland,
115 maintainers are listed. 25% of the maintainers are from Germany. Local and
French maintainers represent 16.5% respectively.

Figure 10: Number and provenance of maintainers in the UK national
list

In United
Kingdom, more maintainers are registered (232); 37% are from UK and 31% from
France and Germany.

Figure 11: Number and provenance of maintainers in the Italian national
list

In Italy, an
important number of maintainers are registered (387); 33% are based in Italy. 19%
are from US, 17% from France and 7% from Germany.

For vegetable crops:

Figure 12: Number and provenance of maintainers in the Dutch
national list

In The Netherlands, with regards to
vegetable variety maintainers, 43% are located in the Netherlands, 21% are
coming from non EU countries (12% from US, 6% from Japan and also Israel and
Taiwan). This reflects the situation where a lot of vegetable seed companies
are located in the Netherlands or have a subsidiary there.

              Annex
X: Inspection costs for forest reproductive material

(Source : EFNA - European Forest Nurseries
Association – summary of questionnaire results from AU, BE, CZ, DE, FR, HU, ES,
NL, SE, UK participants)

\* Registration of new Selected Seed
Stands or Qualified Seed Orchards:

generally done by State authorities (except in DK)

FR, ES || No cost

AU || Cost: small fee

BE || For new Selected Seed Stands or Orchards, no cost for registration but an inspection is needed by the INBO (Institute of Nature and Forestry Research).

CZ || Costs for seed stand and qualified orchards: EUR 20/hour and travel costs. Registering of identified source is for free.

DE || Variable from Land to Land, e.g. EUR 150-200 in Lower Saxony.

HU || EUR 120/stand plus a sliding fee scale from EUR 10-100 depending on stand size

UK || £70 to inspect, no cost of registration

SE || EUR 1000/hour for registration

\* Inspections during collection

|| Number of inspections

DK, IE || 1-2

AU, UK || 1 – 3

CZ || Minimun two

FR || 1 inspection at the collection. 1 inspection for certification

BE, ES || 1 inspection every day of collection and per seed stand

DE || Some collections are controlled daily, some only as spot check. Before collection, the possibility of doing a collection should get checked.

NL || 1-5 depending upon species and crop

HU ||  Not specified but they take place

SE || Normally no inspection during collection

|| Cost for supervising seed collection

AU, CZ, ES, FR, IE, UK || No cost for nurseries

DE || Variable among Landers

HU || EUR 40 plus EUR 10 Euros for each specified quantity of seed collected / 1000 kg Quercus, 100 kg Robinia, 50 kg Fagus, 10 kg Salix, Populus, 1000 kg cones of any species.

NL || EUR 88/hour (accounted by half hours) for any inspection made EUR 96 plus travel if outside NL

SE || Included in the yearly fee

DK || EUR 300 Euro each number/origin

\* Master Certificate of
provenance/origin for a seed lot

AU, CZ, ES, FR, IE || No cost

BE || If the seeds are collected for own purpose and if they are sown out in own nursery (no trade), there is no additional cost. The only cost to be paid is EUR 10.5 € for every lot of FRM

DE || Variable among Landers: from EUR 15 to max EUR 300 per certificate

DK || EUR 500 in DK

HU || Sealing carried out by authorities at EUR 100 per batch

NL || basic cost : EUR 45/certificate + additional cost depending upon species and weight collected (Conifers EUR 15/kg, Oak/Sweet chestnut EUR 0.75/kg, Beech/other broadleaves collected green EUR 1.4/kg, Other broadleaves collected dry EUR 3.0/kg, Alder/Birch EUR 15/kg) If an FRM species is sown for non-forestry purposes a fee of EUR 45 is charged for the certificate “not for forestry use”

SE || inclusion in the annual fee

   \* Inspection of seed companies,
nurseries

|| Number of inspections

AU, CZ, DK, HU || Once a year

IE || One to two

BE || +/- 20 times a year

DE || Variable among Landers and upon the size of the enterprise: from several times a year until once every 5th year.

ES || Forest nurseries: minimum of 2 times/year

FR || Every 2 weeks

NL || 1-5 depending upon crop

SE || Not every year

UK || Some every year some less frequently

|| Cost for inspections

AU, CZ, DE, ES, FR[54], IE, UK || No cost

BE || Fixed cost of EUR 52.50 + EUR 105.00 for suppliers of FRM + EUR 10.5 for every lot of FRM (yearly cost)

DK || one for nursery and one for Seed company  + EUR 100-125/hour according to number of FRM plants

HU || Annual charge EUR 40 plus sliding scale 50-100 (thousands of seedlings or transplants) EUR 90 100-200 -> EUR 100                700-800 -> EUR 300  200-300 -> EUR 130                 800-900 -> EUR 330 300-400 -> EUR 170                 900-1000 -> EUR 370 400-500 -> EUR 200                 1000-1500 -> EUR 420 500-600 -> EUR 230                 1500-2000 -> EUR 470 600-700 -> EUR 270                 2000-2500 -> EUR 570                                                                                                above 2500 000  -> EUR 200/each million.        For conifers you pay only the 50% of the amounts above.

