# EUR-Lex - 52013PC0262 - EN

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# 52013PC0262

**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) /* COM/2013/0262 final - 2013/0137 (COD) */**

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

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

2.           RESULTS
OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

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

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

The Impact Assessment identified the following
main axes along which the system has to change in order to be fit for the
changing economic, environmental, social, scientific circumstances: (i)
Simplification of the basic legal acts (from 12 Directives to one Regulation),
(ii) Cost recovery and improvement of the effectiveness and efficiency of the
system and (iii) Horizontal coordination with recent, already 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
micro-enterprises have been addressed throughout, especially in order to ensure
access for these enterprises to public services for the execution of certain
tasks they cannot perform themselves and to support and further develop their
flexibility to gain improved access to the plant reproductive material market.
Specific attention is given to trade-offs between transferring operational work
and keeping of quality of plant reproductive material.

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

3.           LEGAL
ELEMENTS OF THE PROPOSAL

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

3.1.        Part I – General provisions

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

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

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

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

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

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

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

Old traditional varieties

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

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

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

3.5.        Part V – Procedural provisions

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

3.6.        Part VI – Final provisions

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

The necessary rules on penalties are laid down.

3.7.        Part VII – Union competence,
subsidiarity and legal form

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

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

4.           BUDGETARY
IMPLICATION

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

5.           OPTIONAL
ELEMENTS

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 procedure[1],

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 seed[2];

(b)     Council Directive 66/402/EEC OF 14
June 1966 on the marketing of cereal seed[3];

(c)     Council Directive 68/193/EEC of 9
April 1968 on the marketing of material for the vegetative propagation of the
vine[4];

(d)     Council Directive 98/56/EC of 20 July
1998 on the marketing of propagating material of ornamental plants[5];

(e)     Council Directive 1999/105/EC of 22
December 1999 on the marketing of forest reproductive material[6];

(f)      Council
Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of
agricultural plant species[7];

(g)     Council Directive 2002/54/EC of 13 June 2002 on the
marketing of beet seed[8];

(h)     Council Directive 2002/55/EC of 13 June 2002 on the
marketing of vegetable seed[9];

(i)      Council Directive 2002/56/EC of 13
June 2002 on the marketing of seed potatoes[10];

(j)      Council Directive 2002/57/EC of 13
June 2002 on the marketing of seed of oil and fibre plants[11];

(k)     Council Directive 2008/72/EC of 15
July 2008 on the marketing of vegetable propagating and planting material,
other than seed[12];

(l)      Council Directive 2008/90/EC of 29
September 2008 on the marketing of fruit propagating material and fruit plants
intended for fruit production[13].

(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
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 waste[14],
Regulation (EC) No 338/97/EC of 9 December 1996 on the protection of species of
wild fauna and flora by regulating trade therein[15], Directive 2001/18/EC of the
European Parliament and of the Council of 12 March 2001 on the deliberate
release into the environment of genetically modified organisms and repealing
Council Directive 90/220/EEC[16],
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of
22 September 2003 on genetically modified food and feed[17], 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/EC[18]
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.

(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 post-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 plants[19], 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 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
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 erosion and for marketing of seed and seed potatoes of
those landraces and varieties[20],
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 varieties[21].
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
micro-enterprises, 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.

(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 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.

(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 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
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, 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:

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;

(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.

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.

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.

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;

(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,

(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.

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.

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 Co-operation 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:

(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').

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:

(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;

(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.

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.

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.

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:

(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.

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'.

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.

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 pre-basic, basic or certified material pursuant to Article
19(1), may be made available on the market by reference to those categories if:

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

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

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

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.

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 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 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

(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.

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;

(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.

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

(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.

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;

(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.

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:

(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;

(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;

(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 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;

(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.

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.

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;

(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).

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 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:

(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.

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;

(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.

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.

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.

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.

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.

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);

(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.

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, micro-propagation, 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);

(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.

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.

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);

(i)      origin: whether the basic material is
autochthonous/indigenous, non autochthonous/non-indigenous or if the origin is
unknown. For non-autochthonous/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:

(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.

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).

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;

(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 non-indigenous basic forest material is mixed
pursuant to paragraph 2 with forest reproductive material derived from basic
forest material of unknown origin, the new combined lot shall be certified as
being ‘of unknown origin’.

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.

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 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 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.

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.

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.

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.

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.

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 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).

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

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.

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.

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.

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.

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.

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.

