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EN ENEUROPEAN
COMMISSION
Brussels, 5.7.2023
COM(2023) 414 final
2023/0227 (COD)
Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the production and marketing of plant reproductive material in the Union, amending
Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of
the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC,
2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and
2008/90/EC (Regulation on plant reproductive material)
(Text with EEA relevance)
{SEC(2023) 414 final} - {SWD(2023) 410 final} - {SWD(2023) 414 final} -
{SWD(2023) 415 final}

EN
EXPLANATORY MEMORANDUM
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Rules for the production and marketing of plant reproductive material (‘PRM’) of
agricultural crops, vegetables, vine, and fruit plants have been in place at Union level since the 1960s. It comprises the following Directives (collectively known as the ‘PRM marketing Directives’):
● Council Directive 66/401/EEC on the marketing of fodder plant seed1,
● Council Directive 66/402/EEC on the marketing of cereal seed2,
● Council Directive 68/193/EEC on the marketing of material for the vegetative
propagation of the vine3,
● Council Directive 2002/53/EC on the common catalogue of varieties of
agricultural plant species4,
● Council Directive 2002/54/EC on the marketing of beet seed5,
● Council Directive 2002/55/EC on the marketing of vegetable seed6,
● Council Directive 2002/56/EC on the marketing of seed potatoes7,
● Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants8,
● Council Directive 2008/72 on the marketing of vegetable propagating and
planting material, other than seeds9, and
● Council Directive 2008/90/EC on the marketing of fruit plant propagating
material and fruit plants intended for fruit production10.
Moreover, Council Directive 98/56/EC11 regulates the marketing of propagating
material of ornamental plants.
---------------------------
1 Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (OJ 125,
11.7.1966, p. 2298).
2 Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (OJ 125, 11.7.1966, p.
2309).
3 Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative
propagation of the vine (OJ L 93, 17.4.1968, p. 15).
4 Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural
plant species (OJ L 193, 20.7.2002, p. 1).
5 Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (OJ L 193, 20.7.2002, p.
12).
6 Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (OJ L 193,
20.7.2002, p. 33).
7 Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (OJ L 193, 20.7.2002,
p. 60).
8 Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L
193, 20.7.2002, p. 74).
9 Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and planting
material, other than seed (OJ L 205, 1.8.2008, p. 28).
10 Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating
material and fruit plants intended for fruit production (OJ L 267, 8.10.2008, p. 8).
11 Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental
plants (OJ L 226, 13.8.1998, p. 16

The PRM marketing Directives were first evaluated in 2008. This evaluation and further studies carried out in 2013 and 2022, in relation respectively to a previous proposal to revise the legislation and to this proposal confirmed that the Directives have had a significant impact on the free movement, availability and quality of PRM on the EU market. This legislation has thus been of major importance for the creation of the single market of PRM in the EU. However, these studies also identified that there is complexity and fragmentation of the legislative framework, that are likely to perpetuate existing uncertainties and discrepancies in its implementation by Member States. This creates unequal marketing opportunities for professional operators and for the marketing of PRM throughout the Union. The legislative framework also needs to be aligned with recent scientific and technological developments and with new policy objectives as regards sustainability, climate change and biodiversity challenges.
This proposal introduces a new approach, with a single regulation replacing all PRM marketing Directives. The proposed regulation on plant reproductive material aims to harmonise implementation, increase efficiency, reduce administrative burden and support innovation. In particular, it takes account of the need to ensure that production of PRM can adapt to evolving agricultural, horticultural and environmental conditions, face the challenges of climate change, to foster the protection of agro-biodiversity, and to meet increasing farmer and consumer expectations related to the quality and sustainability of PRM.
The proposal also aims to facilitate the technical progress in PRM production and plant breeding, in accordance with the rapid evolution of European and global standards. It creates a framework for the introduction of digital technologies, and for the adoption of novel technologies, such as the use of bio-molecular techniques for the identification of varieties.
The general objective of this initiative is to ensure, for all types of users, PRM of high quality and diversity of choice, adapted to current and future projected climatic conditions that will in turn contribute to food security, protection of biodiversity and restoration of forest ecosystems. The availability and access to varieties and basic material with strengthened sustainability characteristics are essential to improve sustainability by ensuring the stability of yield of agricultural production and of the
productivity of forest ecosystems. More specifically:
● To increase clarity and coherence of the legal framework through simplified, clarified and harmonised basic rules on fundamental principles presented in a modern legal form;
● To enable the uptake of new scientific and technical developments;
● To ensure availability of PRM suitable for future challenges;
● To support the conservation and sustainable use of plant and forest genetic
resources.
● To harmonise the framework for official controls on PRM;
● To improve coherence of PRM legislation with the plant health legislation.
The proposed regulation is part of the Regulatory Fitness Programme (REFIT).
After consultations with Member States and stakeholders, it has been concluded that
Council Directive 98/56/EC still adequately covers the needs of the sector of

propagating material of ornamental plants, therefore it is not included in the scope of this proposed regulation.
• Consistency with other Union policies
In recent years, agricultural policy in the Union has come to be seen as strategically important for self-sufficiency, agri-food security and safety.
The proposed Regulation is submitted within this context. It is also part of the overall policies of the European Green Deal12 and the related strategies: the Farm to Fork Strategy13, the Biodiversity Strategy14 and the EU Strategy on adaptation to climate change15.
The proposal is consistent with the Farm to Fork Strategy, which intends to make food systems fair, healthy and environmentally friendly and thus more sustainable while ensuring the availability of PRM and thus the security of agricultural production and food security. It aims to contribute to sustainable food production and climate change adaptation by steering plant breeding in a more sustainable direction. It does so by introducing rules for testing and marketing of varieties with value for sustainable cultivation and use.
The proposal additionally aims to support the conservation and sustainable use of plant genetic resources and to contribute to agro-biodiversity by introducing lighter and adapted rules on organic varieties, conservation varieties, seed conservation networks and exchange of seed in kind between farmers. It also facilitates the production and marketing of PRM of heterogeneous material, which does not belong to any variety.
Finally, the proposal creates the framework for introducing digital technologies to record all certification activities, the electronic submission of variety data by Member States through one single portal (EU Plant Variety Portal), and the possibility to issue electronic official labels at a later stage, in line with European Digital Strategy16.

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
This proposal introduces rules on the production and marketing of plant reproductive material in the EU, which are necessary for pursuing the objectives of the common

------------------------------
12 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, The European Green
Deal (COM/2019/640 final).
13 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork
Strategy for a fair, healthy and environmentally-friendly food system (COM(2020) 381 final).
14 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity
Strategy for 2030 Bringing nature back into our lives (COM(2020) 380 final).
15 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, Forging a climate-
resilient Europe - the new EU Strategy on Adaptation to Climate Change (COM(2021) 82 final).
16 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, 2030 Digital
Compass: the European way for the Digital Decade (COM(2021)118 final).

agricultural policy. Therefore, the legal basis for this proposal is Article 43(2) of the Treaty on the Functioning of the European Union (TFEU) that provides the legal basis for adopting provisions necessary for the pursuit of the objectives of the common agricultural policy.
• Subsidiarity (for non-exclusive competence)
According to Article 4(2)(d) of the TFEU a shared competence between the EU and Member States applies in the area of agriculture and fisheries, excluding the conservation of marine biological resources.
Since the adoption of the PRM marketing Directives, all fields of marketing of PRM have to a very large extent been regulated at Union level. The Directives adoption has been a major contributor to the establishment of the internal market in PRM. The impact assessments carried out in 2013 and 2023 confirmed that the EU rules in place on the marketing of PRM have had a generally positive impact on the free movement, the availability and quality of PRM on the Union market, and have thus facilitated trade within the Union. Fragmentation of the PRM market into 27 different national systems would introduce serious obstacles to the movement of PRM on the internal market and increase the financial burden associated with variety registration and the necessary controls on its quality and identification. Therefore, the
respective policy objectives can be better achieved by exclusively regulating at Union level.
• Proportionality
As discussed in Chapter 7.4 of the impact assessment accompanying this proposal, the measures proposed are limited to actions that need to be taken at Union level in order to be effective and efficient. To achieve these needs and take account of the important differences between the species and different types of PRM, the PRM Marketing Directives will be replaced by a single regulation on PRM, which aims at addressing all elements necessary for the production and marketing of a wide variety of PRM: from seeds and rootstocks, to branches, tubers, small plants, entire trees, agricultural crops, potatoes, vegetables, vine, fruit plants and others.
This type of instrument is considered most suitable, considering that a key element of the proposal is to establish harmonised rules for the production and marketing of PRM. Uniform requirements for PRM are the most appropriate way to ensure (i) a high level of its quality for users, (ii) the proper functioning of the internal market and a level playing field for operators; and (iii) sustainable agricultural and food production.
There is a need to ensure that all Member States apply the same high standards, many of them agreed at international level, and thus reduce the possibilities for derogations to lower standards, unless otherwise allowed by the proposed Regulation. Such standards also protect the interests of the professional operators and competition by eliminating the application of different and discriminatory rules across Member State’s borders.
To adapt technical requirements to their specific agro-ecological conditions, Member States may, under certain conditions and temporarily, and if duly justified lay down more stringent national requirements for PRM quality under the authorisation by the Commission. Member States are further given the flexibility to implement rules on examination of varieties for the value for sustainable cultivation and use, in ways that are adapted to local agro-ecological conditions.

• Choice of the instrument
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 the free movement of PRM.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER
CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
In 2019, the Council17 asked the Commission to present a study on the Union’s
options to update the existing legislation on the production and marketing of plant
reproductive material18. The study was supported by an external data gathering
study19. That study identified five key problems with the existing legislation. Those
concerned:
1. the non-harmonised implementation of the legislation causing a non-level
playing field for operators;
2. complex and rigid procedures creating a cumbersome decision-making process;
3. the rigidity of the legal framework posing difficulties to address policy issues
identified in the European Green Deal and its related strategies;
4. the lack of a harmonised and risk-based framework for official controls causing
a non-level playing field for official controls, and
5. the lack of provisions in the legal framework to take account of scientific and
technological progress.
The 2019 Council request contained a revision clause. That clause allowed the
Commission to present a legislative proposal if the outcome of the aforementioned
study made this an appropriate course of action.
• Stakeholder consultations
The impact assessment accompanying the proposed Regulation on plant reproductive
material involved a wide range of consultations addressing all types of stakeholders.
The types of consultation comprised: an inception impact assessment, a public
consultation, working groups with competent national authorities and stakeholders,
and bilateral meetings with stakeholder organisations.
● The consultation on the inception impact assessment gathered 66 responses
from 16 countries, while the public consultation received 2449 responses from
29 countries.

-----------------------
17 Council Decision (EU) 2019/1905 of 8 November 2019 requesting the Commission to submit a study
on the Union’s options to update the existing legislation on the production and marketing of plant
reproductive material, and a proposal, if appropriate in view of the outcomes of the study (OJ L 293,
14.11.2019, p. 105).
18 Commission Staff Working Document Study on the Union’s options to update the existing legislation
on the production and marketing of plant reproductive material (SWD(2021)90 final).
19 ICF (2021) Data gathering and analysis to support a Commission study on the Union’s options to
update the existing legislation on the production and marketing of plant reproductive material.
https://doi.org/10.2875/406165.

● Position papers were submitted by 39 respondents to the inception impact
assessment and by 181 respondents to the public consultation.
● There were targeted consultations to gather more specialised feedback from
competent national authorities and SMEs, resulting in 25 and 251 responses,
respectively.
● A targeted survey by an external consultant supporting the Commission’s
impact assessment returned 99 responses.
● The consultant also conducted 43 in-depth interviews and organised a focus
group with 10 participants.
Stakeholder consultations showed that there is overall support in the PRM sector for
maintaining the current regulatory system and its two basic pillars of variety
registration (based on Distinctness, Uniformity, Stability (‘DUS’) and, where
applicable, Value for cultivation and use (‘VCU’) and PRM certification. Competent
national authorities and all stakeholders representing the seed industry stressed that
the current system works well and that the PRM industry in the Union receives
international recognition for the high quality of the seed produced and traded.
One of the main objectives of the revision is to extend the assessment of
characteristics of PRM contributing to sustainable production. Plant breeders and
most competent national authorities recognised that the current VCU requirements
for agricultural plant species already contribute to this objective, as they allow for the
acceptance of varieties with characteristics such as disease resistance, nutrient
efficiency, drought tolerance and increased yield. Stakeholders supported the
introduction of requirements for the examination of new varieties of vegetables, fruit
plants and vine for such characteristics, though not in the form of the current VCU
for agricultural plant species, as the uses especially for vegetable PRM are very
diverse. The need for flexibility to address the different conditions across Europe was
stressed by almost all respondents.
All stakeholders agreed with the need for derogations from the basic system of
variety registration and PRM certification to meet objectives relevant to conservation
and sustainable use of plant genetic resources, organic production and production in
marginal areas. However, views differed as to the degree of such derogations,
ranging from calls for a total exception of exchange in kind, conservation activities
and marketing to amateur gardeners, to the opinion that existing derogations are
sufficient and do not need to be extended. Several NGOs called for the new
legislation to explicitly implement farmers’ rights as defined in the International
Treaty on Plant Genetic Resources for Food and Agriculture and the United Nations
Declaration on the Rights of Peasants. The main arguments against total exemption
are the concerns about plant health, respect for plant variety rights and the avoidance
of unequal competition, as well as the need to guarantee minimum quality and
traceability of PRM.
Most operators agreed that harmonising the requirements for official controls is
desirable. Views were split on whether to include official controls under the PRM
legislation in the scope of Regulation (EU) 2017/625 of the European Parliament and
of the Council20 due to concerns over a potential increase in administrative burden.

