Commissione europea- Produzione e disponibilità mercantile di coltivazioni vegetali.


EN EN
EUROPEAN
COMMISSION
Brussels, 6.5.2013
COM(2013) 262 final
2013/0137 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
On the production and making available on the market of plant reproductive material
(plant reproductive material law)
(Text with EEA relevance)
{SWD(2013) 162 final}
{SWD(2013) 163 final}
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EXPLANATORY MEMORANDUM
1. CONTEXT OF THE PROPOSAL
Plant reproductive material is a fundamental input for the productivity, the diversity,
and the health and quality of agriculture, horticulture and food and feed production
and our environment. Forests cover a large area of the Union and fulfil multiple
social, economic, environmental, ecological and cultural functions. The current EU
legislation for making available on the market of plant reproductive material is based
on two main pillars, namely the registration of varieties/material and the certification
of individual plant reproductive material lots of plant species as identified in the
Directives (‘EU listed species’).
The draft proposal consolidates and updates the legislation on marketing of plant
reproductive material by repealing and replacing the following 12 Directives:
Council Directive 66/401/EEC on the marketing of fodder plant seed, Council
Directive 66/402/EEC on the marketing of cereal seed, Council Directive
2002/53/EC on the common catalogue of varieties of agricultural plant species,
Council Directive 2002/54/EC on the marketing of beet seed, Council Directive
2002/55/EC on the marketing of vegetable seed, Council Directive 2002/56/EC on
the marketing of seed potatoes, Council Directive 2002/57/EC on the marketing of
seed of oil and fibre plants, Council Directive 68/193/EEC on the marketing of
material for the vegetative propagation of the vine, Council Directive 1998/56/EC on
the marketing of propagating material of ornamental plants, Council Directive
92/33/EEC on the marketing of vegetable propagating and planting material, other
than seed, Council Directive 2008/90/EC on the marketing of fruit plant propagating
material and fruit plants intended for fruit production and Council Directive
1999/105/EC of 22 December 1999 on the marketing of forest reproductive material.
The majority of Council Directives for making available on the market of plant
reproductive material have first been adopted between 1966 and 1971 and some
Directives are more recent. The old Directives have been updated both frequently
and substantially, creating the need for clarity and transparency. As a consequence of
this history, the Directives are quite diverse in the technical backgrounds they are
based on, but also in their approaches, ranging from official controls on products to
official supervision of processes. In particular, the product control is very demanding
for competent authorities.
Furthermore, the complexity and fragmentation of the existing legislation is likely to
perpetuate existing uncertainties and discrepancies in its implementation between the
Member States. This creates an uneven playing field for professional operators on the
single market. There is a need to harmonise implementation of the legislation, reduce
cost and administrative burdens and support innovation. It is also important to adapt
to the technical progress in plant breeding, and to the rapid evolution of the European
and global market of plant reproductive material. All those needs make the update
and modernisation of the legislative framework imperative. The aim of in situ
conservation of agro-biodiversity should be further strengthened. In addition, the
weak horizontal coordination with other EU legislation, policies and strategies is an
obstacle to their more efficient implementation. In the past years, agricultural policy
in the EU has come to be seen as strategically important for food security and safety,
the nutritional value of food, the environment, biodiversity and climate change.
“Sustainable intensification” and greening of food crop production, in which yields
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are increased without adverse environmental impact and without the cultivation of
more land, have become a central concern. Plant reproductive material legislation is
critically important for reaching this aim. The EU Forest Strategy emphasises the
importance of the multifunctional role of forest and its sustainable management.
Coherence and synergies with the Plant Health Law concerning the plant health
checks which are part of the plant reproductive material certification process or
integration of general principles relating to official controls embedded in Regulation
(EC) No 882/2004 on official controls are needed.
2. RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND
IMPACT ASSESSMENTS
The impact assessment of this proposal builds on the results of the evaluation of the
EU legislation on the marketing of seed and plant propagating material (now plant
reproductive material) that was carried out in 2007/2008 by the Food Chain
Evaluation Consortium (FCEC), on the results of a study on variety registration
conducted by the same consortium in the first half of 2010. It is furthermore based on
a broad survey of all interested parties, in particular the competent authorities in the
Member States, private sector representatives at EU and at national level, relevant
international standard setting bodies, non-governmental organisations and the
Community Plant Variety Office (CPVO). A number of Commission Horizontal
Working Party meetings covering all the plant species were held in 2009-2011. In
May 2011, four task forces created under the Hungarian presidency worked on
specific topics. In addition, the Commission consulted the working group ‘Seeds and
Propagating Material’ of the Advisory Group on the Food Chain, Animal and Plant
Health on several occasions from 2009 – 2011. On 18 March 2009 an open
conference “Ensuring Seed Availability in the 21st Century” was organised to
present and discuss the evaluation results with different stakeholders. Finally, a webbased
stakeholder survey using an “Interactive Policy Making” (IPM) questionnaire
to collect comments on an “Options and Analysis” paper was organised from 19
April to 30 May 2011. It yielded 257 responses from a very wide range of
stakeholder groups.
The main objective of the consultations was to seek views on the provisions and
application of existing legislation and the needs for change. Overall, stakeholders
were satisfied with the principles underlying the existing Directives, but supported
the Commission’s intention to revise the legislation. Room for improvement was in
particular identified pertaining to legal simplification, cost reductions and efficiency
gains, increased flexibility for professional operators, the level of harmonisation
among Member States, the role of niche and emerging markets and the conservation
of agro-biodiversity and plant genetic resources. Maintaining the general principles
of the current legislation – especially the procedures for the registration of varieties
and the pre-marketing certification of seed lots – was strongly supported by a
majority of stakeholders. In addition, concerning the EU legislation on forest
reproductive material, the stakeholders requested to maintain the current approach.
The Impact Assessment identified the following main axes along which the system
has to change in order to be fit for the changing economic, environmental, social,
scientific circumstances: (i) Simplification of the basic legal acts (from 12 Directives
to one Regulation), (ii) Cost recovery and improvement of the effectiveness and
efficiency of the system and (iii) Horizontal coordination with recent, already
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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 plant reproductive material,
competitiveness and addressing new challenges such as biodiversity. Based on these
3 axes, 5 policy options were identified, where legal simplification and cost recovery
are constant for all options. In the various options, issues regarding SMEs and microenterprises
have been addressed throughout, especially in order to ensure access for
these enterprises to public services for the execution of certain tasks they cannot
perform themselves and to support and further develop their flexibility to gain
improved access to the plant reproductive material market. Specific attention is given
to trade-offs between transferring operational work and keeping of quality of plant
reproductive material.
The impact assessment concludes that no single option succeeds in achieving the
objectives of the review in an efficient, effective and coherent manner and suggests,
in line with stakeholder opinion, a preferred option which combines elements from
option 2, 4 and 5. The proposal thus creates an environment providing legal security
for professional operators and consumers, guaranteeing high quality of plant
reproductive material and securing competitive advantage on the internal and the
world markets. This combination aims at striking a balance between flexibility for
professional operators (option 2 and 4) and biodiversity (option 4) and the necessary
rigor in health and quality requirement (elements of option 2 and 5) for the fair
functioning of the market and for maintaining the quality and health of plant
reproductive material. This is combined with elements allowing minor crops or crops
with particular uses low-burden access to specific or small market segments, but with
coupled minimum obligations ensuring traceability, health and information to the
consumer so that a level playing for all professional operators is established.
3. LEGALELEMENTS OF THE PROPOSAL
The aim of the proposal is to replace the existing 12 Directives by one single
proposed Regulation.
3.1. Part I – General provisions
The scope of the proposed Regulation covers all types of plant reproductive material.
The largest part of it covers, though, the species currently regulated by the
12 Directives (so called ‘listed species’). However, to clarify and harmonise the
existing approaches in the Member States on the other species, i.e. plant species not
listed and thus not covered by the current Directives, also these species will be
subject to some very basic rules (see Part III, Title III).
In order to take into account the needs of producers and the requirements of
flexibility and proportionality, the Regulation will not to apply to plant reproductive
material intended for testing and scientific purposes and intended for breeding
(selection) purposes. In addition, it should not apply to material intended to or
maintained in gene banks, organisations and networks of ex-situ and in-situ or on
farm conservation of genetic resources following national strategies on conservation
of genetic resources. Furthermore, plant reproductive material exchanged in kind
between two persons other than professional operators is excluded from the scope of
the Regulation.
As regards definitions, the main change is the introduction of a common term to
cover all the plant reproductive material, either in the form of seeds or other types of
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plant propagating material. Plant reproductive material is defined to mean plants or
parts of plant capable of and intended for producing or reproducing entire plants.
This includes also young plants. All those types of plant reproductive material are
subject to common principles with regard to their production with a view to making
available on the market and with regard to making them available on the market.
3.2. Part II – Professional operators
As under this Regulation the definition of operator does not include private persons,
the term ‘professional operator’ is used. Professional operators are defined by a single
definition and shall be registered to ease the control activities. This register shall be
combined with the register established under [title of the new Plant Health
Regulation]. Basic obligations will be introduced for professional operators
concerning the identification of the plant reproductive material they are producing or
making available on the market, keeping of records, facilitation of controls and
maintenance of the material. The traceability of any plant reproductive material is
ensured by the obligation for the professional operators to have information one step
before and one step after their commercial activities.
3.3. Part III – Plant reproductive material other than forest reproductive material
Title I General provisions
Definitions of variety and its maintenance, variety with official description or variety
with officially recognised description, clone as well as of the different marketing
categories are laid down.
Title II Production and making available on the market of listed species
In general, the basic approach on registration of varieties/material and
certification/inspection of lots before making available on the market will be
maintained. However, more flexibility will be given to the professional operators so
that they may decide to carry out the necessary examination for variety registration
or inspections, sampling and analysis of plant reproductive material for certification
under the official supervision of the competent authorities. In addition, secondary
acts will be adopted setting out the specific requirements for the production and
making available on the market of particular species and their categories (pre-basic,
basic, certified and standard material). This is important to increase flexibility for
changes due to technical and scientific developments and at the same time respecting
proportionality and sustainability in regulatory approach.
The requirements for making available on the market of plant reproductive material
may be summarised as follows:
– it belongs to a variety or clone registered in accordance the provisions of this
Regulation;
– it complies with the specific requirements adopted for the marketing category
concerned per genera and species;
– it bears an official label for pre-basic, basic or certified material, or an
operator’s label in case of standard material;
– it complies with the handling requirements;
– it complies with the requirements for certification and identification.
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The obligation of variety registration shall not apply to rootstocks which do not fulfil
the conditions of a variety. In addition, in order to introduce flexibility for future
technical and scientific developments, heterogeneous material, which does not fulfil
the definition of a variety, could be exempted under certain conditions from the
requirement that that material belongs to a registered variety. Furthermore, a specific
derogation for niche market plant reproductive material is laid down.
Certain genera and species of plant reproductive material, which are listed in the
current Directives, should continue to be subject to enhanced requirements relating to
their production and making available on the market (listed species). However, there
is a need to set criteria to decide on these plant species. Genera or species of plants
which represent a significant area and value of production, are produced and made
available on the market by a significant number of professional operators or they
contain substances requiring specific rules to protect human, animal health or the
environment should be included in the list.
Plant reproductive material should only be produced and made available on the
market as pre-basic, basic, certified or standard material, in order to ensure
transparency and informed choices for users. Detailed criteria need to be established
to decide which genera and plant species shall not be made available on the market
as standard material to ensure enhanced quality and health, identity and traceability
of plant reproductive material as well as food and feed security. Specific
requirements should be adopted per genera and species for each of those categories.
The requirements on identity, purity, health and other quality requirements, labelling,
lots, packaging including small packages, post-certification control tests,
comparative tests and trial and mixtures will continue to be applied.
Derogations
The existing permanent derogations on making available on the market to a limited
extent not-yet registered varieties for testing on farm and not finally certified
material and authorisation of more stringent national requirements should be
maintained. This should also concern the important temporary derogations on
emergency measures, temporary difficulties in supply and temporary experiments.
Derogation on niche market plant reproductive material
In addition, proportionate and sustainable rules for small scale activities concerning
plant reproductive material, which is adapted to local conditions, and made available
on the market in small quantities, should be established. Such varieties should be
exempted from the requirements on registration and making available on the market.
This material is defined as niche market plant reproductive material. The exemption
should concern e.g. farmer-breeders or gardener-breeders whether being professional
operators or not. However, some basic rules on labelling and traceability of the
material should be laid down. In order to prevent an abuse of the exemption the
material should only be made available on the market in a defined size of packages.
Imports and exports
The EU equivalence system is maintained as a basic condition for imports from third
countries. However, exports are included in the scope of the Regulation. Exports
should take place in line with legislation, standards, code of practice or any other
legal or administrative procedure in place in the importing third country. Where a
bilateral or multilateral agreement between the Union and the third country exists,
the exports from the Union shall comply with the agreement. Furthermore, in the
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absence of the latter, an agreement conducted between the professional operators
shall apply.
Title III Production and making available on the market of plant reproductive
material belonging to non-listed genera or species
Plant reproductive material not belonging to the listed genera and species shall also
be subject to a few basic requirements with regard to its health status, fitness for
purpose, appropriate reference to varieties, where applicable, and identification of the
respective material and imports.
Title IV Registration of varieties in national and Union registers
Variety registers
The varieties, in order to be made available on the market throughout the Union,
shall be included in a national register or in the Union register via direct application
procedure to the CVPO. CPVO will keep the updated information on all plant
varieties that can be made available on the market in the Union, including the
varieties registered in national registers (Union plant variety database).
For new improved varieties the basic requirement of DUS (distinct, uniform and
stable) will be maintained. The uniformity examination should take into account the
type of variety and type of reproduction. In addition, by secondary act it can be
decided for which plant species additional requirements on value for cultivation and
use (VCU) can be laid down. The Member States shall adopt more detailed criteria
for the VCU examination of these plant species as regards their yield, quality
characteristics, resilience and suitability for low input production systems including
organic production. Thus, given the specific characteristics required for organic
farming, the methodology and requirements established for variety examination
should take due account of the specific needs.
Rules on a sustainable value for cultivation will be laid down and harmonised in the
EU by adopting specific requirements concerning resistance to specific pests,
reduced need for input of resources, decreased content of undesirable substances or
increased adaptation to divergent agro-climatic environment. This is an important
tool to guide the breeding process to a more sustainable direction.
If a variety has been granted a Union Plant Variety Right pursuant to Regulation
(EC) No 2100/1994, or pursuant to national rules, that variety should be deemed to
be distinct, uniform and stable and to have a suitable denomination for the purposes
of variety registration under this Regulation.
The basic principle of the use of a single denomination throughout the Union for one
variety is kept. In certain specific cases synonyms will be allowed. The CPVO is best
made available to have an overview of applicable denominations of varieties
throughout the Union. Therefore, and in order to ensure coherence regarding the
assignment of denominations throughout the Union, the competent authorities should
consult CPVO to check a denomination, before the respective variety is registered in
a national variety register.
The Regulation establishes the detailed requirements for the variety registration
procedure regarding conditions for registration, submission and content of
applications, formal and technical examinations, examination reports, decisions on
registration, period of validity and its renewal, revocation/deletion of registration and
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maintenance of varieties. For coherence, the same rules shall also apply to direct
variety applications to the CPVO for registration in the Union variety register.
Specific provisions are set out on the registration in the Union variety register and
with regard to the possibility for the applicant to launch an appeal against a CPVO
decision. Such provisions are not laid down for the registration in the national variety
registers, because they are subject to national administrative procedures.
A new obligation for each national variety examination centre to be audited by the
CPVO will be introduced with the aim to ensure the quality and harmonisation of the
variety registration process in the Union. The examination centre of the professional
operators will be audited and approved by the national competent authorities. In case
of direct application to the CPVO it will audit and approve the examination centres it
uses for variety examination.
The competent authorities and the CPVO should charge fees for the processing of
applications, the formal and technical examinations including audits, variety
denomination, and the maintenance of the varieties for each year for the duration of
the registration. Therefore, harmonised rules for those fees should be set out in this
Regulation. The general principle of cost recovery shall prevail. However, the microenterprises
shall be exempted from fees to fulfil the Commission’s commitment to
lower the burden on very small businesses, in line with its new policy on minimizing
regulatory burden for SMEs and adapting EU regulation to the needs of microenterprises.
Moreover, the fee for registration of varieties with officially recognised
description and heterogeneous material shall be reduced in a manner to ensure that
the fee does not constitute a barrier to the registration of the variety or material
concerned.
Old traditional varieties
Concerning old varieties, such as conservation varieties (including landraces), or so
called ‘amateur varieties’, less stringent requirements should continue to be laid down
in view of promoting their on farm conservation and use as currently regulated under
the Directives 2008/62/EC and 2009/145/EC. The varieties will continue to be
registered, however, on the basis of an ‘officially recognised description’ which shall
be recognised – but not produced – by the competent authorities. For that description
DUS examination is no longer obligatory. The officially recognised description shall
only describe the specific characteristics of the plants and parts of plants which are
representative for the variety concerned and make the variety identifiable, including
the region of origin. This description can be based on an old official description of
the variety, description produced at the time by e.g. a scientific, academic body or
organisation. The accuracy of its content could be supported by previous official
inspections, unofficial examinations or knowledge gained from practical experience
during cultivation, reproduction and use. The current quantitative restrictions are
abolished. The users are informed about the material by a label indicating that this
variety is identified by an officially recognised description and the region of origin.
Plant reproductive material belonging to those varieties should only be made
available on the market as standard material.
3.4. Part IV – Production and making available on the market of forest reproductive
material
The EU legislation sets a specific approach including specific terminology on forest
reproductive material. Therefore, for this area a separate part is laid down in which
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the current basic approach is kept. The requirements for forest reproductive material
concern approval of basic material, inclusion in national register and Union list,
master certificate, marketing categories, lots, mixtures, labelling, packaging and
establishment of the conditions of EU equivalence for imports. In addition, the
following derogatory rules need to be set: authorisation of more stringent national
requirements, prohibition to make available to end user specified forest reproductive
material, rules concerning temporary difficulties in supply and rules concerning
temporary experiments.
3.5. Part V – Procedural provisions
Rules for delegated acts and the committee procedure are laid down.
3.6. Part VI – Final provisions
The Regulation (EC) NO 2100/94 on Community Variety Rights is amended as
regards the name and role of CPVO. The name of the agency is amended to follow
the recommendations of the EU inter-institutional working group to ‘European
Agency on Plant Varieties’ (EAPV). The mission of CPVO is extended to the area of
variety registration, in particular the management of Union variety register and the
registration of plant varieties via direct application procedure to the CPVO. In
addition, a number of tasks are attributed to the CPVO within its new mission on
offering recommendations on variety denominations, database on reference
collections of varieties, harmonisation of technical examination of varieties, audits of
technical examination centres, advisory tasks, training and technical support.
The necessary rules on penalties are laid down.
3.7. Part VII – Union competence, subsidiarity and legal form
The plant reproductive material legislative framework is based on the Treaty on the
Functioning of the European Union (TFEU) Article 43 implementing the Common
Agricultural Policy (CAP). The objectives of that policy are to increase agricultural
productivity, to ensure a fair standard of living for the agricultural community, to
stabilise markets, to assure the availability of supplies and to ensure that supplies
reach consumers at reasonable prices. Requirements with regard to the sustainability
of agriculture have been integrated through the successive revisions of the CAP. The
Lisbon Treaty qualifies agriculture as shared competence between the EU and its
Member States. It is obvious, however, that to a very large extent all fields of
agricultural activity as well as ancillary activities upstream and downstream have
been regulated at the EU level. This means that legislation is predominantly a role for
the institutions of the European Union.
The proposal takes the form of a Regulation of the European Parliament and of the
Council. Other means would not be appropriate because the objectives of the
measure can be achieved most efficiently by fully harmonised requirements
throughout the Union, ensuring free movement of plant reproductive material.
4. BUDGETARYIMPLICATION
The financial appropriations for implementing the Regulation up to 31 December
2020 are being presented in the Regulation on laying down provisions for the
management of expenditure relating to the food chain, animal health and animal
welfare, and relating to plant health and plant reproductive material.
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5. OPTIONALELEMENTS
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2013/0137 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
On the production and making available on the market of plant reproductive material
(plant reproductive material law)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular
Article 43(2) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national Parliaments,
Having regard to the opinion of the European Economic and Social Committee,
Having regard to the opinion of the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure1,
Whereas:
(1) The following Directives set out rules for the production and marketing of seeds and
propagating material of agricultural crops, vegetables, vine, fruit plants, forest
reproductive material and ornamental plants:
(a) Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder
plant seed2;
(b) Council Directive 66/402/EEC OF 14 June 1966 on the marketing of cereal
seed3;
(c) Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for
the vegetative propagation of the vine4;
(d) Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating
material of ornamental plants5;
(e) Council Directive 1999/105/EC of 22 December 1999 on the marketing of
forest reproductive material6;
1 Position of the European Parliament of … and position of the Council at first reading of … Position of
the European Parliament of … and decision of the Council of ….
2 OJ L 125, 11.7.1966, p. 2298.
3 OJ L 125, 11.7.1966, p. 2309.
4 OJ L 93, 17.4.1968, p. 15.
5 OJ L 226, 13.8.1998, p. 16.
6 OJ L 11, 15.1.2000, p. 17.
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(f) Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of
varieties of agricultural plant species7;
(g) Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed8;
(h) Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable
seed9;
(i) Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed
potatoes10;
(j) Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil
and fibre plants11;
(k) Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable
propagating and planting material, other than seed12;
(l) Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit
propagating material and fruit plants intended for fruit production13.
(2) The basic objective of the above Directives is sustainable agricultural, horticultural
and forestry production. In order to ensure productivity, the health, quality and
diversity of plant reproductive material is of outmost importance for agriculture,
horticulture, food and feed security, and the economy in general. Moreover, to ensure
sustainability, legislation should take account of the need to meet consumers’
expectations, to ensure the adaptability of production to manifold agricultural,
horticultural and environmental conditions, to face the challenges of climate change
and to foster the protection of agro-biodiversity.
(3) Evolution in the areas of agriculture, horticulture, forestry, plant breeding and making
available on the market of plant reproductive material has shown that the legislation
needs to be simplified and further adapted to the developments of the sector.
Therefore, the above Directives should be replaced by a single Regulation on the
production, with a view to making available on the market, and the making available
on the market, of plant reproductive material within the Union.
(4) Plant reproductive material, should be defined in a comprehensive manner, including
all plants capable of, and intended for, producing (including reproducing at any further
stage of production) entire plants. This Regulation should, therefore, cover seeds, as
well as all other forms of plant at any growth stage, intended for and capable of
producing entire plants.
(5) This Regulation should also cover plant reproductive material used for the production
of agricultural raw materials intended for industrial purposes, since that material
represents a major part of several sectors and should fulfil certain quality standards.
(6) In order to determine the scope of the several provisions of this Regulation it is
necessary to define the concepts of “professional operator” and “making available on
the market”. In particular, in view of the marketing developments of the sector, the
7 OJ L 193, 20.7.2002, p. 1.
8 OJ L 193, 20.7.2002, p. 12.
9 OJ L 193, 20.7.2002, p. 33.
10 OJ L 193, 20.7.2002, p. 60.
11 OJ L 193, 20.7.2002, p. 74.
12 OJ L 205, 1.8.2008, p. 28.
13 OJ L 267, 8.10.2008, p. 8.
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definition of ‘making available on the market’ should be as wide as possible to ensure
all forms of transactions of plant reproductive material. That definition should include
inter alia persons concluding sales through distance contracts (e.g. electronically) and
persons who collect basic forest material.
(7) Given the needs of producers and the requirements for flexibility and proportionality,
this Regulation should not apply to reproductive material intended solely for testing,
scientific and breeding purposes, to gene banks, organisations and networks devoted to
the exchange and conservation of genetic resources (including on-farm conservation),
or to reproductive material exchanged in kind between persons other than professional
operators.
(8) Directive 94/62/EC of 20 December 1994 on packaging and packaging waste14,
Regulation (EC) No 338/97/EC of 9 December 1996 on the protection of species of
wild fauna and flora by regulating trade therein15, Directive 2001/18/EC of the
European Parliament and of the Council of 12 March 2001 on the deliberate release
into the environment of genetically modified organisms and repealing Council
Directive 90/220/EEC16, Regulation (EC) No 1829/2003 of the European Parliament
and of the Council of 22 September 2003 on genetically modified food and feed17,
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22
September 2003 concerning the traceability and labelling of genetically modified
organisms and the traceability of food and feed products produced from genetically
modified organisms and amending Directive 2001/18/EC18 and Regulation (EU) No
…/… [Office of publications, please add number of Regulation on protective measures
against pests of plants], should also apply for the production and making available on
the market of plant reproductive material.
(9) In order to ensure transparency and more effective controls on the production and
making available on the market of plant reproductive material, professional operators
should be registered. However, in order to reduce the administrative burden for
professional operators, by allowing them to register only once in a single register, it is
appropriate that they register in the public registers established by the Member States
pursuant to Regulation (EU) No …/… (Office of Publication, please insert number of
Regulation on protective measures against pests of plants).
(10) Basic obligations should be introduced for professional operators active in the
production and making available on the market of plant reproductive material area to
ensure the proper application of this Regulation.
(11) Experience has shown that the reliability and quality of reproductive material made
available on the market can be jeopardised where it is impossible to trace reproductive
material not complying with applicable standards. It is therefore necessary to establish
a comprehensive system of traceability allowing withdrawals to be undertaken or
information to be given to consumers or competent authorities. For that reason, the
keeping of the necessary information and records on transfers from and to professional
users should be mandatory. On the basis of the principle of proportionality, that rule
should not apply in case that supply is part of making available on the market in retail.
14 OJ L 365, 31.12.1994, p. 10–23
15 OJ L 61, 3.3.1997, p. 1–69
16 OJ L 106, 17.4.2001, p. 1–39
17 OJ L 268, 18.10.2003, p. 1–23
18 OJ L 268, 18.10.2003, p. 24–28
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(12) Certain genera and species of plant reproductive material should be subject to
enhanced requirements concerning their production and making available on the
market due to their increased economic, health or environmental importance. That
importance should be determined through the area or value of production of those
genera or species, the number of professional operators or the content of substances
which present a potential risk for health or the environment. The majority of those
genera and species is currently regulated by the above Directives. Those genera and
species should be inserted in a specific list (hereinafter: ‘listed genera and species’).
(13) In order to ensure transparency and enable informed choices by consumers, plant
reproductive material belonging to listed genera and species should only be produced
or made available on the market under predefined categories. Those categories should
reflect different quality levels and production stages and be named “pre-basic”,
“basic”, “certified” and “standard”,
(14) In order to ensure the widest possible availability of plant reproductive material and
choices by its users, professional operators should, in principle, be able to make
available on the market plant reproductive material belonging to listed genera or
species under any of the categories. However, in order to ensure food and feed
security, and to achieve a high level of identity, quality and health of plant
reproductive material, plant reproductive material should not be made available on the
market as standard material if the certification costs are proportionate to those
objectives.
(15) Plant reproductive material belonging to varieties with officially recognised
description, as well as heterogeneous material and niche market material, should be
subject to minimum requirements. Therefore, such material should in all cases be
produced and made available on the market only as standard material.
(16) In order to allow for informed choices by users concerning its identity and
characteristics, plant reproductive material belonging to listed genera and species
should only be produced and made available on the market if it belongs to varieties
registered in national variety registers or in the Union variety register.
(17) In order to facilitate adaptation to developments in plant breeding, and to possible new
techniques, heterogeneous plant reproductive material, which does not fulfil the
definition of a variety in the meaning of this Regulation, should be allowed to be
produced or made available on the market, under certain conditions, without belonging
to a registered variety, and even if it does not comply with the requirements
concerning registration of varieties, namely distinctiveness, uniformity or stability, or
the requirements concerning the satisfactory value for cultivation or those concerning
the sustainable value for cultivation. The registration of such material should take into
account its contribution to increase the genetic variability of agricultural crops, the