NL[55] || Every business selling FRM has to pay a minimum fee of EUR 200 which includes the first 0.5ha of the nursery or first EUR 5000 of turnover.  + sliding scale based which varies from EUR 1610/ha for nurseries 0.5-1 ha in size to a charge of EUR 1811.16 + EUR 490/ha for nurseries over 20 ha. Nurseries can choose to pay according to turn-over rather than area for three year periods; the rate is about 1.5% of gross turn-over. If a nursery has to be re-checked due to some irregularity, a levy of 96 Euros on top of the normal EUR 88 hourly rate is charged. Standard fee of EUR 17.5/ batch of FRM grown/inspected. + proposal for an additional inspection charge of EUR 0.20/1000 plants for nurseries with more than 10,000,000 plants to EUR 0.5/1000 plants up to one million plants

SE || Yearly fee: company who sells and/or produces more 10000 plants has to pay EUR 1428 (13000SEK); other EUR 493 (4500SEK) + EUR 659 (6000 SEK)/visit

|| Proportion for document and stock looking

AU, SE, CZ || Variable

BE, IE || 80% administration, 20% looking at stock

DE, UK || 90%  books;  10% field

DK, FR, ES || 50 % of each

\* quantity of seed sown, number of
plants produced and sold

|| Methods

AU || seed lot samples stored at the “Federal office of Forests” for comparison

BE || seed lot number estimated according to seed viability and field germination

CZ. || Forest research institute: table with theoretically plant numbers produced from 1 kg of seed for forestry species. All batches should have analysis and every year every FRM nursery has to send stocktaking and amount of sold stock to Forest management institute.

DE || Germination % test from the seeds and %  lost during production.

ES || number of plants in some samples during the growing season inspection

FR || Germination controlled once a year and surviving plants after transplanting; numbers of saleable plants are checked on beds before lifting.

SE || Correlation between the amount of seed sold per master certificate and of produced plants

UK || Audit trial

|| Audit for seeds or plants sold over more than one year

AU, BE, CZ, DE, DK, FR, ES, SE, IE || Yes

AU || Notice to the authority, punishment

BE || no possibility to sell more plants than estimated once the field inspection took place

CZ || Fine up to EUR 40 000

DK || Added control / inspection and punishment by losing  rights to sell FRM plants.

FR || Warning system: eventual destruction + legal action against the nurseryman

ES, SE, UK || ?

The
French Organisations for Forest Seeds and Nursery

GIE Improved Forest Seeds: harvesting 1 ton of certified seed of
seed orchards. It combines the
Vilmorin private Company and the ‘’Office National des Forêts’’.

French Forest Nursery (nursery
growers and poplar producers): 80%
of French production of seedlings
(60 million in 2008-2009).

8.           The
Forest Nursery Association of the Czech Republic: 76 members
managing 1.400 ha of forest nurseries, i.e. about 90% of total Czech forest
seedling production area.

              ANNEX
XI: Graphical presentation of the five scenarios

              Annex XII:
Variety registration and seed certification systems in major third countries

AUSTRALIA – Variety registration and seed certification

The Australian
Seeds Authority (ASA) is responsible for supervising the implementation of both
the OECD and the Australian Seed Certification Schemes in relation with
harmonised technical standards and quality control procedures for the
production, processing and labelling of certified seed. To meet this obligation
ASA has commissioned the National Association of Testing Authorities (NATA), as
an independent authority for the accreditation of inspection bodies, to
implement a national accreditation scheme for certification agencies. NATA
accreditation of Plant Laboratories requires compliance with the international
quality management systems standard ISO/IEC 17020.

To be eligible
for certification under the OECD or Australian Seed Certification Schemes a variety
must be listed with ASA. ASA is responsible for maintaining and publishing a national list of varieties which have
been accepted in Australia as eligible for certification in the OECD and
Australian Seed Certification Schemes.

Additional
information on the variety must accompany the application for listing. A
statement detailing the origin and breeding history of the variety, a
morphological description of the variety, a statement of authorisation from the
breeder (if the applicant is not the breeder) to apply for certification and to
multiply the variety in Australia, a brief statement of the expected agronomic
value of the variety in Australia, and a maintenance plan indicating the number
of generations and the number of harvests allowed for each generation, are
required.

DUS: Evidence must be provided on the
uniformity and stability of the variety having regard to the species concerned
and the breeding system used. It must be indicated the period over which the
generations of seed multiplication have been observed as being uniform and
stable. If off-types have been observed, their frequency must be stated and a
description of them supplied. A detailed morphological description of the
variety is required. Comparative information with other varieties of the same
species currently in use should be included.

VCU: There are no standards for agronomic value but applicants must
indicate the anticipated agronomic value of the variety in Australian
agriculture relative to other commonly grown varieties.

The applicant
must provide details of the maintenance plan adopted for the production of
Pre-Basic, Basic and Certified Seed. The Variety Maintainer is responsible for
ensuring that multiplication of Breeders and Pre-Basic Seed is carried out in a
satisfactory manner so that only authentic, uncontaminated seed of the variety
is released for further multiplication under the certification schemes.