---------------------------
20 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official
controls and other official activities performed to ensure the application of food and feed law, rules on

Almost all competent national authorities and operators were against including the
PRM certification system as such under the Official Controls Regulation. Most
competent national authorities and operators saw benefits from inclusion in terms of
more efficient marketing and import controls. Most stakeholders in all categories
called for maintaining some flexibility in the organisation of official controls and
keeping costs as low as possible.
Most stakeholders agreed that the use of bio-molecular techniques and digital
solutions could bring benefits and called for the legal framework to allow the latest
technologies to be applied, in line with developments in international standards.
Detailed information about the stakeholder consultations can be found in Chapter
5.2.5. and Annex 2 of the impact assessment for the proposed PRM regulation.
• Collection and use of expertise
An external consultant engaged by the Commission conducted a study in support of
the impact assessment21. The consultant and its experts worked closely with the
relevant Commission departments during the various stages of the study.
The consultant gathered additional data and comments through desk research, a
targeted survey, a focus group, in-depth interviews with stakeholders, a case study on
the exchange in kind of seed between farmers, and a qualitative comparative analysis
of Member State experiences with conservation varieties of fruit plants and vine. The
support study considered the problem definition, the case for EU action, the
objectives of policy intervention and the baseline scenario. It went to assess the
potential impacts of three options proposed by the Commission, each including
variations on up to 19 specific measures.
The support study served to refine the policy options and select the preferred policy
option.
• Impact assessment
This proposal is based on an impact assessment which received a positive opinion
with reservations from the Regulatory Scrutiny Board on 17 February 2023.
There are two main problems that this proposal aims to address, as identified with the
current PRM legal framework:
1. There is a non-harmonised internal market characterised by divergent
conditions for operators and marketed plant reproductive material across
Member States. The implementation of various aspects of the legislation differs
among Member States, because (i) the legislation leaves room for
interpretation, (ii) Member States try to find practical solutions to overcome

------------------------------

animal health and welfare, plant health and plant protection products, amending Regulations (EC) No
999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council
Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC,
2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC)
No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC,
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision
92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
21 ICF (20223) Study supporting the Impact Assessment for the revision of the plant and forest
reproductive material legislation. https://data.europa.eu/doi/10.2875/4381.

rigid provisions and (iii) the legislation has not followed the new developments
in science and technology in good time.
2. The legislation is not aligned with the objectives of the European Green Deal
and the related strategies. In particular, and under the current legislation,
genetically diverse varieties, PRM subject to activities of seed conservation
networks and seed exchanged by farmers are still subject to requirements for
variety registration. This is rather disproportionate as such varieties, seed and
material cannot always meet those requirements. Moreover, the increasing
occurrence of extreme weather events, in combination with insufficient
assessment of sustainability characteristics in the registration of new varieties,
puts pressure on the stability of yields and thus on the resilience of agri-food
production.
The general objective of this initiative is thus to ensure, for all types of users, the
availability of PRM of high quality and diversity of choice that is adapted to current
and future projected climatic conditions.
The impact assessment compiled all possible measures for analysis. This was based
on: (i) an external data gathering study supporting a Commission study on the
Union’s options to update the legislation on plant reproductive material, (ii) a study
in support of the impact assessment conducted by an external consultant, (iii) various
stakeholder consultation activities, (iv) an online public consultation and (v) in-depth
interviews.
The diverse, complex and often interrelated measures were grouped under three
policy options, which are compared against a ‘no-policy-change’ scenario. Three
options were assessed. Option 1 offered the most flexibility, while Option 3 offered
the most harmonisation, so as to minimise differences in how the legislation is
implemented. Option 2 balanced the need for flexibility with a higher degree of
harmonisation to overcome the problems stemming from differences in
interpretation.
All options contained a number of common elements: (i) simplified administrative
procedures and a more flexible decision-making process; (ii) streamlined rules for
organic and conservation varieties; and (iii) harmonisation with the plant health
legislation.
1. Option 1 - Highest degree of flexibility: Option 1 would lay down minimum
requirements for official controls on plant reproductive material, but without
linking them to the Official Controls Regulation. Guidelines on the use of
innovative production processes, bio-molecular techniques and digital solutions
would be adopted. The existing assessment of new varieties of agricultural
plant species for characteristics contributing to sustainable production would
be strengthened. A voluntary assessment would be introduced for vegetables
and fruit plants. The activities of seed conservation networks, marketing to
amateur gardeners and exchange in kind of PRM between farmers would be
exempted from the legislation’s scope.
2. Option 2 - Balancing flexibility and harmonisation (preferred option):
Option 2 would bring the official controls on plant reproductive material under
the scope of the Official Controls Regulation, but with simplified import
controls at appropriate places within the Union to ensure a more targeted and
efficient enforcement of the existing rules. Basic principles for the use of

innovative production processes, bio-molecular techniques and digital solutions
would be included in the legislation. The assessment of new varieties for
characteristics contributing to sustainable production would become a
requirement for all crop groups, but with flexibility for Member States to
implement it according to their own agro-ecological conditions. The activities
of seed conservation networks, marketing to amateur gardeners and exchanges
in kind between farmers would be subject to lighter rules to stimulate the
increase in genetic diversity of PRM but also to guarantee a minimum quality.
3. Option 3 - Highest degree of harmonisation: Option 3 would bring the official
controls on PRM/FRM under the scope of the Official Controls Regulation,
with stricter import controls at border control posts requiring special import
documentation to strengthen and fully harmonise enforcement. Detailed and
binding rules for the use of innovative production processes, bio-molecular
techniques and digital solutions would be included in the legislation. The
assessment of new varieties for characteristics contributing to sustainable
production would become a requirement for all crops, with detailed and
harmonised requirements and methodologies for all Member States. The
activities of seed conservation networks, marketing to amateur gardeners and
exchanges in kind between farmers would be subject to the general
requirements of the PRM legislation to achieve homogenous rules for all
market segments.
Based on the outcome of the impact assessment, the Commission concluded that
Option 2 is the best option to effectively address all the objectives of the revision of
the PRM legislation in an efficient and consistent manner.
The preferred option will bring efficiency gains for operators and competent national
authorities through; (i) extended possibilities for operators to undertake activities
under official supervision, (ii) harmonisation with the plant health legislation, (iii)
the introduction of risk-based official controls and (iv) the possibility to use bio-
molecular techniques and digital solutions in the variety registration and PRM
certification systems. Mandatory strengthened sustainability requirements combined
with flexibility to adapt to local agro-ecological conditions will contribute to more
sustainable agri-food production and food security, as varieties which are more
suitable for the changing agro-climatic conditions will have a more stable yield.
The preferred option presents considerable economic costs for operators and
competent national authorities due to the need for additional investments to conduct
additional sustainability assessments for varieties of vegetables and fruit. These are,
however, proportionate to the objectives and will be in balanced in the medium term
by the benefits coming from the sustainability of agri-food production. They will also
be balanced with the adaptation to climate changes in relation to e.g. the reduced use
of resources or higher yield stability. Other measures do not result in new obligations
for operators but provide them with new options or lighter conditions for accessing
the market.
• Regulatory fitness and simplification
The proposal introduces a simpler and less burdensome regulatory regime in
particular for marketing to amateur gardeners and PRM, serving the purposes of
conservation and sustainable use of plant genetic resources.

The proposal gives professional operators the option to carry out certification of
PRM under the official supervision of the competent authorities, if they wish so. It
also offers the option to carry out technical examinations for the testing of varieties
to prove that such varieties have a value for sustainable cultivation and use
(‘VSCU’), in breeders premises under the official supervision of the competent
authority. Both of those options offer to professional operators more flexibility and
options to make their business planning.
Moreover, the proposal introduces lighter and adjusted rules concerning:
(a) access to market for organic and conservation varieties;
(b) PRM intended for final users (such as amateur gardeners);
(c) PRM intended solely for, and retained by, certain gene banks, organisations
and networks;
(d) seed exchanged in kind between farmers.
Several processes will be simplified. All the simplification measures benefit a
significant number of both SMEs and micro-enterprises, which constitute the vast
majority of the sector’s business. In addition, the proposal excludes fully from its
scope PRM sold or transferred in any other way, whether free of charge or not,
between any persons for their own private use and outside their trade, as well as
PRM used solely for official testing, breeding, inspections, exhibitions or scientific
purposes. Finally, the proposal introduces new measures concerning the digitalisation
of the PRM sector and rules on the bio-molecular techniques as to increase the
efficiency and efficacy of variety registration and PRM certification.
• Fundamental rights
The proposed regulation respects all provisions of the Charter of Fundamental Rights
of the European Union, and especially by setting out rules aiming at freedom to
conduct business, avoidance of discrimination, and consumer and environmental
protection.
4. BUDGETARY IMPLICATIONS
There are no budgetary implications.
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
By the fifth year after the date of application of this Regulation, and every five years
thereafter, Member States are required to submit a report to the Commission on
several aspects of the Regulation, and in particular the use of derogations and
policies aiming to support the conservation and sustainable use of plant genetic
resources, agro-biodiversity and simplified procedues for small producers. This is
necessary in order to review the effectiveness of those new policies and examine
whether improvements would be needed. Specifically, these concern reporting on the
following elements:
● quantities of certified and standard PRM and areas used for their production
per year and species, specifying the quantities used for organic varieties
suitable for organic production;

● quantities of marketed PRM of heterogeneous material and areas used for their
production per year and species;
● quantities of marketed PRM of conservation varieties per year and species;
● the number of professional operators using the derogations for marketing to
final users, the species concerned and total quantities of PRM per species;
● the number of gene banks, organisations and networks with a statutory or other
declared objective to conserve plant genetic resources, and species concerned;
● the quantities, as determined per species, for seed exchanged in kind between
farmers;
● the quantities authorised per species for PRM intended for tests and trials for
the breeding of new varieties;
● quantities of PRM per genera and species used in case of temporary difficulties
in supplies;
● quantities of PRM per genera and species imported from third countries;
● the number of professional operators established in the Member State’s
territory.
• Explanatory documents (for directives)
Not applicable
• Detailed explanation of the specific provisions of the proposal
(i) Scope
The proposed regulation will replace the 10 PRM marketing Directives. It will
apply to a list of species of agricultural crops, vegetables, fruit plants and vine,
with particular economic and social importance, such as food security, for the
Union.
It will not cover forest reproductive material, which is currently regulated by
Council Directive 1999/105/EC. A separate proposal has been submitted to
replace that Directive by a new regulation of the European Parliament and of
the Council.
The proposal will also not cover reproductive material for ornamental plants.
It will also exclude PRM exported to third countries.
(ii) Requirements for production and marketing
The proposed regulation retains the two main pillars of the PRM marketing
Directives, namely the registration of varieties and the certification of
individual PRM lots.
The proposal introduces the general rule that PRM is permitted to be produced
and marketed, only if it belongs to varieties registered in national variety
registers and to predefined categories: ‘pre-basic’, ‘basic’, ‘certified’ and
‘standard’ material or seed. It also provides for the registration of
heterogeneous material, which is not a variety nor a mixture of varieties, and of
clones, selected clones, multiclonal mixtures and polyclonal PRM.
PRM as pre-basic, basic, certified and standard seed or material must be
produced and marketed in accordance with the applicable international

standards for those categories and the respective species. Those standards are
in particular the Rules and Regulations of the Organisation for Economic Co-
operation and Development (OECD) Schemes for the Varietal Certification or
the Control of Seed Moving in International Trade (22) (‘OECD Seed
Schemes’), the seed potato standards of the United Nations Economic
Commission for Europe (UNECE), and the rules on seed sampling and testing
of the International Seed Testing Association (ISTA).
Compliance of PRM with the requirements for the categories of pre-basic,
basic and certified seed or material must be confirmed by inspections,
sampling, and testing carried out by the competent authorities (‘official
certification’) and attested by an official label. The proposal introduces a list of
species, the seeds of which may only be produced and marketed as pre-basic,
basic or certified seeds. This reflects the current rules of the PRM marketing
Directives and the respective international standards. Moreover, lighter rules
on standard seed and material for certain categories are laid down.
As part of the modernisation of the certification system, responsibilities are
entrusted to professional operators. Under the proposal, it will also be possible
for the competent authority to authorise professional operators to: (i) perform
PRM certification (‘certification under official supervision’) and (ii) print the
official label.
The proposal introduces rules for the labelling, packaging, sealing and lots of
PRM. These are largely based on the OECD Seed Scheme Rules and
Regulations and the experience gained from implementing of the PRM
marketing Directives.
Seed varieties will be allowed to be produced and marketed in mixtures with
other seed varieties of the same or other genera or species covered by this
Regulation. However, Member States have the possibility to allow the
production and marketing of a mixture of seeds with seeds not falling under the
Regulation’s scope, for the purposes of conserving genetic resources and
preserving the natural environment.
Finally, control plot tests will be conducted to verify the varietal identity and
purity of individual seed lots. Bio-molecular tests may be used for verifying
varietal identity and purity.
(iii) Derogations
The proposal introduces a flexible approach for certain activities, PRM and
varieties. In those cases, less stringent requirements are set based on the
experience gained from the PRM marketing Directives, international standards,
and in particular the need to support agro-biodiversity and conservation of
genetic resources.
In this light, the proposal introduces less stringent rules for conservation
varieties, heterogeneous material, PRM sold to final users (like amateur
gardeners), PRM marketed to or between gene banks, organisations and
networks, and seeds exchanged in kind between farmers.

