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Document 52013SC0163
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL On the production and making available on the market of plant reproductive material (plant reproductive material law)
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL On the production and making available on the market of plant reproductive material (plant reproductive material law)
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL On the production and making available on the market of plant reproductive material (plant reproductive material law)
/* SWD/2013/0163 final */
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL On the production and making available on the market of plant reproductive material (plant reproductive material law) /* SWD/2013/0163 final */
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL On the production and making
available on the market of plant reproductive material
(plant reproductive material law) 1. Problem Definition Background The EU commercial seed market now has a value
of approx. EUR 6.8 billion, representing more than 20% of the total worldwide
market for commercial seed. In 2002/2003, the EU became a net exporter of
planting seeds. Currently, the EU PRM sector is highly competitive at global
level: it is the largest exporter with an export value of EUR 4.4 billion which
is more than 60% of the worldwide export. The sector is highly concentrated
(the largest 10 companies represent nearly 67% of the global seed market), but
SME and micro-enterprises play a crucial role in the internal market, notably
in niche markets such as organic crops. Plant reproductive material (PRM) is a fundamental
input for the productivity, the diversity, and the quality of plants and food.
This has been reflected in national legislation since the late 19th
century and in European legislation. The current EU legislation for PRM has
been developed since the 1960s This framework consists today of 12 basic
Council Directives covering variety listing as an authorisation for
marketing and specific marketing requirements for different species (fodder
plant seed, cereal seed, beet seed, seed of oil and fibre plants and vegetable
seed, vine propagating material, seed potatoes, vegetable reproductive material
other than seed, fruit plant propagating material, ornamental plants, forest reproductive
material). GMOs are dealt with in a separate legislation (Directive
2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EC) No 1830/2003) and
are not covered by this initiative. Problem Identification While the existing PRM EU legislation has been valuable in achieving
the initial objectives of guaranteeing free marketing of material and providing
healthy and quality PRM and thus contributing to productivity in the
agriculture, horticulture or forestry sectors, an increasing number of problems
have been emerging: ·
The complexity and fragmentation of the
legislation, lack of coherence with other policies, no EU rules for cost
recovery, the non-harmonised transposition and implementation of the current
Directives and the consequent differences in e.g. technical requirements are
obstacles to the establishment of a level playing field for all operators.
There is also a need to achieve major gains in legal simplification and policy
coherence. The review of the PRM legislation is
therefore part of a package of four reviews relating to the health of plants,
health of animals, marketing of plant reproductive material and official
control of food and feed. ·
The rigidity of the current legislation in
allocating tasks puts a high administrative burden on public authorities and
limits the flexibility of business operators (e.g. impossibility to conduct
certain tasks). ·
The absence of horizontal coordination with
other EU policies and strategies is an obstacle to a more efficient
implementation of existing EU legislation, policies and strategies (sustainable
agriculture and forestry, biodiversity protection, climate change,
bio-economy). These problems are described in more detail in
the report in section 2.3. Considering the Europe 2020 Strategy "Smart,
sustainable and inclusive growth" and the need to foster the
competitiveness of European business, notably SMEs, furthermore taking into
account the Commission's principles of Smart regulation and the evolution of
the economic and scientific-technical contexts of the
PRM sector, it is not sufficient to make amendments to the legislation and
better implement them. Evaluation, analysis and broad consultations
with Member States and stakeholders thus proved the need to update the system.
This can be done by combining measures along three axes (as follows) and which
resulted in policy options to be considered: (1) Simplification: the legal
architecture requires substantive simplification in form of a Regulation so
that a harmonised implementation in all Member States and a level playing field
for all operators is assured. (2) Flexibility and responsibility
sharing: operators require more flexibility to carry out work in the
context of variety registration and certification and the work of competent
authorities needs to focus more on the supervision of the production of PRM in
the EU (moving from product inspection to process audits). For this, public
services need to be secured financially. The
listing of PRM varieties under a unique name in national and the EU registers
generally is a requirement for marketing and based on the identity
(Distinctness, Uniformity and Stability - DUS) and characteristics (Value for
Cultivation and Use - VCU) of the variety. In addition, individual lots of PRM
are subject to a quality control system. These activities could be carried out
by competent authorities, by operators under official supervision or (for
certain categories of PRM) under the operator’s responsibilities. This responsibility sharing and increased flexibility should lead
to overall costs savings by a more efficient and timely organisation of the
work and will accelerate the access of new innovative varieties to the Internal market. (3) Coherence and horizontal linkages:
sustainability, biodiversity protection and climate change have to be addressed
in addition to productivity and PRM quality. How would the problem evolve if no action
was taken? The current legislation only allows variety
examinations by official authorities. To a certain extent, certification tasks
can be carried out by operators under official supervision. However,
limitations do not allow certification under supervision for certain species
(e.g. potatoes) and categories of PRM. This has an impact on business with
limited room to operate, especially when the international context is evolving.