ASA must have
access to all records of maintenance of varieties in the certification schemes.
The Maintenance Plan should also indicate whether or not a certification agency
will be overseeing and assisting with the production of Pre-Basic Seed; this
collaboration is encouraged as it can often result in the identification and
correction of any varietal purity issues prior to larger scale production of
Certified Seed.

ASA also
co-ordinates official Australian interaction with the International Seed
Testing Association (ISTA) on international seed testing policy and practice,
and has signed Authorisation Agreements with four ISTA-accredited laboratories
to test certified seed prior to its final release as certified seed.

CANADA – Variety registration and seed certification

The Canadian
Food Inspection Agency is responsible for the administration of the Seeds Act and Regulations
to help to ensure that seeds sold in, imported into and exported from Canada
meet established standards for quality and are labelled so that they are
properly represented in the marketplace, and are registered prior to sale in
Canada (most agricultural crop varieties). In
2009, amendments to the Seeds
Regulations were introduced in order to increase the flexibility of
the variety registration system. This is accomplished by dividing the list of
all crop kinds that require variety registration, into three parts with three
levels of registration requirements. For all parts, basic variety registration
information continues to be required, including information demonstrating
conformity with minimum health and safety standards, information confirming the
identity of new varieties, information supporting the verification of claims,
and information required for seed certification purposes.

Part I (status quo): The registration of new varieties
requires pre-registration testing and merit assessment to determine whether the
variety performs as well as or better than reference varieties (Merit
assessment VCU). This part is intended for crop kinds for which there is a
continuing need for government oversight to ensure that varieties meet
standards.

Part II: The
registration of new varieties requires pre-registration testing, but not merit
assessment. This part is intended for crop kinds where official oversight to
confirm the validity of pre-registration testing data is useful, but where
merit assessment is burdensome.

Part III: New
varieties are subject to only basic variety registration requirements.

Seed crop
certification is a program of planned production, record keeping, inspections,
and standards to ensure the production of high quality seed. Certified is
labelled with an official blue certified tag (or bulk pedigreed certificate)
and graded with a Canada pedigreed grade name when sold in Canada. The
pedigreeing of seed ensures varietal purity. This is especially important to
maintain yield, quality, disease resistance and the other distinguishing
characteristics of a variety. There are 3 categories: (i) Breeder Seed from
plant breeders of public research institutions and private companies, (ii) Foundation
Seed produced from Breeder seed and rogued for off-types to meet variety
descriptions and purity standards, (iii) Certified Seed produced from
Foundation seed by seed growers for sale to farmers to use in planting their
commercial grain acreage. Seed certification is performed for seed growers and
processors dedicated to taking the extra steps necessary in planting,
harvesting, handling, storage, and conditioning to produce Certified seed.

NEW ZEALAND - Variety registration and seed certification

The New Zealand Seed Certification
Scheme operates on a voluntary basis. The scheme aims at
providing the consumer with seed of high varietal purity but gives no guarantee
of this other than to certify that an acceptable procedure has been followed to
attain this goal. It gives no warranty as to the germination of the seed but
requires a minimum standard of physical purity.

There are four
main classes in certification:

Breeders Seed (Pre-Basic):
Produced from nucleus material grown by the plant breeder.
Basic Seed: Produced from
areas sown with Breeders seed. It is produced by selected growers under
the supervision of the breeder or his agent.
Certified Seed 1st Generation:
Produced from areas sown with Basic seed and is traded freely both in New
Zealand and overseas.
Certified Seed 2nd Generation: Produce from areas
sown with certified seed 1st Generation and applies to certain arable
crops only. (See under standards for varieties).

Any merchant,
exporter and seed cleaning operator involved in seed certification must have a
MAFB NZ approved organisation system detailing their operating procedures.

A grower must
be registered with the SCB to be eligible to grow certified seed. Applications
for certification of proprietary varieties cannot be accepted from growers who
do not hold a contract or agreement with the owner of the variety.

A seed variety
must be registered with the SCB for it to be eligible for certification.

The variety
registration conditions for the Acceptance of Agricultural Varieties (Arable and
Herbage) into the New Zealand Seed Certification Scheme) are the following:

DUS: Evidence
must be provided of the uniformity and stability of the variety having regard
to the species concerned and the breeding systems used. An acceptable way of
providing this evidence would be to indicate the period over which the
generations of seed multiplication have been observed as being uniform and
stable. If off-types have been observed, state their frequency and supply a
description of them. A morphological description of the variety is required.
Comparative information with other varieties of the same species currently in
use should be included.

VCU: There are
no standards for agronomic value but applicants are required to indicate the
anticipated use or place in New Zealand agriculture.

In addition, NZ puts strong regulation
for the importation of seeds:

Biosecurity Act 1993
Hazardous Substances and New
Organisms Act 1996 (HSNO Act 1996)
MAF Biosecurity Standard PBC-NZ-TRA-PQCON:
Specification for the Registration ofa Plant Quarantine or Containment
Facility, and Operator.