-----------------------------
22 Decision Revising the OECD Schemes for the Varietal Certification or the Control of Seed Moving in
International Trade [OECD/LEGAL/0308] (‘OECD Seed Schemes’).

The proposal further establishes derogations for the marketing of (i) PRM for
breeders in order to develop new varieties, (ii) PRM of not yet registered
varieties used for PRM multiplication or for trials, (iii) PRM in cases of
temporary difficulties in its supply, (iv) seeds not yet finally certified. It also
establishes derogations for emergency measures and temporary experiments.
(iv) Imports
The import of PRM from third countries will only be allowed, if an assessment
establishes that such PRM fulfils requirements equivalent to those applicable to
PRM produced and marketed in the Union. Such assessment will be based on a
thorough examination of the information provided by the third country and its
relevant legislation. It will also be based on the satisfactory outcome of an
audit carried out by the Commission in the respective third country, where that
audit has been considered necessary.
(v) Professional operators
Professional operators must be registered in the registers to be kept and
updated under Regulation (EU) 2016/2031 for reasons of simplification as, to a
very large extent, they are already covered by the scope referred to in that
Regulation. Professional operators must fulfil some basic requirements to
ensure appropriate knowledge on, and handling of, the PRM under their
control. PRM marketed between professional operators will be subject to
traceability requirements.
(vi) Variety registration
The proposal introduces the general rule that PRM must belong to registered
varieties. It further sets out the procedure and conditions for registration of
those varieties.
The proposal stipulates that a variety must be included in at least one national
variety register. That fact will be enough to immediately allow the variety to be
marketed throughout the EU. That variety will also be submitted in a Union
variety register using the EU Plant Variety Portal, which will provide an
overview of all varieties allowed for marketing.
Varieties will be registered under two categories:
(i) varieties with an official description, which undergo a test for their
distinctness, uniformity and stability (DUS); and
(ii) conservation varieties with an officially recognised description, with no
need to be tested for DUS and subject to less stringent marketing
requirements.
Varieties subject to DUS testing (official description) will further undergo
testing for their value for sustainable cultivation and use (VSCU). The
proposed Regulation extends the scope of the VSCU assessment from
agricultural crops (current scope of PRM Directives) to vegetables and fruit
species too, in order to ensure a wider and more sustainable approach for the
entire PRM sector. In order to be registered, those varieties must, as a whole,
bring an improvement compared to the other varieties of the same genera or
species concerning the following aspects:
● yield, including yield stability and yield under low-input conditions;

● tolerance/resistance to biotic stresses, including plant diseases caused by
nematodes, fungi, bacteria, viruses, insects and other pests;
● tolerance/resistance to abiotic stresses, including adaptation to climate
change conditions;
● more efficient use of natural resources, such as water and nutrients;
● reduced need for external inputs, such as plant protection products and
fertilisers;
● characteristics that enhance the sustainability of storage, processing and
distribution;
● quality or nutritional characteristics.
Those aspects are important to ensure that new varieties contribute to a
sustainable agricultural production, which serves economic, environmental and
broader societal needs.
On account of the important of DUS testing, such testing will only be carried
out by the competent authorities. The premises used for that testing will be
audited by the Community Plant Varieties Office (CPVO) due to its expertise
in this sector.
However, testing for VSCU can be carried out also by the professional
operators under the official supervision of the competent authorities. This is
justified as the scope of VSCU is extended to more species and there is need to
ensure availability of testing facilities. The premises used by the professional
operators will be audited by the competent authorities.
Varieties that have been granted a plant variety right pursuant to Council
Regulation (EC) No 2100/94, or pursuant to the legislation of a Member State,
will be deemed to be DUS and to have a suitable denomination for the
purposes of the proposed regulation. Competent authorities may also use the
DUS and VSCU testing of other Member State authorities in order to register a
variety in their national registers.
The proposal further sets out rules concerning the submission, content, formal
examination and date of submission of applications for variety registration,
technical examinations, and organisation, additional rules on technical
examination, confidentiality, the provisional examination report and the
provisional official description, the examination report and the final official
description, the examination of the denomination of a variety, and the decision
on the registration of a variety in the national variety register.
The period of the registration of a variety will be 10 years, in order to
encourage innovation and replacement of those varieties by new ones. For
varieties of fruit plants and vine propagating material the registration period
will be 30 years, This is due to the longer time required to complete the
productive cycle of such species. The period of registration will be subject to
renewal.
The proposal sets out rules for the maintenance, documentation and sampling
of the registered varieties, in order to ensure their identification and effective
control throughout the period of their registration.
(vii) Amendments of other Union acts and final provisions

The proposed regulation includes an amendment of Regulation (EU)
2016/2031 of the European Parliament and of the Council23, by clarifying that
regulated non-quarantine pests (RNQPs) are exclusively regulated under that
Regulation. It further introduces the possibility that the OECD label for
imported PRM be combined with the plant passport in a single format.
The proposal further introduces an amendment of Regulation (EU) 2017/625 of
the European Parliament and of the Council to include PRM rules under the
scope of Union legislation on official controls. The basic rules and principles
of official controls will also apply for the production and marketing of PRM,
including those for the competences of authorities, delegation of tasks, and
certification. The Commission will be empowered to adopt special rules for
official controls of PRM marketing and professional operators, as needed. In
the case of imports, the general rules will apply on a risk basis.
Finally, the proposed regulation amends Regulation (EU) 2018/848 of the
European Parliament and of the Council24 for organic production, in order to
update the content of the ‘plant reproductive material’ and ‘organic
heterogeneous material’ as referred to in that Regulation It also ensures that all
rules on PRM of heterogeneous material, both organic and non-organic
heterogeneous material, are set out exclusively by the proposed Regulation.
The proposed regulation will apply 3 years after its entry into force, in order to
give the competent authorities and professional operators the appropriate time
to adapt to the new provisions. It will also give the Commission time to adopt
the necessary delegated and implementing acts. An additional transition period
of 2 years will apply for the application of the new requirements for VSCU
testing of new varieties of fruit plants and vegetables.

-----------------------

23 Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on
protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No
652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council
Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC
(OJ L 317, 23.11.2016, p. 4).
24 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic
production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ
L 150, 14.6.2018, p. 1).

2023/0227 (COD)
Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on the production and marketing of plant reproductive material in the Union, amending
Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of
the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC,
2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and
2008/90/EC (Regulation on plant reproductive material)

(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 Committee1,
Acting in accordance with the ordinary legislative procedure,
Whereas:
(1) Rules for the production and marketing of plant reproductive material (‘PRM’) of
agricultural crops, vegetables, vine and fruit plants have been established at Union
level since the 1960s. The production and marketing of PRM on the Union territory is
regulated by Council Directives 66/401/EEC(2); 66/402/EEC(3); 68/193/EEC(4);
2002/53/EC(5); 2002/54/EC(6); 2002/55/EC(7); 2002/56/EC(8); 2002/57/EC(9);

-----------------------

1 Not published yet.
2 Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (OJ 125,
11.7.1966, p. 2298).
3 Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (OJ 125, 11.7.1966, p.
2309).
4 Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative
propagation of the vine (OJ L 93, 17.4.1968, p. 15).
5 Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural
plant species (OJ L 193, 20.7.2002, p. 1).
6 Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (OJ L 193, 20.7.2002, p.
12).
7 Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (OJ L 193,
20.7.2002, p. 33).
8 Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (OJ L 193, 20.7.2002,
p. 60).
9 Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L
193, 20.7.2002, p. 74).

2008/72/EC(10) and 2008/90/EC(11) (the ‘PRM marketing Directives’). These legal
acts have formed the legal framework for the production and marketing of PRM and
therefore have been of major importance for the creation of the internal market of
PRM in the Union.
(2) The impact assessments carried out by the Commission in 2013 and 2023 confirmed
that those Directives have had a significant impact on the free movement, availability
and high quality of PRM on the Union market and have thus facilitated the trade of
PRM within the Union.
(3) However, the rules on production and marketing of PRM need to be adapted to the
scientific and technical developments in the areas of agricultural and horticultural
production techniques and plant breeding. Moreover, the legislation needs to be
updated on the basis of changes in international standards and experience gained by
the application of the PRM Directives. Those rules need to be clarified in order to
facilitate a more harmonised implementation. Therefore, the PRM marketing
Directives should be replaced by a single Regulation on the production and marketing
of PRM within the Union.
(4) PRM constitutes the starting material for plant production in the Union. Therefore, it is
critical for the production of raw material for food and feed purposes and for the
efficient use of plant resources. It contributes to environmental protection and the
quality of the food chain and food supply in the Union as a whole. In this regard, the
availability, quality and diversity of PRM appears to be of outmost importance to
achieve the transition to sustainable food systems called for in the Farm to Fork
Strategy12, agriculture, horticulture, environmental protection, climate change
mitigation and adaptation, food and feed security, and the economy in general.
(5) In order to achieve this transition to sustainable food systems, the Union legislation
should therefore take account of the need to ensure the adaptability of the PRM
production to the changing agricultural, horticultural and environmental conditions, to
face the challenges of climate change, to protect and restore biodiversity and to meet
increasing farmers’ and consumers’ expectations related to quality and sustainability
of PRM.
(6) The scope of this Regulation should only cover the PRM of certain genera and species
of increased economic and social importance. That importance should be assessed
depending on whether such genera and species represent a significant area of
production and value in the Union, on their role for the security of food and feed
production in the Union, and on whether they are marketed in at least two Member
States. That area of production and value may concern several technical aspects.
Depending on the circumstances, it may be calculated on the basis of factors such as
the total size of productive land in several different areas of the Union, the marketing
value of PRM in relation to specific sectors, or the demands for those species by
farmers, final users and industry.

-------------------------

10 Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and planting
material, other than seed (OJ L 205, 1.8.2008, p. 28).
11 Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating
material and fruit plants intended for fruit production (OJ L 267, 8.10.2008, p. 8).
12 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork
Strategy for a fair, healthy and environmentally-friendly food system (COM(2020) 381 final).

(7) Those genera and species should be listed and classified by their intended use, namely as agricultural crops, vegetables, fruit plants or vine. That classification is necessary to ensure a proportionate approach, as some species are only important for certain uses.
(8) Furthermore, some varieties may have certain characteristics that, when cultivated
under certain conditions, could have undesirable agronomic effects that would
undermine the objective of the Regulation to contribute to the sustainability of
agricultural production. This objective can only be achieved if such varieties are
subject to appropriate cultivation conditions under which those undesirable agronomic
effects are avoided. Those conditions should apply to the cultivation of those varieties
for the production of food, feed or industrial materials and not only when intended for
the production and marketing of PRM. Therefore, this Regulation should cover the
conditions under which those varieties are cultivated, also for the production of food,
feed or other products.
(9) PRM should be defined in a comprehensive manner, including all plants capable of,
and intended for, producing entire plants. This Regulation should, therefore, cover
seeds, as well as all other forms of plants at any growth stage, capable of and intended
for producing entire plants.
(10) This Regulation should not cover forest reproductive material due to its particular
characteristics, and very different concepts and applicable terminology. For this
reason, forest reproductive material is subject to a separate legal act, and namely
Regulation (EU) .../... of the European Parliament and of the Council13 +.
(11) This Regulation should not cover propagating material of ornamental plants, because
after consultations with Member States and stakeholders it has been concluded that
Council Directive 98/56/EC (14) still adequately covers the needs of that sector.
(12) This Regulation should cover neither PRM exported to third countries, nor PRM used
solely for official testing, breeding, inspections, exhibitions or scientific purposes.
This is because such categories of PRM do not require particular harmonised identity
or quality standards and do not compromise the identity and quality of other PRM
marketed in the Union.
(13) This Regulation should not cover PRM sold or transferred in any other way, whether
free of charge or not, between any persons for their own private use and outside their
trade. It would be disproportionate to set out rules for such use of PRM, as this kind of
transfer is usually limited to very small amounts, has no commercial purposes and is
restricted to private activities.
(14) In order to allow for informed choices by the users, PRM should be produced and
marketed only if it belongs to varieties registered in national a variety register.
(15) However, it is appropriate to exempt, where necessary, rootstocks from the
requirement to belong to a variety, as although of a significant value, they frequently
do not fall under the definition of a variety.