genetic resource basis and biodiversity in the Union, as well as to the sustainability of
agriculture and thus to the adaptation to climate change. The methodology for the
registration should particularly take into account those specific characteristics and it
should be based on the minimum possible burden for operators who wish to register
such material. It would also be appropriate and proportionate to exempt from the same
requirement rootstocks, as they have a significant commercial and practical value for
the sectors where they are used, but they frequently do not fulfil the definition of a
variety.
(18) Rules should be set out for the certification of plant reproductive material, as well as
for the activities aiming at verifying the reliability of certification at the postEN
15 EN
certification stage, to ensure the fulfilment of the applicable quality requirements.
Those rules should be adapted to the technical and scientific developments.
(19) The quality requirements and certification schemes should take into account
international recommendations, such as the Seed Scheme Rules and Regulations of the
Organisation for Economic Co-operation and Development (OECD), the seed potato
standards of the United Nations Economic Commission for Europe (UNECE) and the
rules on sampling and testing of the International seed testing association (ISTA).
(20) Given the thresholds established for the presence of quality pests by Regulation (EU)
No …/… (Office of Publication, please insert number of Regulation on protective
measures against pests of plants) on protective measures against pests of plants19, it is
appropriate to establish detailed inspection and examination procedures leading to a
single certification as regards compliance with the requirements adopted pursuant to
this Regulation and to Regulation (EU) No. …/… (Office of Publication, please insert
number of Regulation on protective measures against pests of plants).
(21) In order to ensure the maximum possible purity of the material and the homogeneity of
production, plant reproductive material belonging to listed genera or species should be
kept in separate lots.
(22) In view of the diversity of plant reproductive material, professional operators should
have the option to produce and make available on the market plant reproductive
material in the form of individual plants, packages, containers or bundles.
(23) Rules should be adopted for the labelling of plant reproductive material of listed
genera or species to ensure the appropriate identification of that material. In the case of
material of the categories subject to certification, the label (hereinafter: ‘official label’)
should be produced and affixed by authorised professional operators and under the
official supervision of the competent authorities. However, and since certain
professional operators may not have the resources to carry out the certification
activities and issue official labels, it should be provided that official labels may be
issued by competent authorities upon request of professional operators.
(24) For the preservation of the natural environment in the context of the conservation of
genetic resources, it is desirable to allow the mixture of plant reproductive material
belonging to listed genera or species with non-listed genera or species. Those mixtures
should be permitted only if their composition is naturally linked to a certain region. In
order to ensure transparency and better control concerning the quality of the mixtures
concerned, the production and making available on the market of those mixtures
should be subject to the authorisation by the competent authorities.
(25) Rules should be adopted for the import of plant reproductive material of listed genera
or species into the Union, only allowing the import of plant reproductive material
fulfilling the same production and quality requirements as for material produced and
made available on the market in the Union.
(26) To ensure flexibility, and facilitate adaptation of the professional operators and the
markets to specific circumstances, or in cases of temporary supply difficulties, it is
appropriate to provide for certain derogations from the general rules of this
Regulation. Those derogations should be granted under specific conditions to avoid
19 (Office of Publication, please insert OJ reference number of Regulation on protective measures against
pest of plants).
EN 16 EN
abuses and to ensure that the overall purposes of this Regulation are respected. They
should concern plant reproductive material belonging to varieties, the registration of
which is pending, plant reproductive material which is not finally certified or not
certified as complying with applicable germination requirements. The possibility
should also exist to adopt emergency measures to address risks for human, animal and
plant health, and the environment.
(27) Plant reproductive material which is made available on the market only in limited
quantities by small producers (“niche market plant reproductive material”) should be
exempted from the requirement of belonging to a registered variety. That derogation is
necessary to prevent undue constraints to the making available on the market of plant
reproductive material, which is of lesser commercial interest, but is important for the
maintenance of genetic diversity. However, it should be ensured that that derogation is
not regularly used by a wide range of professional operators and it is only used by
professional operators which cannot afford the costs and administrative burden of
variety registration. This is important to avoid abuses of that derogation and to ensure
the application of the rules of this Regulation. Therefore, niche market material should
only be made available on the market by professional operators employing a small
number of persons and with a small annual turnover.
(28) It is desirable to organise temporary experiments for the purpose of seeking improved
alternatives to any measures adopted for listed genera or species. In the organisation of
those experiments the evolution of techniques relating to the production and control of
plant reproductive material should be taken into account.
(29) Exported plant reproductive material of listed genera or species to third countries
should comply with the rules on plant reproductive material produced and made
available on the market in the Union, unless the material concerned is subject to
bilateral or multilateral agreements or rules of third countries.
(30) Basic requirements should be set for plant reproductive material not belonging to
listed genera or species, to ensure minimum quality and identification standards for
their production and making available on the market.
(31) In order to ensure that all varieties have access to registration and are subject to
common rules and conditions rules should be established for the registration of
varieties and should apply to varieties of listed genera or species as well as to varieties
of non-listed species.
(32) Experience so far has shown that some breeders are interested in making available on
the market their varieties in the entire Union market, or in the bigger part of it. It is
therefore appropriate to offer the breeders the option of registering their varieties
either in a national variety register or in a Union variety register. The task of
establishing , publishing and updating the Union variety register should be assigned to
the European Agency on Plant Varieties (hereinafter: ‘the Agency’), previously titled
‘Community Plant Variety Office’ as established pursuant to Article 4 of Regulation
(EC) No 2100/1994 of the Council, which is currently in charge of granting plant
variety rights. The activities of the Agency should thus cover all aspects of plant
variety management.
(33) Varieties should, in principle, be registered on the basis of an official description
produced by a competent authority or the Agency. However, in order to reduce the
burden for the competent authorities and the Agency and ensure flexibility, it is
EN 17 EN
appropriate to provide for the possibility that the examinations necessary to produce
the official description may also be carried out by the applicants.
(34) Further to the basic registration requirements, varieties belonging to species with
particular importance for the development of agriculture and horticulture in the Union
should be subject to the additional requirements ensuring satisfactory and sustainable
value for cultivation or use.
(35) The requirements ensuring sustainable value for cultivation should be established at
Union level in order to support sustainable development, direct plant breeding and
meet breeders’, producer and consumer demands concerning that type of development.
The requirements ensuring satisfactory value for cultivation and use may be only
developed by Member States according to their agro-climatic and agricultural
conditions. Therefore, the respective varieties should only be registered in the national
variety registers. The requirements ensuring satisfactory value for cultivation and use
should concern yields and quality characteristics. When Member States develop and
apply such requirements, they should consider the constraints characterising specific
agricultural management practices. In particular, they should duly take into account
the specific needs of organic farming as regards resilience and low input conditions.
(36) In the context of the Convention on Biological Diversity to which the Union is a party,
the Union has committed to maintain the genetic diversity of cultivated plants, and of
wild relatives, and to minimise genetic erosion. That commitment complements the
objective of the Union to halt biodiversity loss by 2020. In that context, certain
varieties should be allowed to be produced and made available on the market even if
they do not comply with the requirements concerning distinctiveness, uniformity or
stability, to ensure their conservation and sustainable use and thus contribute to the
sustainability of agriculture and the adaptation to climate change. Therefore, those
varieties should only be registered on the basis of an officially recognised description.
(37) However, the varieties registered on the basis of an officially recognised description
should be produced in the region where they have been historically grown and
adapted, to ensure their authenticity and their added value for the conservation of
genetic diversity and the protection of the environment. Therefore, they should only be
included in national variety registers. For the same reason, those varieties should have
been available on the market and/or collected e.g. in gene banks before the entry into
force of this Regulation, or, should have been deleted for more than five years from
the national variety register or Union variety register, in case they have been registered
there on the basis of a technical examination concerning their distinctness, uniformity
and stability.
(38) Rules should be established concerning the procedures for the registration of varieties
and clones in the national variety registers to ensure uniform conditions for all
applications and a transparent framework for all interested parties.
(39) Certain varieties which are naturally adapted to the local and regional conditions and
threatened by genetic erosion, or which have no intrinsic value for commercial crop
production but have been developed for growing under particular conditions, are
already accepted in national catalogues, lists or registers of varieties pursuant to
Article 3 of Directive 2008/62/EC of the Commission of 20 June 2008 providing for
certain derogations for acceptance of agricultural landraces and varieties which are
naturally adapted to the local and regional conditions and threatened by genetic
EN 18 EN
erosion and for marketing of seed and seed potatoes of those landraces and varieties20,
and pursuant to Article 3(1) of Directive 2009/145/EC of the Commission of 26
November 2009 providing for certain derogations, for acceptance of vegetable
landraces and varieties which have been traditionally grown in particular localities and
regions and are threatened by genetic erosion and of vegetable varieties with no
intrinsic value for commercial crop production but developed for growing under
particular conditions and for marketing of seed of those landraces and varieties21.
Those varieties have not been subject to complete technical examination concerning
their distinctiveness, uniformity or stability. It is therefore appropriate that those
varieties be registered directly in the national variety registers without any further
proceedings as varieties with an officially recognised description.
(40) The Union variety register should also include all varieties that are registered in the
national variety registers. In this way, it will be ensured that the Union variety register
offers a transparent overview of all varieties registered in the Union.
(41) Rules should be adopted for the registration of varieties and clones in the Union
variety register. For the purposes of consistency, those rules should be similar to the
rules on registration in national variety registers.
(42) The competent national authorities and the Agency should charge fees for the
processing of applications, the formal and technical examinations and for each year of
the registration period. This would be necessary to ensure the necessary resources for
the overall system of registration of varieties, and that the main beneficiaries of that
registration bear the costs for the functioning of that system. Rules concerning the
fixing of those fees should be set out in this Regulation.
(43) In order to facilitate the registration of varieties which serve at combating genetic
erosion in the Union, Member States should apply a reduced fee for varieties with
officially recognised description and for heterogeneous material. Such reduced fees
should be sufficiently low as not to constitute a deterrent or a barrier to the making
available on the market of those varieties. In order to provide support to microenterprises,
they should be fully exempted from the payment of fees.
(44) In order to protect the commercial interests and intellectual property of professional
operators, the results of the examination and the description of the genealogical
components should be treated as confidential, if the breeder so requests. For the sake
of transparency, all descriptions of varieties listed in the national variety registers or in
the Union variety register should be made publicly available.
(45) Forests cover a large area of the Union and fulfil social, economic, environmental,
ecological and cultural functions. There is, therefore, a need for specific approaches
and actions for the different types of forests, considering the wide range of conditions
characterising the forests in the Union.
(46) Forest reproductive material of tree species and artificial hybrids which are important
for forestry purposes should be genetically suited to local conditions and of high
quality. The conservation and enhancement of biodiversity of forests, including the
genetic diversity of the trees, are essential to sustainable forest management.
20 OJ L 162, 21.6.2008, p. 13–19.
21 OJ L 312, 27.11.2009, p. 44–54.
EN 19 EN
(47) Requirements should be set for forest reproductive material as regards basic material,
categories under which the material may be made available on the market, lots,
labelling, small packages, to ensure the appropriate quality and marketing standards,
and to adapt to the technical and scientific developments of the sector.
(48) In order to ensure flexibility and adaptation to particular circumstances, derogations
should be provided, under conditions, for the production and making available on the
market of forest reproductive material. Those derogations should concern the
possibility for Member States to adopt more stringent requirements, the case of
temporary difficulties of supply, the need of making seed rapidly available on the
market, the conduct of temporary experiments and the adoption of emergency
measures.
(49) In order to serve the interest of conservation and sustainable use of forestry plant
genetic resources, Member States should be allowed to adopt less stringent
requirements on forest reproductive material which is naturally adapted to the local
and regional conditions and threatened by genetic erosion.
(50) The competent authorities should charge fees for the registration/approval of basic
forest material and the issuance of master certificates for the forest material derived
from registered/approved basic forest material. This would be necessary to ensure the
necessary resources for the certification of forest reproductive material, and that the
main beneficiaries of that certification bear the respective costs. In order to provide
support to micro-enterprises, they should be fully exempted from the payment of fees.
The rules concerning those fees should be set out in this Regulation, as they concern
the effective production, registration and making available on the market of forest
reproductive material.
(51) Regulation (EC) No 2100/1994 needs to be amended to include variety registration in
the mission of the Agency and to amend its former title ‘Community Plant Variety
Office’.
(52) In order to ensure that the Annexes of this Regulation are adapted to the technical and
scientific developments, the power to adopt acts in accordance with Article 290 TFEU
should be delegated to the Commission in respect of amending the Annexes of this
Regulation.
(53) In order to follow the technical and economic developments of the sector, the power to
adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission in respect of listing the genera or species whose plant reproductive
material may not be placed on the market as standard material.
(54) In order to follow the technical and economic developments of the sector, the power to
adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission in respect of setting out the plant reproductive material which may be
produced and made available on the market without belonging to a registered variety,
and the requirements for its production and making available on the market.
(55) In order to ensure that plant reproductive material of listed genera or species, and
certain types of forest reproductive material, fulfils the highest possible identity,
quality and health requirements, as appropriate for the characteristics of the genera,
species or categories concerned, the power to adopt acts in accordance with Article
290 TFEU should be delegated to the Commission in respect of adopting production
and quality requirements, and certification schemes, for those genera or species, and in
respect of adopting quality requirements for making available on the market specific
EN 20 EN
parts of plants and planting stock of species and artificial hybrids of forest
reproductive material.
(56) In order to ensure that plant reproductive material is made available on the market
under conditions adapted to the specific characteristics of particular genera or species
to which it belongs, the power to adopt acts in accordance with Article 290 TFEU
should be delegated to the Commission in respect of the maximum size, composition
and identification of lots, and the requirements concerning small packages, of plant
reproductive material belonging to particular genera or species.
(57) In order to adapt the rules concerning the official labels and operators’ labels to the
characteristics of certain types of plant reproductive material, the power to adopt acts
in accordance with Article 290 TFEU should be delegated to the Commission in
respect of setting out additional rules concerning the label for specific categories and
other groups of plant reproductive material, indications concerning a label number,
indications of generations of pre-basic, basic, certified and standard material, the
indication of variety types including intraspecific or interspecific hybrids, the
indication of subdivisions of categories satisfying different conditions, in case of
mixtures, the indication of the percentage by weight of the various components by
species and, where appropriate, by variety, and indications concerning the intended
use of the material.
(58) In order to ensure the ability of the professional operators to properly carry out a
reliable certification of the plant reproductive material concerned, the power to adopt
acts in accordance with Article 290 TFEU should be delegated to the Commission in
respect of setting out more detailed requirements concerning the qualification of
professional operators and of the inspectors which may be entrusted with certification
activities, suitability of premises and availability of particular equipment to be used by
the professional operators and laboratories.
(59) In order to ensure updated standards for the official supervision of certification carried
out by operators as appropriate for the characteristics of particular genera or species,
the power to adopt acts in accordance with Article 290 TFEU should be delegated to
the Commission in respect of setting out more detailed requirements concerning the
way competent authorities must supervise the certification.
(60) In order to ensure updated standards for post-certification as appropriate for the
characteristics of particular genera or species, the power to adopt acts in accordance
with Article 290 TFEU should be delegated to the Commission in respect of setting
out requirements concerning proportion of samples to be submitted to tests and
concerning testing procedures.
(61) In order to ensure that mixtures of plant reproductive material are produced and made
available on the market pursuant to the appropriate quality requirements per genera
and species, and in order to ensure informed choices for their users, the power to adopt
acts in accordance with Article 290 TFEU should be delegated to the Commission in
respect of adopting rules concerning the production and making available on the
market of mixtures of plant reproductive material belonging to different genera or
species listed in Annex I, or different varieties of those genera or species, and in
respect of adopting rules concerning mixture of plant reproductive material belonging
to genera or species listed in Annex I, with plant reproductive material belonging to
genera or species not listed in Annex I.
EN 21 EN
(62) In order to ensure that plant reproductive material belonging to varieties, registration
of which is pending, is made available on the market in a transparent manner and to a
limited extent only, the power to adopt acts in accordance with Article 290 TFEU
should be delegated to the Commission in respect of setting out requirements
concerning labelling of packages and the maximum authorised quantities which may
be made available on the market for specific genera or species.
(63) In order to ensure that niche market material is made available on the market in a
limited and transparent manner, the power to adopt acts in accordance with Article 290
TFEU should be delegated to the Commission in respect of setting out the maximum
size of packages, containers or bundles, and requirements concerning traceability, lots,
and labelling of the niche market material concerned.
(64) It is important to ensure that plant reproductive material not finally certified, and seed
not confirmed as complying with germination requirements, can be produced and
made available on the market under particular conditions. Therefore, the power to
adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission in respect of setting out specific rules for plant reproductive material
concerning the packages, containers and bundles, rules on small packages and
containers, the labelling of that material, the duration of period in which such seed
may be made available on the market, and the content of the provisional analytical
reports concerning germination.
(65) It is important to ensure that plant reproductive material imported from third countries
fulfils the requirements of this Regulation. Therefore, the power to adopt acts in
accordance with Article 290 TFEU should be delegated to the Commission, in respect
of deciding whether plant reproductive material of specific genera, species οr
categories produced in a third country, or particular areas of a third country, fulfils
requirements equivalent with those applicable to plant reproductive material produced
and made available on the market in the Union.
(66) It is important to ensure that the production and making available on the market of
plant reproductive material of particular genera or species responds to increased
requirements of the society concerning their agricultural performance and quality
characteristics for processing. In order to follow the technical and economic
developments of the sector, the power to adopt acts in accordance with Article 290
TFEU should be delegated to the Commission in respect of listing the genera or
species with particular importance for the satisfactory and sustainable development of
agriculture in the Union.
(67) In order to ensure updated standards for the registration of varieties as appropriate for
the characteristics of genera or species with particular importance for the sustainable
development of agriculture in the Union, the power to adopt acts in accordance with
Article 290 TFEU should be delegated to the Commission in respect of setting out
rules for the registration of varieties of those genera or species concerning resistance to
pests, reduced need for input of specific resources, decreased content of undesirable
substances and increased adaptation to divergent agro-climatic environment.
(68) In order to ensure updated conditions for the suitability of variety denominations in
particular cases, the power to adopt acts in accordance with Article 290 TFEU should
be delegated to the Commission in respect of setting out rules concerning the relation
of denominations to trade marks, their relation to geographical indications or
designations of origin for agricultural products, written consents of holders of prior
rights to remove impediments to the suitability of a denomination, specific criteria to
EN 22 EN
determine whether a denomination is misleading or confusing, and the use of a
denomination in the form of a code.
(69) It is important to ensure that plant reproductive material belonging to clones may only
be produced and placed on the market if it fulfils particular quality and health
requirements, and also belongs to genera or species which have a particular value for
particular market sectors. Therefore, the power to adopt acts in accordance with
Article 290 TFEU should be delegated to the Commission in respect of adopting
quality and health requirements for clones of particular genera or species, and in
respect of listing the genera or species, to which the clones must belong in order to be
made available on the market.
(70) In order to ensure that the information provided in the applications for registration of
varieties remain up to date to the developments of the sector, and is relevant to the
particular features of the varieties belonging to those genera or species, the power to
adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission in respect of setting out additional items to be included in the application
for particular genera or species.
(71) In order to ensure updated standards for the audits by the Agency and the competent
authorities of premises of technical examinations and of the organisation of those
examinations, the power to adopt acts in accordance with Article 290 TFEU should be
delegated to the Commission in respect of setting out rules concerning those audits.
(72) In order to ensure updated standards for the technical examinations of varieties, the
power to adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission in respect of setting out rules concerning obligations for the qualification
and training of the staff of competent authorities or the applicants, the equipment
necessary to carry out the technical examination, the establishment of variety reference
collections, the establishment of quality management systems, and the conduct of
growing trials and laboratory tests for particular genera or species.
(73) In order to ensure proportionate, fair and updated amounts for the fees to be paid by
the applicants for the registration of a variety in the Union variety register, the power
to adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission in respect of setting out the amount of the fees to be paid by the
applicant.
(74) In order to ensure a comprehensive submission of information for particular categories
or species of forest reproductive material, the power to adopt acts in accordance with
Article 290 TFEU should be delegated to the Commission in respect of setting out
conditions under which the operator’s label be supplemented by another document
produced by the professional operator.
(75) In order to avoid risks in relation to quality and health of the forest reproductive
material concerned, the power to adopt acts in accordance with Article 290 TFEU
should be delegated to the Commission in respect of supplementing the requirements
set out in this Regulation concerning clones and clonal mixtures, by determining the
maximum number of years or the maximum number of ramets to which the approval
of clones or clonal mixtures should be restricted.
(76) In order to ensure that the exemption of small quantities of seeds of forest reproductive
material, from the information requirements concerning germination or viability, is
applied in a proportionate manner, the power to adopt acts in accordance with Article
290 TFEU should be delegated to the Commission in respect of setting out the
EN 23 EN
maximum quantities of those small quantities for particular types of forest
reproductive material.
(77) In order to ensure that the cost items for the fees charged by the competent authorities
on the registration of approved basic forest material and the issuance of master
certificates are appropriate to the conducted work and updated, the power to adopt acts
in accordance with Article 290 TFEU should be delegated to the Commission in
respect of setting out those items.
(78) It is of particular importance that the Commission carry out appropriate consultations
during its preparatory work for the adoption of delegated acts, including at expert
level. The Commission, when preparing and drawing-up delegated acts, should ensure
a simultaneous, timely and appropriate transmission of relevant documents to the
European Parliament and to the Council.
(79) Implementing powers should be conferred on the Commission in order to ensure
uniform conditions for the implementation of the provisions of this Regulation
concerning the following:
(a) authorisation of Member States to adopt more stringent requirements than
those adopted pursuant to this Regulation concerning plant reproductive
material of listed genera or species and forest reproductive material of listed
species and artificial hybrids,
(b) adoption of emergency measures,
(c) authorisation of Member States to permit, for a maximum period of one year,
the production and making available on the market of plant reproductive
material belonging to a variety of listed genera or species not yet included in a
national variety register or in the Union register,
(d) authorisation of Member States to permit, for a maximum period of one year,
the making available on the market of plant reproductive material of listed
genera or species complying with lower requirements that those adopted
pursuant to this Regulation,
(e) the organisation of temporary experiments,
(f) the format of the national variety registers and the Union variety register,
(g) the format for the application for the registration of varieties,
(h) modalities concerning the submission of notifications concerning the
registration of varieties,
(i) the form of national lists concerning forest reproductive material,
(j) the format of the notification of inclusion of forest reproductive material in the
national list, and
(k) the format of master certificates for forest reproductive material.
(80) Those implementing powers should be exercised in accordance with Regulation (EU)
No 182/2011 of the European Parliament and of the Council of 16 February 2011
laying down the rules and general principles concerning mechanisms for control by
Member States of the Commission’s exercise of implementing powers.
(81) This Regulation respects the fundamental rights and observes the principles recognised
in particular by the Charter of Fundamental Rights of the European Union and notably
respect for private and family life, the right to property, the protection of personal data,
EN 24 EN
freedom to conduct business and the freedom of art and science. This Regulation
should be applied by the Member States in accordance with those rights and
principles.
(82) Since the objective of this Regulation, namely to establish the rules concerning
production and making available on the market of plant reproductive material to
ensure quality of the material and informed choices for the users, cannot be
sufficiently achieved by the Member States and can therefore, by reason of its effect,
complexity, trans-border and international character, be better achieved at Union level,
the Union may adopt measures, in accordance with the principle of subsidiarity as set
out in Article 5 of the Treaty on European Union. In accordance with the principle of
proportionality, as set out in that Article, this Regulation does not exceed what is
necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
EN 25 EN
PART I
GENERAL PROVISIONS
Article 1
Scope
This Regulation lays down rules on:
(a) the production, with a view to making available on the market, of plant reproductive
material; and
(b) the making available on the market of plant reproductive material.
Article 2
Exclusions
This Regulation shall not apply to plant reproductive material:
(a) intended solely for testing or scientific purposes;
(b) intended solely for breeding purposes;
(c) intended solely for, and maintained by, gene banks, organisations and networks of
conservation of genetic resources, or persons belonging to those organisations or
networks;
(d) exchanged in kind between persons other than professional operators.
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1) ‘plants’ means plants as defined in Article 2(1) of Regulation (EU) No …/… (Office
of Publications, please insert number of Regulation on protective measures against
pests of plants) on protective measures against pests of plants;
(2) ‘plant reproductive material’ means plant(s) capable of, and intended for, producing
entire plants;
(3) ‘mother plant’ means an identified plant from which plant reproductive material is
taken for reproduction of new plants;
(4) ‘generation’ means a group of plants constituting a single step in the line of descent of
plants;
(5) ‘making available on the market’ means the holding for the purpose of sale within
the Union, including offering for sale or for any other form of transfer, and the sale,
distribution, import into, and export out of, the Union and other forms of transfer,
whether free of charge or not;
(6) ‘professional operator’ means any natural or legal person carrying out, as a
profession, at least one of the following activities with regard to plant reproductive
material:
(a) producing;
(b) breeding;
EN 26 EN
(c) maintaining;
(d) providing services;
(e) preserving, including storing; and
(f) making available on the market.
(7) ‘competent authorities’ means competent authorities as defined in accordance with
Article 2(5) of Regulation (EU) No …/…. [Office of Publication, please insert
number of Regulation on Official Controls];
(8) ‘genetically modified organism’ means a genetically modified organism as defined in
Article 2(2) of Directive 2001/18/EC;
(9) ‘forest reproductive material’ means plant reproductive material intended for forestry
purposes;
(10) ‘lot’ means a unit of plant reproductive material, identifiable by its homogeneity of
composition and origin.
Article 4
Free circulation
Plant reproductive material shall be subject to no restrictions concerning its production and
making available on the market, other than those laid down in this Regulation, in Directive
94/62/EC, Regulation (EC) No 338/97, Directive 2001/18/EC, Regulation (EC) No
1829/2003, Regulation (EC) No 1830/2003, Regulation (EU) No …/… [Office of Publication,
please insert number of Regulation on protective measures against pests of plants] and in
Union legislation restricting the production or making available on the market of invasive
alien species.
EN 27 EN
PART II
PROFESSIONAL OPERATORS
Article 5
Registers of professional operators
Professional operators shall be registered in the registers referred to in Article 61 of
Regulation (EC) No …/… (Office of Publication, please insert number of Regulation on
protective measures against pests of plants) in accordance with the provisions of Article 62 of
that Regulation.
Article 6
General responsibilities of professional operators
Professional operators shall ensure that plant reproductive material produced and made
available on the market under their control fulfils the requirements of this Regulation.
Article 7
Specific responsibilities of professional operators producing plant reproductive material
Professional operators producing plant reproductive material shall:
(a) be available personally, or designate a person, to liaise with the competent authorities
for the purpose of facilitating the official controls;
(b) identify and monitor the critical points of the production process, or of the making
available on the market, which may influence the quality of the plant reproductive
material;
(c) keep records of the monitoring of the critical points referred to in point (b), which
shall be available for examination when requested by the competent authorities;
(d) ensure that lots remain separately identifiable;
(e) keep updated information on the premises and other locations used for the production
of plant reproductive material;
(f) make sure that competent authorities have access to the premises of production,
including premises and fields of third contracting parties, and to the records of the
monitoring and all related documents;
(g) take measures, where appropriate, for the maintenance of the identity of the plant
reproductive material in accordance with the applicable requirements of this
Regulation;
(h) make available to the competent authorities, on request, any contracts with third
parties.
Article 8
Traceability
1. Professional operators shall ensure that plant reproductive material is traceable at all
stages of production and making available on the market.
EN 28 EN
2. For the purpose of paragraph 1, professional operators shall keep information
allowing them to identify the professional operators, which have supplied them with
plant reproductive material, and the material concerned.
On request, they shall make such information available to the competent authorities.
3. For the purpose of paragraph 1, professional operators shall keep information
allowing them to identify the persons to whom they have supplied plant reproductive
material and the material concerned, unless that material has been supplied in retail.
On request, they shall make such information available to the competent authorities.