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 could become more problematic
given the consequences of growing pressures on national budgets. Furthermore,
discrepancies with regard to PRM technical requirements are not supportive to
the establishment of a level playing field on the internal market for business.
The complexity and fragmentation of the legislation will perpetuate existing
uncertainties in its implementation. As regards new issues such as
biodiversity, climate change, bio-economy, the current legislation will
continue to address them as marginal topics. 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) No. 882/2004 would be obtained. 2. Analysis of subsidiarity The PRM legislative framework is based on
Article 43 of the Treaty on the Functioning of the European Union (Common
Agricultural Policy) whose objectives are to: increase agricultural
productivity, ensure a fair standard of living for the agricultural community,
stabilise markets, assure availability of supplies at reasonable prices for
consumers. The Lisbon Treaty qualifies Agriculture as shared competence. In
addition, the rules on the internal market (TFEU 114) and the preservation of
the environment (TFEU 191) complete the legal base for EU action. The introduction in the 60s of the EU
legislation on the PRM marketing has contributed to the creation of an internal
market for PRM. As confirmed by many stakeholders, these EU rules have had a
positive impact on free movement, availability and quality of PRM and
facilitated trade within the EU. Pre-market
authorisations of PRM are performed by national authorities valid for all
Member states, which ensure open competition on the Single market while safeguarding
subsidiary elements for Member States taking into consideration their national
needs (e.g. VCU are based on agro-ecological evaluation). 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 have been established
for PRM quality (OECD, UNECE) and health (IPPC, WTO/SPS agreement) which
justify an EU action for establishing a level playing field and a harmonised
implementation. With a view to ensuring proportionality of measures, notably
reducing administrative burden for stakeholders, the system must take into
consideration the freedom and economic viability of stakeholders as well as SME
and micro-entities. Measures on conservation or amateur varieties help to
ensure access of growers, including amateur gardeners, to wide range of PRM and
play a role in maintaining resilient systems in agriculture production and
genetic diversity at the field level. Smart growth is fostered by allowing
simplified market access for specific varieties. 3. Policy objectives 3.1. Overall objectives ·
To assure the health and high quality of PRM; ·
To provide a single regulatory framework
supportive to innovation and competitiveness; ·
To support sustainable production, biodiversity,
adaptation to climate change and to contribute to food
security and poverty alleviation. 3.2. Specific objectives ·
To ensure a level playing field through
simplified, harmonised rules; ·
To reduce unnecessary costs and administrative
burden and increase flexibility; ·
To align PRM legislation with other recent Union
strategies; ·
To foster market access for innovation in plant
breeding. 3.3. Operational objectives ·
To provide one PRM Law with flexible and
proportionate procedures; ·
To promote an harmonised implementation of
legislation by audits and training; ·
To foster innovation by increasing timeliness
and information provided in the EU register; ·
To enhance market transparency and traceability
through the registration of operators. 4. Policy Options The problem definition identified the following
main axes along which the system has to change in order to be fit for the
changing economic, environmental, social, scientific circumstances: (i) Simplification of the basic legal acts
(from 12 Directives to one Regulation), (ii) Cost recovery and improvement
of the effectiveness and efficiency of the system, (iii) Horizontal
coordination with recent, already adopted EU policies. Various ways –
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
biodiversity. Based on these 3 axes, 5 policy options have been identified in a
first stage, where legal simplification and cost recovery are constant for all
options. 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. The baseline and the five options are outlined
here: –
Option 0 – baseline: no change in the current situation (12 Directives and no rule with