----------------------------

13 Regulation (EU) .../... of the European Parliament and of the Council .... (OJ...., p....).
+ OJ: Please insert in the text the number of the Regulation contained in document (... (COD)) and insert
the number, date, title and OJ reference of that Regulation in the footnote.
14 Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental
plants (OJ L 226, 13.8.1998, p. 16).

(16) In order to ensure the identity, quality and transparency and to enable informed
choices by the users, PRM should as a general rule be produced or marketed under
predefined categories. Those categories should reflect different generation stages and
quality levels, and, on the basis of the internationally established terminology, be
named ‘pre-basic’, ‘basic’, ‘certified’ and ‘standard’ seed, and ‘pre-basic’, ‘basic’,
‘certified’ and ‘standard’ material, in the case of PRM other than seeds, and .
(17) PRM of each of those categories should be produced and marketed in accordance with
the applicable international standards, in order to ensure the highest possible level of
its identification and quality, and to be in line with the latest technical and scientific
developments. Those standards should include, as applicable, the Schemes for the
Varietal Certification or the Control of Seed Moving in International Trade (15)
(‘OECD Seed Schemes’), the seed potato standards of the United Nations Economic
Commission for Europe (UNECE) and the rules on seed sampling and testing of the
International Seed Testing Association (ISTA).
(18) In accordance with those standards, compliance of PRM with the requirements for the
categories pre-basic, basic or certified should be confirmed by inspections, sampling,
testing and official control plot testing carried out by the competent authorities
(‘official certification’) and should be attested by an official label.
(19) Specific rules should be established for the production and marketing of clones,
selected clones, multiclonal mixtures and polyclonal PRM, due to their increased
importance and use in the PRM sector. In order to ensure transparency, informed
choices for their users and effective official controls, the clones should be registered in
a special public register established by the competent authorities. Rules for the
maintenance of the clones should also be established to ensure their preservation and
identification.
(20) Professional operators should be authorised by the competent authority to perform
certification under official supervision of PRM belonging to certain species and
categories and print the official label. Rules should be set out for the respective official
supervision by the competent authority and the withdrawal of that authorisation or its
modification. Those rules are necessary to ensure that the entire certification system
functions effectively.
(21) In order to ensure the maximum possible purity and homogeneity of PRM, PRM
should be kept in separate lots, and separate from other material different to PRM,
such as grain for food or feed.
(22) In view of the large diversity of PRM, professional operators should be able to market
the PRM lots in the form of individual plants, packages, bundles or containers, or in
bulk.
(23) Rules should be adopted for the labelling of PRM to ensure the appropriate
identification of that material per category through the attestation of compliance with
the respective requirements concerning pre-basic, basic, certified and standard seed
and material.
(24) In the case of pre-basic, basic and certified seed and material, an official label should
be issued by the competent authority, while for standard seed or material an operator’s

----------------------------

15 Decision Revising the OECD Schemes for the Varietal Certification or the Control of Seed Moving in
International Trade [OECD/LEGAL/0308] ( ‘OECD Seed Schemes’).

label should be issued. This is necessary to make a distinction between PRM subject to
certification (official certification or certification under official supervision) and PRM
produced under the responsibility of the professional operator. Issuing of a specific
label aims at facilitating informed choices by the professional operators and
consumers who may wish to select PRM of different standards. It would also facilitate
the work of the competent authorities in designing their official controls in accordance
with the respective requirements of each category.
(25) The official label should be printed 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 all the
certification activities and print official labels, it should be provided that any
certification steps may also be carried out by the competent authorities upon request of
professional operators.
(26) Rules should be set out concerning the contents and form of the official label and
operator’s label, to ensure a uniform application of the respective production and
marketing requirements for each category and the identification of those labels.
(27) Each official label and operator’s label should contain a serial number, so as to
guarantee the appropriate identification and traceability of the PRM concerned and the
effectiveness of the official controls.
(28) The PRM marketing Directives and international practice and standards require that
seeds belonging to certain species are only produced and marketed as pre-basic, basic
or certified seeds, due to their importance for food security and industrial processing,
and for the protection of the interests of the farmers using them. For this reason,
certain seeds should only be produced and marketed as pre-basic, basic or certified
seeds, if the costs for their production and marketing are proportionate to the purpose
of ensuring quality seed for the farmers, food and feed security, or are proportionate to
the purpose of ensuring high value of industrial processing. Those costs should also be
proportionate to the achievement of the highest standards concerning the identity and
quality of the seed, in line with the requirements for pre-basic, basic and certified seed.
A list of those species of seeds for which seed may only be produced and marketed as
pre-basic, basic or certified seeds should thus be established.
(29) Seeds are frequently marketed in varietal mixtures of same species or species
mixtures. However seeds of genera or species, covered by this Regulation, should be
allowed to be produced and marketed in mixtures only with seeds of the genera or
species covered by this Regulation. This is necessary to ensure that the respective
production and marketing standards are respected. However, Member States should
have the possibility to allow the production and marketing of a mixture of seeds
covered by this Regulation, with seeds not belonging to genera or species covered by
this Regulation, for the purposes of conservation of genetic resources and preservation
of the natural environment. This is is because those species are the ones most
appropriate for the purpose of that preservation. Rules should be set out concerning
those mixtures to ensure their identity and quality.
(30) Requirements should be established concerning the re-packaging and re-labelling of
pre-basic, basic and certified seed, in order to guarantee that the identity and the
quality of the respective PRM will not be subject to change during those operations.
(31) Control plot tests should be conducted to verify the varietal identity and purity of
individual seed lots. Specific rules should be set out concerning those tests on pre-

basic, basic, certified and standard seed, on the basis of the applicable international
standards and the experience gained by the application of the PRM marketing
Directives.
(32) Certain types of varieties do not fulfil the established requirements concerning
distinctness, uniformity and stability. However, they are important for the
conservation and sustainable use of plant genetic resources. They are traditionally
grown or new locally produced varieties under specific local conditions and adapted to
those conditions. They are characterised, in particular, by reduced uniformity due to a
high level of genetic and phenotypical diversity between individual reproductive units.
Those varieties are referred to as ‘conservation varieties’. The production and
marketing of those varieties contribute to the objectives of the International Treaty on
Plant Genetic Resources for Food and Agriculture to promote the conservation and
sustainable use of plant genetic resources for food and agriculture (16). As a party to
the Treaty the Union has committed to support those objectives.
(33) In view of those special characteristics of the conservation varieties, and by way of
derogation from the established requirements for production and marketing, the
production and marketing of PRM belonging to them should be allowed under less
stringent requirements. That objective is in line with the principles of the European
Green Deal, and in particular, with the principle of protection of the biodiversity. It is
thus appropriate to allow for that material to comply with the requirements for
standard material for the species concerned. That PRM belonging to conservation
varieties should therefore be labelled with the indication ‘Conservation varieties’.
Those varieties should also be registered, to enable their control by the competent
authorities and guarantee the informed choices for their users and the effectiveness of
official controls.
(34) Experience from the application of the marketing Directives has shown that final users
of PRM (amateur gardeners and others) are often interested in using more diverse
PRM that responds to different needs, without necessarily having the same quality
demands as the professional operators. It is therefore appropriate to allow, by way of
derogation from certain rules, that PRM may be marketed to final users without having
to comply with the requirements for variety registration and without having to comply
with the certification requirements or with the requirements for standard material. That
derogation is necessary to ensure a wider variety for consumer offer, while respecting
the general quality requirements. Moreover, for reasons of transparency and better
control, rules should be set out for the packaging and labelling of PRM intended for
final users only. For the same reason, professional operators using this derogation for
marketing to final users should notify that activity to the competent authorities.
(35) Many gene banks, organisations and networks operate in the Union with an objective
to conserve plant genetic resources. In order to facilitate their activity, it is appropriate
to allow that PRM which is marketed to them, or among them, derogates from the
established production and marketing requirements, and that instead it complies with
less stringent rules.
(36) Farmers habitually exchange in kind small quantities of seeds in order to carry out
dynamic management of their own seed. It is thus appropriate that a derogation from

-----------------------

16 Council Decision 2004/869/EC of 24 February 2004 concerning the conclusion, on behalf of the
European Community, of the International Treaty on Plant Genetic Resources for Food and Agriculture
(OJ L 378, 23.12.2004, p. 1).

the established requirements is provided for the exchanges of small quantities of seeds
between farmers. Such derogation could apply if those seeds do not belong to a variety
for which plant variety rights have been granted in accordance with Council
Regulation (EU) 2100/94(17). Member States should be allowed to define those small
quantities for specific species per year, in order to ensure that there is no misuse of
such derogation impacting the marketing of seeds.
(37) According to the PRM marketing Directives, derogations from the established
requirements are allowed for the marketing of PRM belonging to not yet registered
varieties; of varieties that have not yet been fully tested; of seed not complying with
the applicable requirements to be made rapidly available on the market; of seed not yet
finally certified; of PRM to be temporarily authorised to address temporary difficulties
in the supply; and of PRM for the conduct of temporary experiments to seek improved
alternatives to certain provisions of the applicable legislation concerning the
requirements for the PRM to belong to a registered variety and to fulfil certain identity
and quality requirements. Those derogations have been useful and necessary for the
professional operators and the competent authorities, without creating problems for the
internal market of PRM. Therefore, they should be maintained. Conditions should be
set out concerning those derogations, to ensure that they are not misused and that they
do not affect adversely the internal market of PRM.
(38) The use of PRM that does not belong to a variety pursuant to this Regulation, but
rather belongs to a plant grouping within a single botanical taxon, with a high level of
genetic and phenotypic diversity between individual reproductive units
(‘heterogeneous material’), could have benefits especially in organic production and
low input agriculture, through improving resilience and increasing the within-species
genetic diversity of cultivated plants. Therefore, PRM of heterogeneous material
should be allowed to be produced and marketed without having to comply with the
requirements for variety registration and the other production and marketing
requirements of this Regulation. Specific requirements for the production and
marketing of that material should be set out.
(39) Union production and marketing of PRM needs to comply with the highest possible
standards. Therefore, the import of PRM from third countries should only be allowed
if an assessment of their applicable identity and quality standards and certification
system establishes that such PRM fulfils requirements equivalent to those applicable
to PRM produced and marketed in the Union. Such assessment should be based on a
thorough examination of the information provided by the third country and its relevant
legislation. It should also be based on the satisfactory outcome of an audit carried out
by the Commission in the respective third country, where that audit is considered
necessary by the Commission.
(40) Rules should be set out concerning labelling and information to be provided for the
imported PRM for the purposes of its proper identification, traceability, and informed
choices by its users and for enabling official controls.
(41) In order to ensure transparency and more effective controls on the production and
marketing of PRM, professional operators should be registered. It is appropriate that
they register in the registers established by Member States pursuant to Regulation

---------------------------

17 Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (OJ L 227,
1.9.1994, p. 1).