4. In the case of plant reproductive material, other than forest reproductive material,
professional operators shall keep records of the plant reproductive material referred
to in paragraphs 2 and 3 for three years after that material has been respectively
supplied to or by them.
In the case of forest reproductive material, the respective period shall be ten years.
EN 29 EN
PART III
PLANT REPRODUCTIVE MATERIAL OTHER THAN
FOREST REPRODUCTIVE MATERIAL
TITLE I
General Provisions
Article 9
Scope
This Part shall apply to the production, with a view to making available on the market, and to
the making available on the market of plant reproductive material other than forest
reproductive material.
Article 10
Definitions
For the purposes of this Part, the following definitions shall apply:
(1) ‘variety’ means a plant grouping within a single botanical taxon of the lowest known
rank, which fulfils all of the following requirements:
(a) it is defined by the expression of the characteristics that results from a given
genotype or combination of genotypes;
(b) it is distinguished from any other plant grouping by the expression of at least
one of the characteristics referred to in point (a); and
(c) it is considered as a unit with regard to its suitability for being reproduced
unchanged;
(2) ‘official description’ means a variety description that has been produced by a
competent authority, includes the specific characteristics of the variety and makes the
variety identifiable by examination of its distinctiveness, uniformity and stability;
(3) ‘officially recognised description’ means a description of a variety, which has been
recognised by a competent authority, includes the specific characteristics of the
variety, makes it identifiable and has been obtained by means other than examination
of the variety’s distinctiveness, uniformity and stability pursuant to the rules
applicable at the time of registration of that variety in accordance with Article 79;
(4) ‘clone’ means an individual progeny, originally derived from another plant by
vegetative reproduction, which remains genetically identical to the latter;
(5) ‘variety maintenance’ means the actions to ensure that a variety remains consistent
with its description;
(6) ‘pre-basic material’ means plant reproductive material which is at the first step of
production and is intended for the production of other categories of plant
reproductive material;
(7) ‘basic material’ means plant reproductive material which has been produced from
pre-basic material, and is intended for the production of certified material;
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(8) ‘certified material” means plant reproductive material which has been produced from
pre-basic or basic material;
(9) ‘standard material’ means plant reproductive material other than pre-basic, basic or
certified material;
(10) ‘category’ means pre-basic material, basic material, certified material or standard
material.
TITLE II
Production and making available on the market of plant
reproductive material belonging to genera and species listed in
Annex I
CHAPTER I
Introductive Provisions
Article 11
Scope
1. This Title shall apply to the production and making available on the market of plant
reproductive material belonging to genera and species which comply with one or
more of the following criteria:
(a) they represent a significant area of production;
(b) they represent a significant value of production;
(c) they are produced or made available on the market by a significant number of
professional operators in the Union;
(d) they contain substances which, for all or particular uses, must be subject to
particular rules concerning the protection of human and animal health, and the
environment.
2. The genera and species referred to in paragraph 1 are listed in Annex I.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, amending Annex I in order to adapt it to the developments of technical
knowledge, scientific knowledge and economic data.
4. This Title shall also apply to rootstocks and other parts of plants (hereinafter jointly
referred to as “rootstocks”), which belong to genera and species not listed in Annex I,
if material of one of the genera or species listed in Annex I, or their hybrids, is
grafted on them.
Article 12
Categories of plant reproductive material
1. Plant reproductive material may only be produced and made available on the market,
under one of the following categories:
(a) pre-basic material,
(b) basic material,
EN 31 EN
(c) certified material,
(d) standard material.
2. Plant reproductive material may not be produced and made available on the market
as standard material, if it belongs to genera or species for which the costs and
certification activities necessary to produce and make available on the market plant
reproductive material as pre-basic, basic and certified material are proportionate:
(a) to the purpose of ensuring food and feed security; and
(b) to the higher level of identity, health and quality of the plant reproductive
material which result from the fulfilment of the requirements for pre-basic,
basic and certified material compared to those for standard material.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, listing the genera or species whose plant reproductive material may not
be placed on the market as standard material, as referred to in paragraph 2.
4. By way of derogation to paragraph 2 and 3, plant reproductive material shall only be
produced and made available on the market as standard material if one or more of the
following cases apply:
(a) it belongs to a variety provided with an officially recognised description;
(b) it is heterogeneous material in the meaning of Article 14(3);
(c) it is niche market material in the meaning of Article 36(1).
CHAPTER II
Requirements for the production and making available on the
market
SECTION 1
LIST OF REQUIREMENTS
Article 13
Production and making available on the market of pre-basic, basic, certified and standard
material
1. Plant reproductive material produced and made available on the market shall comply
with:
(a) the registration requirements set out in Section 2;
(b) the production and quality requirements set out in Section 3 for the relevant
category;
(c) the handling requirements set out in Section 4;
(d) the identification, and, where applicable, certification requirements set out in
Section 5.
2. Paragraph 1(b) shall not apply to production requirements of plant reproductive
material referred to in Article 14(3) and Article 36.
EN 32 EN
Article 14
Requirement to belong to registered varieties
1. Plant reproductive material may be produced and made available on the market only
if it belongs to a variety registered in a national variety register referred to in Article
51 or in the Union variety register referred to in Article 52.
2. By way of derogation to paragraph 1 of this Article, rootstocks may be produced and
made available on the market without belonging to a variety registered in a national
variety register or in the Union variety register.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out that, by way of derogation to paragraph 1 of this Article,
plant reproductive material may be produced and made available on the market
without belonging to a variety in the meaning of point (1) of Article 10 (‘hereafter
‘heterogeneous material’) and not fulfilling the requirements on distinctiveness,
uniformity and stability as set out in articles 60, 61 and 62 and satisfactory value for
cultivation and/or use or sustainable value for cultivation and/or use as set out in
articles 58 and 59.
Those delegated acts may set out one or more of the following for heterogeneous
material:
(a) rules on labelling and packaging;
(b) rules concerning description of the material, including the breeding methods
and parental material used, description of the production scheme for the plant
reproductive material and availability of standard samples;
(c) rules relating to information and samples of production to be kept by the
professional operators and the maintenance of the material;
(d) establishment by the competent authorities of registers for heterogeneous
material, modalities for registration and content of those registers;
(e) establishment of fees, and cost items for the calculation of those fees,
concerning the registration of heterogeneous material referred to in point (d) in
a manner ensuring that the fee does not constitute a barrier to the registration of
the heterogeneous material concerned.
Those delegated acts shall be adopted by [Office of Publications, please insert date
of application of this Regulation…]. They may be adopted per particular genera or
species.
Article 15
Requirement to belong to registered clones
Plant reproductive material belonging to a clone may be produced and made available on the
market only if that clone is registered in a national variety register referred to in Article 51 or
in the Union variety register referred to in Article 52.
EN 33 EN
SECTION 2
PRODUCTION AND QUALITY REQUIREMENTS
Article 16
Production and quality requirements for plant reproductive material
1. Plant reproductive material shall be produced in accordance with the production
requirements set out in Part A of Annex II and shall be made available on the market
only if it fulfils the quality requirements set out in Part B of Annex II.
2. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, supplementing the requirements referred to in paragraph 1. Where
appropriate, those delegated acts may specify those requirements set out in Part D of
Annex II.
3. Those delegated acts shall take into account the relevant international technical and
scientific standard recommendations:
(a) the Seed Scheme Rules and Regulations of the Organisation for Economic Cooperation
and Development (hereinafter: ‘OECD’);
(b) the seed potato standards of the United Nations Economic Commission for
Europe (hereinafter: ‘UNECE’);
(c) the rules on sampling and testing of the International Seed Testing Association
(hereinafter ‘ISTA’); and
(d) the rules of the European and Mediterranean Plant Protection Organisation
(EPPO).
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, amending Part A and Part B of Annex II to adapt them to the technical
and scientific developments.
SECTION 3
HANDLING REQUIREMENTS
Article 17
Lots
1. Plant reproductive material shall be made available on the market in lots. Those lots
shall be sufficiently homogeneous and identified as distinct from other lots of plant
reproductive material.
2. During processing, packaging, storage, transport or at delivery, lots of plant
reproductive material of different origins may be merged into a new lot. In that case
the professional operator shall keep records including data about the origin of the
individual components of the new lot.
3. During processing, packaging, storage, transport or at delivery, lots of plant
reproductive material may be split into two or more lots. In that case the professional
operator shall keep records concerning the origin of the new lots.
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, establishing additional rules for particular genera or species in relation to
one or more of the following elements:
EN 34 EN
(a) maximum size of lots to ensure homogeneity of the plant reproductive material
concerned;
(b) composition of lots to ensure the maintenance of the identity of the plant
reproductive material concerned;
(c) identification of lots to ensure the traceability of the plant reproductive material
concerned.
Article 18
Packages, containers and bundles, and rules on small packages and containers
1. Plant reproductive material shall be made available on the market as individual
plants, or in packages, containers or bundles.
2. Packages and containers shall be closed in such a way that they cannot be opened
without damaging the closure and, in the case of packaging, without the packaging
showing signs of tampering.
3. Bundles shall be tied up in such a way that the material forming parts of the bundles
cannot be separated without damaging the tie or ties.
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out rules for specific genera or species one or more of the
following elements:
(a) the closure, including sealing or resealing, of packages, containers or bundles
to ensure the identity of the plant reproductive material concerned and to avoid
uncontrolled mixtures of lots;
(b) the establishment of a requirement that plant reproductive material is to be
made available on the market only in packages, containers or bundles in order
to facilitate the traceability of the lots concerned.
5. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out specific rules for the production and making available on the
market of particular genera or species in small packages, containers or bundles.
Those rules may concern one or more of the following elements:
(a) maximum size and volume of the small packages, containers or bundles;
(b) colour and content of labels, and methods of labelling, of the small packages,
containers or bundles;
(c) examination of the small packages, containers or bundles and the contained
plant reproductive material;
(d) closure of the small packages.
SECTION 4
CERTIFICATION, IDENTIFICATION AND LABELLING REQUIREMENTS
Article 19
Certification and identification of pre-basic, basic or certified material, and identification
of standard material
1. Pre-basic, basic or certified material shall be certified and identified through an
official label (‘official label’).
EN 35 EN
2. Official labels shall certify that pre-basic, basic or certified material complies with
the relevant production and quality requirements as referred to in Article 16.
3. The certification referred to in paragraphs 1 and 2 shall be based on field inspections,
sampling and testing carried out in accordance with the rules referred to in Article 20
(hereinafter: ‘certification schemes’) and with the provisions of Articles 22 to 26.
4. Standard material shall be identified through an operator’s label (‘operator’s label’).
5. Operators’ labels shall attest that standard material complies with the relevant quality
requirements as referred to in Article 16.
Article 20
Certification schemes
1. The certification schemes for pre-basic, basic or certified material are set out in Part
C of Annex II.
2. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, supplementing the certification schemes. Where appropriate, those
delegated acts may specify those schemes, as set out in Part D of Annex II.
3. Those delegated acts shall take into account the applicable international technical and
scientific standard recommendations such as:
(a) the Seed Scheme Rules and Regulations of OECD;
(b) the seed potato standards of UNECE;
(c) the rules on sampling and testing of ISTA; and
(d) the rules of EPPO.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, amending Part C and Part D of Annex II to adapt them to the technical
and scientific developments.
Article 21
Content of the official label and operator’s label
1. The official label and the operator’s label shall contain the information set out in Part
A of Annex III.
2. The official label and the operator’s label shall be written in one of the official Union
languages. They shall be legible, indelible, printed on one side, not previously been
used and easily visible.
3. The official label shall have a distinct colour per category of plant reproductive
material.
4. In case the issuance of a plant passport is required pursuant to Article 74(1) and
Article 75(1) of Regulation (EU) No …/… [Office of Publication, please insert
number of Regulation on protective measures against pests of plants], the official
label shall include the plant passport as set out in Article 78(3) of that Regulation.
5. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out requirements, further to the requirements referred to in
paragraphs 1 and 2, for official labels and operators’ labels. Those requirements shall
concern one or more of the following elements:
EN 36 EN
(a) the colours of the label for specific categories and other groups of plant
reproductive material;
(b) indications concerning a label number;
(c) indications of generations of pre-basic, basic, certified and standard material;
(d) the indication of variety types including intraspecific or interspecific hybrids;
(e) the indication of subdivisions of categories satisfying different conditions;
(f) in case of mixtures, the indication of the percentage by weight of the various
components by species and, where appropriate, by variety;
(g) indications concerning the intended use of the material.
6. This Article shall apply without prejudice to Article 49(4) of Regulation (EC) No
1107/2009 concerning the label and the documents accompanying treated seeds in
the meaning of that Regulation.
7. The Commission shall, by means of implementing acts, adopt the format(s) of the
official label and operator’s label. Those formats may be adopted per genera or
species. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 141(3).
Article 22
Responsibility to produce and affix official labels
The official labels shall be produced and affixed by:
(a) the professional operator, under the official supervision of the competent authority;
or
(b) the competent authority, if requested so by the professional operator, or if the
professional operator concerned is not authorised pursuant to Article 23.
Article 23
Authorisation of professional operators to carry out certification and produce official labels
1. Professional operators may be authorised by the competent authority to carry out the
certification and produce the official labels under official supervision, as referred to
in point (a) of Article 22, only if they fulfil all of the following conditions:
(a) they possess the necessary knowledge to fulfil the production and quality
requirements and comply with the certification schemes adopted pursuant to
Articles 16(2) and 20(2), and, where applicable, fulfil the requirements adopted
pursuant to point (a) of paragraph 3 of this Article;
(b) they possess, or have access to, adequate equipment and laboratories to apply
correctly and efficiently the requirements referred to in Articles 16(2) and
20(2), in particular equipment and laboratories complying with the
requirements adopted pursuant to point (b) and (c) of paragraph 3;
(c) they have identified, and have the capability to monitor, the critical points of
the production process which may influence the quality and identity of the
plant reproductive material, and keep records of the results of that monitoring;
(d) they are capable to ensure that lots remain identifiable as referred to in
Article 7;
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(e) they have in place systems and provisions to ensure the fulfilment of the
traceability requirements set out in Article 8;
(f) they use appropriately qualified inspection and laboratory staff, in particular
inspection and laboratory staff, complying with the requirements adopted
pursuant to point (c) of paragraph 3.
2. The authorisation referred to in paragraph 1 may be granted for particular or all
genera or species.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, supplementing the provisions of paragraph 1, to ensure the ability of the
professional operators to properly carry out a reliable certification of the plant
reproductive material concerned. Those delegated acts may concern one or more of
the following elements:
(a) qualification, training and activities of professional operators, and of other
persons which may be entrusted, by the professional operators, with field
inspections, sampling and testing;
(b) suitability of premises and availability of particular equipment to be used by
the professional operators concerned;
(c) requirements for laboratories which may be entrusted with testing by the
professional operators.
Article 24
Official supervision by the competent authorities
1. For the purposes of the official supervision referred to in point (a) of Article 22,
competent authorities shall, at least once per year, conduct audits to ensure that the
professional operator fulfils the requirements referred to in Article 23.
2. For the purposes of the official supervision referred to in point (a) of Article 22,
competent authorities shall furthermore carry out official inspection, sampling and
testing on a proportion of the crops in the fields and the lots of plant reproductive
material, to confirm compliance of that material with the production and quality
requirements referred to in Article 16(2). That proportion shall be determined on the
basis of the potential risk of non-compliance with those requirements.
3. In addition to the inspection, sampling and testing referred to in paragraph 2, the
competent authorities may carry out further field inspections, sampling or testing, if
requested so by the professional operator.
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, supplementing the provisions of paragraphs 1, 2 and 3. Those delegated
acts may concern one or more of the following elements:
(a) the proportion of the crops in the fields to be subject to inspections, sampling
and testing, as referred to in paragraph 2, for particular genera or species;
(b) monitoring activities to be carried out by the competent authorities.
EN 38 EN
Article 25
Official labels produced by the competent authorities
Where the official labels are produced by the competent authorities, as referred to in point (b)
of Article 22, the competent authorities shall carry out all necessary field inspections,
sampling and testing in accordance with the certification schemes, adopted pursuant to Article
20(2), to confirm compliance with the production and quality requirements adopted pursuant
to Article 16(2).
Article 26
Withdrawal or modification of the authorisation
1. Where a competent authority finds, after granting the authorisation referred to in
Article 23(1), that a professional operator does not fulfil the requirements referred to
in that Article, it shall request the professional operator to take corrective actions
within a specified period of time.
2. The competent authority shall without delay withdraw, or modify as appropriate, the
authorisation if the professional operator does not apply the corrective measures
referred to in paragraph 1 of this Article within the specified period of time.
Article 27
Notification of the intended production and certification of pre-basic, basic and certified
material
Professional operators shall inform the competent authorities in due time about their intention
to produce pre-basic, basic and certified material plant reproductive material, and to carry out
the certification referred to in Article 19(1). That notification shall state the plant species and
categories concerned.
Article 28
Production of operator’s label for standard material
Operators’ labels shall be produced and affixed by the professional operator after verifying
through its own inspections, sampling and testing, that the plant reproductive material
complies with the production and quality requirements as referred to in Article 16.
Article 29
Reference to lots
1. The official label and the operator’s label shall be produced with reference to a lot.
They shall be affixed, where applicable, to individual plants or on the outside of
packages, containers and bundles.
2. If a lot is split into more lots, a new official label or operator’s label shall be issued
for each lot. If several lots are merged into a new lot, a new official label or
operator’s label shall be issued for that new lot.
EN 39 EN
CHAPTER III
Tests
Article 30
Post certification tests for pre-basic, basic and certified material
1. After the certification referred to in Article 19(1), the competent authorities may
carry out tests on the plant reproductive material (hereinafter ‘post certification tests’)
to confirm that it complies with the quality requirements as referred to in Article
16(2) and the certification schemes adopted pursuant to Article 20(2).
2. Competent authorities shall design and plan the post certification tests on the basis of
a risk analysis concerning possible non-compliance of the respective plant
reproductive material with those requirements.
3. Post certification tests shall be carried out through samples taken by the competent
authority. They shall assess the identity and purity of the plant reproductive material
concerned.
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out rules for the post certification tests of plant reproductive
material belonging to particular genera or species. Those rules shall take into account
the development of scientific and technical knowledge. They may concern the
following:
(a) the proportion of samples per genera and species and categories submitted to
tests;
(b) the testing procedure.
Article 31
Non-compliance of professional operators with quality requirements and certification
schemes
1. Where the post certification tests show that pre-basic, basic or certified material has
not been produced or made available on the market in compliance with the
production and quality requirements referred to in Article 16(2), and with the
certification schemes referred to in Article 20(2), the competent authorities shall
ensure that the professional operator concerned takes the necessary corrective
actions. Those actions shall ensure that the material concerned either complies with
those requirements or is withdrawn from the market.
2. If it is repeatedly found, during the post certification tests, that a professional
operator produces or makes available on the market plant reproductive material
which does not comply with the quality requirements referred to in Article 16(2), or
with the certification schemes referred to in Article 20, the provisions of Article
26(2) shall apply.
EN 40 EN
CHAPTER IV
Mixtures
Article 32
Mixtures of genera and species listed in Annex I
1. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, adopting rules concerning the production and making available on the
market of mixtures of plant reproductive material belonging to different genera or
species listed in Annex I, or different varieties of those genera or species. Those rules
may derogate from the following provisions:
(a) the production and quality requirements adopted pursuant to Article 16(2);
(b) the provisions of Article 17 concerning lots;
(c) the provisions of Article 18 concerning packages, containers and bundles, and
rules on small packages and containers; and
(d) the provisions of Article 21, concerning the content and format of the official
label and operator’s label.
2. The rules referred to in paragraph 1 shall concern one or more of the following
elements:
(a) maximum size and volume of lots, packages, containers or bundles;
(b) colour and content of labels;
(c) denomination of the mixture and description of the composition of the mixture;
(d) closure of packages, containers or bundles;
(e) requirements for the production and inspections of those mixtures;
(f) requirements facilitating the traceability of the percentage by weight of the
various components shown by species and, where appropriate, by variety.
Article 33
Preservation mixtures
1. Competent authorities may authorise the production and making available on the
market of a mixture of plant reproductive material belonging to genera or species
listed in Annex I, with plant reproductive material belonging to genera or species not
listed in Annex I, if that mixture fulfils both of the following conditions:
(a) it contributes to the conservation of genetic resources and the preservation of
the natural environment;
(b) it is naturally associated with a particular region (hereinafter: ‘region of
origin’). Hereinafter, such mixture is referred to as ‘preservation mixture’.
2. When a competent authority authorises the production and making available on the
market of a preservation mixture, it shall identify the region of origin taking into
account information from plant genetic resource authorities or organisations.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out, with regard to all or particular genera or species, the
following:
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(a) a procedure for the authorisation referred to in paragraph 1;
(b) requirements for the authorisation referred to in paragraph 1, further to the
requirements set out in that paragraph;
(c) requirements for the packages and containers of a preservation mixture;
(d) labelling requirements for preservation mixtures;
(e) rules on the identification of region of origin;
(f) the obligation for professional operators to report on the production and
making available on the market of preservation mixtures;
(g) the obligation for Member States to report to the Commission on the
application of the provisions of this Article.
CHAPTER V
Derogations
SECTION 1
DEROGATIONS FROM REGISTRATION REQUIREMENTS
Article 34
Plant reproductive material of varieties whose registration is pending
1. By way of derogation from Article 14(1), competent authorities may authorise
professional operators, for a specified period of time, to make available on the
market for tests and trials, on farms or other production premises, maximum
quantities of plant reproductive material belonging to a variety not registered in a
national variety register pursuant to Article 79 or the Union variety register pursuant
to Article 94(1).
2. The authorisation referred to in paragraph 1 may only be granted if the plant
reproductive material belongs to a variety for which an application has been
submitted for registration in a national variety register pursuant to Article 66 or for
registration in the Union variety register pursuant to Article 94.
3. In order to obtain the authorisation referred to in paragraph 1, the professional
operator shall submit to the competent authorities of the Member States, where the
relevant tests and trials are to take place, a request with the following information:
(a) a description of the proposed tests and trials;
(b) the objectives pursued by those proposed tests and trials;
(c) the locations in which those tests and trials are to be carried out;
(d) the provisional denomination of the variety indicated in the application for
registration;
(e) the procedure for the maintenance of the variety;
(f) information about the authority before which the application for the registration
of the variety is pending, and the reference assigned to that application;
(g) the duration of the authorisation requested;
(h) the quantities of the material to be made available on the market.
EN 42 EN
4. The Member States whose competent authorities have granted the authorisation
referred to in paragraph 1 shall inform thereof the other Member States, the
Commission and the European Agency for Plant Varieties (hereinafter: “the
Agency”).
5. By 31 March of each year, the Agency shall report to the Commission and the
Member States on the authorisations granted pursuant to paragraph 1 and the
information submitted pursuant to paragraph 3 during the preceding year.
6. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, supplementing paragraphs 1, 2 and 3 by setting out requirements
concerning the following elements:
(a) labelling of packages; and
(b) the maximum quantities which may be made available on the market for
specific genera or species pursuant to paragraph 1.
Article 35
Derogations from registration requirements in the case of temporary difficulties in supply
1. By way of derogation from Article 14(1), and in order to remove temporary
difficulties in the general supply of plant reproductive material that may occur in the
Union, the Commission may, by means of implementing acts, authorise Member
States to permit, for a maximum period of one year, the production and making
available on the market of plant reproductive material belonging to a variety not
included in a national variety register or in the Union variety register. Those
implementing acts may set out the maximum quantities which may be made
available on the market per genera or species.
2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with
the examination procedure referred to in accordance with Article 141(3).
3. The authorisations referred to in paragraph 1 shall be granted on the basis of a
reasoned request submitted by the Member State concerned.
4. Those authorisations shall only be granted if the derogation referred to in paragraph 1
is necessary and proportionate to the objective of removing the temporary difficulties
in the general supply of the plant reproductive material concerned.
5. The label of the plant reproductive material made available on the market pursuant to
paragraph 1 shall be brown. It shall state that the reproductive material in question
belongs to a non-registered variety.
Article 36
Derogations from registration requirements in the case of niche market plant reproductive
material
1. Article 14(1) shall not apply to plant reproductive material where all of the following
conditions are fulfilled:
(a) it is made available on the market in small quantities by persons other than
professional operators, or by professional operators employing no more than
ten persons and whose annual turnover or balance sheet total does not exceed
EUR 2 million;
(b) it is labelled with the indication ‘niche market material’.
EN 43 EN
That plant reproductive material is hereinafter referred to as ‘niche market material’.
2. The persons who produce niche market material shall keep records of the quantities
of the material produced and made available on the market, per genera, species or
type of material. On request, they shall make those records available to the
competent authorities.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out, with regard to the production and making available on the
market of niche material belonging to particular genera or species, one or more of the
following:
(a) the maximum size of packages, containers or bundles;
(b) requirements concerning traceability, lots and labelling of the niche market
material concerned.
(c) modalities of making available on the market.
SECTION 2
DEROGATION FROM PRODUCTION AND QUALITY REQUIREMENTS
Article 37
Reduced germination requirements, and other reduced quality requirements, in case of
temporary difficulties in supply
1. In order to remove temporary difficulties in the general supply of plant reproductive
material that may occur in a Member State, the competent authority of the Member
State concerned may authorise the making available on the market of seed with a
reduced germination rate, provided that such rate is reduced by less than 5%
compared to the germination rate required pursuant to Article 16(2).
That authorisation shall be granted, on the basis of a reasoned request submitted by
the professional operator concerned, for a specific period of time which shall not
exceed four months.
The label of the seed referred to in paragraph 1 shall indicate the actual lower
germination rate.
2. In order to remove temporary difficulties in the general supply of plant reproductive
material that may occur in a Member State, the competent authority of the Member
State concerned may authorise the making available on the market of plant
reproductive material with reduced quality requirements, other than the reduced
germination requirements as referred to in paragraph 1, compared to the quality
requirements applicable pursuant to Article 16(2).
That authorisation shall be granted, on the basis of a reasoned request submitted by
the professional operator concerned, for a specific period of time which shall not
exceed four months.
The label of the plant reproductive material made available on the market pursuant to
this paragraph shall be brown. It shall state that the reproductive material in question
complies with lower quality requirements than those referred to in Article 16(2).
3. Member States shall notify the Commission and the other Member States of each
authorisation granted pursuant to paragraphs 1 and 2.
EN 44 EN
4. The Commission may decide, by means of implementing acts, that the authorisations
referred to in paragraphs 1 or 2 are to be repealed or amended, in case those
measures are not in compliance with the conditions of those paragraphs, or are
deemed inappropriate or disproportionate to achieve the objectives of those
paragraphs. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 141(3).
SECTION 3
DEROGATIONS FROM LABELLING, CERTIFICATION AND IDENTIFICATION
REQUIREMENTS
Article 38
Plant reproductive material which is not finally certified
1. Plant reproductive material, other than the seeds referred to in Article 39, which has
been harvested in one Member State, but has not yet been finally certified as prebasic,
basic or certified material pursuant to Article 19(1), may be made available on
the market by reference to those categories if:
(a) prior to the harvesting, a field inspection has been carried out by the competent
authority and has confirmed compliance of that material with the production
and quality requirements referred to in Article 16(2);
(b) the plant reproductive material is identified as not finally certified material
pursuant to Article 19; and
(c) the requirements set out in paragraphs 2 to 6 are fulfilled.
2. Plant reproductive material referred to in paragraph 1 may be made available on the
market only once from one professional operator to another, without being further
transferred to any other person.
3. The professional operator shall inform in advance the competent authority concerned
of its intention to make available on the market plant reproductive material referred
to in paragraph 1.
4. If the Member State, where the plant reproductive material has been harvested
(hereinafter: ‘Member State of production’), and the Member State where the plant
reproductive material is certified pursuant to Article 19(1) (hereinafter: ‘Member
State of certification’) are different, the competent authorities of the Member States
concerned shall exchange the relevant information concerning the making available
on the market of that material.
5. On request, the Member State of production shall supply all relevant production
information to the Member State of certification. The Member State of certification
shall supply information on the quantities certified to the Member State of
production.
6. The Commission shall be empowered to adopt, in accordance with Article 140,
delegated acts setting out specific rules for plant reproductive material referred to in
paragraph 1, concerning the following elements:
(a) packages, containers and bundles, and rules on small packages and containers;
(b) the labelling of that material.
EN 45 EN
7. Plant reproductive material, other than the seeds referred to in Article 39, which has
been harvested in a third country, but has not yet been finally certified as pre-basic,
basic or certified material pursuant to Article 19(1), may be made available on the
market by reference to those categories if:
(a) a decision on equivalence has been adopted pursuant to Article 44 concerning
that third country,
(b) the requirements set out in paragraphs 1(a) and (b), 2 and 3 and adopted
pursuant to paragraph 6 are fulfilled,
(c) the competent authorities of the Member State and third country concerned
exchange the relevant information concerning the making available on the
market of that material, and
(d) on request, the competent authorities of third country concerned supplies all
relevant production information to the Member State of certification.