UNITED STATES OF AMERICA - Variety registration and seed certification

Seed certification in the United States is
the responsibility of each individual state; within each, there is an agency
designated to certify seed.

Certification programs
in the United States are generally non-profit programs,
but must generate funds to cover salaries, overhead, and operating expenses.

A four generation
scheme has been devised to do this:

1. Breeder seed is produced under the
direct supervision or authorization by the plant breeder and represents the
true pedigree of the variety.

2. Foundation
seed is
the first generation seed from breeder seed and is produced under contract by a
foundation seed organization as authorized by the plant breeder. Foundation
seed is also labelled with white certification tags.

3. Registered
seed is
the seed from foundation seed and is intended for the purpose of increasing
seed another generation before the production of certified seed. Registered seed
is not intended to be a commercial class of seed. In two states (Michigan and
Wisconsin), all certified seed is the progeny of foundation seed, and no
registered class is used.

4. Certified seed
is
produced from foundation or registered seed and represents the final product of
the certification program.

Varietal Release

To be eligible for certification, a variety must be properly
released, named, and described. Regardless of the releasing agency, a procedure
must be available for evaluating potential varieties and recommending their
release. When plant breeders have a candidate for release, they submit to the
appropriate review board a description of their variety, its identifying
characteristics, and performance data.

To help clarify this situation, an ad hoc committee representing the
USDA, the Association of Official Seed Certifying Agencies, the American
Society of Agronomy, and the American Seed Trade Association[56], has developed a comprehensive
consensus definition of different kinds of varieties.

Individual certification agencies are aided in determining the
eligibility of varieties for certification by national variety review boards
which have been established by AOSCA. Four review boards have been established
representing alfalfa, grasses, soybeans, and small grains.

However, in actual practice, many individual agencies still require
varieties to meet adaptability and performance standards established for their
particular state.

              Annex
XIIi: Detailed presentation of the Measures included in the preferred option

General
principles

·
Cost recovery for services carried out by
competent authorities. Exemptions are possible depending on the degree of
public interest in the respective variety’s marketing. The latter exemption
will mainly affect conservation varieties.

·
Operators can carry out,
under official supervision by the competent authority, as many activities as
possible for themselves. Official examination or inspection services shall
always be available in case that operators do not possess the resources to
carry out these tasks.

·
All operators have to
be registered.

·
Specific and strict
obligations concerning registration and certification shall apply to a closed
list of species. General minimum requirements shall apply to all other PRM on
the market and shall cover labelling obligations and a provision of fitness for
use.

·
Inspections for plant
health and certification shall be combined.

·
Forest reproductive
material: Following the Impact Assessment and the stakeholder consultation the
basic approach on FRM identification and certification will not be changed and
official controls will be maintained. A separate chapter in the proposed Regulation
is dedicated to FRM.

Specific provisions

Variety registration: DUS technical
examination

·
CPVO holds a database
with the description of all these varieties.

·
CPVO audits the
national examination offices for a full harmonisation of DUS examination.

·
The possibility is
offered to the private sector to carry out DUS and VCU technical examination.

·
Support the extension
of bilateral agreements in order to facilitate the flow of DUS reports in the
EU.

·
Have a same and unique
DUS testing for registration of varieties with a view to market and for
Community Plant Variety Rights protection (‘one key- several doors’ approach).

·
The registration of officially
tested varieties in national and common registers  shall be an option that is
given to conservation and amateur varieties for reasons of public good. The
listing of this latter group shall be based on an officially recognised
description by the breeder.

·
Quantitative
restrictions for the marketing of conservation varieties shall be abolished.

·
National catalogues
shall continue to exist. Inclusion in the National catalogue will be the only
precondition for the marketing throughout the EU for all crops.

·
CPVO shall take over
practical arrangements for the publication of the EU common catalogues as a
database.

·
CPVO verifies denominations
for all applications.

·
As an alternative to
national registration, centralised variety registration by CPVO shall be
offered for species that do require to undergo VCU-evaluation.

Variety registration: VCU evaluation

·
VCU shall be maintained
and shall be decided on a species-by species basis. VCU criteria shall focus
more on public goods and become a “VCU for sustainability and health”.

·
VCU shall be continuously
improved as much as possible to take care of any evolution of public and
private needs. Harmonisation of VCU protocols is most likely to be practical
and useful across agro-ecological regions. Coordination between Member States
of official observations and national decisions for VCU, possibly under
bilateral agreements, should be encouraged.

·
VCU should be a set of species-specific
endorsed information made as widely available as possible to users of PRM.

·
At the EU level, a high
level group including all relevant stakeholers shall be established for
providing policy guidance on variety registration.

Certification/inspection of lots

·
Mandatory certification
of lots of certain crops shall be maintained. The list of species that have to
be covered by this obligation shall be determined on a crop-by crop basis to
allow for future changes in, for example, health risks or economical
importance.

·
The examination under
official supervision shall be widened to all species and all categories (i.e.
basic and pre-basic crops).

·
“Reference
Certification Centres” shall be established to develop, harmonise and
disseminate best practices in PRM certification.