(EU) 2016/2031 of the European Parliament and of the Council (18), in order to reduce
the administrative burden for those professional operators. This is also proportionate
because the vast majority of professional operators producing and marketing PRM are
already registered in the professional operators’ registers of that Regulation.
(42) Specific obligations should be introduced for professional operators active in the area
of the production and marketing of PRM, to ensure their accountability, more effective
official controls and proper application of this Regulation.
(43) Experience has shown that the reliability and quality of the marketed PRM can be
jeopardised where it is impossible to trace material not complying with the applicable
standards. It is therefore necessary to establish a comprehensive traceability system
allowing withdrawals from the market or the submission of information to users of
PRM or competent authorities. For that reason, the keeping of information and records
on transfers from and to professional users should be mandatory for the professional
operators. However, such record keeping is not appropriate for marketing in retail.
(44) It is important to ensure that, as a general rule, all PRM of the genera and species
within the scope of this Regulation are subject to the registration of the variety to
which that PRM belongs, the description of the variety and the corresponding rules.
(45) Varieties should be registered in a national variety register, to ensure informed choices
by their users and more effective official controls.
(46) The national variety register should include two types of varieties: varieties registered
on the basis of an official description, if they fulfil the requirements of distinctness,
uniformity and stability (‘DUS’), and varieties registered on the basis of an officially
recognised description in the case of conservation varieties. The existence of those two
different descriptions is necessary to separate the two categories of varieties, whereby
the first one is based on DUS testing results, while the other one is based on historical
data concerning the use of the variety and practical experience. In addition, such
approach can offer the necessary information about the characteristics of the varieties
and their identity.
(47) The registered varieties should be further notified by the competent authorities via the
EU Plant Variety Portal to the Union variety register, to ensure an overview of all
varieties allowed for marketing in the Union.
(48) Herbicide tolerant varieties are varieties that have been bred to be intentionally
tolerant to herbicides, in order to be cultivated in combination of the use of those
herbicides. If such cultivation is not done under appropriate conditions, it may lead to
development of weeds resistant to those herbicides, spread of such resistance genes in
the environment or to the need to increase of quantities of herbicides applied. As this
Regulation aims to contribute to the sustainability of agricultural production, the
competent authorities of Member States responsible for the registration of varieties
should be able to subject the cultivation of those varieties in their territory to
cultivation conditions appropriate for avoiding those undesirable effects. Moreover,
where varieties have particular characteristics, other than tolerance to herbicides, that

-----------------------------
18 Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on
protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No
652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council
Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC
(OJ L 317, 23.11.2016, p. 4).

could have undesirable agronomic effects, they should also be subject to cultivation
conditions, in order to address those agronomic effects. Those conditions should apply
to the cultivation of those varieties for any purpose, including food, feed and other
products, and not only for purposes of production and marketing of PRM. This is
necessary to achieve the objectives of this Regulation to contribute to sustainable
agricultural production beyond the stage of production and marketing of PRM.
(49) In order to contribute to the sustainability of agricultural production and serve
economic, environmental and broader societal needs, new varieties of all genera or
species should show an improvement compared to the other varieties of the same
genera or species registered in the same national variety register, concerning certain
aspects. Among those aspects are their yield, including yield stability and yield under
low input conditions; tolerance/resistance to biotic stresses, including plant diseases
caused by nematodes, fungi, bacteria, viruses, insects and other pests;
tolerance/resistance to abiotic stresses, including adaptation to climate change
conditions; more efficient use of natural resources, such as water and nutrients;
reduced need for external inputs, such as plant protection products and fertilisers;
characteristics that enhance the sustainability of storage, processing and distribution;
and quality or nutritional characteristics (‘value for sustainable cultivation and use’).
For the purpose of deciding on the variety registration and in order to provide
sufficient flexibility to register varieties with the most desirable characteristics, those
aspects should be considered for a given variety as a whole.
(50) As organic varieties suitable for organic production as defined in Article 3 of
Regulation (EU) 2018/848 are characterised by a high level of genetic and
phenotypical diversity between individual reproductive units, it is appropriate that
their registration is subject to adjusted DUS, and in particular as regards the
requirements concerning uniformity. Furthermore, in order for that such varieties to be
better adapted to the specific needs of organic production, their examination of the
value for sustainable cultivation and use should be conducted under organic
conditions.
(51) For reasons of efficiency and reduction of the administrative burden, varieties that
have been granted a plant variety right pursuant to Article 62 of Regulation (EC) No
2100/94, or pursuant to the legislation of a Member State, should be deemed to be
distinct, uniform and stable and to have a suitable denomination for the purposes of
this Regulation.
(52) The procedure of variety registration should be precisely defined, in order to ensure
legal certainty for the applicants and the competent authorities, and a level playing
field for all applicants. For this reason, rules should be set out concerning the
submission, content, formal examination and date of submission of the applications,
technical examinations, audit of the competent authority’s premises and organisation,
additional rules on technical examination, confidentiality, provisional examination
report and provisional official description, examination report and final official
description, examination of the denomination of a variety and decision on the
registration of a variety in the national variety register.
(53) For reasons of efficiency and in order to reduce administrative burden for competent
authorities and applicants, the competent authorities should 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
respective Member States pursuant to Directives 2002/53/EC, 2002/55/EC,

2008/90/EC and 68/193/EEC. As those varieties are already marketed in the Union
and used by farmers and other professional operators, they should not be subject to a
new registration procedure.
(54) Rules should be set out concerning the technical examination of varieties, in order to
conclude whether they are distinct, uniform and stable. Due to the importance of that
examination for the variety breeding sector and the fact that it leads to the production
of an official description, that technical examination should be carried out only by the
competent authority.
(55) However, there should be the possibility to carry out the technical examination for the
satisfactory value for sustainable cultivation and use of a variety on the premises of the
applicant and under the official supervision of the competent authority. This is
necessary in order to ease the administrative burden, ensure the availability of testing
facilities and reduce costs for the competent authorities. However, the competent
authority should be in charge of the testing arrangements. Moreover, professional
operators involved in the breeding of new varieties, and on the basis of their co-
operation with the competent authorities, have proven qualified to carry out such
examinations as they possess the respective expertise, knowledge and appropriate
resources.
(56) In order to ensure the credibility and high quality of the examinations on distinctness,
uniformity and stability, the premises of the competent authorities where they take
place should be audited by the Community Plant Variety Office (‘CPVO’).The
premises of the applicants where the examination for the satisfactory value for
sustainable cultivation and use takes place under official supervision, should be
audited by the respective competent authorities, to ensure compliance with the
applicable requirements.
(57) The period of the registration of a variety should be 10 years, so as to encourage
innovation in the breeding sector, and the removal from the market of old varieties and
their replacement by new ones. However, that period should be 30 years for varieties
of genera or species of fruit plants and vine, due to the longer time required for the
completion of the productive cycle of those genera or species.
(58) Upon a request of any interested person, the period of registration of a variety should
be subject to renewal, in order to allow for the continuation of marketing of certain
varieties if a need is established and they still fulfil applicable requirements.
(59) Rules should be set out concerning variety maintenance in accordance with accepted
practices. This is necessary to ensure the varietal identity during the period of its
registration, which can only be ensured if the maintenance of the respective variety is
carried out by the applicant, or other persons notified by the applicant to the competent
authority, pursuant to certain requirements and subject to official controls by the
competent authorities.
(60) Rules should be set out concerning the content of the national variety registers and the
Union variety register, and the keeping of samples of the registered varieties (‘official
sample’ or ‘standard sample’) which is a living description of the variety. This is
important to ensure accessibility to the necessary information on the variety, its
identification during the period of its registration and the availability of standard
samples for control plot testing in the context of PRM certification.
(61) The PRM marketing Directives should be repealed, as this Regulation replaces them.
As a consequence, Regulation (EU) 2016/2031 should be amended to remove

references to those Directives and to ensure that Regulated Non-Quarantine Pests
(‘RNQPs’) are exclusively regulated by that Regulation.
(62) Regulation (EU) 2017/625 of the European Parliament and of the Council19 should be
amended to include in its scope the production and marketing of PRM in line with this
Regulation. This is important in order to guarantee a uniform approach as regards
official controls for the entire plant production and food chain, since Regulation (EU)
2017/625 also applies to the scope of Regulation (EU) 2016/2031, and Regulation
(EU) 2018/848 of the European Parliament and of the Council20.
(63) In this respect, the Commission should be empowered to adopt specific rules on
official controls and on actions taken by the competent authorities in relation to PRM,
in particular for laying down rules for the performance of official controls on PRM for
verifying compliance with Union rules, for the import into, and marketing within, the
Union of PRM, and on the activities of operators during the production of PRM.
(64) Regulation (EU) 2018/848 should be amended to align the definitions of ‘plant
reproductive material’ and ‘heterogeneous material’ with the definitions provided for
by this Regulation. Moreover, the empowerment for the Commission to adopt specific
provisions for the marketing of PRM of organic heterogeneous material should be
excluded from Regulation (EU) 2018/848, as all rules concerning the production and
marketing of PRM should be set out in this Regulation for reasons of legal clarity.
(65) In order to adapt the list of genera and species of PRM, subject to the scope of this
Regulation, to the developments related to the significance of area and value of
production, food/feed security and number of Member States where it is cultivated, the
power to adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission in respect of amending that list.
(66) In order to adapt the rules on the production and marketing of PRM to the technical
and scientific developments and the applicable international standards, the power to
adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission in respect of amending the requirements of this Regulation concerning
the production and marketing of pre-basic, basic, certified and standard material and
seeds.
(67) In order to adapt the rules on the production and marketing of PRM of heterogeneous
material to the technical and scientific developments, and take into account the
experience gained from the application of the rules of this Regulation, the power to
adopt acts in accordance with Article 290 TFEU should be delegated to the

------------------------------
19 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official
controls and other official activities performed to ensure the application of food and feed law, rules on
animal health and welfare, plant health and plant protection products, amending Regulations (EC) No
999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council
Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC,
2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC)
No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC,
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision
92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
20 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic
production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ
L 150, 14.6.2018, p. 1).

Commission in respect of amending the requirements concerning the production and
marketing of heterogeneous material.
(68) In order to adapt the content of variety registers to the technical developments and
follow up to the experience gained from variety registration, the power to adopt acts in
accordance with Article 290 TFEU should be delegated to the Commission in respect
of amending the requirements concerning that content.
(69) In order to adapt the cultivation of varieties to the development of technical and
scientific knowledge, the power to adopt acts in accordance with Article 290 TFEU
should be delegated to the Commission in respect of adopting conditions of cultivation
of varieties that are herbicide-tolerant or have other characteristics that could lead to
undesirable agronomic effects. Those conditions should include measures in the field,
such as crop rotation; monitoring measures; the notification of those measures by
Member States to the Commission and the other Member States; reporting by
professional operators to the competent authorities concerning the application of those
measures; and the indications of those conditions in the national variety registers.
(70) In order to adapt testing and requirements for the sustainable value of cultivation and
use requirements to the potential technical and scientific developments, and the
possible development of international standards, the power to adopt acts in accordance
with Article 290 TFEU should be delegated to the Commission in respect of
supplementing this Regulation with certain elements. Those consist of the necessary
methodologies for the growing trials to be carried out with a view to assessing, and
adopting further requirements for, sustainable value of cultivation and use for certain
genera or species.
(71) In order to adapt the rules on variety denomination to the technical and scientific
developments, and follow up on the experience gained from the application of those
rules, the power to adopt acts in accordance with Article 290 TFEU should be
delegated to the Commission in respect of supplementing this Regulation by setting
out specific criteria concerning the suitability of variety denominations.
(72) In order to adapt the provisions of this Regulation concerning technical examinations
of varieties to the technical and scientific developments and the practical needs of
competent authorities and professional operators, and follow up on the experience
gained from the application of the respective rules, the power to adopt acts in
accordance with Article 290 TFEU should be delegated to the Commission in respect
of supplementing this Regulation by setting out the rules concerning the audit of the
premises of professional operators to carry out technical examinations for the
satisfactory value for sustainable cultivation and use.
(73) In order to adapt the provisions of this Regulation concerning the examination for
sustainable cultivation and use to the technical or scientific developments, and to any
new Union policies or rules on sustainable agriculture, the power to adopt acts in
accordance with Article 290 TFEU should be delegated to the Commission in respect
of supplementing this Regulation by establishing the minimum requirements for
carrying out this examination, establishing the methodologies for assessing the
characteristics examined, establishing the standards for the evaluation and the
reporting of the results of this examination and amending the characteristics examined.
(74) It is of particular importance that the Commission carry out appropriate consultations
during its preparatory work, including at expert level, and that those consultations be
conducted in accordance with the principles laid down in the Interinstitutional

Agreement of 13 April 2016 on Better Law-Making21. In particular, to ensure equal
participation in the preparation of delegated acts, the European Parliament and the
Council receive all documents at the same time as Member States’ experts, and their
experts systematically have access to meetings of Commission expert groups dealing
with the preparation of delegated acts.
(75) In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission. Those powers should
be exercised in accordance with Regulation (EU) No 182/2011 of the European
Parliament and of the Council22.
(76) In order to ensure uniform conditions for the implementation of this Regulation, and to
improve the performance of professional operators and the identity and quality of
PRM produced and marketed by them, implementing powers should be conferred to
the Commission with respect to specifying the requirements for the audits, training,
examinations, inspections, sampling and testing, with regard to particular genera or
species, for the official supervision of the professional operators by the competent
authorities.
(77) In order to ensure uniform conditions for the implementation of this Regulation
concerning handling and marketing of PRM, and adapt the respective rules to the
experience gained from the application of the provisions of this Regulation,
implementing powers should be conferred to the Commission for adopting specific
requirements for all or certain species of PRM, concerning the merging or splitting of
lots in relation to the origin of PRM lots, their identification, records on that operation
and labelling following the merging or splitting of PRM lots.
(78) In order to ensure uniform conditions for the implementation of this Regulation,
follow up on the practical experience gained by the application of its provisions, and
improve the integrity of the marketed PRM, implementing powers should be conferred
to the Commission for adopting specific requirements concerning the sealing,
fastening, size and form of packages, bundles and containers of specific species of
PRM.
(79) In order to ensure uniform conditions for the implementation of this Regulation, and in
particular concerning the legibility, recognisability and security of labels,
implementing powers should be conferred to the Commission for adopting specific
provisions concerning the official labels, labels used for certain derogations and, labels
used for some specific types of PRM, and set out the content, size, colour and form of
those labels for the respective categories or types of PRM.
(80) In order to ensure uniform conditions for the implementation of this Regulation and
follow up on any practical experience gained by the application of the respective rules,
implementing powers should be conferred to the Commission for adopting specific
provisions concerning mixtures of seeds.
(81) In order to ensure uniform conditions for the implementation of this Regulation with
respect to retail marketing of PRM, and make the marketing of PRM as practical and
suitable for each species as possible, implementing powers should be conferred to the

----------------------------
21 OJ L 123, 12.5.2016, p. 1.
22 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, OJ L 55, 28.2.2011, p. 13–18.