8. For that purpose references made in those paragraphs to the Member States of
production shall be construed as references made to the third country concerned, and
references made in those paragraphs to the requirements set out pursuant to Article
16(2) shall be construed as references made to equivalent requirements.
Article 39
Seeds not certified as complying with applicable germination requirements
1. Competent authorities may authorise the making available on the market of seeds for
a specific period of time, as pre-basic, basic or certified material, without the
germination requirements established pursuant to Article 16(2) having been yet
confirmed, if this is considered necessary to make seed rapidly available on the
market.
2. Seed referred to in paragraph 1 may be made available on the market only once, from
one professional operator to another, without being further transferred to any other
person, on the basis of a provisional analytical report concerning germination.
3. The Commission shall be empowered, in accordance with Article 140, to adopt
delegated acts setting out the conditions under which seed of particular genera or
species may be made available on the market as pre-basic, basic material or certified
material pursuant to paragraphs 1 and 2. Those conditions may concern the
following:
(a) labelling requirements;
(b) the duration of period in which such seed may be made available on the
market; and
(c) the content of the provisional analytical reports concerning germination.
SECTION 4
DEROGATIONS FROM MISCELLANEOUS REQUIREMENTS
Article 40
More stringent quality requirements
1. The Commission may authorise Member States, by means of implementing acts, to
adopt more stringent production and quality requirements than those referred to in
EN 46 EN
Article 16(2), or more stringent certification rules than those referred to in Article
20(1).
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 141(3).
2. In order to obtain the authorisation referred to in paragraph 1, Member States shall
submit to the Commission a request setting out:
(a) the draft provisions containing the proposed requirements;
(b) a justification on the necessity and proportionality of such requirements; and
(c) whether the proposed requirements would be permanent or for a specified
period.
3. The authorisation referred to in paragraph 1 shall be granted only if the following
conditions are fulfilled:
(a) the implementation of the draft provisions, as referred to in point (a) of
paragraph 2, ensures improvement of the quality of the plant reproductive
material concerned, protection of the environment or sustainability of
agricultural development; and
(b) the draft provisions are necessary and proportionate to their objective.
Article 41
Emergency measures
1. Where plant reproductive material is likely to constitute a serious risk to human,
animal and plant health and environment, and such risk cannot be contained
satisfactorily by means of measures taken by the Member State concerned, the
Commission shall take without delay, by means of implementing acts, any
appropriate interim emergency measures. Those measures may include provisions
restricting or prohibiting the making available on the market of the plant
reproductive material concerned, depending on the gravity of the situation.
2. The measures referred to in paragraph 1 may be taken on the Commission’s own
initiative or at the request of a Member State. They shall be adopted in accordance
with the examination procedure referred to in Article 141(3).
3. On duly justified imperative grounds of urgency to address a serious risk to human
health, the Commission shall adopt immediately applicable implementing acts in
accordance with the procedure referred to in Article 141(4).
4. Where a Member State officially informs the Commission of the need to take
emergency measures and the Commission has not acted in accordance with
paragraph 1, that Member State may adopt any appropriate interim emergency
measures. Those measures may include provisions restricting or prohibiting within
the territory of that Member State the making available on the market of the plant
reproductive material concerned, depending on the gravity of the situation. The
Member State concerned shall immediately inform the other Member States and the
Commission of the measures adopted, stating the grounds for its decision.
5. The Commission may decide, by means of implementing acts, that the national
interim emergency measures referred to in paragraph 4 are to be repealed or
amended. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 141(3). The Member State concerned
EN 47 EN
may maintain its national interim emergency measures until the date of application of
the implementing acts referred to in this paragraph.
6. This Article shall apply without prejudice to any measures adopted pursuant to
Article 23(2) of Directive 2001/18/EC or Article 34 of Regulation (EC) No
1829/2003 which prohibits or restricts the cultivation of genetically modified
organisms.
Article 42
Temporary experiments
1. The Commission may, by means of implementing acts, decide the organisation of
temporary experiments to identify improved alternatives to any measures set out in,
or adopted under, this Part. Those implementing acts may provide for derogations
from the provisions of this Part. They shall be adopted in accordance with the
examination procedure referred to in Article 141(3).
2. The implementing acts referred to in paragraph 1 shall specify the genera or species
concerned, the conditions of the experiments per genera or species, the duration of
the experiments, and the monitoring and reporting obligations of the participating
Member States. They shall take into account the evolution of techniques for
reproduction, production and control of the plant reproductive material concerned.
3. The duration of an experiment shall not exceed seven growing cycles of the plant
reproductive material concerned, and shall in any case, not exceed seven years.
CHAPTER VI
Imports from and exports to third countries
SECTION 1
IMPORTS
Article 43
Imports on the basis of Union equivalence
Plant reproductive material may be imported from third countries only if it is established,
pursuant to Article 44, that it fulfils requirements equivalent to those applicable to plant
reproductive material produced and made available on the market in the Union.
Article 44
Commission Decision on equivalence
1. The Commission may decide, by means of implementing acts, whether plant
reproductive material of specific genera, species οr categories produced in a third
country, or particular areas of a third country, fulfils requirements equivalent with
those applicable to plant reproductive material produced and made available on the
market in the Union, on the basis of:
(a) a thorough examination of information and data provided by the third country
concerned pursuant to Article 124(1) of Regulation (EU) No …/… [Office of
Publications, please insert the number of the Regulation on official controls];
and
EN 48 EN
(b) the satisfactory outcome of a control performed in accordance with Article
119(1) of Regulation (EU) No …/… [Office of Publications, please insert the
number of the Regulation on official controls].
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 141(3).
2. When adopting the decisions referred to in paragraph 1, the Commission shall
consider whether:
(a) the controls on variety maintenance carried out in the third country afford the
same assurances as those provided for in Article 86, if varieties registered in a
national variety register or in the Union variety register are to be maintained in
the third country concerned; and
(b) the requirements in the third country concerning the production and making
available on the market of plant reproductive material:
(i) afford the same assurances as the production requirements set out in Part
A to Annex II, and the requirements adopted pursuant to Article 16(2);
(ii) afford the same assurances as the quality requirements set out in Part B to
Annex II, and the requirements adopted pursuant to Article16(2);
(iii) afford the same assurances as the certification schemes of Part C to
Annex II, and the requirements adopted pursuant to Article 20(1);
(iv) afford the same assurance as the controls carried out according to
Regulation (EU) No …/… [Office of Publications, please insert number
of Regulation on Official Controls].
3. For the purpose of adopting the decisions referred to in paragraph 1, the Commission
may apply the provisions of Article 71 of Regulation (EU) No …/… [Office of
Publication, please insert number of Regulation on Official Controls] concerning the
approval of pre-export controls carried out by third countries.
Article 45
Information to be provided in the case of imports
1. Plant reproductive material imported from third countries shall be made available on
the market with the following information:
(a) an indication that the plant reproductive material concerned ‘meets EU rules
and standards’;
(b) the species, variety, category and lot number of the plant reproductive material
concerned;
(c) the date of official closure, in case of making available on the market in
containers, packages or bundles;
(d) the third country of production and the respective competent authority;
(e) where applicable, the last third country where the plant reproductive material is
imported from;
(f) the declared net or gross weight of the imported plant reproductive material or
declared number of imported lots of plant reproductive material;
(g) the person importing the plant reproductive material.
EN 49 EN
2. The information referred to in paragraph 1 shall be provided:
(a) in the case of pre-basic, basic or certified material, on an official document or
on an additional official label;
(b) in the case of standard material, on the operator’s label.
SECTION 2
EXPORTS
Article 46
Exports from the Union
1. Where the export of plant reproductive material to a third country is governed by an
agreement with that third country, that export shall comply with that agreement.
2. Where the export of plant reproductive material to a third country is not governed by
an agreement with that country, that export shall take place in accordance with the
rules of the third country into which that plant reproductive material is to be
exported.
3. Where the export of plant reproductive material to a third country is neither governed
by an agreement with a third country nor by the rules of the third country into which
that plant reproductive material is to be exported, the requirements for production
and making available on the market of plant reproductive material within the Union
territory, as set out in Articles 13 to 42, shall apply.
TITLE III
Production and making available on the market of plant
reproductive material not belonging to genera or species listed in
Annex I
Article 47
Scope
This Title shall apply to the production and making available on the market of plant
reproductive material belonging to genera and species other than the ones listed in Annex I.
Article 48
Basic requirements
1. Plant reproductive material shall be made available on the market in accordance with
the following requirements:
(a) it shall be visually free from any defects likely to impair its usefulness for the
purposes it is intended;
(b) it shall have good vigour and appropriate dimensions, as appropriate for the
genera and species concerned, to ensure its usefulness for the purposes it is
intended;
(c) in the case of seeds, it shall have satisfactory germination, as appropriate for
the genera and species concerned, to allow an appropriate number of plants per
area after sowing, and to ensure the maximum yield and quality of the
production;
EN 50 EN
(d) if made available on the market with reference to a variety, it shall have
sufficient varietal identity and purity, as appropriate for the genera and species
concerned, to ensure informed choices by its users;
(e) it shall at least on visual inspection, be substantially free from any pests
impairing quality, or any signs or symptoms thereof, which reduce its
usefulness.
2. Compliance with the requirements of points (a), (b), (c), (d) and (e) of paragraph 1
shall be assessed in light of the applicable international standard recommendations:
(a) the Seed Scheme Rules and Regulations of OECD;
(b) the seed potato standards of UNECE;
(c) the rules on sampling and testing of the International seed testing association
ISTA for the genera or species concerned;
(d) and the rules of EPPO.
3. Where no international standard recommendations exist for genera or species
concerned, compliance with the requirements of points (a), (b), (c), (d) and (e) of
paragraph 1 shall be assessed in the light of, the relevant national standards of the
Member State, where the plant reproductive material is for first time made available
on the market
4. Plant reproductive material shall be made available on the market in lots. Where lots
of plant reproductive material of different origins are merged into a new lot during
packaging, storage, transport or at delivery, the professional operator shall keep
records including data about composition and the origin of the individual
components of the new lots.
If a lot is split into more lots, the professional operator shall keep records for each
new lot and its origin.
Article 49
Labelling
1. Plant reproductive material, when made available on the market, shall be
accompanied by a label, containing the information set out in Part B to Annex III.
2. The label referred to in paragraph 1 shall be produced by the professional operator
and shall be clear and indelible. It shall be affixed on the outside of the package, the
container or the bundle of plant reproductive material. It shall be printed in at least
one of the official languages of the Union.
3. Where reproductive material is made available on the market with a reference to
genera or species rather than a variety, the professional operator shall indicate on the
label referred to in paragraph 1 the species or group of species in such a way as to
avoid confusion with any varietal denomination.
4. The colour and form of the label shall be substantially distinct from the colour and
the form of the official labels referred to in Articles 19(1).
5. This Article shall apply without prejudice to Article 49(4) of Regulation (EC) No
1107/2009 concerning the label and documents accompanying treated seeds in the
meaning of that Regulation.
EN 51 EN
Article 50
Making available on the market with reference to varieties
1. Plant reproductive material shall be made available on the market with reference to a
variety only in one or more of the following cases:
(a) the variety is legally protected by a plant variety right in accordance with the
provisions of Regulation (EC) No 2100/94 or in accordance with national
provisions;
(b) the variety is registered in a national variety register as referred to in Article 51
or in the Union variety register as referred to in Article 52;
(c) the variety has been entered in any other public or private list with an official
or officially recognised description and a denomination.
2. Plant reproductive material made available on the market pursuant to points (a) and
(b) of paragraph 1 shall bear the same variety denomination in all Member States.
Where the variety is not protected by a plant variety right or registered pursuant to
Title IV, as referred to in points (a) and (b) of paragraph 1, but has been entered in a
public or private list with an official or officially recognised description and a
denomination as referred to in points (b) and (c) of that paragraph, the professional
operator may request the advice of the Agency concerning the suitability of the
denomination pursuant to the provisions of Article 64. Following that request, the
Agency shall submit to the applicant a recommendation on the suitability of the
variety denomination, as requested by the applicant, taking into account the
requirements set out in Article 64.
TITLE IV
Registration of varieties in national and Union variety registers
CHAPTER I
Establishment of national and Union variety registers
Article 51
Establishment of national variety registers
1. Each Member State shall establish, publish and update a single national register of
varieties and clones (hereinafter ‘national variety register’).
2. The Commission shall adopt, by means of implementing acts, the format of the
national variety registers. Those implementing acts shall be adopted in accordance
with the examination procedure referred to in Article 141(3).
Article 52
Establishment of a Union variety register
1. The Agency shall establish, publish and update a single register of varieties and
clones (hereinafter “Union variety register”).
The Union variety register shall include the following:
(a) varieties and clones directly registered in the Union variety register in
accordance with Chapter V; and
EN 52 EN
(b) varieties and clones registered in national variety registers in accordance with
Chapter IV, as notified by the Member States to the Agency in accordance with
Chapter VI.
2. The Commission shall adopt, by means of implementing acts, the format of the
Union variety register. Those implementing acts shall be adopted in accordance with
the examination procedure referred to in Article 141(3).
CHAPTER II
Content of the national and Union variety registers
Article 53
Data concerning varieties
1. For varieties, the national and Union variety registers shall include at least:
(a) the name of the genus or species to which the variety belongs;
(b) the denomination of the variety and, for varieties made available on the market
before the entry into force of this Regulation, where applicable, its synonyms;
(c) the name, and, where applicable, the reference number, of the applicant;
(d) the date of the registration of the variety and, where applicable, of the renewal
of the registration;
(e) the date of the end of validity of registration;
(f) the official description of the variety, or, where, applicable, the officially
recognised description of the variety with an indication of the region(s) where
the variety has historically been grown and to which it is naturally adapted
(“region(s) of origin”);
(g) the name of the professional operator responsible for the maintenance of a
variety;
(h) where applicable, the indication that the variety contains a genetically modified
organism;
(i) where applicable, the indication that the variety is a component variety of
another registered variety;
(j) where applicable, the indication that plant reproductive material belonging to
the variety is only produced and made available on the market in rootstocks;
(k) where applicable, a summary of the results of the examinations for satisfactory
value for cultivation and/or use as referred to in Article 58, or sustainable value
for cultivation and/or use as referred to in Article 59.
2. Notwithstanding point (g) of paragraph 1, the names of the professional operators
need not be indicated in the register when several professional operators are
responsible for the maintenance of the variety. In that case, the national variety
registers and the Union variety register shall indicate the competent authority holding
the list of names of professional operators responsible for the maintenance of the
variety.
EN 53 EN
Article 54
Data concerning clones
For clones, the national and Union variety registers shall include at least:
(a) the name of the genus or species to which the clone belongs;
(b) the reference under which the variety, to which the clone belongs, is registered in the
national variety register or Union variety register;
(c) the denomination of the variety to which the clone belongs and, for varieties made
available on the market before the entry into force of this Regulation, where
applicable its synonyms;
(d) the date of the registration of the clone and, where applicable, of the renewal of the
registration;
(e) the end of validity of the registration;
(f) where applicable, the indication that the variety to which the clone belongs has been
registered with an officially recognised description, including the region of origin of
that variety;
(g) where applicable, the indication that the clone contains, or consists of, a genetically
modified organism.
Article 55
Additional data to be included in the Union variety register
In the case of a variety or clone, notified by a Member State to the Agency in accordance with
Chapter VI, the Union variety register shall include, in addition to the data required pursuant
to Articles 53 and 54:
(a) the name of the Member States having established the relevant national variety
register(s); and
(b) the reference under which the variety or clone has been registered in the national
variety register(s).
CHAPTER III
Requirements for registration in the national and Union variety
registers
SECTION 1
VARIETIES
Article 56
Registration requirements for varieties
1. Varieties may be registered in a national variety register pursuant to Chapter IV, or in
the Union variety register pursuant to Chapter V, only if they fulfil the following
requirements:
(a) they bear a denomination deemed suitable pursuant to Article 64;
(b) they do not pose an unacceptable risk for human, animal and plant health, or
the environment;
EN 54 EN
(c) in case of varieties belonging to a genetically modified organism, that organism
is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation
(EC) 1829/2003.
2. In order to be registered in a national variety register pursuant to Chapter IV,
varieties shall fulfil, in addition to the requirements set out in paragraph 1, the
following requirements:
(a) they have an official description showing compliance with the requirements of
distinctiveness, uniformity and stability set out in Articles 60, 61 and 62, or are
provided with an officially recognised description pursuant to Article 57;
(b) in case they belong to genera or species with particular importance for the
satisfactory development of agriculture in the Union, as referred to in
paragraph 5, they have a satisfactory value for cultivation and/or use pursuant
to Article 58;
(c) in case they belong to genera or species with particular importance for the
sustainable development of agriculture in the Union, as referred to in paragraph
6, they have a sustainable value for cultivation and/or use pursuant to Article
59.
3. The requirements set out in paragraph 2(b) and (c) shall not apply to the following
varieties:
(a) varieties provided only with an officially recognised description;
(b) varieties used only as components for the creation or production of other
varieties.
4. In order to be registered in the Union variety register pursuant to Chapter V, varieties
shall fulfil, in addition to requirements set out in paragraph 1, the following
requirements:
(a) they have an official description showing compliance with the requirements of
distinctiveness, uniformity and stability set out in Articles 60, 61 and 62;
(b) they do not belong to genera or species with particular importance for the
satisfactory development of agriculture in the Union, as referred to in
paragraph 5;
(c) in case they belong to genera or species with particular importance for the
sustainable development of agriculture in the Union, as referred to in paragraph
6, they have a sustainable value for cultivation and/or use pursuant to Article
59;
(d) they are not used as mere components for the creation or production of other
varieties.
5. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, listing the genera or species with particular importance for the
satisfactory development of agriculture in the Union. Those genera or species shall
be listed in accordance with the criteria set out in Part A of Annex IV.
6. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, listing the genera or species with particular importance for the
sustainable development of agriculture in the Union. Those genera or species shall be
listed in accordance with the criteria set out in Part B of Annex IV.
EN 55 EN
Article 57
Registration of varieties provided with an officially recognised description
1. A variety may be registered in a national variety register on the basis of an officially
recognised description if one of the following conditions are complied with:
(a) in case the variety had been previously not registered in a national variety
register or in the Union variety register and plant reproductive material
belonging to that variety has been made available on the market before the
entry into force of this Regulation;
(b) in case the variety had been previously registered in any national variety
register or in the Union variety register on the basis of a technical examination
pursuant to Article 71, but has been deleted from those registers more than five
years before the submission of the current application and would not fulfil the
requirements laid down in Articles 60, 61 and 62 and, where applicable, Article
58(1) and Article 59(1).
2. In order to be registered on the basis of an officially recognised description, a variety
shall comply, in addition to paragraph 1, with the following conditions:
(a) it is produced in the region(s) of origin;
(b) it is not included in a national variety register or in the Union variety register,
as a variety with an official description;
(c) it is not protected by a Union plant variety right as provided for in Article 62 of
Council Regulation (EC) No 2100/94, or by a national plant variety right, and
it is not the subject of a pending application for such a right.
3. After the registration of a variety in a national variety register pursuant to paragraph
2(a), competent authorities may approve additional region(s) of origin for that
variety.
4. The officially recognised description shall comply with the following requirements:
(a) it is based, where available, on information from plant genetic resources
authorities or from organisations recognised for that purpose by the Member
States; and
(b) its accuracy is supported by the results of previous official inspections or
unofficial examinations or knowledge gained from practical experience during
cultivation, reproduction and use.
Article 58
Satisfactory value for cultivation and/or use
1. For the purpose of paragraph 2(b) of Article 56, varieties shall be deemed to have a
satisfactory value for cultivation and/or use if, compared to other varieties examined
under similar agro-climatic conditions and similar production systems, their
characteristics, taken as a whole, offer, at least as far as production in any region is
concerned, a clear improvement either for cultivation in general or for the specific
uses which can be made of the crops or the products derived therefrom.
2. Member States shall adopt rules concerning the examinations to determine the
satisfactory value for cultivation and/or use of the varieties to be registered in their
national variety register. Those rules shall concern the characteristics of the varieties
in one or more of the following areas:
EN 56 EN
(a) quality and agronomic characteristics, including yields;
(b) suitability for cultivation in resilience and low input production systems,
including for organic agricultural production.
Each Member State shall publish those rules and notify them to the Agency, the
Commission and the other Member States.
Article 59
Sustainable value for cultivation and/or use
1. For the purpose of paragraph 2(c) and paragraph 3(c) of Article 56, varieties shall be
deemed to have a sustainable value for cultivation and/or use if, compared to other
varieties examined under similar agro-climatic conditions and similar production
systems, their characteristics, taken as a whole, offer, at least as far as susceptibility
to pests, input of resources, susceptibility to undesirable substances or adaptation to
divergent agro-climatic conditions are concerned, a clear improvement either for
cultivation in general or for the specific uses which can be made of the crops or the
products derived there from.
2. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out rules concerning the examinations to determine the
sustainable value for cultivation and/or use of the varieties. Those rules shall concern
the characteristics of the varieties in one or more of the following areas:
(a) resistance to pests;
(b) reduced need for input of specific resources;
(c) decreased content of undesirable substances; or
(d) increased adaptation to divergent agro-climatic environment.
Those rules shall take into account, where applicable, the available technical
protocols.
Article 60
Distinctness
1. For the purposes of the official description, referred to in point (a) of Article 56(2)
and (3), a variety shall be deemed to be distinct, if it is clearly distinguishable, by
reference to the expression of the characteristics that results from a particular
genotype or combination of genotypes, from any other variety whose existence is
commonly known on the date of the application determined pursuant to Article 70.
2. The existence of another variety, as referred to in paragraph 1, shall be deemed to be
commonly known, if on the date of the application determined pursuant to Article 70
one or more of the following conditions are complied with:
(a) that variety is included in a national variety register or in a Union variety
register;
(b) an application has been filed for registration of that variety in a national variety
register pursuant to Article 66, or in the Union variety register pursuant to
Article 95(1), or for the granting of a plant variety right in respect of that
variety in the Union;
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(c) an official description of that variety has been produced in the Union, and the
technical examination has been conducted pursuant to the provisions of
Article 69, Article 71 and, where applicable, Article 73 .
3. Where point (c) of paragraph 2 applies, the person(s) responsible for the technical
examinations shall make available to the competent authorities and the Agency the
official description of the variety examined by them.
Article 61
Uniformity
For the purposes of the official description, referred to in point (a) of Article 56(2) and (3), a
variety shall be deemed to be uniform if, subject to the variation that may be expected from
the particular features of its reproduction and type, it is sufficiently uniform in the expression
of those characteristics which are included in the examination for distinctness, as well as in
the expression of any other characteristics used for its official description.
Article 62
Stability
For the purposes of the official description referred to in point (a) of Article 56(2) and (3), a
variety shall be deemed to be stable if the expression of those characteristics which are
included in the examination for distinctness, as well as any other characteristics used for the
variety description, remains unchanged after repeated reproduction or, in the case of cycles of
reproduction, at the end of each such cycle.
Article 63
Granted plant variety rights
If a variety has been granted a plant variety right pursuant to Article 62 of Regulation (EC)
No 2100/1994, or pursuant to the legislation of a Member State, that variety shall be deemed
to be distinct, uniform and stable, for the purpose of the official description as referred to in
point (a) of Article 56(2) and (3) and to have a suitable denomination for the purposes of point
(a) of Article 56(1).
Article 64
Denomination of varieties
1. For the purposes of point (a) of Article 56(1), the denomination of a variety shall not
be deemed suitable if:
(a) its use in the territory of the Union is precluded by the prior right of a third
party;
(b) it may commonly cause its users difficulties as regards recognition or
reproduction;
(c) it is identical to, or may be confused with, a variety denomination under which
another variety of the same or of a closely related species is entered in a
national variety register or in the Union variety register, or under which
material of another variety has been made available on the market in a Member
State or in a Member of the International Union for the Protection of New
Varieties of Plants, unless that other variety no longer remains in existence and
its denomination has acquired no special significance;
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(d) it is identical to, or may be confused with, other designations which are
commonly used for the making available on the market of goods or which have
to be kept free pursuant to other Union legislation;
(e) it is liable to give offence in one of the Member States or is contrary to public
order;
(f) it is liable to mislead or to cause confusion concerning the characteristics, the
value or the identity of the variety, or the identity of the breeder.
2. Without prejudice to paragraph 1, if a variety is already registered in other national
variety registers, or in the Union variety register, the denomination shall only be
deemed suitable if it is identical to that appearing in those registrations.
3. Paragraph 2 shall not apply if:
(a) the denomination is likely to mislead or cause confusion concerning the
relevant variety in one or more Member States; or
(b) the rights of third parties impede the free use of that denomination in
connection with the variety in question.
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out specific rules concerning the suitability of variety
denominations. Those rules may concern:
(a) their relation to denominations of trade marks;
(b) their relation to geographical indications or designations of origin for
agricultural products;
(c) written consents of holders of prior rights to remove impediments to the
suitability of a denomination;
(d) specific criteria to determine whether a denomination is misleading or
confusing as referred to in paragraph 1(f); and
(e) the use of a denomination in the form of a code.
SECTION 2
CLONES
Article 65
Registration requirements for clones
1. A clone may be included in the national variety register, or in the Union variety
register, only if it complies with the following requirements:
(a) it belongs to genera or species which have a particular value for particular
market sectors and listed pursuant to paragraph 3;
(b) it belongs to a variety registered in a national variety register pursuant to
Chapter IV or in the Union variety register pursuant to Chapter V;
(c) it has been subject to genetic selection;
(d) it bears a suitable denomination.
2. For the purpose of establishing whether a denomination is suitable as referred to in
paragraph 1(d) of this Article, the provisions of Article 64 shall apply with the
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necessary modifications. References made in Article 64 to varieties shall be
construed as references to clones.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, listing the genera or species, the clones of which have a particular value
for particular market sectors.
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out the following:
(a) that clones belonging to particular genera or species shall be subject to sanitary
selection for the purpose of inclusion in a national variety register or in the
Union variety register; and
(b) the requirements for the sanitary selection referred to in point (a);
CHAPTER IV
National variety register procedures
SECTION 1
VARIETY REGISTRATION PROCEDURE
Article 66
Submission of applications
1. Any person may submit to the competent authority an application for registration of a
variety in the national variety register.
2. The application referred to in paragraph 1 shall be submitted in writing. That
submission may take place electronically.
Article 67
Content of applications
1. The application for registration of a variety in a national variety register shall contain
the following items:
(a) a request for registration;
(b) the identification of the botanical taxon (genus or species) to which the variety
belongs;
(c) the reference number of the applicant, where applicable, and its name and
address, or, where appropriate, the names and addresses of the joint applicants,
and the credentials of any procedural representative;
(d) a provisional denomination;
(e) the name and address of the person responsible for the maintenance of the
variety, and, where applicable, the reference number of that person;
(f) a description of the main characteristics of the variety and, if available, a
completed technical questionnaire;
(g) a description of the procedure of variety maintenance;
(h) the geographic origin of the variety;
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(i) information on whether the variety is registered in another national variety
register, or the Union variety register, and on whether it is known to the
applicant that an application for registration in one of those registers is
pending;
(j) where the variety contains or consists of a genetically modified organism,
evidence that the genetically modified organism in question is authorised for
cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No
1829/2003;
(k) where the application is based on an officially recognised description of the
variety, a file containing that description and any document or publication
supporting it;
(l) in the case of an application concerning varieties granted a plant variety right
as referred to in Article 63, the proof that the variety is protected by such right,
with the corresponding official description;
(m) where applicable, a declaration that the variety has satisfactory value for
cultivation and/or a use as referred to in Article 58(1) and/or sustainable value
for cultivation and/or use as referred to in Article 59(1).
2. The application for registration of a variety in a national variety register shall be
accompanied by the submission of a sample of sufficient quality and quantity of the
variety, as specified by the competent authority.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out additional items to be included in the application for
particular genera or species, in relation with the particular features of the varieties
belonging to those genera or species.
Article 68
Application format
The Commission shall adopt, by means of implementing acts, the format of the application
referred to in Article 66. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 141(3).
Article 69
Formal examination of application
1. The competent authority shall register each application for registration in the national
variety register it receives, and shall carry out the formal examination of that
application. The formal examination of the application shall examine whether the
application complies with:
(a) the content requirements laid down in Article 67; and
(b) the format adopted pursuant to Article 68.
2. If the application does not comply with the requirements laid down in Article 67 or
the format adopted pursuant to Article 68, the competent authority shall give the
applicant the possibility to make its application compliant within a given time.
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Article 70
Date of application
The date of application for registration shall be the date on which an application complying
with the content requirements laid down in Article 67 and the format adopted pursuant to
Article 68 was submitted to the competent authority.
Article 71
Technical examination
1. Where, as a result of the formal examination, the application is found to comply with
the content requirements referred to in Article 67 and the format adopted pursuant to