ANNEX II
REQUIREMENTS FOR PRE-BASIC, BASIC, CERTIFIED AND STANDARD MATERIAL, AND
ELEMENTS FOR THE ADOPTION OF THOSE REQUIREMENTS

PART A

Requirements for the production of
Plant Reproductive Material as referred to in Article 16(2)

The following requirements for fields and
crops shall apply, depending on the characteristics of each genus or species:

1.           Sowing or planting:

(a)     the identity of the plant reproductive
material, including where applicable mother plants, shall be determined to
ensure the traceability of the plant reproductive material. The label of the
material or the records on the mother plant shall be kept.

(b)     the material shall be planted and /or
sowed in a way that there is:

(i)      sufficient distance from pollen
sources of the same species and/or the same varieties, according to isolation
rules per botanical characteristics and breeding techniques, to ensure
protection from any undesirable foreign pollination and to avoid cross
pollination with other crops;

(ii)      an appropriate source and level of
pollination to ensure the subsequent reproduction;

(iii)     an appropriate rotation (previous
cropping and duration between cropping period with the same species) to avoid
impurities;

(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:

The plant reproductive material shall be
harvested in bulk or as individual plants, as appropriate to ensure the
identity and purity of the harvested material.

(d)     Maintenance:

Plant reproductive material, including where
applicable mother plants, shall be maintained in a way to ensure the identity
of the variety. That maintenance shall be based on the official description or
the officially recognised description of the variety.

(e)     Union quality pests

The plant reproductive material shall be
cultivated in a manner to ensure that the presence of Union quality pests, as
listed pursuant to the implementing act referred to in Article 37(2) of
Regulation (EU) No .../... (Office of Publications, please insert number of
Regulation on protective measures against pests of plants), in that plant
reproductive material complies with the provisions of that act.

(f)      Where appropriate, the cultivation of
plant reproductive material shall take place separately from the cultivation of
material belonging to the same genera or species for food or feed purposes, to
ensure health of the material concerned.

(g)     Where applicable, micro-propagation
may also be used for the reproduction of plant reproductive material.

PART B

Requirements for the Quality of
Plant Reproductive Material referred to in Article 16(2)

Plant reproductive material shall fulfil
one or more of the following quality requirements, depending on the
characteristics of each genus or species:

(a)          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;

(i)           the presence of Union quality
pests, as listed pursuant to the implementing act referred to in Article 37(2)
of Regulation (EU) No [...] on protective measures against pests, in plant
reproductive material shall comply with the provisions of that act.

PART C

Requirements for the certification of Plant
reproductive material as indicated in Article 20(1)

A.           Frequency and methods of field inspections

The frequency of inspections and the relevant
growth stage(s) of the plant reproductive material for inspections shall ensure
efficient observations and inspections.

The methods for inspections shall be such
ensure the reliability of the observations.

Where applicable, the mother
plants shall be inspected, at least by visual
inspection, at the most appropriate period(s) of the year to check the presence
of pests or their vectors

The mother plants shall be maintained in all
phases of cultivation under conditions to enable the production of plant reproductive material and permit the
verification of the identity based on the description of the variety.

Inspections shall concern, where appropriate,
compliance with the rules set out pursuant Article 37(2) of Regulation (EU) No
.../... [Office of Publications, please insert number of Regulation on
protective measures against plants] concerning the presence of quality
pests on the plant reproductive material concerned. The quality of soil,
substrates, mother plants and the immediate environment shall be checked to
avoid presence of pests or their vectors.

B.           Sampling and testing

1.      The sampling method shall fulfil the
following requirements:

(a)     the sample to be drawn from a lot shall
have the appropriate minimum weight for determining content of certain weeds,
to ensure representative sampling and suitable size for the analysis of the
material to assess whether the quality requirements have been fulfilled.

(b)     the intensity of sampling, the
equipment of sampling, and methods to be used, shall ensure that reliable
samples are collected for testing.

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.

PART D

Elements for the Adoption of the Requirements
for the Production and Quality of plant reproductive material referred to in
Article 16(2), and for the certification of Plant reproductive material as referred to
in Article 20(1)

The production and quality requirements
referred to in Parts A and B, and the certification schemes referred to in Part
C, may be laid down per one or more of the following elements:

(a)          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.

ANNEX III

PART A

Content
of official label and operator's label as referred to in article 21(1)

The official label and operator's label
shall contain the following:

(a)          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 2[22] 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.

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'.

ANNEX IV

PART A

Criteria
for genera or species with satisfactory value for cultivation and/or use

The requirements set out in Article 58(2)
on satisfactory value for cultivation and/or use shall apply to genera and
species which comply with one or more of the following criteria:

(a)          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.