Commission for adopting rules concerning the size, form, sealing and handling
requirements of the small packages for seeds and the packages and bundles for other
PRM marketed to final users.
(82) In order to ensure uniform conditions for the implementation of this Regulation and to
address urgent supply difficulties of PRM, implementing powers should be conferred
to the Commission for authorising, in the case of temporary difficulties in the supply
of PRM, for a maximum period of 1 year, the marketing of PRM of the categories of
pre-basic, basic or certified material or seed subject to less stringent requirements, or
to derogate from the requirement to belong to a variety, and with respect to repealing
and amending that authorisation.
(83) In order to ensure uniform conditions for the implementation of this Regulation, and
ensure some flexibility to Member States to adopt national measures adapted to their
agro-climatic conditions and higher quality standards, implementing powers should be
conferred to the Commission for authorising the Member States to adopt, with regards
to production and marketing of PRM, more stringent production or marketing
requirements, in all or part of the territory of the Member State concerned, and with
respect to repealing or amending such measures adopted pursuant to the PRM
marketing Directives.
(84) In order to ensure uniform conditions for the implementation of this Regulation, and
ensure a swift response to sudden risks, implementing powers should be conferred to
the Commission for taking emergency measures, where the production or marketing of
PRM is likely to constitute a serious risk to human, animal or plant health, the
environment or cultivation of other species, and such risk cannot be contained
satisfactorily by measures taken by the Member State concerned, and with respect to
repealing or amending any such measure taken by a Member State.
(85) In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred to the Commission for deciding on the
organisation of temporary experiments to seek improved alternatives to the scope and
certain provisions of this Regulation.
(86) In order to ensure uniform conditions for the implementation of this Regulation with
regard to the import of PRM, and ensure compliance of the third country requirements
with the equivalent Union requirements, implementing powers should be conferred to
the Commission with respect to recognising whether PRM 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 PRM produced and marketed in the
Union, in order to be imported.
(87) In order to ensure uniform conditions for the implementation of this Regulation and to
ensure appropriate maintenance of the registered varieties in third countries too,
implementing powers should be conferred to the Commission with respect to
recognising that the controls on variety maintenance carried out in the third country
afford the same guarantees as those set out in the Union.
(88) In order to ensure uniform conditions for the implementation of this Regulation, and to
adapt its provisions to the evolving applicable protocols of the International Union for
the Protection of new Varieties of Plants (UPOV) or protocols established by the
CPVO, and the relevant technical and scientific developments, implementing powers
should be conferred to the Commission for adopting specific requirements concerning
distinctness, uniformity and stability per genera or species of varieties.

(89) In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred to the Commission for adopting specific
rules as regards the size of the standard sample of registered varieties used for the
official post controls of PRM, the rules for the renewal of those samples and the
provision of those samples to other Member States.
(90) Since the objective of this Regulation, namely to ensure a harmonised approach with
regard to the production and marketing of PRM, cannot be sufficiently achieved by the
Member States but can rather, by reason of its effects, complexity 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. In this view, and as necessary, it introduces derogations or specific
requirements for certain types of PRM and professional operators.
(91) This Regulation should apply from 3 years after its entry into force, in order to allow
the competent authorities and the professional operators to adapt to its provisions and
also to provide the necessary time for the adoption of the respective delegated and
implementing acts. The rules concerning the satisfactory value for sustainable
cultivation and use of varieties of vegetables and fruit plants should however apply
from 5 years after its entry into force. That additional time period is needed for the
competent authorities and professional operators to make the necessary preparations
and carry out the first tests in the fields complying with those new rules.
HAVE ADOPTED THIS REGULATION:

CHAPTER I
GENERAL PROVISIONS

Article 1
Subject matter

This Regulation lays down rules for the production and marketing in the Union of plant
reproductive material (‘PRM’), and in particular requirements for the production of PRM in
the field and other sites, categories of material, identy and quality requirements, certification,
labelling, packaging, imports, professional operators and the registration of varieties.
This Regulation also lays down rules concerning the conditions of cultivation of certain
varieties that could have undesirable agronomic effects, including the cultivation for purposes
beyond the production and marketing of PRM, for the production of food, feed and other
products.

Article 2
Scope and objectives
1. This Regulation applies to the genera and species listed for the respective uses
referred to in Parts A to E of Annex I.
Its requirements concern, respectively, all types of PRM, only seeds, or only material
other than seeds.

The requirements concerning production of PRM shall apply only to production with
a view to its marketing.
2. The objectives of this Regulation are the following:
(a) to ensure quality and diversity of choice for PRM, and its availability for
professional operators and final users;
(b) to ensure a equal conditions for the competition of the professional operators
across the Union and the functioning of the internal market in PRM;
(c) to support innovation and competitiveness of the PRM sector in the Union;
(d) to contribute to conservation and sustainable use of plant genetic resources and
agro-biodiversity;
(e) to contribute to sustainable agricultural production, adapted to current and
future projected climatic conditions;
(f) to contribute to food security
3. The Commission is empowered in accordance with Article 75 to adopt delegated
acts, amend Annex I, in order to adapt it to the developments of technical and
scientific knowledge, and the economic data concerning production and marketing of
genera and species, by adding genera and species to or removing them from the list
that Annex.
The delegated act referred to in the first subparagraph shall add genera or species to
the list in Annex I if they fulfil at least two of the following elements:
(a) represent a significant area of production of PRM and a significant value of
marketed PRM in the Union
(b) are of substantial importance for security of food and feed production in the
Union, compared to other genera and species not listed in that Annex; and
(c) are marketed in at least two Member States.
The delegated act referred to in the first subparagraph shall remove genera or species
from the list in Annex I if they no longer fulfil at least two of the elements set out in
the second subparagraph.
4. This Regulation does not apply to:
(a) propagating material of ornamental plants as defined in Article 2 of Directive
98/56/EC;
(b) forest reproductive material as defined in Article 3 of Regulation (EU) .../... of
the European Parliament and of the Council23+;
(c) PRM produced for export to third countries;
(d) PRM sold or transferred in any way, whether free of charge or not, between
final users for their own private use and outside their commercial activities;
(e) PRM used solely for official testing, breeding, inspections, exhibitions or
scientific purposes.

-------------------------------------
23 Regulation (EU) .../... of the European Parliament and of the Council .... (OJ...., p....).
+ OJ: Please insert in the text the number of the Regulation contained in document (... (COD)) and insert
the number, date, title and OJ reference of that Regulation in the footnote.

Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘plant reproductive material’ (‘PRM’) means plants as defined in Article 2(1) of
Regulation (EU) 2016/2031, capable of, and intended for, producing entire plants;
(2) ‘professional operator’ means any natural or legal person, involved professionally in
one or more of the following activities in the Union concerning PRM:
(a) production;
(b) marketing;
(c) maintenance of varieties;
(d) provision of services for identity and quality;
(e) preservation, storage, drying, processing, treating, packaging, sealing,
labelling, sampling or testing;
(3) ‘marketing’ means the following actions conducted by a professional operator: sale,
holding, transfer for free, or offering for sale or any other way of transferring or
distribution within, or import into, the Union
(4) ‘variety’ means a variety as defined in Article 5(2) of Regulation (EC) No 2100/94;
(5) ‘clone’ means an individual plant progeny, originally derived from another single
plant by vegetative reproduction, remaining genetically identical to that plant;
(6) ‘selected clone’ means a clone that has been selected and chosen for some special
intravarietal phenotypic traits and its phytosanitary status that give the selected clone
a better performance, is true to the description of the variety to which it belongs and,
in the case of selected clones not belonging to a variety, it is true to the description of
the species to which it belongs;
(7) ‘polyclonal plant reproductive material’ means a group of several distinct individual
plant progenies derived from different genotypes, each of which is true to the
description of the variety to which it belongs;
(8) ‘multiclonal mixture’ means a mixture of selected clones, all belonging to the same
variety or species, as appropriate, whereby each of them has been obtained through
independent selection;
(9) ‘competent authoritiy’ means the central or regional authority of a Member State, or,
where applicable, the corresponding authority of a third country, responsible for the
organisation of official controls, registration, certification and other official activities
concerning the production and marketing of PRM, or any other authority to which
that responsibility has been conferred in accordance with Union law;
(10) ‘official description’ means a description that has been established by a competent
authority, includes the relevant characteristics of the variety and makes the variety
identifiable as a result of the examination on its distinctness, uniformity and stability;
(11) ‘officially recognised description’ means a written description of a conservation
variety, which has been recognised by a competent authority, includes the specific
characteristics of the variety, and has been obtained by other means than the
examination of its distinctness, uniformity and stability;

(12) ‘variety maintenance’ means the actions taken for controlling varietal purity and
identity with the aim to ensure that a variety remains in accordance with its
description over subsequent cycles of reproduction;
(13) ‘seeds’ means seeds in the botanical sense;
(14) ‘pre-basic seed’ means seed that belongs to a generation preceeding the generation of
the basic seed, is intended for the production and certification of basic or certified
seed, and has been found by means of official certification, or certification under
official supervision, to satisfy the respective conditions laid down in Part A of Annex
II;
(15) ‘basic seed’ means seed that has been produced from pre-basic seed or preceding
generations of basic seed, is intended for the production of further generations of
basic seed or certified seed, and which has been found by means of official
certification, or certification under official supervision, to satisfy the respective
conditions laid down in Part A of Annex II;
(16) ‘certified seed’ means seed that has been produced from pre-basic, basic or preceding
generations of certified seed, and which has been found by means of official
certification, or certification under official supervision, to satisfy the respective
conditions laid down in Part A of Annex II;
(17) ‘standard seed’ means seed, other than pre-basic, basic or certified seed, that is not
intended for further multiplication, and satisfies the respective conditions laid down
in Part A of Annex III;
(18) ‘pre-basic material’ means PRM, other than seeds, that belongs to a generation
preceeding the generation of basic material, is intended for the production and
certification of basic or certified material, and has been found by means of official
certification or certification under official supervision to satisfy the respective
conditions laid down in Part B of Annex II;
(19) ‘basic material’ means PRM, other than seed, that has been produced from pre-basic
material or preceding generations of basic material, is intended for the production
and certification of further generations of basic material or certified material, and has
been found by means of official certification or certification under official
supervision to satisfy the respective conditions laid down in Part B of Annex II;
(20) ‘certified material’ means PRM, other than seed, that has been produced from pre-
basic, basic or preceding generations of certified material, and has been found by
means of official certification or certification under official supervision to satisfy the
respective conditions laid down in Part B of Annex II;
(21) ‘standard material’ means PRM other than seed, and other than pre-basic, basic or
certified material, that is not intended for further multiplication, and satisfies the
respective conditions laid down in Part B of Annex III;
(22) ‘official certification’ means official attestation by the competent authority of the
compliance of pre-basic, basic or certified seed or material with the respective
requirements of this Regulation, where all relevant inspections on site, sampling and
testing including where appropriate control plot testing have been carried out by that
authority, and if it has concluded that the seed or material concerned meets those
requirements;
(23) ‘certification under official supervision’ means attestation by a specifically
authorised professional operator that pre-basic, basic or certified seed or material

complies with the applicable requirements, and where at least one or more of the
relevant inspections, sampling, testing or label printing have been carried out by that
professional operator, under the official supervision of the competent authority, and
if it has concluded that the seed or material concerned meets those requirements;
(24) ‘category’ of PRM means a group or an individual unit of PRM that qualifies as pre-
basic, basic, certified or standard seed or material and is identifiable by complying
with specific identity and quality requirements;
(25) ‘genetically modified organism’ means a genetically modified organism as defined in
Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council
(24), excluding organisms obtained through the techniques of genetic modification
listed in Annex I B to Directive 2001/18/EC;
(26) ‘lot’ means a unit of PRM, identifiable by its homogeneity of composition and
origin;
(27) ‘heterogeneous material’ means a plant grouping within a single botanical taxon of
the lowest known rank which:
(a) presents common phenotypic characteristics;
(b) is characterised by a high level of genetic and phenotypic diversity between
individual reproductive units, so that that plant grouping is represented by the
material as a whole, and not by a small number of units;
(c) is not a variety; and
(d) is not a mixture of varieties;
(28) ‘final user’ means any person acquiring, transferring and using PRM for purposes
which are outside that person’s professional activities;
(29) ‘conservation variety’ means a variety that is:
(a) traditionally grown or locally newly bred under specific local conditions in the
Union, and adapted to those conditions; and
(b) characterised by a high level of genetic and phenotypical diversity between
individual reproductive units;
(30) ‘quality pests’ means pests fulfilling all of the following:
(a) they are not Union quarantine pests, protected zone quarantine pests, or
regulated non-quarantine pests (‘RNQPs’) within the meaning of Regulation
(EU) 2016/2031, nor pests subject to the measures adopted pursuant to Article
30(1) of that Regulation;
(b) they occur during PRM production or storage; and
(c) their presence has an unacceptable adverse impact on the quality of the PRM,
and an unacceptable economic impact as regards the use of that PRM in the
Union;

----------------------------
24 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 (OJ L 106, 17.4.2011, p. 1).