Article 68, a technical examination of the variety shall be carried out for the purpose
of establishing an official description.
2. The technical examination referred to in paragraph 1 shall verify:
(a) the compliance with the requirements for distinctiveness, uniformity and
stability of the variety, as laid down in Articles 60, 61 and 62;
(b) where applicable, that the variety has a satisfactory value for cultivation and/or
use, according to Article 58(1) and a sustainable value for cultivation and/or
use according to Article 59(1).
3. The technical examination referred to in paragraph 1 shall be carried out by the
competent authorities in accordance with the requirements referred to in Article 74.
On request submitted by the applicant to the competent authority, the technical
examination, or part of it, may be carried out by the applicant, in accordance with the
provisions of Article 73 and the requirements referred to in Article 74.
4. In case an official description of the variety, produced by the Agency or a competent
authority, is already available, the competent authority shall decide that the technical
examination referred to in paragraph 1 is not necessary.
5. By way of derogation from paragraph 4, the competent authority may decide that the
technical examination referred to in paragraph 1 is necessary in the case of a variety
the registration of which is requested pursuant to point (b) Article 57(1).
Article 72
Audit of the competent authority’s premises and organisation
1. The competent authority may carry out the technical examination referred to in
Article 71(1) only if its premises, which must be dedicated to this purpose, and its
organisation have been audited by the Agency.
That audit shall verify whether the premises and the organisation of the competent
authority are suitable for carrying out the technical examination as regards:
(a) compliance with the requirements for distinctiveness, uniformity and stability
referred to in Articles 60, 61 and 62; and
(b) compliance with the requirements of a sustainable value for cultivation and/or
use referred to in Article 59(1).
2. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out the rules concerning the audit referred to in paragraph 1.
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3. On the basis of the audit referred to in paragraph 1, the Agency may recommend to
the competent authority, if appropriate, actions to ensure the suitability of the
premises and organisation of the competent authorities. Further to the audit referred
to in paragraph 1, the Agency may carry out additional audits and, where applicable,
recommend to the competent authorities corrective actions to ensure the suitability of
their premises and organisation.
Article 73
Technical examination by the applicant
1. The applicant may carry out the technical examination referred to in Article 71(1), or
part of it, only if it has been authorised thereto by the competent authority. Technical
examination by the applicant shall be carried out in particular premises, which are
dedicated to this purpose.
2. Prior to granting the authorisation to carry out the technical examination, the
competent authority shall audit the premises and the organisation of the applicant.
That audit shall verify whether the premises and organisation are suitable for
carrying out the technical examination as regards:
(a) compliance with the requirements for distinctiveness, uniformity and stability
referred to in Articles 60, 61 and 62; and
(b) compliance with the requirements of a satisfactory value for cultivation and/or
use referred to in Article 58(1);
(c) compliance with the requirements of a sustainable value for cultivation and/or
use referred to in Article 59(1).
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out the rules concerning the audit referred to in paragraph 2.
4. On the basis of the audit referred to in paragraph 1, the competent authority may
recommend to the applicant, if appropriate, actions to ensure the suitability of the
applicant’s premises and organisation.
5. Further to the authorisation and audit referred to in paragraph 1, the competent
authority may carry out additional audits and, where applicable, recommend to the
applicant, within a specific period of time, corrective actions concerning the
applicant’s premises and the organisation.
In case the competent authority concludes that the applicant’s premises and organisation are
not suitable, it may revoke or modify the authorisation referred to in paragraph 1.
Article 74
Additional rules on technical examination
1. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, supplementing the requirements on the technical examination laid down
in Articles 71, 72 and 73. Those delegated acts may concern:
(a) qualification, training and activities of staff of the competent authority, or of
the applicant, for the purposes of the technical examination referred to in
Article 71(1);
(b) the necessary equipment, including laboratories for disease resistance
characteristics, necessary to carry out the technical examination;
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(c) the establishment of a variety reference collection to assess distinctness, and
the storage management of such reference collection;
(d) the establishment of quality management systems, including record of activities
and protocols or guidelines, to be used for the technical examination;
(e) the conduct of growing trials and laboratory tests for particular genera or
species.
Those delegated acts shall take into account the available technical and scientific
protocols.
2. Where no requirements have been adopted pursuant to paragraph 1, technical
examinations shall be carried out in accordance with national protocols as regards the
elements referred in points (a) to (e) of paragraph 1.
Article 75
Confidentiality
1. Where, in the framework of the technical examination referred to in Article 71(1), an
examination of the genealogical components is necessary, the results of that
examination and the description of the genealogical components shall be treated as
confidential, if the applicant so requests.
2. In the case of varieties of plant reproductive material intended exclusively for the
production of agricultural raw materials for industrial purposes, and if so requested
by the applicant, the results of the technical examination referred to in Article 71(1)
and the intended uses of those varieties shall be treated as confidential.
Article 76
Provisional examination report and provisional official description
1. Following the technical examination referred to in Article 71(1), the competent
authority shall produce a provisional examination report and, where it considers that
the distinctiveness, uniformity and stability requirements, as referred to in
Articles 60, 61 and 62, are complied with, a provisional official description of the
variety on the basis of that report.
2. The provisional examination report may refer to findings of other examination
reports, produced on the relevant variety, by the competent authority concerned,
other competent authorities or the Agency.
3. The competent authority shall communicate the provisional examination report and
the provisional official description of the variety to the applicant.
4. Where the competent authority does not consider the examination report to constitute
a sufficient basis for a decision on the registration of the variety, it shall provide a
complementary examination of its own motion, after consulting the applicant, or on
request of the applicant. Any complementary examination carried out until a decision
is taken pursuant to Article 79(1) shall be considered to be part of the technical
examination referred to in Article 71(1).
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Article 77
Examination report and official description
1. After having given the applicant an opportunity to comment on the provisional
examination report and the provisional official description, the competent authority
shall establish a final examination report and a final official description.
2. Competent authorities shall, on reasoned request, make available the examination
reports to third parties, subject to national or Union provisions on data protection and
applicable rules on confidentiality.
Article 78
Examination of the denomination
1. After the formal examination of the application referred to in Article 69, and prior to
the registration of a variety in a national variety register pursuant to Article 79, the
competent authority shall consult the Agency on the variety denomination proposed
by the applicant.
2. The Agency shall submit to the competent authority a recommendation on the
suitability of the variety denomination proposed by the applicant, in accordance with
the requirements set out in Article 64. The competent authority shall inform the
applicant on that recommendation.
Article 79
Decision on registration
1. If, on the basis of the procedure set out in Articles 66 to 78, it is concluded that the
variety complies with the applicable requirements set out in Article 56, the
competent authority shall decide to register the variety in the national variety
register.
2. The competent authority shall adopt a decision refusing registration in the national
variety register if:
(a) it establishes that the applicable requirements set out in Article 56, are not
fulfilled; or
(b) the applicant has failed to comply with any obligations set out for it in Articles
66 to 74.
3. Decisions refusing the registration shall state the reasons justifying the refusal.
4. The competent authority shall communicate to the applicant a copy of the decision
referred to in paragraphs 1 and 2.
Article 80
Already registered varieties and clones
1. By way of derogation from Articles 66 to 79, the competent authorities shall register
in their national variety registers all varieties officially accepted or registered, before
the entry into force of this Regulation, in the catalogues, lists or registers established
by their Member States pursuant to Article 3 of Directive 2002/53/EC, Article 3(2)
of Directive 2002/55/EC, Article 7(4) of Directive 2008/90/EC and Article 5 of
Directive 68/193/EEC and all clones registered pursuant to Article 5 of Directive
68/193/EEC, Article 7(4) of Directive 2008/90/EC, Chapter II of Directive
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2008/62/EC and Section I of Chapter II and Section I of Chapter III of Directive
2009/145/EC.
2. Varieties accepted in accordance with Article 3 of Directive 2008/62/EC and Article
3(1) of Directive 2009/145/EC shall be registered in the national variety registers as
varieties provided with an officially recognised description.
Article 81
New denomination after registration
Where, after the registration of a variety, it is established by the competent authority that at
the time of the registration the denomination of the variety was not suitable within the
meaning of Article 64, the applicant shall submit an application for a new denomination. The
competent authority shall decide on that application upon consultation with the Agency. The
competent authority may permit the previous denomination to be used temporarily.
SECTION 2
REGISTRATION PERIOD AND VARIETY MAINTENANCE
Article 82
Validity period of the registration
1. The validity period of the registration of a variety in a national variety register shall
be 30 years.
2. In the case of varieties consisting of, or containing, a genetically modified organism,
the validity of the registration shall be limited to the period for which that genetically
modified organism is authorised for cultivation pursuant to Directive 2001/18/EC or
Regulation (EC) No 1829/2003.
Article 83
Duration of the renewal period
1. The registration of a variety in a national variety register may be renewed for further
periods of 30 years, in accordance with the procedure and the conditions laid down in
Article 84.
2. In the case of a variety consisting of or containing a genetically modified organism,
the renewal shall be limited to the period for which that genetically modified
organism is authorised for cultivation pursuant to Directive 2001/18/EC or
Regulation (EC) No 1829/2003.
Article 84
Procedure and conditions for registration renewal
1. Any person intending to renew the registration of a variety shall submit an
application, no earlier than 12 months, and no later than six months, before the
expiration of the validity period as referred to in Article 82.
2. The application shall be submitted in writing. That submission may take place
electronically. It shall be accompanied by evidence showing that the conditions set
out in paragraphs 3 and 4 are fulfilled.
3. The renewal of the registration of a variety in a national variety register shall only be
granted if the following conditions are met:
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(a) the variety continues complying with the requirements of Article 56, and,
where applicable of Article 57;
(b) the competent authority determines that a person is responsible for maintaining
the variety in accordance with the provisions of Article 86.
4. The competent authority may renew the registration of a variety in a national variety
register, without an application for renewal being submitted pursuant to paragraphs 1
and 2, where it considers that the renewal of that registration serves sustainable
agricultural production and the preservation of genetic diversity, and that the
conditions of paragraph 3 are fulfilled.
Article 85
Deletion from national variety registers
1. The competent authority shall decide to delete a variety from the national variety
register, in the following cases:
(a) if the competent authority concludes, on the basis of any new evidence, that the
requirements for registration, as set out in Article 56 are no longer fulfilled;
(b) if a request to delete the variety from the national variety register has been
submitted by the applicant;
(c) if the applicant does not pay the annual fee pursuant to point (d) of Article
87(1)(e);
(d) if the person responsible for the maintenance of the variety, as referred to in
Article 86(1), so requests, unless maintenance of the variety is assured by
another person;
(e) if the variety is no longer maintained pursuant to requirements of Article 86;
(f) if the variety is maintained in a third country, that third country has not
provided assistance on the controls of that maintenance pursuant to Article
86(8);
(g) if at the time of the application, false or fraudulent data were supplied
concerning the facts on the basis of which the registration was decided;
(h) if, by the deadline to submit an application for renewal referred to in Article
84(1), the applicant has not submitted such an application and the validity
period referred to in Article 82(1) has expired.
2. On request by the applicant, the competent authority may allow a variety deleted
from the national variety register in accordance to paragraph 1(b) to continue to be
made available on the market until 30 June of the third year following the deletion
from the register.
That request shall be submitted no later than the date of the expiration of the
registration period.
3. After a variety is deleted from the national variety register, the competent authority
shall submit a sample of that variety, and its description, to a gene bank dedicated to
the conservation of genetic resources.
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Article 86
Variety maintenance
1. Varieties registered in a national variety register shall be maintained by the applicant
or by any other person acting in mutual agreement with the applicant. That other
person shall be notified by the applicant to the competent authority.
2. Variety maintenance shall take place in accordance with accepted practices
concerning, as appropriate, genera, species or types of varieties.
3. The persons referred to in paragraph 1 shall keep records concerning the
maintenance of the variety. It shall at all times be possible for the competent
authority to check the maintenance of the variety from those records. Those records
shall also cover the production of pre-basic, basic, certified and standard material,
and the stages of production prior to pre-basic material.
4. Varieties provided with an officially recognised description shall be maintained in
their region(s) of origin.
5. The competent authority shall carry out controls on the manner in which variety
maintenance is carried out and may, to this purpose, take samples of the varieties
concerned.
6. Where a competent authority finds that the person responsible for variety
maintenance does not comply with paragraphs 1 to 4, it shall give that person the
opportunity to take corrective action.
7. Where variety maintenance takes place in a Member State other than the Member
State in whose national variety register the variety has been registered, the competent
authorities of the two Member States concerned shall assist each other in the controls
on variety maintenance.
8. Where variety maintenance takes place in a third country, the competent authorities
of the Member State in whose national variety register the variety has been registered
concerned shall request the third country’s authorities assistance in the controls on
variety maintenance.
SECTION 3
REGISTRATION FEES
Article 87
Registration fees
1. The competent authorities shall charge fees to recover the necessary costs incurred
for the following actions:
(a) the formal examination of the application referred to in Article 69;
(b) the technical examination and the audits referred to in Article 71 and Article
73(1);
(c) the examination of the variety denomination referred to in Article 78;
(d) the decision on registration referred to in Article 79, and any administrative
appeal lodged pursuant to national rules against that decision;
(e) the inclusion of the variety, or where applicable the clone, in the national
variety register for each year of the duration of the registration;
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(f) controls on the maintenance as referred to in Article 86(5).
2. The actions referred to in paragraph 1 shall only be carried out on demand submitted
by the applicant to the competent authority, and after the respective fees have been
paid. The demand shall be deemed not to have been made, if the fees have not been
paid within one month from the date on which the competent authority requested
payment of the fees and indicated in that request the consequences of the failure to
pay.
3. The Commission shall be empowered to adopt delegated acts, in accordance with the
procedure referred to in Article 140, setting out the specific cost items to be covered
pursuant to paragraph 1(a) to (f).
Article 88
Fees for varieties provided with an officially recognised description
1. In the case of varieties provided with an officially recognised description, no fees
shall be charged for the actions referred to in point (e) of Article 87(1).
2. In the case of varieties provided with an officially recognised description, the
competent authorities shall reduce the amount of the fee for the actions referred to in
of points (a), (c), (d), and (f) of Article 87(1). That reduction shall take place in a
manner to ensure that the fee does not constitute a barrier to the registration of the
variety concerned.
Article 89
Exemptions from the payment of registration fees
1. Fees provided for in Article 87 and 88 shall not directly or indirectly be refunded,
unless unduly collected.
2. Applicants employing fewer than 10 persons and whose annual turnover or annual
balance sheet total does not exceed EUR 2 million shall be exempted from the
payment of the fees provided for in Article 87 and Article 88.
3. The costs referred to in Articles 87 and 88 shall not include those incurred for the
performance of official controls on the applicants referred to in paragraph 2.
SECTION 4
REGISTRATION OF CLONES
Article 90
Applicable provisions
1. For the registration of a clone in a national variety register, Sections 1, 2 and 3 shall
apply with the necessary modifications, excluding the following provisions:
(a) the provisions on the content of applications as set out in Article 67;
(b) the provisions referring to varieties provided with officially recognised
descriptions;
(c) the provisions referring to varieties with sustainable or satisfactory value for
cultivation and/or use.
2. As regards the content of applications, Article 92 shall apply instead of Article 67.
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Article 91
References
When applying Sections 1, 2 and 3 for the registration of a clone in a national variety register,
references shall be construed as follows:
(a) references to varieties shall be construed as references to clones;
(b) references to Article 56 shall be construed as references to Article 65;
(c) references to the requirements set out in Articles 60, 61 and 62 shall be construed as
references to requirements set out in Article 65(1)(b) and (3);
(d) references to Article 67, concerning the content of applications, shall be construed as
references to Article 92.
Article 92
Content of applications
1. The application for registration of a clone in a national variety register shall contain
the following items:
(a) a request for registration;
(b) the identification of the variety to which the clone belongs;
(c) the name and address of the applicant, or, where appropriate, the joint
applicants, and the credentials of any procedural representative;
(d) a provisional denomination;
(e) the name and address of the person responsible for the maintenance of the
clone, and, where applicable, the reference number of that person;
(f) a description of the main characteristics of the clone and, if available, a
completed technical questionnaire;
(g) the geographic origin of the clone;
(h) information on whether the clone is registered in another national variety
register or Union variety register, and on whether it is known to the applicant
that an application for registration of the clone in those registers is pending;
(i) in the case of a clone containing or consisting of a genetically modified
organism, evidence that the genetically modified organism in question is
authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC)
No 1829/2003.
2. The application for the registration of a clone in a national variety register shall be
accompanied by the submission of a sample of sufficient quality and quantity of the
clone.
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CHAPTER V
Procedures concerning the Union variety register
SECTION 1
SCOPE OF THE CHAPTER
Article 93
Relevant varieties and clones
This Chapter shall apply to varieties and clones not registered in any national variety register
pursuant to Article 79.
SECTION 2
REGISTRATION PROCEDURE
Article 94
Applicable provisions
1. For the registration of a variety or clone in the Union variety register, Chapter IV
shall apply with the necessary modifications, excluding the following provisions:
(a) the provisions on the examination of denominations set out in Article 78;
(b) the provisions on variety maintenance set out in Article 86;
(c) the provisions referring to varieties provided with an officially recognised
description;
(d) the provisions on exemptions from the payment of registration fees, set out in
Article 89(2) and (3).
2. For the examination of denominations, for variety and clone maintenance and for
exemptions from the payment of registration fees, Articles 95, 96 and 97 shall apply
instead of the provisions referred to in paragraph 1(a), (b) and (d).
3. When applying Chapter IV for the registration of a variety or clone in the Union
variety register, references shall be construed as follows:
(a) references to the competent authority shall be construed as references to the
Agency;
(b) references to national variety registers shall be construed as references to the
Union variety register;
(c) references to Article 78 shall be construed as references to Article 95;
(d) references to Article 86 shall be construed as references to Article 96;
(e) references to administrative appeal lodged pursuant to national rules against the
respective decision shall be construed as references to the appeal referred to in
Article 98.
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Article 95
Examination of the denomination
1. After the formal examination of the application referred to in Article 69, as applied
pursuant to Article 94, and before a variety or clone is registered in the Union variety
register, the Agency shall examine the denomination of the variety or clone proposed
by the applicant.
2. The Agency shall decide on the suitability of the variety or clone denomination, in
accordance with the requirements set out in Article 64.
Article 96
Maintenance of varieties and clones
1. Varieties and clones registered in the Union variety register shall be maintained by
the applicant, or by any other person acting in mutual agreement with the applicant.
The other person shall be notified to the Agency.
2. The maintenance shall take place in accordance with accepted practices, as
appropriate per genera, species or types of varieties.
3. The person referred to in paragraph 1 shall keep records concerning the maintenance
of the variety or the clone. It shall at all times be possible for the Agency to check the
maintenance of the variety or the clone from those records. Those records shall also
cover the production of pre-basic, basic, certified and standard material, and stages of
production prior to pre-basic material.
4. The Agency shall check the way the maintenance is carried out and may, to this
purpose, take samples of the varieties and the clones.
5. The competent authorities of the Member State where the maintenance of the variety
or the clone concerned takes place, shall assist the Agency as regards controls on
maintenance.
6. In case the Agency finds that the person responsible for the maintenance does not
comply with the provisions of paragraphs 1, 2 and 3, it shall give that person the
opportunity to take corrective action.
Article 97
Amount of fees
1. The Commission shall be empowered to adopt delegated acts, in accordance with the
procedure referred to in Article 140, setting out the amount of the fees referred to in
Article 87(1) as applied pursuant to Article 94.
2. The level at which the fees are set pursuant to paragraph 1 shall reflect the principle
of sound financial management to allow the Agency to maintain a balanced budget.
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SECTION 3
APPEALS
Article 98
Right of appeal
An appeal shall lie from decisions of the Agency which have been taken pursuant to Section
2. It shall be examined by the Board of Appeal of the Agency referred to in Article 46 of
Regulation (EC) No 2100/1994.
Article 99
Provisions applicable to appeals
1. Chapters V and VI of Part Four of Regulation (EC) No 2100/1994 shall apply, with
the necessary modifications, to appeals referred to in Article 98.
2. Notwithstanding paragraph 1 of this Article, the following provisions of Chapters V
and VI of Part Four of Regulation (EC) No 2100/1994 shall not apply to appeals
referred to in Article 98:
(a) Article 67 (1) and (3);
(b) Article 74;
(c) Article 80(5).
Article100
References
For the purposes of Article 99(1), references contained in Chapters V and VI of Part Four of
Regulation (EC) No 2100/1994 shall be construed as follows:
(a) the reference made in Article 68 to Article 82 shall be omitted;
(b) the reference made in Article 70(1) to “the body of the Office which has prepared the
decision” shall be construed as a reference made to the Agency;
(c) the reference made in Article 76 to the “examination made pursuant to Articles 54
and 55” shall be construed as a reference made to the technical examination of the
application for registration carried out by the Agency pursuant to this Regulation;
(d) the reference made in Article 78(3) and (4) to Article 90(2) shall be omitted;
(e) the reference made in Article 79 to the “competent offices” shall be construed as a
reference made to the competent authorities;
(f) the reference made in Article 80(1) to the “applicant for a Community plant variety
right or the holder” shall be construed as a reference made to the applicant for
registration;
(g) the reference made in Article 80(3) to the “time limits specified in Article 52 (2), (4)
and (5) shall be omitted;
(h) the reference made in Article 81 to the “staff of the Examination Offices” shall be
omitted.
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CHAPTER VI
Notification of varieties to the Union variety register
Article 101
Notification procedure
1. Each competent authority shall notify within five working days the Agency of the
application for registration of a variety, the adoption of the decision referred to in
Article 79, the new denomination after registration pursuant to Article 81, the
renewal of the registration pursuant to Article 83, and the deletion of a variety
pursuant to Article 85.
2. Each competent authority shall notify the Agency of the person responsible for the
maintenance of the variety pursuant to Article 86. That notification shall take place
within five working days from the date on which the competent authority has become
aware of that person.
3. The Commission shall establish, by means of implementing acts, procedures for
submission of the notifications referred to in paragraph 1. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in
Article 141(3).
CHAPTER VII
Keeping and handling of information
Article 102
Documentation on the national variety registers and on the Union variety register
1. The competent authority shall keep a file on each variety registered in the national
variety register, containing the official description, the examination report and any
complementary examination report pursuant to Article 76. Where applicable, the file
shall only contain the officially recognised description of the variety, and the
documents supporting that description.
2. The Agency shall keep a file on each variety registered in the Union variety register,
containing the official description and the examination report issued pursuant to
Article 94(1).
Article 103
Access to information of the national variety registers
1. Each Member State shall inform the other Member States, the Agency and the
Commission on the access to its national variety register.
2. By 31 March of each year, each competent authority shall notify to the other
competent authorities and the Commission any amendments of the respective
national variety registers which took place during the preceding year.
3. Each competent authority shall, on request, make available to another competent
authority, the Agency or the Commission:
(a) where applicable, the examination reports of varieties registered in the
respective national variety register, as referred to in Article 77(1);
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(b) where applicable, the results of technical examinations referred to in Article
71(1);
(c) the list of varieties for which an application for registration is pending;
(d) any other information available in respect of registered or deleted varieties.
4. The competent authority shall take appropriate measures to make available the
information contained in the files of the national variety register to any person
requesting access to this information. This provision shall not apply where the
information must be treated as confidential pursuant to Article 75.
Article 104
Access to information of the Union variety register
1. The Agency shall notify the competent authorities and the Commission of the
information required to access the Union variety register.
2. By 31 March of each year, the Agency shall notify the competent authorities and the
Commission of any amendments of the Union variety register made during the
preceding year with regard to the varieties registered pursuant to Article 94(1).
3. The Agency shall, on request, and with regard to varieties registered in the Union
variety register pursuant to Article 94(1), make available to a competent authority or
the Commission:
(a) the examination reports or the official description of the registered varieties;
(b) the results of technical examinations;
(c) the list of varieties for which applications for registration are pending;
(d) any other information available in respect of registered or deleted varieties.
4. The Agency shall take appropriate measures to make available the information
contained in the files of the Union variety register to any person requesting access to
that information. This provision shall not apply where the information must be
treated as confidential under Article 75.
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PART IV
PRODUCTION AND MAKING AVAILABLE ON THE
MARKET OF FOREST REPRODUCTIVE MATERIAL
TITLE I
General provisions
Article 105
Scope
This Part shall apply to the production and making available on the market, of forest
reproductive material.
Article 106
Definitions
1. For the purposes of this Part, the following definitions shall apply:
(a) “basic forest material” means seed source, stand, seed orchard, parents of
family, clone or clonal mixture;
(b) “seed source” means trees within a delimited area from which seed is collected;
(c) “stand” means a delineated population of trees possessing sufficient uniformity
in composition;
(d) “seed orchard” means a plantation of selected clones or families, which is
isolated or managed so as to avoid or reduce pollination from outside sources,
and managed to produce frequent, abundant and easily harvested crops of seed;
(e) “parents of family” means trees used to obtain progeny by controlled or open
pollination of one identified parent used as a female, with the pollen of one
parent (full-sibling) or a number of identified or unidentified parents (half
sibling);
(f) “clone” means group of individuals (ramets) derived originally from a single
individual (ortet) by vegetative reproduction, including by cuttings, micropropagation,
grafts, layers or divisions;
(g) “clonal mixture” means a mixture of identified clones in known proportions;
(h) ”Autochthonous stand” or “autochthonous seed source” means a stand or seed
source which:
(i) has been continuously regenerated by natural regeneration; or
(ii) has been regenerated artificially from reproductive material collected in
the same stand or seed source; or
(iii) has been regenerated artificially from reproductive material collected in
stands or seed sources, within the close proximity, meeting the
description in points (i) and (ii);
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(i) “Indigenous stand” or ‘indigenous seed source’ means a stand or seed source
raised artificially from seed, the origin of which is situated in the same region
of provenance;
(j) “origin” means:
(i) for an autochthonous stand or seed source – the place in which the trees
are growing;
(ii) for a non-autochthonous stand or seed source – the place from which the
seed or plants were originally introduced;
(k) “provenance” means the place in which any stand is growing;
(l) “region of provenance” means, for a species or sub-species, the area or group
of areas subject to sufficiently uniform ecological conditions in which stands or
seed sources showing similar phenotypic or genetic characters are found, and is
delimited, where appropriate, by altitudinal boundaries;
(m) “category” means any of the following groupings of derived forest reproductive
material: source-identified, selected, qualified or tested reproductive material;
(n) “source-identified”: means derived from basic forest material which may be
either a seed source or stand located within a single region of provenance;
(o) “selected”: means derived from basic forest material consisting of a stand
located within a single region of provenance and which has been
phenotypically selected at the population level;
(p) “qualified”: means derived from basic forest material consisting of seed
orchards, parents of families, clones or clonal mixtures, the components of
which have been phenotypically selected at the individual level;
(q) “tested”: means derived from basic forest material consisting of stands, seed
orchards, parents of families, clones or clonal mixtures of superior quality;
(r) “planting stock” means one of the following:
(i) plants raised from seed units;
(ii) plants raised from parts of plants; or
(iii) plants raised from natural regeneration(s);
(s) “seed unit” means cones, infructescences, fruits and seeds intended for the
production of planting stock;
(t) “parts of plants” means stem cuttings, leaf cuttings and root cuttings, explants
or embryos for micro-propagation, buds, layers, roots, scions, sets and any
parts of a plant intended for the production of planting stock;
(u) “area of utilisation” means the area where the forest reproductive material is
used for a specified purpose.
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TITLE II
Basic forest material
Article 107
Approval of basic forest material
1. Basic forest material shall be approved by the competent authority for the production
of the relevant categories of forest reproductive material if it meets the requirements
set out in Annexes V, VI, VII or VIII.
2. Each unit of approved basic forest material (hereinafter: ‘unit of approval’) shall be
identified by a unique reference to the register referred to in Article 112(1).
3. The approval shall be withdrawn, if the requirements referred to in paragraph 1 are
no longer met.
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, supplementing the requirements set out in point 3 of Annex VII
concerning clones, and point 4 of Annex VII concerning clonal mixtures, by
determining the maximum number of years or the maximum number of ramets to
which the approval of clones or clonal mixtures shall be restricted
Article 108
Provisional approval of basic forest material intended for the production of tested material
1. Basic forest material intended for the production of forest reproductive material
under the ‘tested’ category, whose compliance with the requirements referred to in
Article 107(1) has not been established, may provisionally be approved by the
competent authorities for a maximum period of ten years, provided that it can be
assumed that the basic forest material will, when tests have been completed, satisfy
the requirements for approval. That assumption shall be based on the provisional
results of the genetic evaluation or comparative tests referred to in Annex VIII.
2. The provisional approval referred to in paragraph 1 may cover all or part of the
territory of the Member Stated concerned.
Article 109
Post approval inspections
After the approval referred to in Articles 107 and 108, basic forest material intended for the
production of forest reproductive material under the selected, qualified and tested categories
shall be re-inspected by the competent authority at regular intervals to confirm compliance
with those Articles.
Article 110
Demarcation of regions of provenance
1. The Member States shall demarcate the regions of provenance of basic forest
material consisting of stands or seed sources and intended for the production of forest
reproductive material under the ‘source-identified’ and ‘selected’ categories.
2. Member States shall draw up and publish maps showing the demarcations of the
regions of provenance. Those maps shall be communicated to the Commission and