              ANNEX
XIV: Cost structure of registration and certification for
SEED

Variety registration

The
major costs centres identified are:

·
Pre-registration
costs: costs related to
the production of preliminary data on the main characteristics of the variety and
administrative costs for applications preparation and submission.

·
Registration costs: DUS and VCU management costs, for each the following sub-costs centres:

·
Technical and administrative management of
demands

·
Planning of experimentation

·
Reception and disposal of materials

·
Conducting of experimentation

·
Networks management and co-ordination

·
Trials approval including field visits

·
Validation and treatment of data

·
Maintenance of reference collections

· Costs related to the administrative management of approved
varieties, i.e. denomination and publications

Post-registration costs:

·
Costs for the examination of the maintenance of
varieties.

Certification: The
Seed Directives allow the sampling and testing of all categories of seed and
the field inspection of certified seed to be carried out either officially
(certification under official examination) or under official supervision
(certification under official supervision). The structure of costs varies
accordingly and the major costs centres identified are:

·
Certification costs
under official supervision

·
Registration of operators, testing laboratories
and staff belonging to the operators or companies by certification authority

·
Field inspection by trained and competent staff

·
Seed lot sampling and seed sample testing by trained
and competent staff

·
Labelling of packages, containers by trained and
competent staff

·
Certification costs
under official examination

·
Registration of operators, testing laboratories
by certification authority

·
Official inspection of production

·
Official lot sampling and sample testing

·
Official labelling packages, containers

·
Post-labelling test

·
Official post-control examination of varietal
identity and purity

·
Official recording of control by certification
authority

·
Official control of marketing

·
Other

·
Granting of equivalence for importation of PRM
from third countries

·
Comparative trials

The
total costs for the 8 Member States are estimated at around EUR 82.5 million
per year. As these 8 Member States represent about 70% of the EU market value,
by extrapolation to all Member States, the total registration and certification
costs for competent authorities for the group ‘Seed’ can reasonably be
estimated to around EUR 120 million[57]
per year (in reality vary +/- 10%).

Table 1 - Total annual registration and
certification costs – All seed crops

FP: Fodder Plant, C: Cereal, B: Beet, VG: Vegetable
Seed, P: Potatoes, OF: Oil and Fibre plant.

A GBP/EUR conversion rate of 1,4187 (April 2007-March
2008) has been used for the costs estimated by UK

Based
on the figures for the overall costs of implementation of the Community
legislation and on the statistics addressing the domestic seed market value, a
ratio Costs/Market Value has been calculated concluding that implementation of
the Community legislation costs for competent authorities represents 2.8% of
the domestic market value (on average on the major seed markets in the EU,
variability from e.g. IT just over 1% to e.g. AT nearly 7%)

The registration
and certification costs respectively represent 43% and 57% of total
annual costs incurred by the national authorities of the 8 Member States
considered for the analysis (caveat see above).

Graph 1 - Distribution between registration
costs and certification costs for national authorities

Registration

Seed registration costs represent around 1.3% of the sum of the values of the domestic commercial market for seed of
19 selected EU Member States (FR, DE, IT, UK, PL, ES, NL, HU, DK, SE, AT, CZ,
GR, BE, SK, FI, IE, PT, SI). Some Member States have transferred totally or
partially the registration costs to the industry.

Table 2 – Current distribution of seed
registration costs between public and private bodies in the Member States

MS || Transfer of registration costs || Additional information

AT || - || Not available

BE || Yes || Partial transfer of costs  (around 50% of DUS and VCU costs)

BG || No transfer of DUS costs, partial transfer of VCU costs

CY || Yes || Partial transfer of costs  (around 50% of DUS and VCU costs)

CZ || Yes || Partial transfer of costs  (between 70% and 80% of DUS and VCU costs)

DE || Yes || Partial transfer of costs (around 50% of DUS and VCU costs)

DK || Yes || Full transfer of DUS and VCU costs (100%)

EE || Yes || Full transfer of DUS and VCU costs (100%)

ES || Yes || Partial transfer of costs

FI || Yes || Full transfer of DUS and VCU costs (100%)

FR || Yes || Partial transfer of costs (around 2/3 of DUS and VCU costs are transferred to the industry)

GR || Yes || Partial transfer of costs

HU || No ||

IE || No ||

IT || Yes || Full transfer of DUS and VCU costs (100%)

LT || No ||

LU || Yes || Partial transfer of costs

LV || No ||

MT || No ||

NL || Yes || Full transfer of DUS and VCU costs (100%)

PL || Yes || Partial transfer of costs (around 25 to 30% of DUS and VCU costs)

PT || Yes || Partial transfer of costs

RO || No ||

SE || Yes || Full transfer of DUS and VCU costs (100%)

SI || Almost no DUS testing performed in Slovenia, around 70% of VCU costs are transferred

SK || Yes || Partial transfer of costs (around 70% of VCU costs)

UK || Yes || Full transfer of DUS and VCU costs (100%)

Source: compiled on the basis of the data provided in
the qualitative and the cost questionnaire