(31) ‘practically free from pests’ means completely free from pests, or a situation where
the presence of quality pests on the respective PRM is so low that those pests do not
affect adversely the quality of that PRM;
(32) ‘seed potatoes’ means tubers of Solanum tuberosum L., used for the reproduction of
other potatoes;
(33) ‘farmer’ means farmer as defined in Article 3(1) of Regulation (EU) 2021/2115 of
the European Parliament and of the Council 25;
(34) ‘off-type’ means, in relation with seed or other plants, a seed or other PRM not
corresponding to the description of the variety or species to which it is supposed to
belong pursuant to this Regulation
(35) ‘hybrid variety’ means a variety produced as a result from the crossbreeding of two
or more other varieties.

Article 4
Compliance with Regulation (EU) 2016/2031
This Regulation shall apply without prejudice to Regulation (EU) 2016/2031.
Any PRM lot produced and marketed in accordance with this Regulation, shall also comply
with the rules set out in, or pursuant to, Articles 36, 37, 40, 41, 42, 49, 53 and 54 of
Regulation (EU) 2016/2031 concerning Union quarantine pests, protected zone quarantine
pests and RNQPs, and with the measures adopted pursuant to Article 30(1) of that Regulation.

CHAPTER II
REQUIREMENTS CONCERNING VARIETIES, CATEGORIES
OF PRM, LABELLING, AUTHORISATIONS, HANDLING,
IMPORTS AND DEROGATIONS

SECTION 1
General requirements for the production and marketing of PRM

Article 5
Belonging to a registered variety
Only PRM belonging to a variety registered in a national variety register referred to in Article
44 may be produced and marketed within the Union, except the following cases:
(a) as rootstocks, if produced and marketed with a reference, contained in an appropriate
labelling, to the species to which they belong;
(b) as heterogeneous material in accordance with Article 27.
(c) as PRM marketed to final users in accordance with Article 28;

--------------------------
25 Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021
establishing rules on support for strategic plans to be drawn up by Member States under the common
agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund
(EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing
Regulations (EU) No 1305/2013 and (EU) No 1307/2013 (OJ L 435, 6.12.2021, p. 1).

(d) as PRM produced and marketed for the purposes of conservation of genetic resources
in accordance with Article 29;
(e) as seed exchanged in kind between farmers in accordance with Article 30;
(f) as breeder’s seed, in accordance with Article 31;
(g) as PRM of not yet registered varieties in accordance with Article 32;
(h) in the event of supply difficulties of PRM in accordance with Article 33;

Article 6
Belonging to certain categories of PRM
1. Only PRM belonging to one of the following categories may be produced and
marketed within the Union, except in the cases provided for in paragraph 2:
(a) pre-basic material or seed;
(b) basic material or seed;
(c) certified material or seed;
(d) standard material or seed.
Where a reference is made in this Regulation to lower or higher categories
concerning identity and quality of PRM, that determination shall be based on the
ranking the order of points (a) - (d), with point (a) indicating the highest rank and
point (d) the lowest one.
2. By way of derogation from paragraph 1, PRM may be produced and marketed
without belonging to a category listed in (a) - (d) in the following cases:
(a) marketing of PRM of heterogeneous material in accordance with Article 27;
(b) marketing to a final user in accordance to Article 28;
(c) marketing to and between conservation networks as referred to in Article 29;
(d) as seed exchanged in kind between farmers in accordance with Article 30;
(e) breeder’s seed as referred to in Article 31.
SECTION 2
Requirements for the production and marketing of pre-basic, basic,
certified and standard material and seed

Article 7
Requirements for the production and marketing of pre-basic, basic and certified
seed and material
1. Pre-basic, basic and certified seed may only be produced and marketed within the
Union, if all the following conditions are fulfilled:
(a) the pre-basic, basic or certified seed is practically free from quality pests;
(b) it is produced and marketed:
(i) following official certification by the competent authorities, or
certification by the professional operator under official supervision;

(ii) in accordance with the requirements set out in Part A of Annex II, and its
compliance with those requirements is attested by the official label
referred to in Article 15(1).
2. Pre-basic, basic and certified material may only be produced and marketed within the
Union, if all the following conditions are fulfilled:
(a) the pre-basic, basic or certified material is practically free from quality pests;
(b) it is produced and marketed:
(i) following official certification by the competent authorities, or
certification by the professional operator under official supervision;
(ii) in accordance with the requirements set out in Part B of Annex II, and its
compliance with those requirements is attested by the official label
referred to in Article 15(1).
3. The Commission is empowered to adopt delegated acts in accordance with Article
75, in order to amend Annex II. Those amendments shall adapt to the developments
of international technical and scientific standards and may concern the requirements
for the following:
(a) sowing and planting, and production in the field, of pre-basic, basic and
certified seed;
(b) harvesting and post-harvesting of pre-basic, basic and certified seed;
(c) marketing of seeds;
(d) sowing and planting, and production in the field, of pre-basic, basic and
certified material;
(e) harvesting and post-harvesting of pre-basic, basic and certified material;
(f) marketing of pre-basic, basic and certified material;
(g) pre-basic, basic and certified material of clones, selected clones, multiclonal
mixtures and polyclonal PRM;
(h) production of pre-basic, basic and certified material produced by in vitro
propagation;
(i) marketing of pre-basic, basic and certified material produced by in vitro
propagation.
4. The Commission may adopt implementing acts specifying the production and
marketing requirements referred to in Part A and Part B of Annex II for certain
genera, species or categories of PRM, and, where appropriate, for certain grades,
classes, generations or other sub-divisions of the category concerned. Those
requirements shall concern one or more of the following elements
(a) specific uses of the genera, species or the types of the PRM concerned;
(b) production methods of PRM, including sexual and asexual reproduction and in
vitro propagation;
(c) conditions for sowing or planting;
(d) field cultivation;
(e) harvesting and post-harvesting;

(c) germination rates, purity and content of other PRM, moisture, vigour, presence
of earth or extraneous matter;
(c) certification methods of PRM, including the application of bio-molecular or
other technical methods, as well as their approval and use, and the listing of
approved methods in the Union;
(d) the conditions for rootstocks and other parts of plants of genera or species other
than those listed in Annex I, or their hybrids, if propagating material of the
genus or species listed in Annex I or their hybrids is grafted onto them;
(e) conditions for the production of seeds from fruit plants or vine;
(f) conditions for the production of fruit plants, vine or seed potatoes from seeds.
Those implementing acts shall be adopted in accordance with the examination
procedure set out in Article 76(2), in order to adapt to the developments of the
relevent international technical and scientific standards.

Article 8
Requirements for the production and marketing of standard seed and material
1. Standard seed may only be produced and marketed within the Union, if all the
following conditions are fulfilled:
(a) it is practically free from quality pests;
(b) it is produced and marketed:
(i) under the responsibility of the professional operator;
(ii) in accordance with the requirements set out in Part A of Annex III, and
its compliance with those requirements is attested by the operator’s label
referred to in Article 16.
2. Standard material may only be produced and marketed within the Union, if all the
following conditions are fulfilled:
(a) it is practically free from quality pests;
(b) it is produced and marketed:
(i) under the responsibility of the professional operator;
(ii) in accordance with the requirements set out in Part B of Annex III, and
its compliance with those requirements is attested by the operator’s label
referred to in Article 16.
3. Once a year, professional operators shall submit to the competent authority a
declaration concerning the quantities per species of standard seed and material they
produced.
4. The Commission is empowered to adopt delegated acts, in accordance with Article
75, in order to amend Annex III, to adapt the requirements referred to in paragraphs 1
and 2 to the scientific and technical developments and to the applicable international
standards. Those amendments shall concern the following:
(a) requirements for sowing and planting, and production in the field, of standard
seeds;
(b) requirements for harvesting and post-harvesting of standard seeds;

(c) requirements for marketing of standard seeds;
(d) requirements for sowing and planting, and production in the field, of standard
material;
(e) requirements for harvesting and post-harvesting of standard material;
(f) requirements for the marketing of standard material;
(g) requirements for clones, selected clones, multiclonal mixtures and polyclonal
PRM of standard material;
(h) requirements for the production of standard material produced by in vitro
propagation;
(i) requirements for the marketing of standard material produced by in vitro
propagation.
5. The Commission may adopt implementing acts specifying the production and
marketing requirements referred to in Part A and Part B of Annex III for certain
genera or species of standard seed or material. Those requirements shall concern one
or more of the following elements:
(a) specific uses of the genera, species or the types of the PRM concerned;
(b) production methods of PRM, including sexual and asexual reproduction and in
vitro propagation;
(c) conditions for sowing or planting;
(d) field cultivation;
(e) harvesting and post-harvesting;
(f) germination rates, purity and content of other PRM, moisture, vigour,
presence of earth or extraneous matter;
(g) the application of bio-molecular or other technical methods, as well as their
approval and use, and the listing of approved methods in the Union;
(h) the conditions for rootstocks and other parts of plants of genera or species other
than those listed in Annex I, or their hybrids, if propagating material of the
genus or species listed in Annex I or their hybrids is grafted onto them;
(i) conditions for the production of seeds from fruit plants or vine;
(j) conditions for the production of fruit plants, vine or seed potatoes from seeds.
Those implementing acts shall be adopted in accordance with the examination procedure set
out in Article 76(2), in order to adapt to the developments of the relevent international
technical and scientific standards.

Article 9
Production, marketing and registration of clones, selected clones, multiclonal mixtures and polyclonal PRM
1. In addition to the requirements referred to in Articles 4 to 43, pre-basic, basic,
certified and standard material of clones, selected clones, multiclonal mixtures and
polyclonal PRM shall be produced and marketed in accordance with paragraphs 2
and 3 and the requirements set out respectively in Annex II, Part C, and Annex III,
Part C.

2. Clones, selected clones, multiclonal mixtures and polyclonal PRM may only be
produced and marketed if they are registered by a competent authority in at least one
official register for clones established by a Member State.
That register shall include all elements referred to in the application for the
registration of a clone, selected clone, multiclonal mixture and polyclonal PRM, as
set out in Annex II, Part B, Part C point 2.
3. Clones, selected clones, multiclonal mixtures and polyclonal PRM shall be
maintained for the purpose of preserving their identity. The persons responsible for
maintenance of the clones, selected clones, multiclonal mixtures and polyclonal
PRM shall take all measures to be able to make them verifiable by the competent
authorities or any other person, on the basis of kept records.

SECTION 3
Authorisation of professional operators and official supervision of the
competent authorities

Article 10
Authorisation of professional operators to carry out certification under official
supervision
1. A professional operator may, upon application, be authorised by the competent
authority to perform all or certain activities required for certification of PRM under
official supervision of the competent authority for pre-basic, basic and certified
material or seeds, and to issue an official label for them.
In order to be granted such authorisation and depending on the activities to be
authorised for, the professional operator shall:
(a) possess the necessary knowledge for complying with the requirements referred
to in Article 7;
(b) be qualified to carry out the inspections referred to in Annex II or employ
personnel qualified for such inspections;
(c) employ qualified personnel for carrying out the sampling referred to in Annex
II, or conclude contracts with companies employing qualified personnel for
those activities;
(d) employ specialised personnel and equipment to carry out the testing referred to
in Annex II, or use laboratories employing qualified personnel for those
activities;
(e) have identified, and have the capability to monitor, the critical points of the
production process which may influence the quality and identity of the PRM,
and keep records of the results of that monitoring;
(f) have in place systems to ensure the fulfilment of the requirements concerning
the identification of lots pursuant to Article 13;
(g) have in place systems to ensure the fulfilment of the traceability requirements
set out in Article 42.
2. The Commission is empowered to adopt delegated acts in accordance with Article
75, supplementing paragraph 1 as regards one or more of the following elements:

(a) procedure for the application submitted by the professional operator;
(b) specific actions to be taken by the competent authority, in order to confirm the
compliance with paragraph 1, points (a) to (g).