other Member States.
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Article 111
Notification of the intention to collect approved basic forest material
The professional operators shall inform the competent authorities in due time about their
intention to collect material from approved basic forest material.
Article 112
National register and national list of approved basic forest material
1. Member States shall establish a national register of basic forest material approved on
their territory pursuant to Article 107 and Article 108. That register shall contain
information concerning the unit of approval together with its unique register
reference.
2. Each Member State shall establish, publish and update a summary of the national
register in the form of a national list.
3. The national list referred to in paragraph 2 shall be drawn up in a common form. It
shall enumerate each unit of approval. However, for basic forest material intended
for the categories ‘source-identified- and ‘selected’, a further summarisation based on
regions of provenance shall be permitted.
4. The national list referred to in paragraph 2 shall contain the following details:
(a) botanical name;
(b) category for the production of which the basic forest material is intended;
(c) purpose of the forest reproductive material which will derive from the basic
forest material;
(d) type of basic forest material (seed source, stand, seed orchard, parents of
family, clone or clonal mixture);
(e) register reference to the unit of approval or, where appropriate, summary
thereof or identity code of the region of provenance;
(f) location: a short name, if appropriate, and any of the following sets of
particulars:
(i) for basic forest material intended for production of the ‘source-identified’
category, region of provenance and geographical position defined by the
latitudinal and longitudinal range;
(ii) for basic forest material intended for production of the ‘selected’
category, the region of provenance and the geographical position defined
by latitude and longitude or the latitudinal and longitudinal range;
(iii) for basic forest material intended for production of the ‘qualified’
category, the exact geographical position(s) where the basic material is
maintained;
(iv) for basic forest material intended for production of the ‘tested’ category,
the exact geographical position(s) where the basic material is maintained;
(g) altitude or altitudinal range;
(h) area: the size of a seed source(s), stand(s) or seed orchard(s);
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(i) origin: whether the basic material is autochthonous/indigenous, non
autochthonous/non-indigenous or if the origin is unknown. For nonautochthonous/
non-indigenous basic material, the origin shall be stated if
known;
(j) in the case of basic forest material intended for the ‘tested’ category, whether it
is genetically modified.
5. The Commission shall, by means of implementing acts, adopt the common form in
which national lists shall be established, as referred to in paragraph 3. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 141(3).
Article 113
Union List of Approved Basic Forest Material
1. Member States shall notify to the Agency, the Commission and the other Member
States the national list referred to in Article 112(2) and any of its updates within five
working days.
2. On the basis of the national lists notified by each Member State, the Agency shall
establish, publish and update a register entitled ‘Union List of Approved Basic Forest
Material for the Production of Forest Reproductive Material’.
The Agency shall include in that register all elements of the Community List of
Approved Basic Material for the Production of Forest Reproductive Material
published pursuant to Article 11(1) of Directive 1999/105/EC.
3. That Union list shall reflect the details contained in the national lists referred to in
Article 112 and indicate the area of utilisation, and any authorisations granted
pursuant to Article 128.
4. The Commission shall adopt, by means of implementing acts, the format of the
notification referred to in paragraph 1 and of the register referred to in paragraph 2.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 141(3).
TITLE III
Making available on the market of material derived from basic
forest material
Article 114
Scope
This title shall apply to the making available on the market of forest reproductive material
derived from basic forest material.
CHAPTER I
List of requirements
Article 115
Requirements for making available on the market of forest reproductive material
Forest reproductive material may only be made available on the market if it complies with:
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(a) the registration requirements set out in Chapter II;
(b) the quality requirements set out in Chapter III for the relevant category;
(c) the handling requirements set out in Chapter IV;
(d) the certification and identification requirements set out in Chapter V.
CHAPTER II
Registration requirements
Article 116
Forest reproductive material derived from basic forest material registered in a national
register
Forest reproductive material may be made available on the market only if it is derived from
approved basic forest material registered in a national register pursuant to Article 112(1) and
approved for the relevant category pursuant to Title II.
CHAPTER III
Quality requirements
Article 117
Quality requirements
1. Forest reproductive material shall be made available on the market under the
categories ‘source-identified’, ‘selected’, ‘qualified’ or ‘tested’.
2. Forest reproductive material belonging to the species and artificial hybrids listed in
Annex IX may not be made available on the market under the source identified
category if it is has been obtained from vegetative reproduction of other forest
reproductive material.
3. Forest reproductive material belonging to the artificial hybrids listed in Annex IX
shall only be made available under the categories ‘selected’, ‘qualified’ or ‘tested’.
4. Forest reproductive material belonging to the species and artificial hybrids listed in
Annex IX may only be made available on the market under ‘selected’ category if it
has been mass propagated from seeds
5. Notwithstanding paragraphs 1 and 2, forest reproductive material belonging to the
species and artificial hybrids listed in Annex IX, which consists wholly or partly of
genetically modified organisms may only be made available on the market under the
‘tested’ category.
6. The types of basic forest material which shall be used for the production of the
various categories of forest reproductive material belonging to the species and
artificial hybrids listed in Annex IX are set out in Annex X.
Article 118
Additional requirements for certain forms of forest reproductive material
Forest reproductive material belonging to the species and artificial hybrids listed in Annex IX
and referred to in Annex XI may only be made available on the market if it meets the quality
requirements set out in Annex XI, in addition to those applicable pursuant to Article 117.
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Article 119
Additional requirements for certain parts of plants and planting stock
The Commission shall be empowered to adopt delegated acts, in accordance with Article 140,
setting out quality requirements for making available on the market specific parts of plants
and planting stock of species and artificial hybrids listed in Annex IX, supplementing the
requirements referred to in Articles 117 and 118. Those requirements shall take into account
the development of scientific and technical knowledge.
CHAPTER IV
Handling requirements
Article 120
Lots
1. Forest reproductive material shall, during all stages of production, be kept in
separated lots by reference to individual units of approval from which it derives.
2. Forest reproductive material shall be made available on the market in lots.
Article 121
Packaging of seed units
Seed units shall be made available on the market only in sealed packages. The sealing device
shall be such that it will become unserviceable when the package is opened.
CHAPTER V
Certification and identification requirements
Article 122
Master certificate
1. After harvesting, a master certificate showing the reference of the register referred to
in point (e) of Article 112(4) shall be issued by the competent authority for all forest
reproductive material derived from approved forest basic material.
2. The master certificate shall contain the relevant information set out, as applicable, in
Part A, Part B and Part C of Annex XII.
3. For subsequent vegetative reproduction in accordance with Article 117(2), a new
master certificate shall be issued.
4. Where mixing takes place in accordance with Article 126(1), (2), (3) or (5), a new
master certificate, or other document, identifying the previous master certificates of
the material composing the mixture shall be issued.
5. The Commission shall determine, by means of implementing acts, the model of the
format of the master certificate as referred to in paragraph 1. Those implementing
acts shall be adopted in accordance with the examination procedure referred to in
Article 141(3).
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Article 123
Identification of lots
1. Each lot shall remain clearly identifiable through the entire process from collection
to delivery to the end user.
2. Each lot of forest reproductive material shall be identified by the following
information:
(a) the master certificate code and number;
(b) the botanical name;
(c) the category of forest reproductive material;
(d) the purpose;
(e) the type of basic forest material from which the forest reproductive material
derives (seed source, stand, seed orchard, parents or family, clone or clonal
mixture);
(f) the register reference of the basic forest material or identity code of the region
of provenance of the basic forest material;
(g) whether the basic forest material, from which the forest reproductive material
derives, is autochthonous or indigenous, non-autochthonous or non-indigenous,
or whether its origin is unknown;
(h) in the case of seed units, the year of ripening;
(i) the age of planting stock, of seedlings or of cuttings;
(j) the type of planting stock (whether undercuts, transplants or containerised);
(k) where applicable, the fact that it is genetically modified;
(l) where applicable, the fact that it has been vegetatively reproduced.
Article 124
Labelling
1. Each lot shall be accompanied by a label produced by the professional operator
(hereinafter ‘operator’s label’). The operator’s label shall contain, in addition to the
information required under Article 123, the following information:
(a) the master certificate number(s) issued under Article 122(1) or the reference to
the other document available according to Article 122(4);
(b) the reference number, where applicable, and the name of professional operator;
(c) the quantity supplied;
(d) in the case of forest reproductive material of the ‘tested’ category derived from
basic forest material which is provisionally approved under Article 108(1), the
words ‘provisionally approved’.
2. In the case of seeds, the operator’s label shall also include the following information:
(a) the percentage by weight of pure seed, other seed and inert matter;
(b) the germination rate of the pure seed, or, where germination rate is impossible
or impractical to assess, the viability percentage assessed by reference to a
specified method;
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(c) the weight of 1 000 pure seeds;
(d) the number of germinable seeds per kilogram of product made available on the
market as seed, or, where the number of germinable seeds is impossible or
impractical to assess, the number of viable seeds per kilogram.
3. The colour of the operator’s label shall be yellow in the case of ‘source-identified’
reproductive material, green in the case of ‘selected’ reproductive material, pink in
the case of ‘qualified’ reproductive material and blue in the case of ‘tested’
reproductive material.
4. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 140, setting out the conditions under which the operator’s label shall be
supplemented by another document produced by the professional operator. Those
delegated acts shall determine the information items to be included in that document.
Article 125
Labelling of forest reproductive material belonging to Populus spp. species
In the case of Populus spp., parts of plants shall only be made available on the market if the
Union classification number according to point 2(b) of Annex XI, Part C is given on the
operator’s label.
Article 126
Mixtures of forest reproductive material
1. Mixtures of forest reproductive material shall be produced and made available on the
market in accordance with the provisions of this Article.
2. Mixing of forest reproductive material derived from two or more units of approval
within the ‘source-identified’ category or within the ‘selected’ category may take
place if the units of approval are located in the same region of provenance.
3. When forest reproductive material derived from different seed sources and stands is
mixed pursuant to paragraph 2 within the ‘source-identified’ category, the new
combined lot shall be certified as ‘reproductive material derived from a seed source’.
4. When forest reproductive material derived from non-autochthonous or nonindigenous
basic forest material is mixed pursuant to paragraph 2 with forest
reproductive material derived from basic forest material of unknown origin, the new
combined lot shall be certified as being ‘of unknown origin’.
5. When mixing takes place in accordance with paragraph 4, the identity code of the
region of provenance may not be substituted for the register reference as provided for
in Article 123(f).
6. Mixing of forest reproductive material derived from a single unit of approval from
different years of ripening may take place provided that the actual years of ripening
and proportion of material from each year are recorded by the professional operator.
Article 127
Amendments to Annexes V to XII
The Commission shall be empowered to adopt delegated acts, in accordance with Article 140,
amending Annexes V to XII. Those amendments shall take into account the development of
scientific or technical knowledge and economic data.
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TITLE IV
Derogations
Article 128
More stringent requirements and prohibitions
1. The Commission may, by means of implementing acts, authorise Member States:
(a) to adopt more stringent quality requirements than those referred to in Article
117 and 118; and
(b) to prohibit the making available on the market with a view to seeding or
planting in all or part of its territory of specified forest reproductive material.
The prohibition referred to in point(b) may be restricted to making available on the
market to the end users only.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 141(3).
2. In order to obtain the authorisation referred to in paragraph 1(a) and (b), Member
States shall submit to the Commission a request setting out:
(a) draft provisions concerning the proposed requirements or prohibitions;
(b) a justification on the necessity and proportionality of such requirements or
prohibitions;
(c) whether the proposed requirements or prohibitions would be permanent or for a
specified period.
3. The authorisation referred to in paragraph 1 shall be granted if the following
conditions are fulfilled:
(a) the implementation of the restrictions or prohibitions referred to in paragraph 1,
ensures improvement of the quality of the forest reproductive material
concerned, protection of the environment or conservation of genetic resources;
and
(b) the restrictions or prohibitions referred to in paragraph 1 are necessary and
proportionate to their objective.
4. The authorisation referred to in paragraph 1 shall be granted on the basis of:
(a) evidence relating to the region of provenance or the origin of the material, and
documentation showing the differences in the respective climatic and
ecological data; or
(b) known results of trials, scientific research, or the results obtained from forestry
practice concerning survival and development of planting stock, including
growth, in relation to morphological and physiological characteristics.
Article 129
Temporary difficulties in supply
1. In order to remove temporary difficulties in the general supply of forest reproductive
material that may occur in a Member State, the competent authority of the Member
State concerned may authorise the making available on the market of forest
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reproductive material belonging to the species and artificial hybrids listed in Annex
IX with reduced requirements, compared to the requirements of Articles 117 and,
where applicable, Article 118 and Article 119.
That authorisation shall be granted, on the basis of a reasoned request submitted by
the professional operator concerned, for a specific period of time.
The label of the forest reproductive material made available on the market pursuant
to this paragraph shall be brown. It shall state that the forest reproductive material
complies with lower quality requirements than those referred to in Articles 117 and,
where applicable, Article 118 and Article 119.
Member States shall notify the Commission and the other Member States of each
authorisation granted pursuant to this paragraph.
2. The Commission may, by means of implementing acts, require a Member State to
repeal or amend an authorisation granted pursuant to paragraph 1, if it concludes that
that authorisation is unnecessary or not proportionate to the objective of removing
the temporary difficulties in the general supply of forest reproductive material. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 141(3).
Article 130
Seed made rapidly available on the market
In order to make seed of the current season’s crop rapidly available, forest reproductive
material may be made available on the market as far as to the first buyer, without the
information on germination or viability being included on the operator’s label pursuant to
Article 124(2)(b) and (d). The information referred to in Article 124(2)(b) and (d) shall be
provided by the professional operator as soon as possible.
Article 131
Exemption for small quantities
1. In the case of seed made available on the market in small quantities, the information
requirements concerning germination or viability as laid down in Article 124(2)(b)
and (d) shall not apply.
2. The Commission shall be empowered to adopt delegated acts, in accordance with the
Article 140, setting out the maximum size of the small quantities referred to in
paragraph 1 for particular categories or species of forest reproductive material to
ensure that the exemption of paragraph 1 is applied in a proportionate manner.
Article 132
Emergency measures
1. Where it is evident that forest reproductive material is likely to constitute a serious
risk to human, animal and plant health or the environment, and that such risk cannot
be contained satisfactorily by means of measures taken by the Member State(s)
concerned, the Commission on its own initiative or at the request of a Member State,
shall without delay take any appropriate interim emergency measures, including
measures restricting or prohibiting the making available on the market of the plant
reproductive material concerned, depending on the gravity of the situation. Those
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measures shall be adopted by means of implementing acts in accordance with the
examination procedure referred to in Article 141(3).
2. On duly justified imperative grounds of urgency to address a serious risk to human
health, the Commission shall adopt immediately applicable implementing acts in
accordance with the procedure referred to in Article 141(4).
3. Where a Member State officially informed the Commission of the need to take
emergency measures and the Commission has not acted in accordance with
paragraph 1, the Member State concerned may adopt any appropriate interim
emergency measures, restricting or prohibiting, within its territory, the making
available on the market of the forest reproductive material concerned, depending on
the gravity of the situation. It shall immediately inform the other Member States and
the Commission thereof, stating the grounds for its decision. The Commission may
adopt implementing acts requiring the Member State to amend or repeal the national
interim emergency measures. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 141(3). The
Member State may maintain its national interim emergency measures until the date
of application of the implementing acts referred to in this paragraph.
4. This Article shall apply without prejudice to any measures adopted pursuant to
Article 23(2) of Directive 2001/18/EC or Article 34 of Regulation (EC) No
1829/2003 prohibiting or restricting the cultivation of genetically modified
organisms.
Article 133
Temporary experiments
1. The Commission may decide, by means of implementing acts, to organise temporary
experiments in order to identify improved alternatives to any provisions set out in
Articles 107, 117 and, where applicable, Article 118 and Article 119. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 141(3).
2. The implementing acts referred to in paragraph 1 shall identify the genera or species
concerned, the conditions of the experiment per genera or species, the duration of the
experiments, and the monitoring and reporting obligations of the participating
Member States. They shall take into account the evolution of techniques for
reproduction, production and control of the concerned material.
The duration of an experiment shall not exceed seven years.
Article 134
Less stringent requirements to conserve genetic resources
1. Member States may adopt requirements less stringent than those set out in Articles
107, 117 and, where applicable, Article 118 and Article 119, in the interest of
conservation and sustainable use of forest genetic resources. In doing so, they shall
consider the need of producing and making available on the market forest
reproductive material which is naturally adapted to the local and regional conditions
and threatened by genetic erosion.
Member States shall submit to the Commission and the other Member States a
reasoned notification of those measures.
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2. The Commission may, by means of implementing acts, require a Member State to
repeal or amend the measures referred to in paragraph 1, if it concludes that those
measures are not necessary or not proportionate to the objective of conservation and
sustainable use of forest genetic resources. Those implementing acts shall be adopted
in accordance with the examination procedure referred to in Article 141(3).
TITLE V
Fees
Article 135
Registration and certification fees
1. Competent authorities shall charge fees for the following actions:
(a) registration of approved basic forest material pursuant to Article 112; and
(b) issuance of a master certificate pursuant to Article 122.
2. The actions referred to in paragraph 1 shall only be carried out on demand submitted
by the professional operator to the competent authority. The demand shall be deemed
not to have been made if the fees have not been paid within one month from the date
on which the competent authority requested payment of the fees and indicated in that
request the consequences of the failure to pay.
3. The Commission shall be empowered to adopt delegated acts, in accordance with the
procedure referred to in Article 140, setting out the specific cost items to be covered
pursuant to paragraph 1(a) and (b).
Article 136
Exemptions from the payment of registration fees
1. Fees provided for in Article 135(1) shall not directly or indirectly be refunded, unless
unduly collected.
2. Applicants employing fewer than 10 persons and whose annual turnover or annual
balance sheet total does not exceed EUR 2 million shall be exempted from the
payment of the fees provided for in Article 135(1).
3. The costs referred to in Article 135(3) shall not include those incurred for the
registration of approved basic forest material and the issuance of a master certificate
referred to in paragraph 2.
TITLE VI
Imports from and exports of forest reproductive material to third
countries
Article 137
Imports on the basis of Union equivalence
1. Forest reproductive material may be imported from third countries only if it is
established, pursuant to Article 138, that it fulfils requirements equivalent to those
applicable to forest reproductive material produced, and made available on the
market in the Union.
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2. Where seed and planting stock are imported into the Union, the professional operator
importing that forest reproductive material shall inform the respective competent
authority in advance of the import.
3. Imported forest reproductive material shall be accompanied by a master certificate,
or an official certificate, issued by the third country of origin, and records containing
details of that material provided by the professional operator in that third country.
Article 138
Commission Decision on equivalence
1. The Commission may decide, by means of implementing acts, whether forest
reproductive material of specific genera, species οr categories produced in a third
country, or particular areas of a third country, fulfils requirements equivalent to those
applicable to forest reproductive material produced and made available on the market
in the Union, on the basis of:
(a) a thorough examination of information and data provided by the third country
concerned pursuant to Article 124(1) of Regulation (EU) No …/… [Office of
Publications, please insert number of Regulation on Official Controls]; and
(b) where appropriate, the satisfactory outcome of a control performed in
accordance with Article 119(1) of Regulation (EU) No …/… [Office of
Publications, please insert number of Regulation on Official Controls];
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 141(3).
2. When adopting the decisions referred to in paragraph 1, the Commission shall
consider whether the systems for approval and registration of basic forest material
and subsequent production of forest reproductive material from that basic forest
material applied in the third country concerned afford the same assurance as those
provided for in Articles 107 and 117, and, where applicable, Article 118 and Article
119, for the ‘source identified’, ‘selected’, ‘qualified’ and ‘tested’ categories.
3. For the purpose of adopting the decisions referred to in paragraph 1, the Commission
may apply the provisions of Article 71 of Regulation (EU) No …/… [Office of
Publication, please insert number of Regulation on Official Controls] concerning the
approval of pre-export controls carried out by third countries.
Article 139
Export from the Union
1. Where the export of forest reproductive material to a third country is governed by an
agreement with that third country, that export shall comply with that agreement.
2. Where the export of forest reproductive material to a third country is not governed by
an agreement with that country, that export shall take place in accordance with the
rules of the third country into which that forest reproductive material is to be
exported.
3. Where the export of forest reproductive material to a third country is neither
governed by an agreement with a third country nor by the rules of the third country
into which that forest reproductive material is to be exported, the requirements for
production and making available on the market of forest reproductive within the
Union territory, as set out in Articles 105 to 134, shall apply.
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PART V
PROCEDURAL PROVISIONS
Article 140
Delegated acts
1. The power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.
2. The delegation of power referred to in Articles 11(3), 13(3), 14(3), 15(5), 16(2),
17(4), 18(4), 18(6), 20(4), 21(5), 23(3), 30(4), 32(1), 33(3), 34(6), 36(4), 38(4),
39(3), 44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67(2), 72(2), 74(1), 119, 124(4), 127,
131(2) and 135(4) and 138(1) shall be conferred on the Commission for an
indeterminate period of time from the date of the entry into force of this Regulation.
3. The delegation of power referred to in Articles 11(3), 13(3), 14(3), 15(5), 16(2),
17(4), 18(4), 18(6), 20(4), 21(5), 23(3), 30(4), 32(1), 33(3), 34(6), 36(4), 38(4),
39(3), 44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67(2), 72(2), 74(1), 119, 124(4), 127,
131(2), 135(4) and 138(1) may be revoked at any time by the European Parliament or
by the Council. A decision of revocation shall put an end to the delegation of the
power specified in that decision. It shall take effect the day following the publication
of the decision in the official Journal of the European Union or at a later date
specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to
the European Parliament and to the Council.
5. A delegated act adopted pursuant to Articles 11(3), 13(3), 14(3), 15(5), 16(2), 17(4),
18(4), 18(6), 20(4), 21(5), 23(3), 30(4), 32(1), 33(3), 34(6), 36(4), 38(4), 39(3),
44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67(2), 72(2), 74(1), 119, 124(4), 127, 131(2)
135(4) and 138(1) shall enter into force only if no objection has been expressed
either by the European Parliament or the Council within a period of two months of
notification of that act to the European Parliament and the Council or if, before the
expiry of that period, the European Parliament and the Council have both informed
the Commission that they will not object. That period shall be extended by two
months at the initiative of the European Parliament or the Council.
Article 141
Committee procedure
1. The Commission shall be assisted by the Standing Committee on Plants, Animals,
Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the
European Parliament and of the Council. That committee shall be a committee within
the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No
182/2011 shall apply.
Where the opinion of the committee is to be obtained by written procedure, that
procedure shall be terminated without result when, within the time-limit for delivery
of the opinion, the chair of the committee so decides or a simple majority of
committee members so request.
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3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No
182/2011 shall apply.
Where the opinion of the committee is to be obtained by written procedure, that
procedure shall be terminated without result when, within the time-limit for delivery
of the opinion, the chair of the committee so decides or a simple majority of
committee members so request.
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No
182/2011, in conjunction with Article 5 thereof shall apply.
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PART VI
FINAL PROVISIONS
Article 142
Amendment of Regulation (EC) No 2100/94
Regulation (EC) No 2100/94 is amended as follows:
(1) Article 4 is replaced by the following:
‘Article 4
Union Agency
1. For purposes of the implementation of this Regulation, a European Agency on
Plant Varieties, hereinafter referred to as ‘Agency’, is hereby established.
2. The Agency shall carry out the following tasks:
(a) to offer recommendations on variety denominations, where requested so
pursuant to Article 50(2) and 78(2) of Regulation (EU) No …/… [Office
of Publications, please insert number of this Regulation];
(b) to promote and coordinate development of uniform technical
examination of varieties, including development of protocols, carried out
pursuant to Article 71 and, where applicable, the acts adopted pursuant to
Article 74 of Regulation (EU) No …/… [Office of Publications, please
insert number of this Regulation]
(c) to carry out audits of competent authorities, including their premises and
organisation of work, carrying out technical examinations, as referred to
in Article 72 of the PRM Regulation;
(d) to offer, and participate in offering, training in its area of mission;
(e) to provide technical support to the Commission in the areas within its
mission;
(f) to commission studies necessary for the accomplishment of its mission;
(g) to search for, collect, collate, analyse and summarise technical data in the
fields within its mission;
(h) to ensure that the public and interested parties receive rapid, reliable,
objective and comprehensible information in the fields within its mission;
(i) to provide technical assistance, when requested to do so by the
Commission, with a view to improving cooperation between the Union,
applicant countries, international organisations and third countries, in the
fields within its mission;
(j) to establish, publish and update a database on reference collections of
varieties.’
3. The Agency shall also manage and support the Union variety register,
established in accordance with Article 52 of Regulation (EU) No …/… [Office
of Publications, please insert number of this Regulation]. It shall implement
the procedure for the registration of varieties in the Union variety register in
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accordance with Chapter V of Title IV of Regulation (EU) No …/… [Office of
Publications, please insert number of this Regulation]’.
(2) The following Article 4a is inserted:
‘Article 4a
References to the Community Plant Variety Office (Office)
References made in this Regulation to the Office and references made in Union
legislation to the Community Plant Variety Office shall be construed as references to
the European Agency on Plant Varieties established by Article 4.’
Article 143
Penalties
The Member States shall lay down the rules on penalties applicable to infringements of this
Regulation and shall take all measures necessary to ensure that they are implemented. The
penalties provided for must be effective, proportionate and dissuasive.
The Member States shall notify those provisions to the Commission within one year after the
entry into force of this Regulation and shall notify without delay any subsequent amendments
of those provisions.
Article 144
Repeals
1. The acts referred to in Annex XIII are hereby repealed.
2. References to the repealed acts shall be construed as references to this Regulation
and shall be read in accordance with the correlation table in Annex XIV.
Article 145
Transitional Provisions
1. Member States shall, by [Office of Publications, please insert date of application of
this Regulation], review the measures adopted pursuant to Article 5 of Directive
66/401/EEC, Article 5 of Directive 66/402/EEC, Article 4(1) of Directive
68/193/EEC, Article 7 of Directive 2002/54/EC, Article 24 of Directive 2002/55/EC,
Article 5 of 2002/56/EC and Article 7 of 2002/57/EC, and take one of the following
actions:
(a) repeal those measures; or
(b) amend those measures to comply with the applicable Union legislation on the
plant reproductive material concerned.
2. Member States shall notify to the Commission and the other Member States:
(a) all measures adopted pursuant to the Directives referred to in paragraph 1 by
[Office of Publications, please insert date of application of this Regulation];
and
(b) any action taken pursuant to points (a) or (b) of paragraph (1).
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Article 146
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
It shall apply from [Office of Publications please insert date counting 36 months from the
entry into force].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament For the Council
The President The President
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ANNEX I
GENERA AND SPECIES AS REFERRED TO IN ARTICLE 11
Abies alba Mill.
Abies cephalonica Loudon
Abies grandis Lindl.
Abies pinsapo Boiss.
Acer platanoides L.
Acer pseudoplatanus L.
Agrostis canina L.
Agrostis capillaris L.
Agrostis gigantea Roth.
Agrostis stolonifera L.
Allium cepa L.
Allium fistulosum L.
Allium porrum L.
Allium sativum L.
Allium schoenoprasum L.
Alnus glutinosa Gaertn.
Alnus incana Moench.
Alopecurus pratensis L.
Anthriscus cerefolium (L.) Hoffm.
Apium graveolens L.
Arachis hypogaea L.
Arrhenatherum elatius (L.) P. Beauv. ex J. Presl & C. Presl.
Asparagus officinalis L.
Avena nuda L.
Avena sativa L.(including A. byzantina K. Koch)
Avena strigosa Schreb.
Beta vulgaris L.
Betula pendula Roth.
Betula pubescens Ehrh.
Brassica juncea (L.) Czern.
Brassica napus L.
Brassica nigra (L.) W.D.J. Koch
Brassica oleracea L.
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Brassica rapa L.
Bromus catharticus Vahl
Bromus sitchensis Trin.
Cannabis sativa L.
Capsicum annuum L.
Carpinus betulus L.
Carthamus tinctorius L.
Carum carvi L.
Castanea sativa Mill.
Castanea Mill. (rootstocks)
Cedrus atlantica (Endl) Manetti ex Carr.
Cedrus libani A. Richard
Cichorium endivia L.
Cichorium intybus L.
Citrullus lanatus (Thunb.) Matsum. & Nakai
Citrus L.
Corylus avellana L.
Corylus L. (rootstocks)
Cucumis melo L.
Cucumis sativus L.
Cucurbita maxima Duchesne
Cucurbita pepo L.
Cydonia oblonga Mill.
Cynara cardunculus L.
Cynodon dactylon (L.) Pers.
Dactylis glomerata L.
Daucus carota L.
Fagus sylvatica L.
Festuca arundinacea Schreb.
Festuca filiformis Pourr.
Festuca ovina L.
Festuca pratensis Huds.
Festuca rubra L.
Festuca trachyphylla (Hack.) Krajina
xFestulolium Asch. et Graebn.
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Ficus carica L.
Foeniculum vulgare Mill.
Fortunella Swingle
Fragaria L.
Fraxinus angustifolia Vahl.
Fraxinus excelsior L.
Galega orientalis Lam.
Glycine max (L.) Merrill
Gossypium L.
Hedysarum coronarium L.
Helianthus annuus L.
Hordeum vulgare L.
Juglans regia L.
Juglans L. (rootstocks)
Lactuca sativa L.
Larix decidua Mill.
Larix kaempferi (Lamb.) Carr.
Larix sibirica Ledeb.
Larix x eurolepis Henry
Linum usitatissimum L.
Lolium × boucheanum Kunth
Lolium multiflorum Lam.
Lolium perenne L.
Lotus corniculatus L.
Lupinus albus L.
Lupinus angustifolius L.
Lupinus luteus L.
Malus domestica Borkh.
Malus Mill. (rootstocks)
Medicago lupulina L.
Medicago sativa L.
Medicago × varia T. Martyn
Olea europaea L.
Onobrychis viciifolia Scop.
Oryza sativa L.
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Papaver somniferum L.
Petroselinum crispum (Mill.) Nyman ex A. W. Hill
Phacelia tanacetifolia Benth.
Phalaris aquatica L.
Phalaris canariensis L.
Phaseolus coccineus L.
Phaseolus vulgaris L.
Phleum nodosum L. (formerly Phleum bertolonii DC.)
Phleum pratense L.
Picea abies (L.) H. Karst.
Picea sitchensis (Bong.) Carr.
Pinus brutia Ten.
Pinus canariensis C. Smith
Pinus cembra L.
Pinus contorta Douglas ex Loud.
Pinus halepensis Mill.
Pinus leucodermis Antoine
Pinus nigra Arnold
Pinus pinaster Aiton
Pinus pinea L.
Pinus radiata D. Don
Pinus sylvestris L.
Pistacia vera L.
Pistacia L. (rootstocks)
Pisum sativum L.
Poa annua L.
Poa nemoralis L.
Poa palustris L.
Poa pratensis L.
Poa trivialis L.
Poncirus Raf.
Populus spp. and artificial hybrids between those species
Prunus amygdalus Batsch
Prunus armeniaca L.
Prunus avium (L.) L.
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Prunus cerasus L.
Prunus domestica L.
Prunus persica (L.) Batsch
Prunus salicina Lindley
Prunus L. (rootstocks)
Pseudotsuga menziesii (Mirb.) Franco
Pyrus communis L.
Pyrus L. (rootstocks)