Total variety registration costs

The
total costs incurred by the national authorities vary in each Member State and
can be grouped into 3 groups as regards the category ‘all seed crops’, by
taking into consideration the annual number of DUS and VCU applications
received as well as the estimated value of the domestic market share of each Member
State:

Table 3 – Grouping of Member
States by based on the total variety registration costs, the annual number of
DUS and VCU applications received and the estimated value of the domestic
market size

MS || Crops || Annual number of DUS applications received || Annual number of VCU applications received || Estimated value of the domestic market size (EUR million) || Total variety registration costs (K. EUR)

FR || All seed crops || 1150 || 900 || 1396.1 || 10.594

DE || All seed crops || 800 || 700 || 974.0 || 14.547

AT || All seed crops || 546 || 675 || 97.4 || 4.700

IT || All seed crops || 1790 || 1240 || 649.4 || 1.398

DK || All seed crops || 300 || 317 || 162.3 || 1.553

UK || All seed crops || 468 || 420 || 259.7 || 1.681

SE || All seed crops || 115 || 111 || 155.8 || 352

BE || All seed crops || 50 || 156 || 123.4 || 810

Cost per applicant

The
following table presents the annual number of DUS and VCU applications received
by the national authorities having responded to the costs questionnaire and the
registration costs per application.

Table 4 –Annual number of
DUS and VCU applications received by the national authorities

                                                                         
Total DUS
7895           Total VCU 6521

FP: Fodder Plant, C: Cereal, B: Beet, VG: Vegetable Seed, P: Potatoes,
OF: Oil and Fibre plant.

The registration
costs per application for national authorities are (DUS and the VCU costs, without pre-and post-registration
costs):

Graph 2- Registration costs per application
for national authorities

FP: Fodder Plant, C: Cereal, B: Beet, VG: Vegetable
Seed, P: Potatoes, OF: Oil and Fibre plant.

The
annual variety registration costs estimated by associations of suppliers.
These costs can concern one or several crops. These costs are not
representative of the total costs for the private operators in the Member
States concerned, as they are rough estimations not based on detailed
accounting system.

Table 5 - Total annual variety registration
costs per Member State and crop for private operators

FP: Fodder Plant, C: Cereal, B: Beet, VG: Vegetable Seed, P: Potatoes,
OF: Oil and Fibre plant.

Certification

Seed
certification costs represent between 1 and 2% of the total production costs.
Seeds produced in the EU have a high quality, so that the original ‘quality’
objective of certification can be considered as largely achieved. Currently, in
most of the Member States, the focus tends to be on reducing the certification
costs while maintaining the same level of quality for seed.

Certification
costs for competent authorities represents 57% of the total costs linked
to the implementation of the Community legislation and represents about 1.7% of
the sum of the sizes of the internal commercial market for seed of the 8
selected EU Member States (FR, DE, IT, UK, DK, SE, BE, and AT).

Table 6 – Current distribution of seed
certification costs between public and private bodies in the Member States

MS || Certification costs are transferred to industry || Additional information

AT || Yes || Partial transfer of costs

BE || Yes || 30% of costs are transferred to the industry

BG || Yes || Partial transfer of costs

CY || Yes || Partial transfer of costs

CZ || Yes || Partial transfer of costs

DE || Yes || Between 30% and 70% depending on the Federal Land concerned

DK || Yes || Full transfer of costs (100%)

EE || Yes || Partial transfer of costs

ES || Yes || Partial transfer of costs

FI || Yes || Full transfer of costs (100%)

FR || Yes || 97% for seed, 65% for vine

GR || Yes || The fee = (reference price) x (certified quantity) x 3%. The rate of the reference price is fluctuating between the farmer’s price and the final selling price of the seed.

HU || Yes || Full transfer of costs (100%)

IE || Yes || Partial transfer of costs

IT || Yes || Full transfer of costs (100%)

LT || Yes || 8% is financed by private sector

LU || Certification is mostly financed by national authorities

LV || Yes || Partial transfer of costs

MT || No ||

NL || Yes || Full transfer of costs (100%)

PL || Yes || Full transfer of costs (100%)

PT || Yes || Full transfer of costs (100%)

RO || Yes ||

SE || Yes || Full transfer of costs (100%)

SI || Yes ||

SK || Yes ||

UK || Yes || 70-80 of costs transferred to the industry and target of 100%

Source: compiled on the base of the answers provided to the cost
questionnaire and by official authorities to the preliminary questionnaire.

The
annual certification costs incurred by the national authorities can
concern one or several crops.

Table 7: Total annual certification costs
per Member State and crop for national authorities

FP: Fodder Plant, C: Cereal, B: Beet, VG: Vegetable
Seed, P: Potatoes, OF: Oil and Fibre plant.

Four
main cost centres have been considered per certification structure:

·
Registration of companies and seed-testing
laboratories;

·
Official field inspection;

·
Official seed lot sampling and testing;

·
Official labelling of lots.

The
following table presents the annual certification costs estimated by the
responding associations of suppliers in the Member States. These costs can
concern one or several crops. Each line of the table corresponds to the data
provided by one association of suppliers in a Member State. These costs are not
representative of the total costs for the private operators in the Member State
concerned, as they are rough estimations not based on detailed accounting
system.