PART B

Criteria
for genera or species with sustainable value for cultivation and/or use

The requirements set out Article 59(1) on
sustainable value for cultivation and/or use shall apply to genera and species
which comply with one or more of the following criteria:

(a)          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.

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 non-autochthonous or non-indigenous basic
material the origin must be stated if known.

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/non-indigenous 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.

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.

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.

ANNEX VIII
REQUIREMENTS FOR THE
APPROVAL OF BASIC MATERIAL INTENDED FOR THE PRODUCTION OF FOREST REPRODUCTIVE
MATERIAL TO BE CERTIFIED AS ‘TESTED’

1.           Requirements
for all tests

(a)     General

The basic material must satisfy the applicable requirements
in Annex V or VI.

Tests set up for the approval of basic material
are to be prepared, laid out, conducted and their results interpreted in
accordance with internationally recognised procedures. For comparative tests,
the forest reproductive material under test must be compared with one or
preferably several approved or pre-chosen standards.

(b)     Characters to be examined

(i)      Tests must be designed to assess
specified characters and these must be indicated for each test;

(ii)      Weight shall be given to adaptation,
growth, biotic and abiotic factors of importance. In addition, other
characters, considered important in view of the intended specific purpose,
shall be evaluated in relation to the ecological conditions of the region in
which the test is carried out.

(c)     Documentation

Records must describe the test sites, including
location, climate, soil, past use, establishment, management and any damage due
to abiotic/biotic factors, and be available to the competent authority. Age of
the material and results at the time of the evaluation must be recorded with
the competent authority.

(d)     Setting up the tests

(i)      Each sample of reproductive material
shall be raised, planted and managed in an identical way as far as the types of
plant material permit;

(ii)      Each experiment must be established
in a valid statistical design with a sufficient number of trees in order that the
individual characteristics of each component under examination can be
evaluated.

(e)     Analysis and validity of results

(i)      The data from experiments must be
analysed using internationally recognised statistical methods and the results
presented for each character examined;

(ii)      The methodology used for the test
and the detailed results obtained shall be made freely available;

(iii)     A statement of the suggested region
of probable adaptation within the country in which the test was carried out and
characteristics which might limit its usefulness must also be given;

(iv)     If during tests it is proved that the
reproductive material does not possess at least the characteristics of the
basic material, then such reproductive material shall be eliminated.

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.

(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.

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

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.

ANNEX X
CATEGORIES UNDER WHICH REPRODUCTIVE MATERIAL FROM
THE DIFFERENT TYPES OF BASIC MATERIAL MAY BE MADE AVAILABLE ON THE MARKET

Type of basic material || Category of forest reproductive material (Label colour if colours label or document used)

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

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;

(vii)    they have excessive stem curvature.

b.      Size classes for sets

Class || Minimum diameter at mid-length (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.

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

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

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'

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

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

26.         Name and address of competent
authority

27.         Stamp of competent authority and
date

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

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 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 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 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 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 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 1 Article 3, Article 2 Article 11(1), (2) 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 46 ─ ─ ─ Article 141 Article 16(2), Article 20(2) Article 12(4), point (a) Article 57 Article 145(1), (2) ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ Article 20(c) ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ 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 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 20 || 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 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 145 || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ Article 8 ─ ─ ─ ─ ─ ─ ─ ─ Article 93 ─ ─ ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

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 17 Article 18 Article 19 Article 20 Article 21 || 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 141 Article 141 ─ ─ Article 145 || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ Article 8 Article 64(1) Article 93 ─ ─ ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ Article 9 ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

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 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 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 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) ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

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 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 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 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 100 ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ Article 8 ─ Article 93 ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

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 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 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 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) 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 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 ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

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 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 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(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 ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ Article 16, Article 31 ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

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) || ─ || ─

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 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 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 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 || ─ ─ ─ ─ Article 100(1) ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

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 || ─ || ─

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) || ─ || ─

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 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 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 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) ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

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 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 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 24 ─ Article 20, point (d) ─ Article 141 ─ ─ Article 4 ─ Article 144 Article 145(1), (2) ─ || ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ Article 36 ─ ─ Article 115 ─ ─ ─ ─ ─ ─ ─ Article 8 ─ ─ ─ ─ ─ ─ ─ ─ Article 8, Article 13 Article 20 ─ Article 93 ─ ─ Article 8 ─ ─ ─ ─ ─ || ─ ─ ─ ─ ─ ─ ─ ─ Article 9, Article 15 ─ ─ ─ Article 64 ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ ─

[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.

[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.

[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

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

[20]             OJ L 162, 21.6.2008, p. 13–19.

[21]             OJ L 312, 27.11.2009, p. 44–54.

[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.