regard to cost recovery). –
Option 1 – Cost recovery: The option does not include any changes to
technical provisions of the current legislation or to the allocation of
responsibilities between operators and competent authorities. The only change
consists in a full recovery from the stakeholders of costs incurred by the
competent authorities in all the Member States, which is already the case in
most of them. –
Option 2 – Co-system: A degree of flexibility
is introduced for operators. Variety registration
continues to be obligatory for a list of crops covered by EU legislation (DUS,
VCU), but the technical examination can be carried out by the operator under
official supervision. The certification requirements for lots of PRM remain unchanged,
but it can be carried out by the operator under supervision of the competent
authority in all cases. The current specific provisions continue to apply for
conservation/amateur varieties. –
Option 3 – Deregulation: More flexibility is put into place by deregulation. As part of the
variety registration, DUS-tests continue to be compulsory,
while VCU for agricultural crops is no longer a legal requirement. There is no
official certification. Instead, all lots of PRM are marketed only on the basis
of a suppliers' label, with minimum criteria. The current specific provisions
continue to apply for conservation/amateur varieties. –
Option 4 – Enhanced flexibility system: A dual system is established giving
operators substantial flexibility by choosing between two systems, namely one
for officially tested varieties (DUS, VCU with sustainability criteria) and one
for non-officially tested varieties with a description supplied by the
applicant to the authority. Certification of PRM is limited to officially tested
varieties. The marketing of, for example, conservation or certain "niche
market" varieties is liberalised as there is no obligatory technical
examination of varieties and no obligatory certification of PRM, so that they can
be marketed as non-tested varieties. –
Option 5 – Centralisation: The Community Plant Variety Office (CPVO) will be given the
mandate to coordinate and decide on variety registration, covering both
technical examination (DUS and VCU) as well as variety denomination. The
certification requirements for lots of PRM remain unchanged, but certification
can be carried out under official supervision. “Reference Certification
Centres” with the task to develop best practices, to carry out comparative
tests and trials and studies in support of policy development and to
disseminate knowledge of PRM certification, will be established. The current specific
provisions continue to apply for conservation/amateur varieties. 5. Assessment of Impacts The current cost of implementing the variety
registration provisions amounts to approximately EUR 55-60 Mio per year in the
EU. DUS and VCU account for 45% and 55% of the cost, respectively. The
expenditure on certification of PRM is in the range of EUR 73-79 Mio. A
majority of Member States does already today fully or partly recover costs,
while a minority does not. At least 60% of these costs are recovered by
competent authorities across all Member States. The combined yearly costs of
registration and certification correspond to approximately 3% (out of which at
least 60% are already borne by operators) of the market value of agricultural
seed crops. The impacts on SMEs and micro-enterprises have been followed
throughout. Option 1 only
addresses cost recovery. This option will establish a level playing field for
operators, decrease costs for Member states' competent authorities and secure
their functioning in the future. This option will not have an impact on
competitiveness and provide no support for innovation and the achievement of
environmental or sustainability aims. Competent authorities continue to
guarantee the availability of public services to perform technical examinations
and inspections. SMEs and micro-enterprises, which do not have the resources to
carry out these tasks themselves, will be the main beneficiaries of this
guarantee. 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. Option 2 will
also provide a more level playing field for competitors on the Internal Market
as costs are fully recovered in all Member States. Administrative burden is
decreased as many tasks (certification, testing for registration) can be
carried out by operators under official supervision. This will significantly
increase the flexibility of operators to bring new varieties to the market.