Quercus cerris L.
Quercus ilex L.
Quercus petraea (Matt.) Liebl.
Quercus pubescens Willd.
Quercus robur L.
Quercus rubra L.
Quercus suber L.
Raphanus sativus L.
Rheum rhabarbarum L.
Ribes L.
Robinia pseudoacacia L.
Rubus L.
Scorzonera hispanica L.
Secale cereale L.
Sicyos angulatus L. (rootstocks)
Sinapis alba L.
Solanum lycopersicum Lam. (formerly Lycopersicon esculentum Mill.)
Solanum lycopersicum Lam.x Solanum spp. (rootstocks)
Solanum melongena L.
Solanum tuberosum L.
Sorghum bicolor (L.) Moench
Sorghum bicolor (L.) Moench × Sorghum sudanense (Piper) Stapf.
Sorghum sudanense (Piper) Stapf
Spinacia oleracea L.
Tilia cordata Mill.
Tilia platyphyllos Scop.
Trifolium alexandrinum L.
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Trifolium hybridum L.
Trifolium incarnatum L.
Trifolium pratense L.
Trifolium repens L.
Trifolium resupinatum L.
Trigonella foenum-graecum L.
Trisetum flavescens (L.) P. Beauv.
xTriticosecale Wittm. ex A. Camus
Triticum aestivum L.
Triticum durum Desf.
Triticum spelta L.
Vaccinium L.
Valerianella locusta (L.) Laterr.
Vicia faba L.
Vicia pannonica Crantz
Vicia sativa L.
Vicia villosa Roth.
Vitis L.
Zea mays L.
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ANNEX II
REQUIREMENTS FOR PRE-BASIC, BASIC, CERTIFIED AND STANDARD
MATERIAL, AND ELEMENTS FOR THE ADOPTION OF THOSE
REQUIREMENTS
PARTA
REQUIREMENTS FOR THE PRODUCTION OF PLANT REPRODUCTIVE MATERIAL AS REFERRED
TO IN ARTICLE 16(2)
The following requirements for fields and crops shall apply, depending on the characteristics
of each genus or species:
1. Sowing or planting:
(a) the identity of the plant reproductive material, including where applicable
mother plants, shall be determined to ensure the traceability of the plant
reproductive material. The label of the material or the records on the mother
plant shall be kept.
(b) the material shall be planted and /or sowed in a way that there is:
(i) sufficient distance from pollen sources of the same species and/or the
same varieties, according to isolation rules per botanical characteristics
and breeding techniques, to ensure protection from any undesirable
foreign pollination and to avoid cross pollination with other crops;
(ii) an appropriate source and level of pollination to ensure the subsequent
reproduction;
(iii) an appropriate rotation (previous cropping and duration between
cropping period with the same species) to avoid impurities;
(c) appropriate attention shall be paid to the machines and any equipment used to
ensure absence of weed or other species which are difficult to distinguish at
seed level in laboratory tests;
(d) the material shall be sown and planted in a manner to ensure that the presence
of Union quality pests or their vectors, as listed in an implementing act adopted
in accordance with Article 37(2) of Regulation EU (No) …/… (Office of
Publications, please insert number of Regulation on protective measures
against pests of plants), complies with the provisions of that act.
2. Cultivation:
(a) Off-types shall be absent to ensure varietal identity and purity, and efficient
production. Where this is not possible due to the characteristics of the plant
reproductive material concerned, they shall be present up to the lowest possible
level.
In case of presence of off-types or other plant species, appropriate treatment
and/or elimination shall be applied to ensure varietal identity and purity.
(b) Mother plants shall be treated or excluded as a source of reproductive material
in case of positive test results or visual symptoms of pests or defects.
(c) Harvesting:
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The plant reproductive material shall be harvested in bulk or as individual
plants, as appropriate to ensure the identity and purity of the harvested
material.
(d) Maintenance:
Plant reproductive material, including where applicable mother plants, shall be
maintained in a way to ensure the identity of the variety. That maintenance
shall be based on the official description or the officially recognised
description of the variety.
(e) Union quality pests
The plant reproductive material shall be cultivated in a manner to ensure that
the presence of Union quality pests, as listed pursuant to the implementing act
referred to in Article 37(2) of Regulation (EU) No …/… (Office of
Publications, please insert number of Regulation on protective measures
against pests of plants), in that plant reproductive material complies with the
provisions of that act.
(f) Where appropriate, the cultivation of plant reproductive material shall take
place separately from the cultivation of material belonging to the same genera
or species for food or feed purposes, to ensure health of the material concerned.
(g) Where applicable, micro-propagation may also be used for the reproduction of
plant reproductive material.
PARTB
REQUIREMENTS FOR THE QUALITY OF PLANT REPRODUCTIVE MATERIAL REFERRED TO IN
ARTICLE 16(2)
Plant reproductive material shall fulfil one or more of the following quality requirements,
depending on the characteristics of each genus or species:
(a) it shall have minimum germination to allow an appropriate number of plant per
square meter (m2 ) after sowing, and consequently to secure the yield and quality of
the production;
(b) it shall have a maximum content of hard seed to allow an appropriate number of
plant per square metre (m2);
(c) it shall have minimum purity to secure the highest level of varietal identity;
(d) it shall have maximum moisture content to ensure the preservation of the material
during processing, storage and making available on the market;
(e) it shall have maximum content of plant reproductive material of other genera or
species to ensure the lowest presence of undesirable plants in the lot;
(f) it shall have minimum vigour, defined dimension, and specific grading, to ensure
appropriateness of the material and sufficient homogeneity of the lot for sowing or
planting;
(g) it shall have maximum presence of earth or extraneous matter to prevent fraudulent
practices and technical impurities;
(h) it shall be free from specific defects and damages to ensure quality and health of the
material;
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(i) the presence of Union quality pests, as listed pursuant to the implementing act
referred to in Article 37(2) of Regulation (EU) No […] on protective measures
against pests, in plant reproductive material shall comply with the provisions of that
act.
PARTC
REQUIREMENTS FOR THE CERTIFICATION OF PLANT REPRODUCTIVE MATERIAL AS
INDICATED IN ARTICLE 20(1)
A. Frequency and methods of field inspections
The frequency of inspections and the relevant growth stage(s) of the plant
reproductive material for inspections shall ensure efficient observations and
inspections.
The methods for inspections shall be such ensure the reliability of the observations.
Where applicable, the mother plants shall be inspected, at least by visual inspection,
at the most appropriate period(s) of the year to check the presence of pests or their
vectors
The mother plants shall be maintained in all phases of cultivation under conditions to
enable the production of plant reproductive material and permit the verification of
the identity based on the description of the variety.
Inspections shall concern, where appropriate, compliance with the rules set out
pursuant Article 37(2) of Regulation (EU) No …/… [Office of Publications, please
insert number of Regulation on protective measures against plants] concerning the
presence of quality pests on the plant reproductive material concerned. The quality of
soil, substrates, mother plants and the immediate environment shall be checked to
avoid presence of pests or their vectors.
B. Sampling and testing
1. The sampling method shall fulfil the following requirements:
(a) the sample to be drawn from a lot shall have the appropriate minimum
weight for determining content of certain weeds, to ensure representative
sampling and suitable size for the analysis of the material to assess
whether the quality requirements have been fulfilled.
(b) the intensity of sampling, the equipment of sampling, and methods to be
used, shall ensure that reliable samples are collected for testing.
2. Testing shall be carried out in accordance with methods, equipment and
growing media established per species, as well as per reference collection for
purity analysis, to ensure that the quality requirements have been fulfilled.
Testing shall include, where appropriate, retesting of germination rate to ensure
the adequate germination after a certain period or mixing of plant reproductive
material.
3. Inspections shall concern, where appropriate, compliance with the rules set out
pursuant Article 37(2) of Regulation (EU) No …/… [Office of Publications,
please insert number of Regulation on protective measures against plants]
concerning the presence of quality pests on the plant reproductive material
concerned. The quality of soil, substrates, mother plans and the immediate
environment shall be checked to avoid presence of pests or their vectors.
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PARTD
ELEMENTS FOR THE ADOPTION OF THE REQUIREMENTS FOR THE PRODUCTION AND
QUALITY OF PLANT REPRODUCTIVE MATERIAL REFERRED TO IN ARTICLE 16(2), AND FOR
THE CERTIFICATION OF PLANT REPRODUCTIVE MATERIAL AS REFERRED TO IN ARTICLE
20(1)
The production and quality requirements referred to in Parts A and B, and the certification
schemes referred to in Part C, may be laid down per one or more of the following elements:
(a) genera, species, categories, and sub-divisions inside the category, including
generations;
(b) the types of variety or plant reproductive material (heterogeneous material or niche
market material), including intraspecific or interspecific hybrids;
(c) the specific uses of the genera, species, or types of plant reproductive material
concerned;
(d) type of reproduction.
EN 104 EN
ANNEX III
PARTA
CONTENT OF OFFICIAL LABEL AND OPERATOR’S LABEL AS REFERRED TO IN ARTICLE 21(1)
The official label and operator’s label shall contain the following:
(a) the botanical name, or names in case of mixture, of the plant species concerned, in
roman characters;
(b) the common name, or names in case of mixture, of the plant species concerned in one
of the official Union languages;
(c) the two-letter code indicated in norm ISO 3166-1 alpha 222 for the Member State
and, where appropriate, the name or acronym of the respective competent
authority(ies) with which the professional operator is registered;
(d) the registration number of the registered professional operator or, in absence of such
number, the name and address of the operator;
(e) the lot number of the plant reproductive material concerned, and, where relevant, a
reference to a unique traceability data carrier, such as bar code, hologram or chip;
(f) the indication of the denomination of the variety or variety denominations in case of
mixture components, when making available on the market in reference to varieties;
(g) the indication ‘EU rules and standards’;
(h) references to the country of production or countries in case of mixture, with the two
letter code referred to in point (c);
(i) references to declared number of seeds, rootstocks or other units of reproductive
material, or, where applicable, the net or gross weight;
(j) indications concerning category of plant reproductive material and, where
appropriate, sub-divisions of categories;
(k) references to month and year of labelling or references to month and year of last
sampling;
(l) the indication, where appropriate, that the plant reproductive material belongs to a
variety with officially recognised description only, and indication of the region of
origin of that variety;
(m) the indication, where appropriate, that the respective plant reproductive material is a
clone or rootstock;
(n) the indication, where applicable, that the plant reproductive material consists of, or
contains, genetically modified organisms.
22 ISO 3166-1:2006, Codes for the representation of names of countries and their subdivisions – Part 1:
Country codes. International Organization for Standardization, Geneva.
EN 105 EN
PART B
INFORMATION TO BE CONTAINED IN THE LABEL FOR GENERA OR SPECIES OTHER THAN THE
SPECIES LISTED IN ANNEX I, AS REFERRED TO IN ARTICLE 47
The label shall contain the following:
(a) the species, indicated with the botanical name and in roman characters;
(b) the common name in one of the official languages of the Union;
(c) the denomination of the variety, if the plant reproductive material is respectively
made available on the market with reference to a variety;
(d) the name and address of the professional operator, and its registration number;
(e) the reference number of the lot given by the operator;
(f) declared number of seeds, rootstocks or other units of reproductive material, or,
where applicable, the net or gross weight;
(g) the indication ‘EU quality’;
(h) the date of the issuance of the label;
(i) in the case of import from third countries, indication of the country of harvesting,
with the two letter code as referred to in point (h) of Part A;
(j) the place of production;
(k) where applicable, the indication that the respective plant reproductive material
belongs to a clone or rootstock, and the denomination of the variety to which that
clone or rootstock may belong to;
(l) where plant reproductive material is produced and made available on the market
together with forest reproductive material, the respective label of plant reproductive
material shall indicate ‘not for forestry purposes’.
EN 106 EN
ANNEX IV
PARTA
CRITERIA FOR GENERA OR SPECIES WITH SATISFACTORY VALUE FOR CULTIVATION AND/OR
USE
The requirements set out in Article 58(2) on satisfactory value for cultivation and/or use shall
apply to genera and species which comply with one or more of the following criteria:
(a) they are of vital importance for food and feed security;
(b) they are of vital importance for food processing, feed processing or industrial
processing;
(c) they are of vital importance for resilience and low-input agriculture, including
organic agricultural production.
PARTB
CRITERIA FOR GENERA OR SPECIES WITH SUSTAINABLE VALUE FOR CULTIVATION AND/OR
USE
The requirements set out Article 59(1) on sustainable value for cultivation and/or use shall
apply to genera and species which comply with one or more of the following criteria:
(a) they are substantially susceptible to pests;
(b) they are subject to particular requirements concerning efficiency of resources;
(c) they are susceptible to the presence of undesirable substances;
(d) they are susceptible to adaptation to diverse agro-climatic conditions.
EN 107 EN
ANNEX V
REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE
CERTIFIED AS ‘SOURCE-IDENTIFIED’
1. The basic material shall be as seed source or stand located within a single Region of
Provenance. A formal inspection must be made where the material is destined for a
specific forestry purpose.
2. The Region of Provenance and the location and the altitude or altitudinal range of the
place(s) where the reproductive material is collected must be stated by the
professional operator concerned to the competent authority. It must be stated whether
the basic material is:
(a) autochthonous or non-autochthonous or the origin is unknown; or
(b) indigenous or non-indigenous or the origin is unknown. In the case of nonautochthonous
or non-indigenous basic material the origin must be stated if
known.
EN 108 EN
ANNEX VI
REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE
CERTIFIED AS ‘SELECTED’
General: The stand will be judged with respect to the specific stated purpose for which the
reproductive material will be intended and due importance shall be given to requirements 1- 9,
depending on the specific purpose. The criteria used for the selection of the forest
reproductive material and the purpose of that material shall be indicated in the National
Register.
1. Origin: It must be determined either by historical evidence or other appropriate
means whether the stand is autochthonous/indigenous, non-autochthonous/nonindigenous
or the origin is unknown and for non-autochthonous/ non-indigenous
basic material the origin must be stated if known.
2. Isolation: Stands must be situated at a sufficient distance from poor stands, including
non-autochthonous/nonindigenous or of unknown origin, of the same species or from
stands of a related species or variety which can form hybrids with the species in
question.
3. Effective Size of the Population: Stands must consist of one or more groups of trees
well distributed and sufficiently numerous to ensure adequate inter-pollination. To
avoid the unfavourable effects of inbreeding, selected stands shall consist of a
sufficient number and density of individuals on a given area.
4. Age and Development: Stands must consist of trees of such an age or stage of
development that the criteria given for the selection can be clearly judged.
5. Uniformity: Stands must show a normal degree of individual variation in
morphological characters. Where necessary, inferior trees shall be removed.
6. Adaptedness: Adaptation to the ecological conditions prevailing in the Region of
Provenance must be evident.
7. Volume production: For the approval of selected stands volume production of wood
must normally be superior to the accepted mean under similar ecological and
management conditions.
8. Wood Quality: The quality of the wood shall be taken into account.
9. Form or Growth Habit: Trees in stands must show particularly good morphological
features, including straightness and circularity of stem, favourable branching habit,
small size of branches and good natural pruning. In addition, the proportion of forked
trees and those showing spiral grain must be low.
EN 109 EN
ANNEX VII
REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE
CERTIFIED AS ‘QUALIFIED’
1. Seed Orchards
(a) The type, objective, crossing design and field layout, components, isolation and
location and any changes of these must be approved and registered with the
competent authority;
(b) The component clones or families shall be selected for their outstanding
characters and special consideration shall be given to the requirements 4, 6, 7,
8, 9 and 10 of Annex III;
(c) The component clones or families shall be planted or shall have been planted
according to a plan which has been approved by the competent authority and
established in such a way that each component can be identified;
(d) Thinning carried out in seed orchards shall be described together with the
selection criteria used for such thinning and registered with the competent
authority;
(e) The seed orchards shall be managed and seed harvested in such a way that the
objectives of the orchards are attained. In the case of a seed orchard intended
for the production of an artificial hybrid, the percentage of hybrids in the
reproductive material must be determined by a verification test.
2. Parents of Family(ies)
(a) The parents shall be selected for their outstanding characters and in accordance
with the requirements 4, 6, 7, 8, 9 and 10 of Annex III, or selected for their
combining ability;
(b) The objective, crossing design and pollination system, components, isolation
and location and any significant changes of these must be approved and
registered with the competent authority;
(c) The identity, number and proportion of the parents in a mixture must be
approved and registered with the competent authority;
(d) In the case of parents intended for the production of an artificial hybrid, the
percentage of hybrids in the reproductive material must be determined by a
verification test.
3. Clones
(a) Clones shall be identifiable by distinctive characters which have been approved
and registered with the competent authority;
(b) The value of individual clones shall be established by experience or have been
demonstrated by sufficiently prolonged experimentation;
(c) Ortets used for the production of clones shall be selected for their outstanding
characters and in accordance with the requirements 4, 6, 7, 8, 9 and 10 of
Annex III.
EN 110 EN
4. Clonal Mixtures
(a) Clonal mixture shall meet the requirements in points 3(a), 3(b) and 3(c);
(b) The identity, number and proportion of the component clones of a mixture, and
the selection method and foundation stock must be approved and registered
with the competent authority. Each mixture must contain sufficient genetic
diversity.
EN 111 EN
ANNEX VIII
REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE
CERTIFIED AS ‘TESTED’
1. REQUIREMENTS FOR ALL TESTS
(a) General
The basic material must satisfy the applicable requirements in Annex V or VI.
Tests set up for the approval of basic material are to be prepared, laid out,
conducted and their results interpreted in accordance with internationally
recognised procedures. For comparative tests, the forest reproductive material
under test must be compared with one or preferably several approved or prechosen
standards.
(b) Characters to be examined
(i) Tests must be designed to assess specified characters and these must be
indicated for each test;
(ii) Weight shall be given to adaptation, growth, biotic and abiotic factors of
importance. In addition, other characters, considered important in view of
the intended specific purpose, shall be evaluated in relation to the
ecological conditions of the region in which the test is carried out.
(c) Documentation
Records must describe the test sites, including location, climate, soil, past use,
establishment, management and any damage due to abiotic/biotic factors, and
be available to the competent authority. Age of the material and results at the
time of the evaluation must be recorded with the competent authority.
(d) Setting up the tests
(i) Each sample of reproductive material shall be raised, planted and
managed in an identical way as far as the types of plant material permit;
(ii) Each experiment must be established in a valid statistical design with a
sufficient number of trees in order that the individual characteristics of
each component under examination can be evaluated.
(e) Analysis and validity of results
(i) The data from experiments must be analysed using internationally
recognised statistical methods and the results presented for each character
examined;
(ii) The methodology used for the test and the detailed results obtained shall
be made freely available;
(iii) A statement of the suggested region of probable adaptation within the
country in which the test was carried out and characteristics which might
limit its usefulness must also be given;
(iv) If during tests it is proved that the reproductive material does not possess
at least the characteristics of the basic material, then such reproductive
material shall be eliminated.
EN 112 EN
2. REQUIREMENTS FOR GENETIC EVALUATION OF COMPONENTS OF BASIC MATERIAL
(a) The components of the following basic material may be genetically evaluated:
seed orchards, parents of family(ies), clones and clonal mixtures.
(b) Documentation
The following additional documentation is required for approval of the basic
material:
(i) The identity, origin and pedigree of the evaluated components;
(ii) The crossing design used to produce the reproductive material used in the
evaluation tests.
(c) Test procedures
The following requirements must be met:
(i) The genetic value of each component must be estimated in two or more
evaluation test-sites, at least one of which must be in an environment
relevant to the suggested use of the reproductive material;
(ii) The estimated superiority of the reproductive material to be marketed
shall be calculated on the basis of these genetic values and the specific
crossing design;
(iii) Evaluation tests and genetic calculations must be approved by the
competent authority.
(d) Interpretation
(i) The estimated superiority of the reproductive material shall be calculated
against a reference population for a character or set of characters;
(ii) It shall be stated whether the estimated genetic value of the reproductive
material is inferior to the reference population for any important
character.
3. REQUIREMENTS FOR COMPARATIVE TESTING OF REPRODUCTIVE MATERIAL
(a) Sampling of the reproductive material
(i) The sample of the reproductive material for comparative testing must be
truly representative of the reproductive material derived from the basic
material to be approved;
(ii) Sexually produced reproductive material for comparative testing shall be:
harvested in years of good flowering and good fruit/seed production;
artificial pollination may be utilised,
harvested by methods that ensure that the samples obtained are
representative.
EN 113 EN
(b) Standards
(i) The performance of standards used for comparative purposes in the tests
shall if possible have been known over a sufficiently long period in the
region in which the test is to be carried out. The standards represent
material that has been shown useful for forestry at the time that the test
starts, and in ecological conditions for which it is proposed to certify the
material. They shall come as far as possible from stands selected
according to the criteria in Annex III or from basic material officially
approved for production of tested material;
(ii) For comparative testing of artificial hybrids, both parent species must, if
possible, be included among the standards;
(iii) Whenever possible several standards are to be used. When necessary and
justified, standards may be replaced by the most suitable of the material
under test or the mean of the components of the test;
(iv) The same standards will be used in all tests over as wide a range of site
conditions as possible.
(c) Interpretation
(i) A statistically significant superiority as compared with the standards
must be demonstrated for at least one important character;
(ii) It will be clearly reported if there are any characters of economic or
environmental importance which show significantly inferior results to the
standards and their effects must be compensated for by favourable
characters.
4. CONDITIONAL APPROVAL
Preliminary assessment of young trials may be the basis for conditional approval.
Claims of superiority based on an early assessment must be re-examined at a
maximum interval of ten years.
5. EARLY TESTS
Nursery, greenhouse and laboratory tests may be accepted by the competent
authority for conditional approval or for final approval if it can be shown that there is
a close correlation between the measured trait and the characters which would
normally be assessed in forest field tests. Other characters to be tested must meet the
requirements set out in paragraph 3.
EN 114 EN
ANNEX IX
LIST OF TREE SPECIES AND ARTIFICIAL HYBRIDS
Abies alba Mill.
Abies cephalonica Loud.
Abies grandis Lindl.
Abies pinsapo Boiss.
Acer platanoides L.
Acer pseudoplatanus L.
Alnus glutinosa Gaertn.
Alnus incana Moench.
Betula pendula Roth.
Betula pubescens Ehrh.
Carpinus betulus L.
Castanea sativa Mill.
Cedrus atlantica Carr.
Cedrus libani A. Richard
Fagus sylvatica L.
Fraxinus angustifolia Vahl.
Fraxinus excelsior L.
Larix decidua Mill.
Larix x eurolepis Henry
Larix kaempferi Carr.
Larix sibirica Ledeb.
Picea abies Karst.
Picea sitchensis Carr.
Pinus brutia Ten.
Pinus canariensis C. Smith
Pinus cembra L.
Pinus contorta Loud.
Pinus halepensis Mill.
Pinus leucodermis Antoine
Pinus nigra Arnold
Pinus pinaster Ait.
Pinus pinea L.
Pinus radiata D. Don
EN 115 EN
Pinus sylvestris L.
Populus spp. and artificial hybrids between those species
Prunus avium L.
Pseudotsuga menziesii Franco
Quercus cerris L.
Quercus ilex L.
Quercus petraea Liebl.
Quercus pubescens Willd.
Quercus robur L.
Quercus rubra L.
Quercus suber L.
Robinia pseudoacacia L.
Tilia cordata Mill.
Tilia platyphyllos Scop.
EN 116 EN
ANNEX X
CATEGORIES UNDER WHICH REPRODUCTIVE MATERIAL FROM THE
DIFFERENT TYPES OF BASIC MATERIAL MAY BE MADE AVAILABLE ON THE
MARKET
Category of forest reproductive material
Type of basic (Label colour if colours label or document used)
material Source identified
(Yellow)
Selected
(Green)
Qualified
(Pink)
Tested
(Blue)
Seed Source x
Stand x x x
Seed Orchard x x
Parents of
Family(ies) x x
Clone x x
Clonal Mixture x x
EN 117 EN
ANNEX XI
PART A
Requirements to be met by fruit and seed lots of the species listed in Annex IX
1. Fruit and seed lots of the species listed in Annex IX may not be marketed unless the
fruit or seed lot reaches a minimum species purity level of 99 %.
2. Notwithstanding the provisions of paragraph 1, in the case of closely related species
in Annex IX, excluding artificial hybrids, the species purity of the fruit or seed lot
shall be stated if it does not reach 99 %.
PART B
Requirements to be met by parts of plants of the species and artificial hybrids listed in
Annex IX
Parts of plants of the species and artificial hybrids listed in Annex IX shall be of fair
marketable quality. Fair marketable quality shall be determined by reference to general
characteristics, health and appropriate size. In the case of Populus spp. it may be stated that
the additional requirements set out in Part C are met.
PART C
Requirements for external quality standards for Populus spp. propagated by stem
cuttings or sets
1. Stem cuttings
a. Stem cuttings shall not be considered to be of fair marketable quality, within
the meaning of Part B, if any of the following defects exist:
(i) their wood is more than two years old;
(ii) they have less than two well formed buds;
(iii) they are affected by necroses;
(iv) they show signs of desiccation, overheating, mould or decay.
b. Minimum dimensions for stem cuttings
– minimum length: 20 cm,
– minimum top diameter: Class EC 1: 8 mm
Class EC 2: 10 mm.
2. Sets
a. Sets shall not be considered to be of fair marketable quality if any of the
following defects exist:
(i) their wood is more than three years old;
(ii) they have less than five well formed buds;
(iii) they are affected by necroses;
(iv) they show signs of desiccation, overheating, mould or decay;
(v) they have injuries other than pruning cuts;
(vi) they have multiple stems;
EN 118 EN
(vii) they have excessive stem curvature.
b. Size classes for sets
Class
Minimum diameter at midlength
(mm)
Minimum height
(m)
Non-Mediterranean regions
N1 6 1,50
N2 15 3,00
Mediterranean regions
S1 25 3,00
S2 30 4,00
PART D
Requirements to be met by planting stock of the species and artificial hybrids listed in
Annex IX
The planting stock shall be of fair marketable quality. Fair marketable quality shall be
determined by reference to general characteristics, health, vitality and physiological quality.
PART E
Requirements to be met by planting stock to be marketed to the end-user in regions
having a Mediterranean climate
Planting stock shall not be marketed unless 95 % of each lot is of fair marketable quality.
1. Planting stock shall not be considered to be of fair marketable quality if any of the
following deficits exist:
(a) injuries other than pruning cuts or injuries due to damage when lifting;
(b) lack of buds with the potential to form a leading shoot;
(c) multiple stems;
(d) deformed root system;
(e) signs of desiccation, overheating, mould or decay;
(f) the plants are not well balanced.
EN 119 EN
2. Size of the plants
Species Maximum age
(years)
Minimum
height
(cm)
Maximum
height
(cm)
Minimum root
collar diameter
(mm)
Pinus halepensis 1 8 25 2
2 12 40 3
Pinus leucodermis 1 8 25 2
2 10 35 3
Pinus nigra 1 8 15 2
2 10 20 3
Pinus pinaster 1 7 30 2
2 15 45 3
Pinus pinea 1 10 30 3
2 15 40 4
Quercus ilex 1 8 30 2
2 15 50 3
Quercus suber 1 13 60 3
3. Size of the container, where used
Species
Minimum volume
of the container
(cm³)
Pinus pinaster
Other species
120
200
EN 120 EN
ANNEX XII
PART A
Information to be included in the master certificate of identity for reproductive material
derived from seed sources and stands
1. Title with the text ‘Issued in accordance with Regulation EU (No) …/… [Office of
Publications, please insert number of this Regulation]’
2. Member State
3. Number of certificate and code of Member State
4. The following indication: ‘It is certified that the forest reproductive material
described below has been produced: (a) in accordance with Regulation EU (No)
…/… [Office of Publications, please insert number of this Regulation]’; (b) under
transitional arrangements.’
5. Botanical name
6. Nature of forest reproductive material (seed unit, part of plants or planting stock)
7. Category of forest reproductive material (source identified, selected or tested)
8. Type of basic material (seed source or stand)
9. Purpose
10. National register reference or identity of basic material in national register
11. The indication ‘autochthonous’, ‘non-autochthnonous’, ‘indigenous’, ‘non-indigenous’
or ‘unknown’
12. Origin of basic material (for non-autochthonous/non-indigenous material, if known)
13. Member State and region of provenance of basic material
14. Altitude or altitudinal range of site of basic material
15. Year in which seeds ripened
16. Quantity of forest reproductive material
17. Indication whether the material covered by this certificate is the result of a
subdivision of a larger lot covered by a previous Union certificate, and, where
applicable, indication of previous certificate number or quantity in initial lot
18. Length of time in nursery
19. Indication on whether there has been subsequent vegetative reproduction of material
derived from seed
20. Other relevant information
21. Name and address of professional operator
22. Name and address of competent authority
23. Stamp of competent authority and date
EN 121 EN
PART B
Information to be included in the master certificate of identity for reproductive material
derived from seed orchards or parents of family(ies)
1. Title with the text ‘Issued in accordance with Regulation EU (No) …/… [Office of
Publications, please insert number of this Regulation]
2. Member State
3. Number of certificate and code of Member State
4. The following indication: ‘It is certified that the forest reproductive material
described below has been produced: (a) in accordance with Regulation EU (No)
…/… [Office of Publications, please insert number of this Regulation]’; (b) under
transitional arrangements.”
5. Botanical name
6. Nature of basic material (as mentioned in the catalogue)
7. Nature of forest reproductive material (seed unit, part of parts or planting stock)
8. Category of forest reproductive material (qualified or tested)
9. Type of basic material (seed orchard or parents of family(ies)
10. Purpose
11. National register reference or identity of basic material in the national register
12. Where appropriate, indication ‘autochthonous’, ‘non-autochthonous’, ‘indigenous’,
‘non-indigenous’ or ‘unknown’
13. Origin of basic material (for non-autochthonous/non-indigenous material, if known)
14. Member State and region of provenance or location of basic material
15. Indication whether seed is derived from open pollination, supplemental pollination or
controlled pollination
16. Year in which seed ripened
17. Quantity of forest reproductive material
18. Indication whether the material covered by the certificate is the result of a
subdivision of a larger lot covered by a previous Union certificate (with reference to
previous certificate number and quantity in initial lot)
19. Length of time in nursery
20. Number of components represented, including indication of families and clones)
21. Altitude or altitudinal range of site of basic material
22. Indication whether genetic modification has been used in the production of the basic
material
23. For forest reproductive material derived from parents or family(ies), indication on
crossing design and range of percentage composition of component families
24. Indication whether there has been subsequent vegetative reproduction of material
derived from seed, including indication of method of reproduction and number of
cycles of reproduction
25. Indication ‘other relevant information’
EN 122 EN
26. Name and address of the professional operator
27. Name and address of the competent authority
28. Stamp of competent authority and date
29. Name and signature of responsible officer
EN 123 EN
PART C
Information to be included in the master certificate of identity for reproductive material
derived from clones and clonal mixtures
1. Title with the text ‘Issued in accordance with Regulation EU (No) …/… [Office of
Publications, please insert number of this Regulation]
2. Member State
3. Number of certificate and code of Member State
4. The following indication: ‘It is certified that the forest reproductive material
described below has been produced: (a) in accordance with Regulation EU (No)
…/… [Office of Publications, please insert number of this Regulation]’; (b) under
transitional arrangements.’
5. Botanical name
6. Name of clone or clonal mixture
7. Nature of forest reproductive material (part of plants or planting stock)
8. Category of forest reproductive material (qualified or tested)
9. Type of basic material (clones or clonal mixtures)
10. Purpose
11. National register reference or identity of basic material in the national register
12. Where appropriate, the indication ‘autochthonous’, ‘non-autochthonous’, ‘indigenous’,
‘non-indigenous’ or ‘unknown’
13. Origin of basic material (for non-autochthonous/non-indigenous material, if known)
14. Member State and region of provenance or location of basic material
15. Indication whether the seed derives from open pollination, supplemental pollination
or controlled pollination
16. Year in which seeds ripened
17. Quantity of forest reproductive material
18. Indication whether the material covered by this certificate is the result of a
subdivision of a larger lot covered by a previous Union certificate, and, where
applicable, indication of previous certificate number or quantity in initial lot
19. Length of time in nursery
20. Altitude or altitudinal range of site of basic material
21. Indication whether genetic modification has been used in the production of the basic
material
22. Where forest reproductive material derives from parents of family(ies), indication of
crossing design and range of percentage composition of component families
23. Indication on whether there has been subsequent vegetative reproduction of material
derived from seed
24. Indication ‘Other relevant information’
25. Name and address of professional operator
EN 124 EN
26. Name and address of competent authority
27. Stamp of competent authority and date
EN 125 EN
ANNEX XIII
REPEALED ACTS AS REFERRED TO IN ARTICLE 144
1. Directive 66/401/EEC
2. Directive 66/402/EEC
3. Directive 68/193/EEC
4. Directive 98/56/EC
5. Directive 1999/105/EC
6. Directive 2002/53/EC
7. Directive 2002/54/EC
8. Directive 2002/55/EC
9. Directive 2002/56/EC
10. Directive 2002/57/EC
11. Directive 2008/72/EC
12. Directive 2008/90/EC
EN 126 EN
ANNEX XIV
CORRELATION TABLES
1. Council Directive 66/401/EEC
Council Directive 66/401/EEC This Regulation Regulation
(EU) No
…/…. (Office
of
Publication,
please insert
number of
Regulation on
Official
Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1
Article 1a
Article 2(1), point A
Article 2(1), points B, C, D, E
Article 2(1), points F, G
Article 2(1a)
Article 2(1b)
Article 2(1d)
Article 2(2)
Article 2(3), (4)
Article 3(1)
Article 3(1a)
Article 3(2)
Article 3(3)
Article 3(4)
Article 3a
Article 4(a)
Article 4(b)
Article 4a(1), first subparagraph
Article 4a(1), second subparagraph
Article 4a(2)
Article 4a(3)
Article 5
Article 5a
Article 6
Article 7
Article 8(1)
Article 8(2)
Article 9
Article 1
Article 3, Article 2
Article 11(1), (2)
Article 16(2), Article 20(2)
Article 18(5)
Article 11(3)