Table 8 - Total annual certification costs
per Member State and crop for private operators

      FP: Fodder Plant, C: Cereal, B: Beet, VG:
Vegetable Seed, P: Potatoes, OF: Oil and Fibre plant.

Total
certification costs incurred by the private operators vary in each Member State
(e.g.: in Poland: EUR 3.473 K and Italy: EUR 6.200 K).

Under
certification under official examination, the two main costly activities for
national authorities are seed lot sampling & analysis and field
inspections. In most of the Member States, seed lot sampling and analysis
represents more than 50% of the total certification costs. Field inspection
costs represent in between 20-30% on average. It should be highlighted that
these ratios are quite similar for certification under official examination and
certification under official supervision.

[1] Depending on the plant species, the term variety or material is
used in the basic Directives. For the ease of reading, in this document the
term variety is used for both cases.

[2] Certification refers to intervention of official services which
includes (1) visual inspections on growing field and (2) sampling and analysis
of PRM lots before marketing, while inspection could be work done by official
services or by the supplier in a number of cases. For the ease of reading, in
this document the term certification is used to cover both cases.

[3] The Marketing Directive for vegetable seeds includes the reference
to the Common catalogue of varieties of vegetables species.

[4] The marketing Directive on vine propagating material includes
reference to national vine varieties officially accepted.

[5] The Marketing Directive for forest reproductive material includes
the reference to national registers of basic material of the various species on
national territory and national list.

[6] CPVO is self-sustained from a financial point of view because of
fees levied for its activities on commercial operators, with an annual budget
of EURO 12.8 Mio and a total number of staff of 46 in 2011.

[7] As economic operators on the PRM sector we include breeders, seed
multipliers, seed cleaners (seed companies or mobile processors), seed
packaging and traders.

[8] The EU common catalogues for agricultural plant species and
vegetable species are available online at http://ec.europa.eu/food/plant/propagation/catalogues/database/public/index.cfm.
The European catalogues offer added value compared to the national catalogues.
For example, the website of GNIS (Groupement National Interprofessionnel des
Semences et Plants) provided information on both national registration and
European registered varieties. In 2010 the European listed varieties received
more hits (approx. 200 000 hits in total) than the varieties registered on the
national French catalogue (information received from GNIS).

[9] VCU evaluation encompasses the assessment of yield, quality,
disease resistance and behaviour with respect to physical factors in the
environment. The characters evaluated in each of these four categories are
species-specific and defined in national protocols.

[10] A conservation variety
is defined as a landrace or plant variety that is naturally adapted to local
and regional conditions and is threatened by genetic erosion. The term amateur
varieties refers to varieties that are not used for commercial agricultural
production ('with no intrinsic value for commercial crop production but
developed for growing under particular conditions'), i.e. varieties that are
only grown for private use by for example hobby gardeners. Preservation seed
mixtures of fodder plants are collected in designated areas contributing to the
conservation of plant genetic resources. The seeds of those species are then
mixed to create a mixture which is composed of those genera, species and
subspecies which are typical for the habitat type of the collection site.

[11] http://www.worldseed.org/isf/seed\_statistics.html.

[12] ITPGRFA: http://www.planttreaty.org/.

[13] COM(2010) 543 Final of 8 October 2010.

[14] ESA document ESA\_07.0243.5A2 (2007).

[15] For example, there currently are different
requirements and tests depending on the crop (DUS, VCU), several levels of
variety catalogues (EU, national, for export or list of recommended varieties
in some Member States).

[16] See p. 57, p. 62 and pp. 155-156 in: FCEC (2008), Evaluation of
the Community acquis on the marketing of seed and plant propagating material
(S&PM). Final Report.

[17] The Krakow Declaration (2011) stressed the importance of reducing
transposition and compliance deficits. This proposal is thus fully in line with
this target.

[18] See pp. 151-152 in: FCEC (2008), Evaluation of the Community
acquis on the marketing of seed and plant propagating material (S&PM).
Final Report.

[19] See the example of winter oilseed rape in: FCEC (2008), Evaluation
of the Community acquis on the marketing of seed and plant propagating material
(S&PM). Final Report. Pp. 82-83.

[20] See the example of winter oilseed rape in: FCEC (2008), Evaluation
of the Community acquis on the marketing of seed and plant propagating material
(S&PM). Final Report. P. 66.

[21] See p. 88, and p. 105 in: FCEC (2008), Evaluation of the
Community acquis on the marketing of seed and plant propagating material
(S&PM). Final Report.

[22] FCEC (2008), Evaluation of the Community acquis on the marketing
of seed and plant propagating material (S&PM). Cost analysis. For
example, the study mentions that VCU-testing of winter oilseed rape costs
around EUR 2000 in Italy and around EUR 9000 in the UK. Both countries claim to
have cost recovery, thus the differences are, as the study shows, to a large
extent due to the number of conditions tested during VCU.

[23] FCEC (2008), Evaluation of the Community acquis on the marketing
of seed and plant propagating material (S&PM). Cost analysis.