Some jobs are likely to move from the public sector to the private sector. 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. This option
also has no clear support for the achievement of environmental or
sustainability aims. Option 3 entails
a risk to the health and quality of PRM because obligatory certification is
abolished. Competent authorities and operators will be able to realize large
cost savings, but abolishing certification means that EU equivalence
requirements for seed import from third countries will also have to be
abolished. It is also likely that economic activities such as seed
multiplication will be relocated to a greater extent to non-EU countries. SMEs
will be disadvantaged as VCU is abolished, which serves as unbiased information
for users independent of market power of the seller. Abolishing VCU also
entails threats to environmental aims as there are no means to steer plant
breeding towards these aims. Option 4 offers additional
cost savings to competent authorities and operators, like option 3, while at
the same time providing some more assurances for the characterisation of PRM
(VCU for officially tested varieties). However, risks due to non-obligatory
certification and variety registration will remain. A diversity of operators,
especially SME and micro-entities active in niche markets, is bound to benefit
from the increased freedom to act. This option also 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. Option 5 offers
strong assurances for the quality and health of PRM by centralisation of
variety registration in the EU, while a level playing field for operators is
established. An efficient and transparent system is established with harmonised
technical requirements. The speed of market access of new, improved varieties
will be increased – this could lead to job growth in the long-term. 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. However, the option
lacks clear means to steer plant breeding towards the aims of sustainability
and the protection of agro-biodiversity; it is more geared towards the needs of
conventional plant breeding. 6. Comparison of Options The summary table below provides an overall
comparison of options in terms of achieving the objectives of the review
compared to current situation. || || 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 EU Register || 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 Preferred option As none of the five options provided an optimal
balance between efficiency of the system, the quality assurance of the PRM, the
maintenance of competitiveness and halt of loss of biodiversity, a preferred
option, combining positive elements of the 5 initial options while maintaining
as much choice and flexibility as possible for operators, was designed and
selected. This preferred option takes up elements from options 2, 4 and 5. This
combination aims at striking a balance between flexibility for operators and
biodiversity (options 2 and 4) and the necessary rigor in health and quality
requirements (option 2 and 5) for the fair functioning of the market and for
maintaining the quality and health of the products. It includes the two
horizontal principles of simplification of the PRM legal architecture and cost
recovery. The General principles are: Cost recovery for services carried out
by competent authorities. Exemptions are possible depending on the degree of
public interest in the respective PRM marketing or in line with the exemptions
envisaged by the revision of Regulation 882/2004. Operators can carry out, under
official supervision by the competent authority, a wide range of activities in
the area of registration and certification. All operators have to be registered
in order to guarantee PRM traceability. Specific and strict obligations
concerning registration and certification shall apply to a specific list of
species important for the EU market. General minimum requirements shall apply
to all other PRM (non-listed species) on the market and cover labelling
obligations and provision of 'fitness for use'. The role of the CPVO will be extended to centralising all information on varieties of
PRM registered at national or European level. CPVO will harmonise technical
requirements and audit the national examination offices which in turn allow
private-sector testing stations to carry out technical examinations. CPVO shall
take an increased role in the arrangements for making information available on
varieties authorised for marketing in the internal market (online database) and
verify denominations for all applications. As an alternative to national
registration, centralised registration for varieties not requiring
VCU-evaluation (e.g. vegetables) by CPVO shall be offered. The registration of non officially tested
varieties, with an officially recognised description, at national and European level shall be an option that is given to
conservation and amateur varieties for reasons of public good. Existing
restrictions for the marketing of conservation varieties shall be relaxed. While VCU shall be maintained and shall be decided on a species-by species basis, its 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 and legislative requirements. 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). The needs of micro enterprises and SMEs will
be specifically taken into account: The equal
access to the internal market for varieties developed by those companies will
be guaranteed by maintaining registration rules (upholding of VCU) not based on
the market power of the seller. In addition, with the possibility of having a
variety description provided by the operator (officially recognised
description) increasing opportunities will be created for specific markets
(e.g. conservation varieties) which are of particular interest for SMEs and
micro-enterprises. Official inspection services shall always be made available
by competent authorities to conduct work that SMEs or micro-enterprises can not
conduct themselves. The preferred option thus achieves the five
main objectives in the following way: (1) simplification through the replacement
of 12 Directives with one Regulation; (2) reducing administrative burden by
introducing cost recovery and the transfer of tasks to operators; (3) fostering innovation through allowing
more operational flexibility to operators; (4) supporting sustainability, biodiversity
and adaption to climate change by "sustainable VCU" and a reduced
burden for conservation varieties; (5) securing transparency and traceability
by the registration of all operators and minimum requirements for non-listed
species. 7. Monitoring and Evaluation To assess the success of the measures
introduced, several indicators are suggested: (1) Harmonisation of legislation and
implementation in the Member States –
Number of requests for clarifications and
complaints received. –
Results of FVO or CPVO audits on implementation
of the legislation in Member States. –
Number of notification received from Member
States on national measures. –
Functional register of operators. (2) Reduction of administrative burden
and costs and introduce flexibility –
Variety registration –
Application: number, time needed, cost recovery.
–
PRM companies applying, with a focus on SMEs:
number, type, evolution. –
Number of varieties registered with an
‘officially recognised description’. –
Number of direct application for variety registration
to CPVO. –
PRM quality control –
Percentage of certification under
official supervision compared to official certification in Member States. –
Cost of PRM quality control. (3) Setting up proportionate rules and
alignment with other EU policy and strategies –
Number, quantity of conservation and amateur
varieties registered and marketed. –
Number of species concerned by this rules. –
Harmonised criteria for variety registration
(e.g. sustainable VCU).