Article 20(2), Article 24
Article 12(1)

Article 12(2)
Article 12(3)
Article 16(3)
Article 12(1)
Article 38
Article 39
Article 2
Article 4


Article 40
Article 20(2)
Article 75
Article 20(2), Article 24
Article 17(1)
Article 17(4), Article 18(5)
Article 18
















































EN 127 EN
Article 10
Article 10a
Article 10b
Article 10c
Article 10d
Article 11
Article 11a
Article 12
Article 13
Article 13a
Article 14(1)
Article 14(1a)
Article 14a
Article 15
Article 16
Article 17
Article 18
Article 19(1)
Article 19(2)
Article 20
Article 21
Article 21a
Article 22
Article 23
Article 23a
Article 24
Article 19, Article 21(1)
Article 18(5)
Article 18(5)
Article 18(5)
Article 18(4)
Article 19(4), (5)
Article 21(1)
Article 21(6)
Article 32, Article 33
Article 42
Article 4
Article 40
Article 20(2), Article 21
Article 38
Article 44
Article 35, Article 37
Article 46



Article 141
Article 16(2)
Article 16(2), Article 20(2)
Article 12(4), point (a)
Article 145(1), (2)



















Article 8

Article 93
































2. Council Directive 66/402/EEC
Council Directive 66/402/EEC This Regulation Regulation (EU)
No …/…. (Office
of Publication,
please insert
number of
Regulation on
Official Controls)
Regulation (EU)
No …/… (Office
of Publication,
please insert
number of
Regulation on
protective
measures against
pests of plants)
Article 1
Article 1a
Article 2(1), point A
Article 1
Article 3, Article 2
Article 11(1), (2)






EN 128 EN
Article 2(1), point B
Article 2(1), points C, Ca, D, E, F, G,
H
Article 2(1a)
Article 2(1b)
Article 2(1c)
Article 2(1e)
Article 2(2)
Article 2(3), (4)
Article 3(1)
Article 3(2)
Article 3(3)
Article 3a
Article 4(1), first subparagraph (a)
Article 4(1), first subparagraph (b)
Article 4(1), second subparagraph
Article 4(4)
Article 4a(1), first subparagraph
Article 4a(1), second subparagraph
Article 4a(2)
Article 4a(3)
Article 5
Article 5a
Article 6
Article 7
Article 8(1)
Article 8(2)
Article 9
Article 10
Article 10a
Article 11
Article 11a
Article 12
Article 13
Article 13a
Article 14(1)
Article 14(1a)
Article 14a
Article 15
Article 16
Article 10(1)
Article 16(2), Article 20(2)
Article 11(3)
Article 16(2), Article 20(2)


Article 16(2), Article 20(2)
Article 20(2), Article 24
Article 12(1), (2)
Article 16(2)
Article 20(2)
Article 12(1)
Article 38
Article 39
Article 39
Article 2
Article 4


Article 40
Article 20(2)
Article 75
Article 20(2), Article 24
Article 17(1)
Article 17(4), Article 18(5)
Article 18
Article 19, Article 21(1)
Article 18(5)
Article 19(4), (5)
Article 21(1)
Article 21(6)
Article 32, Article 33
Article 42
Article 4
Article 40
Article 20(2), Article 21
Article 38
Article 44
Article 35, Article 37













Article 20(c)





























































EN 129 EN
Article 17
Article 18
Article 19(1)
Article 19(2)
Article 20
Article 21
Article 21a, Article 21b
Article 22
Article 22a
Article 23
Article 23a
Article 24
Article 46



Article 141
Article 16(2), Article 20(2)
Article 12(4), point (a)
Article 57
Article 145(1), (2)



Article 8

Article 93


















3. Council Directive 68/193/EEC
Council Directive 68/193/EEC This Regulation Regulation (EU)
No …/…. (Office
of Publication,
please insert
number of
Regulation on
Official Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1
Article 2(1)
Article 2(2)
Article 3(1)
Article 3(2)
Article 3(3), first subparagraph,
points (a) and (b) and second
subparagraph
Article 3(3), first subparagraph,
point (c)
Article 3(3), third subparagraph
Article 3(4)
Article 3(5)
Article 4
Article 5(1)
Article 5(2)
Article 5(3)
Article 5a
Article 5b(1)
Article 5b(2)
Article 1
Article 3

Article 12(1), (2)

Article 12(1), (2)
Article 12(4), point (a)
Article 4
Article 16(2)
Article 12(1), (2)
Article 40
Article 51
Article 14(1)
Article 15(1), Article 51
Article 56(2), point (a)
Article 60
Article 61
































EN 130 EN
Article 5b(3)
Article 5ba
Article 5c
Article 5d(1), (2)
Article 5d(3)
Article 5e(1)
Article 5e(2), first sentence
Article 5e(2), second sentence
Article 5f
Article 5g
Article 7
Article 8(1)
Article 8(2)
Article 9
Article 10(1)
Article 10(2)
Article 10(3)
Article 10(4)
Article 10(5)
Article 10(6)
Article 10a
Article 11(1)
Article 11(2)
Article 12
Article 12a
Article 13
Article 14
Article 14a
Article 15(1)
Article 15(2)
Article 16
Article 16a
Article 16b
Article 17
Article 17a
Article 18
Article 18a
Article18b
Article 19
Article 62
Article 4, Article 56(1),
point (b)
Article 4
Article 71, Article 74
Article 64(2)
Article 85(1)
Article 103(3)
Article 52
Article 53(1), point (h)
Article 86
Article 17(1)
Article 18(1), (2), (3), (4)
Article 18(5)
Article 18
Article 19(1), Article 22
Article 17(2), Article 29(2)

Article 21(4)


Article 21(1)

Article 45
Article 4
Article 4
Article 38
Article 35, Article 36
Article 42
Article 46
Article 44



Article 141


























Article 8








Article 93











































EN 131 EN
Article 20 Article 145 ─ ─
4. Council Directive 98/56/EC
Council Directive 98/56/EC This Regulation Regulation (EU) No
…/…. (Office of
Publication, please
insert number of
Regulation on
Official Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1(1)
Article 1(2), (3)
Article 2
Article 3
Article 4
Article 5(1)
Article 5(2)
Article 5(3), (4)
Article 5(5)
Article 6
Article 7(1)
Article 7(2)
Article 7(3)
Article 7(4)
Article 8(1)
Article 8(2), (3)
Article 8(4)
Article 9(1)
Article 9(2)
Article 9(3)
Article 9(4)
Article 10
Article 11(1)
Article 11(2)
Article 11(3)
Article 11(4)
Article 12
Article 13
Article 14
Article 15
Article 16
Article 1
Article 2
Article 3
Article 6
Article 4
Article 16(2), Article 48(1)
Article 64(1)
Article 16(2)

Article 5
Article 7

Article 8

Article 17, Article 48(2)
Article 19(4), Article 49

Article 50
Article 50(2), Article 64(4)


Article 35, Article 37
Article 44
Article 43





Article 4


























Article 8
Article 64(1)
Article 93












Article 9



















EN 132 EN
Article 17
Article 18
Article 19
Article 20
Article 21
Article 141
Article 141


Article 145










5. Council Directive 1999/105/EC
Council Directive 1999/105/EC This Regulation Regulation (EU)
No …/…. (Office
of Publication,
please insert
number of
Regulation on
Official Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1
Article 2
Article 3(1)
Article 3(2)
Article 3(3), first subparagraph
Article 3(3), second subparagraph
Article 3(4)
Article 4(1)
Article 4(2)
Article 4(3), point (a)
Article 4(3), point (b)
Article 4(4)
Article 4(5)
Article 5
Article 6(1)
Article 6(2)
Article 6(3), first subparagraph
Article 6(3), second subparagraph
Article 6(4)
Article 6(5)
Article 6(6)
Article 6(7)
Article 6(8)
Article 7
Article 8
Article 9
Article 105
Article 106
Article 119
Article 4
Article 105, Article 3(9)
Article 8(4)
Article 139
Article 114
Article 107(1), (2)
Article 107(3)
Article 109
Article 134
Article 108
Article 4
Article 115, point (b)
Article 117(5)
Article 118

Article 5
Article 2, point (a)

Article 134

Article 128

Article 110




















































EN 133 EN
Article 10
Article 11
Article 12
Article 13(1)
Article 13(2)
Article 13(3)
Article 14(1), (2)
Article 14(3)
Article 14(4)
Article 14(5)
Article 14(6)
Article 14(7)
Article 15
Article 16(1)
Article 16(2)
Article 16(3), (4), (5)
Article 16(6)
Article 17(1)
Article 17(2)
Article 17(3)
Article 17(4)
Article 18
Article 19
Article 20
Article 21
Article 22
Article 23
Article 24
Article 25
Article 26
Article 27
Article 28
Article 29
Article 30
Article 31
Article 112
Article 113
Article 122
Article 123
Article 117(2)
Article 126
Article 124(1), (2)
Article 130
Article 131
Article 125
Article 124(3)
Article 4
Article 121




Article 4
Article 128

Article 128(1), point (b)
Article 129
Article 137, Article 138

Article 133
Article 4
Article 127


Article 141


Article 144
Article 145(1), (2)














Article 8
Article 100(1)

Article 106(2)





















































EN 134 EN
6. Council Directive 2002/54/EC
Council Directive 2002/54/EC This Regulation Regulation
(EU) No …/….
(Office of
Publication,
please insert
number of
Regulation on
Official
Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1, first subparagraph
Article 1, second subparagraph
Article 2(1)
Article 2(2)
Article 2(3)(A)
Article 2(3)(B)
Article 2(4)
Article 3(1)
Article 3(2)
Article 4
Article 5, first subparagraph, point
(a)
Article 5, first subparagraph, point
(b)
Article 5, second subparagraph
Article 5, third subparagraph
Article 6(1), first subparagraph, point
(a)
Article 6(1), first subparagraph, point
(b)
Article 6(1), second subparagraph
Article 6(2)
Article 6(3)
Article 7
Article 8
Article 9(1)
Article 9(1a)
Article 9(1b)
Article 9(2)
Article 10(1)
Article 10(2)
Article 11(1)
Article 11(2)
Article 1
Article 46
Article 3, Article 10
Article 20(2)
Article 20(2), Article 23
Article 20(2), Article 143
Article 24
Article 12(1), (2)
Article 20(2)
Article 12(1)
Article 37
Article 39


Article 2, points (a) and (b)
Article 34(1)
Article 4
Article 34(6)

Article 40
Article 75(1)
Article 20(2), Article 24
Article 23(1)
Article 23(1), point (a)
Article 20(2)
Article 17(1)
Article 17(4)
Article 18
Article 18(4)













Article 100








































EN 135 EN
Article 11(3)
Article 12(a)
Article 12(b)
Article 13
Article 14
Article 15
Article 16
Article 17
Article 18
Article 19
Article 20
Article 21
Article 22(1)
Article 22(2)
Article 22(3)
Article 23
Article 24
Article 25(1)
Article 25(2)
Article 26
Article 27
Article 28
Article 29
Article 30(1), point (a)
Article 30(1), point (b)
Article 30(1), point (c)
Article 30(2)
Article 30A
Article 31
Article 32
Article 33
Article 34
Article 35
Article 18(5)
Article 19, Article 21

Article 18(5)
Article 18(5)
Article 18

Article 21(1)
Article 21(6)
Article 42
Article 4
Article 16(2)
Article 38(1)
Article 38(6)
Article 44(2), point (b)(iii)
Article 44
Article 37



Article 16(3)
Article 141
Article 4
Article 16(2)
Article 12(4), point (a)




Article 144
Article 145(1)

















Article 8

Article 93











































EN 136 EN
7. Council Directive 2002/55/EC
Council Directive 2002/55/EC This Regulation Regulation (EU)
No …/…. (Office
of Publication,
please insert
number of
Regulation on
Official Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1, first subparagraph
Article 1, second subparagraph
Article 2(1), point (a)
Article 2(1), point (b)
Article 2(1), point (c)
Article 2(1), point (d)
Article 2(1), point (e)
Article 2(1), point (f)
Article 2(1), point (g)
Article 2(2)
Article 2(3)
Article 2(4)
Article 3(1)
Article 3(2)
Article 3(3)
Article 3(4)
Article 4(1)
Article 4(2), (3)
Article 4(4)
Article 5(1)
Article 5(2)
Article 5(3)
Article 6
Article 7(1)
Article 7(2)
Article 7(3)
Article 7(4), (5)
Article 8
Article 9(1)
Article 9(2), (3)
Article 9(4)
Article 9(5)
Article 1
Article 46
Article 3(5)
Article 11(2)
Article 10(7)
Article 10(8)
Article 10(9)

Article 18(5)
Article 11(3)
Article 53(1), point (i)
Article 20(2), Article 24(4)
Article 14(1)
Article 51
Article 52
Article 14(1)
Article 56(2), point (a)
Article 4
Article 57
Article 60
Article 61
Article 62
Article 14(1)
Article 71
Article 74
Article 75
Article 4
Article 66, Article 67
Article 51, Article 86
Article 64
Article 102(1)
Article 53(1), point (h)
































































EN 137 EN
Article 9(6)
Article 10(1), (2), (3), (4)
Article 10(5)
Article 11
Article 12(1)
Article 12(2)
Article 12(3)
Article 13(1)
Article 13(2)
Article 13(3)
Article 13(4)
Article 14(1), (2)
Article 15(1)
Article 15(2)
Article 15(3)
Article 16(1)
Article 16(2)
Article 17
Article 18
Article 19
Article 20(1), (2), (3)
Article 20(4)
Article 21
Article 22(a)
Article 22(b)
Article 23(1), point (a)
Article 23(1), point (b)
Article 23(2)
Article 23(3)
Article 24
Article 25(1)
Article 25(1a)
Article 25(1b)
Article 25(2)
Article 26(1)
Article 26(2)
Article 26(3)
Article 27
Article 28(1)
Article 64(1)
Article 103
Article 76(3), (4)
Article 86
Article 82
Article 83
Article 84(4)

Article 85(1)
Article 81

Article 85(1)
Article 85(1)
Article 85(2)

Article 4
Article 4, Article 56(1),
point (c)
Article 52, Article 53
Article 41

Article 12
Article 20(2)
Article 2
Article 37
Article 39
Article 2
Article 34(1)
Article 34(6)

Article 40
Article 16(2), Article 20(2)
Article 23(1)
Article 23(1), point (a)
Article 20(2)
Article 17(1)
Article 18(5)
Article 32(1)
Article 18
Article 19(1), Article 21








































































EN 138 EN
Article 28(2)
Article 28(3)
Article 28(4)
Article 29
Article 30
Article 31
Article 32
Article 33
Article 34(1)
Article 34(2)
Article 35
Article 36(1)
Article 36(2)
Article 36(3)
Article 37
Article 38
Article 39
Article 40
Article 41
Article 42
Article 43
Article 44
Article 45
Article 46
Article 47
Article 48
Article 48(1)(b)
Article 49
Article 50
Article 51
Article 52
Article 53
Article 18(5)
Article 19(4)

Article 18(5)
Article 21(5)
Article 21(1)
Article 21(6)
Article 42
Article 4
Article 12(1), (2)
Article 20(2), Article 21(1)

Article 19(1), (2)

Article 44
Article 35, Article 37

Article 30
Article 20(2), Article 28
Article 31

Article 14(4), Article 56
Article 16(2), Article 20(2)
Article 141
Article 4
Article 32, Article 33
Article 12(4), point (a)


Article 144
Article 145(1), (2)

















Article 8



Article 93









































EN 139 EN
8. Council Directive 2002/56/EC
Council Directive 2002/56/EC This Regulation Regulation (EU)
No …/…. (Office
of Publication,
please insert
number of
Regulation on
Official Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1, first subparagraph
Article 1, second subparagraph
Article 2
Article 3(1), first sentence
Article 3(1), second sentence
Article 3(1), third sentence
Article 3(2), (3), (4)
Article 4
Article 5
Article 6(1), first subparagraph
Article 6(1), second subparagraph
Article 6(2)
Article 6(3)
Article 7
Article 8
Article 9
Article 10(1)
Article 10(2)
Article 10(3)
Article 11(1)
Article 11(2)
Article 12(1)
Article 12(2)
Article 12(3)
Article 13(1)
Article 13(2)
Article 14
Article 15
Article 16
Article 17(1)
Article 17(2), first sentence
Article 17(2), second sentence
Article 1
Article 46
Article 3
Article 12(1), Article 16(2)


Article 16(2)
Article 12(1)
Article 40
Article 2
Article 4


Article 20(2)
Article 16(2)
Article 16(2)
Article 16(2)
Article 17(4)
Article 17(4)
Article 17, Article 18
Article 18(5)
Article 18(2), (4)
Article 18(4)
Article 18(5)
Article 19(3), Article 21
Article 18(5)

Article 21(1)
Article 21(6)
Article 4
Article 40
































































Article 16, Article 31
EN 140 EN
Article 18
Article 19
Article 20
Article 21
Article 22(1)
Article 22(2)
Article 22(3)
Article 23(1)
Article 23(2)
Article 24
Article 25
Article 26
Article 27(1), point (a)
Article 27(1), point (b)
Article 27(1), point (c)
Article 27(2)
Article 28
Article 29
Article 30
Article 31
Article 16(2)
Article 42

Article 44
Article 35, Article 37
Article 34


Article 45
Article 16(2)
Article 141
Article 4
Article 16(2)
Article 12(4), point (a)

Article 16(2)

Article 144
Article 145(1)



Article 93




Article 8
































9. Council Directive 2002/57/EC
Council Directive 2002/57/EC This Regulation Regulation
(EU) No
…/…. (Office
of
Publication,
please insert
number of
Regulation on
Official
Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1, first subparagraph Article 1 ─ ─
Article 1, second subparagraph Article 46 ─ ─
Article 2(1)(a) Article 3, Article 10 ─ ─
Article 2(1)(b) Article 11(1), (2), (4) ─ ─
Article 2(1)(c), (d), (e), (f), (g), (h), (i),
(j), (k)
Article 16, Article 20
─ ─
Article 2(2) Article 11(3) ─ ─
EN 141 EN
Article 2(3) ─ ─ ─
Article 2(3a) ─ ─ ─
Article 2(4)(a) Article 16(2) ─ ─
Article 2(4)(b) Article 20(2) ─ ─
Article 2(5) Article 20(2) ─ ─
Article 2(6) Article 20(2) ─ ─
Article 3(1), (2), (3) Article 12(3) ─ ─
Article 3(4)
Article 4
Article 5, first subparagraph (a)
Article 5, first subparagrpah (b)
Article 5, second subparagraph
Article 5, third subparagraph
Article 6(1), first subparagraph, point
(a)
Article 6, first subparagraph, point (b)
Article 6(1), second subparagraph
Article 6(2)
Article 6(3)
Article 7
Article 8
Article 9
Article 10(1)
Article 10(2)
Article 11
Article 12(1)
Article 12(2)
Article 12(3)
Article 13
Article 14
Article 15
Article 16
Article 17
Article 18
Article 19
Article 19a
Article 20
Article 16(3)
Article 12(1)
Article 37
Article 39
Article 44

Article 2
Article 4
Article 34


Article 40
Article 75(1)
Article 20(2)
Article 17(1), Article 18(1)
Article 18(5)
Article 18
Article 19(1), Article 20(1)

Article 21(5), point (g)

Article 21(1)
Article 21(6)
Article 42
Article 4
Article 20(2)

Article 20(2)
Article 42




Article 100(1)

















































EN 142 EN
Article 21(1)
Article 21(2)
Article 21(3)
Article 22(1)
Article 22(2)
Article 23
Article 24
Article 25
Article 26
Article 27(1), point (a)
Article 27(1), point (b)
Article 27(1), point (c)
Article 27(2)
Article 28
Article 29
Article 30
Article 31
Article 32
Article 33
Article 37
Article 19




Article 20(2)
Article 141
Article 4
Article 16(2)
Article 12(4), point (a)

Article 57(2)



Article 144
Article 145
Article 145
































10. Council Directive 2008/90/EC
Council Directive 2008/90/EC This Regulation Regulation (EU) No
…/…. (Office of
Publication, please insert
number of Regulation on
Official Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1(1) Article 1 ─ ─
Article 1(2) Article 11(2) ─ ─
Article 1(3) Article 4 ─ ─
Article 1(4) Article 46 ─ ─
Article 2 Article 3 ─ ─
Article 3(1) Article 12(1) ─ ─
Article 3(2) Article 4 ─ ─
Article 3(3) Article 4 ─ ─
Article 3(4) Article 2 ─ ─
Article 4 Article 16, Article 20 ─ ─
Article 5 Article 5 ─ ─
Article 6(1) Article 7 ─ ─
EN 143 EN
Article 6(2) ─ ─ Article 9(1)
Article 6(3) Article 8 ─ ─
Article 6(4) ─ ─ ─
Article 7(1) Article 14, Article 50(1) ─ ─
Article 7(2), first
subparagraph
Article 7(2), second
subparagraph
Article 14, Article 50(1)
Article 12(4), point (a)


Article 7(3) Article 50(2) ─ ─
Article 7(4) Article 57 ─ ─
Article 7(5) Article 56 ─ ─
Article 7(6) Article 51, Article 52 ─ ─
Article 8(1) Article 17(1) ─ ─
Article 8(2) Article 17(2) ─ ─
Article 9(1), point (a) Article 19 (4), (5) ─ ─
Article 9(1), point (b) Article 19 (1), (2) ─ ─
Article 9(1), second
subparagraph
Article 21(5) ─ ─
Article 9(2) ─ ─ ─
Article 9(3) Article 21(1) ─ ─
Article 10 ─ ─ ─
Article 11 Article 37 ─ ─
Article 12 Article 44 ─ ─
Article 13 ─ Article 8 and Article 20,
point (b)

Article 14(1)
Article 14(2)


Article 13(1)
Article 93


Article 14(3)
Article 14(4)
Article 14(5)
Article 14(6)
Article 14(7)
Article 15

Article 93(3), point (d)
Article 93(3), point (b)
Article 161, point
(a)(ii)(b)
Article 161, point
(a)(ii)(b)
Article 93
Article 115

Article 16 ─ Article 118 ─
Article 17(1) Article 4 ─ ─
Article 17(2) Article 40 ─ ─
Article 18 Article 11(3) ─ ─
EN 144 EN
Article 19 Article 141 ─ ─
Article 20 ─ ─ ─
Article 21 ─ ─ ─
Article 22 Article 144 ─ ─
Article 23 Article 145 (1), (2) ─ ─
Article 24 ─ ─ ─
11. Council Directive 2002/53/EC
Council Directive 2002/53/EC This Regulation Regulation (EU) No …/….
(Office of Publication,
please insert number of
Regulation on Official
Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1(1)
Article 1(2)
Article 1(3)
Article 2
Article 3(1)
Article 3(2)
Article 3(3)
Article 4(1)
Article 4(2)
Article 4(3)
Article 4(4), (5)
Article 4(6)
Article 5(1)
Article 5(2)
Article 5(3)
Article 5(4)
Article 6
Article 7(1)
Article 7(2)
Article 7(3)
Article 7(4)
Article 7(5)
Article 8
Article 9(1)
Article 9(2), (3)
Article 52(1)
Article 52(1), point (b)
Article 46

Article 51
Article 56(3), (4)
Article 4
Article 56
Article 56(2)

Article 4
Article 57
Article 60
Article 61
Article 62
Article 58
Article 4
Article 71
Article 74
Article 75
Article 4
Article 4
Article 67(1), point (i)
Article 53(1)
Article 64


















































EN 145 EN
Article 9(4)
Article 9(5)
Article 9(6)
Article 10(1), (2), (3), (4)
Article 10(5)
Article 11
Article 12(1)
Article 12(2)
Article 12(3)
Article 13(1)
Article 13(2)
Article 13(3)
Article 13(4)
Article 14
Article 15
Article 16(1)
Article 16(2)
Article 17
Article 18
Article 19
Article 20(1)
Article 20(2)and 20(3), point
(a)
Article 20(3), point (b)
Article 21
Article 22
Article 23
Article 24
Article 25
Article 26
Article 27
Article 28
Article 102(1)
Article 53(1), point (g)
Article 64(1)
Article 103
Article 76(3)
Article 86
Article 82
Article 83(1), Article 84
Article 84(4)

Article 85(1)
Article 81

Article 85
Article 85
Article 4
Article 4, Article 85(1)
Article 52, Article 55
Article 45, Article 85(1)
Article 84(4)

Article 57


Article 44
Article 141


Article 144
Article 145(1), (2)





























































EN 146 EN
12. Council Directive 2008/72/EC
Council Directive 2008/72/EC This Regulation Regulation (EU) No
…/…. (Office of
Publication, please
insert number of
Regulation on
Official Controls)
Regulation (EU) No
…/… (Office of
Publication, please
insert number of
Regulation on
protective measures
against pests of
plants)
Article 1(1)
Article 1(2)
Article 1(3)
Article 2
Article 3
Article 4
Article 5(1)
Article 5(2)
Article 5(3)
Article 5(4)
Article 6(1)
Article 6(2)
Article 6(3)
Article 6(4)
Article 7
Article 8(1)
Article 8(2), points (a) and (b)
Article 8(2), point (c)
Article 8(3)
Article 9(1), (2)
Article 9(3)
Article 10(1)
Article 10(2)
Article 10(3)
Article 11(1), first subparagraph
Article 11(1), second
subparagraph
Article 11(2)
Article 12
Article 13
Article 14
Article 15
Article 16
Article 1
Article 11(1), (2), (4)
Article 11(3)
Article 46
Article 3, Article 10
Article 16(2)
Article 6
Article 7, Article 8


Article 5


Article 24

Article 5
Article 2
Article 12(4), point a

Article 14(1)
Article 52
Article 17(1)
Article 17(2)

Article 17(1), Article 28



Article 35, Article 37
Article 4
Article 4, Article 40
Article 43, Article 44











Article 36


Article 115







Article 8
















Article 9, Article 15



Article 64


















EN 147 EN
Article 17
Article 18
Article 19
Article 20
Article 21
Article 22
Article 23(1)
Article 23(2)
Article 24
Article 25
Article 26
Article 27
Article 24

Article 20, point (d)

Article 141


Article 4

Article 144
Article 145(1), (2)

Article 8, Article 13
Article 20

Article 93


Article 8
















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