[24] See p. 94 and pp. 168-172 in: FCEC (2008), Evaluation of the
Community acquis on the marketing of seed and plant propagating material
(S&PM). Final Report.

[25] See pp. 105-106 in: FCEC (2008), Evaluation of the Community
acquis on the marketing of seed and plant propagating material (S&PM).
Final Report.

[26] Rutz, H.W. (1990) Seed certification in the Federal Republic of Germany.
Plant Varieties and Seeds 3, 157-163.

[27] Kahre, L. (1990) The history of seed certification in Sweden. Plant
Varieties and Seeds 3, 181-193.

[28] For
an analysis see Howard, P.H. (2009) Visualizing Consolidation in the Global
Seed Industry: 1996–2008. Sustainability 1, 1266-1287.

[29] Extrapolation of data obtained in the 2010 PRM testing and
registration study. It concerns all species for which variety registration is
mandatory under EU legislation.

[30] This figure includes the additional cost flowing from stricter
national provisions. Also, it should be stressed that part of the expenditure
is compensated by incoming fees.

[31] FCEC (2008), Evaluation of the Community acquis on the marketing
of seed and plant propagating material (S&PM). Cost analysis.

[32] When the evaluation was carried out, Romania reported no cost
recovery for registration. Information received recently from Romanian
authorities lead to the conclusion that presently partial, if not full,
recovery for registration has been established.

[33] This can be inferred from data in Annex VIII which show that
comparatively few R&D employees work in the new Member States and that most
research is done in Member States with companies that have a relatively large
number of employees.

[34] The data used to construct these tables are uncertain. They are
intended to provide an indicative assessment of the distributional impact of
requiring cost recovery based on current rates of recovery. Actual impacts will
be influenced by a range of factors in addition to current cost recovery rates.

[35] See for example FranceAgriMer (Sep. 2011) Observatoire des
exploitations horticoles et pépinières. p. 9.

[36] FCEC (2011) Quantification of costs and
benefits of amendments to the EU plant health regime. Final report.

[37] In France, for basic and pre-basic crops there are approximately
6000 contracts between farmers and seed producers each year. Currently, these
crops have all to be examined officially. With official supervision, at least
5% would have to be examined. This is a small number compared to the number of
inspections under official supervision for certified field crops that are
already undertaken, approximately 2000 – 3000 per year. (GNIS, pers. comm.).

[38] This figure includes the additional cost flowing from stricter
national provisions. It should also be stressed that part of the expenditure is
compensated by incoming fees.

[39] FCEC (2008) Evaluation of the Community acquis on the
marketing of seed and plant propagating material (S&PM). Final report.

[40] Information from industry

[41] This number is based on the situation in the Netherlands. The main
other European producers of seed potatoes are Germany, France and the UK and we
assume that the inspection costs are roughly similar in these countries.

[42] Based on information from industry sources.

[43] Calculation on the basis of roughly equivalent percentage of labour
cost for variety registration and for certification, and on the estimated cost
for implementing these two elements of the seed marketing legislation.

[44] Data (as from 2009) from http://www.worldseed.org/isf/seed\_statistics.html.

[45] FCEC (2008) Evaluation of the Community acquis on the
marketing of seed and plant propagating material (S&PM). Final report.

[46] Calculation on the basis of roughly equivalent percentage of labour
cost for variety registration and for certification, and on the estimated cost
for implementing these two elements of the seed marketing legislation.

[47] Directive 2009/128/EC of the European Parliament and of the Council
of 21 October 2009 establishing a framework for Community action to achieve the
sustainable use of pesticides.

[48] Networks for VCU evaluation are in general far larger than those
for DUS. For example, in France 60 stations carry out VCU for wheat. It is not
realistic to assume that CPVO will be able to audit and control all such
testing stations for all species in all Member States. One possibility is that
CPVO audits one or a small number of entrusted authorities, which in turn audit
the rest of the national network.

[49] Terminology not directly applicable to Forest Reproductive Material

[50] Criteria are crop- specific and depend on marketing category

[51] For small EU packages of fodder plants and beet seed and for lower
marketing categories of non-agricultural crops

[52] industry
information - 2010

[53] http://epp.eurostat.ec.europa.eu/cache/ITY\_PUBLIC/5-11102011-AP/EN/5-11102011-AP-EN.PDF

[54] FR: a fee is paid in the context of the deliverance of the
phytosanitary passport

[55] NL: charge per plant passport  of  0,08€ 
and  suppliers document of 7,50€

[56] The Association of Official Seed Certifying Agencies (AOSCA) is an
organization of certification agencies in the United States, Canada, and New
Zealand. Its purposes are: (1) to establish minimum standards for genetic
purity and recommend minimum standards for the classes of certified seed. (2)
to standardize seed certification regulations and procedures. (3) to encourage
cooperation with all individuals, agencies, groups, and organizations to
accomplish these purposes, and (4) to assist its member agencies in seed promotion,
production, and distribution.

[57] 117.94 million EUR = 82.555 million EUR/0.7

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