Article 11
Withdrawal or modification of the authorisation of a professional operator
Where an authorised professional operator no longer fulfils the requirements set out in Article
10(1), the competent authority shall request that operator to take corrective actions within a
specified period of time.
The competent authority shall without delay withdraw, or modify as appropriate, the
authorisation, if the professional operator does not apply the corrective actions referred to in
the first subparagraph within the specified period of time. In case it is concluded that the
authorisation had been granted following fraud, the competent authority shall impose the
appropriate sanctions to the professional operator.

Article 12
Official supervision by the competent authorities
1. For the purposes of the certification under official supervision, the competent
authorities shall, at least once per year, conduct audits to ensure that the professional
operator fulfils the requirements referred to in Article 10(1).
They shall also organise training and examinations of the personnel carrying out field
inspections, sampling and testing provided for in this Regulation.
2. For the purposes of the certification under official supervision, the competent
authorities shall carry out official inspections, sampling and testing on a portion of
the crops on the site of production and on lots of the PRM in order to confirm
compliance of that material with the requirements referred to in Article 7.
That portion shall be determined on the basis of the assessment of the potential risk
of non-compliance of the PRM with those requirements.
3. The Commission may, by means of implementing acts, specify the requirements for
the audits, training, examinations, inspections, sampling and testing, as referred to in
paragraphs 1 and 2, with regard to particular genera or species.
Those implementing acts may specify one or more of the following elements:
(a) the risk criteria as referred to in paragraph 2 and minimum portion of the crops
and the lots of PRM, to be subject to inspections, sampling and testing, as
referred to in paragraph 2;
(b) monitoring activities to be carried out by the competent authorities;
(c) use of particular accreditation schemes by the professional operator, and the
possibility for the competent authorities to reduce the inspections, sampling
and testing, and monitoring activities referred to in this Article due to the use
of those schemes.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).
SECTION 4

HANDLING REQUIREMENTS

Article 13
Lots
1. PRM shall be marketed in lots. The content of the varieties and species of each lot
shall be sufficiently homogeneous regarding and identifiable by its users as distinct
from other lots of PRM.
2. During processing, packaging, storage, or at delivery, lots of PRM may be merged
into a new lot only if they belong to the same variety and harvest year.
Where lots consisting of different certification categories are merged, the new lot
shall belong to the category of the component of the lowest category. The merging
operation may only be undertaken in a facility and by persons authorised by the
competent authority for this specific purpose.
3. During processing, packaging, storage, or at delivery, lots of PRM may be split into
two or more lots.
4. In cases of merging or splitting of the lots of PRM, as referred to in paragraphs 2 and
3, the professional operator shall keep records concerning the origin of the new lots.
5. The Commission may, by means of implementing acts, adopt specific requirements
for all or certain species of PRM, concerning the maximum size of lots, their
identification and labelling, the merging or splitting of lots in relation to the origin of
the PRM lots, recording of those operations and labelling following the merging or
splitting. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 76(2).

Article 14
Packages, bundles and containers
1. PRM shall be marketed in fastened packages, bundles or containers, bearing a
sealing device and marking. In the case of PRM other than seeds, it may also be
marketed in the form of individual plants.
2. The packages, bundles and containers referred to in paragraph 1 shall be fastened in
such a way, that they cannot be opened without destroying that fastening or leaving
traces demonstrating that the package, bundle or container has been opened. the The
effectiveness of the fastening device shall be ensured, either by incorporating the
labels provided for in Articles 15 and 16 in the device or by use of a seal. Packages
and containers shall be exempted from this requirement if the fastening cannot be
reused.
3. In the case of pre-basic, basic or certified PRM, those packages, bundles and
containers shall be fastened by the competent authority, or by the professional
operator under the official supervision of the competent authority. Those packages
and containers shall not be refastened unless this is done by the competent authority
or by the professional operator under the official supervision of the competent
authority. If a package, bundle or a container is refastened, the date of refastening
and the details of the responsible competent authority shall be stated on the label
referred to in Article 15.

4. Lots of pre-basic, basic or certified PRM may be repackaged, re-labelled, and re-
sealed only under official control or under the official supervision of the competent
authority.
5. By way of derogation from paragraph 1, seeds may be marketed from a professional
operator directly to a farmer in bulk.
That professional operator shall be authorized for that purpose by the competent
authority. It shall inform the competent authority in advance of such activity and of
the lot from which such seed comes.
Where seed is loaded directly into the farmer’s machinery or trailer, the professional
operator and the farmer concerned shall ensure traceability of that seed by issuing
and retaining documents indicating the species and variety, quantity, the time of
transfer and lot identification.
6. The Commission may, by means of implementing acts, adopt specific requirements
concerning sealing, fastening, size and form of packages, bundles and containers of
specific species of PRM, and specify conditions for the marketing of seeds in bulk.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).

SECTION 5
LABELLING REQUIREMENTS

Article 15
Official label
1. Pre-basic, basic and certified material and seeds shall be identified, and their
compliance with this Regulation shall be attested, through an official label, issued
after the conclusion by the competent authority that the requirements referred to in
Article 7 have been fulfilled.
2. The official label shall be issued by the competent authority and bear a serial number
given by the competent authority.
It shall be printed by:
(a) the competent authority, if so requested by the professional operator, or if the
professional operator is not authorised to carry out certification under official
supervision, by the competent authority in accordance with Article 10; or
(b) the professional operator, under the official supervision of the competent
authority, where the professional operator is authorised to carry out
certification under official supervision in accordance with Article 10.
3. The official label shall be affixed to the outside of the bundle, package or container
by the professional operator under the official supervision of the competent
authority, or by a person acting under the responsibility of the professional operator.
4. The official label shall benewly issued. Adhesive official labels may be used, if so
authorised by the competent authority where there is no risk that they can be re-used.
5. The Commission is empowered to adopt delegated acts in accordance with Article
75, supplementing this Article by establishing the following rules on:

(a) the digital recording of all actions taken by the professional operators and the
competent authorities in order to issue the official label;
(b) the establishment of a centralised platform that connects the Member States
and the Commission to facilitate the processing of, access to, and use of those
records;
(c) the technical arrangements for the issuance of electronic official labels.
Following the adoption of such delegated act, the official label may also be issued in
an electronic form (‘electronic official label’).
6. By way of derogation from paragraphs 1 to 5, pre-basic, basic material and seed
basic material and seed and certified material and seed, imported from third countries
pursuant to Article 39, shall be marketed in the Union with the respective OECD
label that was accompanying them at import.

Article 16
Operator’s label
Standard material and standard seed shall be identified through an operator’s label. That label
shall attest that standard material or standard seed complies with the relevant production and
marketing requirements, referred to in Article 8, on the basis of inspections, sampling and
testing carried out by the professional operator.
The operator’s label shall be issued, printed and affixed by the professional operator, or by a
person acting under the responsibility of the professional opeartor, on the outside of a bundle,
package or container.

Article 17
Content of labels
1. The official label and the operator’s label, shall be written in at least one of the
official Union languages.
2. The official label and the operator’s label shall be legible, indelible, not modifiable if
tampered with, printed on one side, not having been used previously, and easily
visible.
3. Any space of the official label or the operator’s label apart from the elements
mentioned in paragraph 4, may be used for additional information by the competent
authority. Such information shall be presented in letters not larger than those used for
the content of the official label or the operator’s label as referred to in paragraph 4.
That additional information shall be strictly factual, it shall not represent advertising
material, and shall be related only to the production and marketing requirements or to
labelling requirements for genetically modified organisms or category 1 NGT plants
as defined in Article 3(7) of Regulation (EU) .../... (Office of Publications, please
insert reference to NGT Regulation ...). .
4. The Commission shall, by means of implementing acts, specify the content, size,
colour and form of the official or operator’s label, as applicable, in relation to the
respective categories or types of PRM, for:
(a) the official label referred to in Article 15(1);
(b) the operator’s label referred to in Article 16;

(c) the label for mixtures referred to in Article 21(1);
(d) the label for preservation mixtures referred to in Article 22(1);
(e) the label for repackaged and relabelled seeds referred to in Article 23(5);
(f) the label for PRM belonging to conservation varieties referred to in Article
26(2);
(g) the label for PRM marketed to final users referred to in Article 28(1), point (a);
(h) the label for the PRM marketed by certain gene banks, organisations and
networks referred to in Article 29;
(i) the label for breeder’s material referred to in Article 31(2);
(j) the label for PRM of not yet registered varieties referred to in Article 32(5);
(k) the label for PRM authorised in cases of temporary difficulties in the supply
referred to in Article 33(2); and
(l) the label for seeds with a provisional authorisation for marketing referred to in
Article 34(3);
(m) the label for seeds which are not finally certified referred to in Article 35(3);
(n) the label for PRM imported from third countries referred to in Article 40(1)
and (2).
That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 76(2).
5. The competent authority may authorise the professional operator to indicate
information other than the content referred to in paragraph 4, and other than
advertising material, placed at the periphery of the official label, in an area of a size
not larger than 20 % of the total area of the official label, bearing the title ‘Non
official information’. Such information shall be in letters not larger than those used
for the content of the official label as referred to in paragraph 4.

Article 18
Reference to lots
The official label and the operator’s label shall be issued for each lot.
If a lot of the same variety is split into two or more lots, a new official label or operator’s
label shall be issued for each lot.
If several lots of the same variety are merged into a new lot, a new official label or operator’s
label shall be issued for that new lot.

Article 19
Non-compliance of PRM with production and marketing requirements
In the case where official controls carried out during the marketing of PRM show that pre-
basic, basic, certified seeds or material, or standard seeds or material, have not been produced
or marketed within the Union in compliance with the respective requirements referred to in
Articles 7 or 8, or in the case where the varietal identity and purity of the PRM were not
confirmed in the control plot testing in accordance with Article 24, the competent authorities
shall ensure that the professional operator concerned takes the necessary corrective actions

concerning the PRM concerned and its premises and production methods, as appropriate.
Those actions shall aim at achieving one or more of the following elements:
(a) the PRM concerned complies with the respective requirements;
(b) the PRM concerned is withdrawn from the market or is used as material other than
PRM;
(c) with the exception of standard seed or standard material, the PRM concerned is
produced or marketed under a lower category, in accordance with the requirements
applicable for that category;
(d) the professional operator is sanctioned by additional means to the withdrawal or
modification of the authorisation referred to in Article 11.

Article 20
PRM to be only produced and marketed as pre-basic, basic or certified seeds or material
1. PRM belonging to the genera or species as listed in Annex IV may only be produced
and marketed as pre-basic, basic or certified seeds or material.
2. The Commission is empowered to adopt a delegated act in accordance with Article
75 in order to amend Annex IV.
The delegated act referred to in the first subparagraph shall add a genus or a species
to Annex IV, if both the following conditions are fulfilled:
(a) there is a need for higher quarantees for the quality of seeds belonging to that
genus or species; and.
(b) the costs of the certification activities, necessary to produce and market the
respective seed as pre-basic, basic and certified seed are proportionate:
(i) to the purpose of ensuring food and feed security, or ensuring high value
of industrial processing; and
(ii) to the economic benefits deriving from the highest standards concerning
identity and quality of the seed, resulting from the compliance with the
requirements for pre-basic, basic and certified seed compared to those for
standard seed.
That proportionality shall be based on an overall assessment of the following
elements in combination: the importance of the respective genus or species for the
Union food and feed security; the volume of its production in the Union; its demand
by the professional operators and operators of the food/feed industry; the costs of the
production of pre-basic, basic and certified seed compared to the cost of production
of other seed of the same genus or species; and the economic benefits derived from
the production and marketing of pre-basic, basic and certified seed compared to other
seed of the same genus or species.
The delegated act referred to in the first subparagraph shall remove a genus or a
species from Annex IV, if one of the conditions set out in the second subparagraph,
point (b), points (i) and (ii), is no longer fulfilled.
SECTION 6
SPECIFIC REQUIREMENTS FOR MIXTURES OF SEEDS, RE-PACKAGING OF
SEEDS AND CONTROL PLOT TESTS FOR SEEDS

Article 21
Mixtures of seeds
1. Mixtures of certified seed or mixtures of standard seed of various genera or species
listed in Part A of Annex I and complying with the requirements of Articles 5 to 8, as
well as of different varieties of those genera or species, may be produced and
marketed in the Union, if they fullfill the requirements of this Article.
The seeds included in those mixtures shall be accompanied by:
(a) an official label, where the mixture consists only of certified seeds; or
(b) an operator’s label, in the case where the mixture consists only of standard
seed, or of certified and standard seed.
For the purposes of the second subparagraph, point (a), the professional operators
shall submit to the competent authority the list of constituent varieties of the mixture
and their ratios, for verification of eligibility of those varieties.
2. Μixtures of seeds referred to in paragraph 1 may only be produced by professional
operators, which are authorised for that purpose by the competent authority. In order
to receive an authorisation for the production of such mixtures, professional
operators shall fulfil the following requirements:
(a) having installed suitable mixing equipment and appropriate procedures
ensuring that the finished mixture is uniform and the stated ratio between the
component varieties in each container can be achieved;
(b) having a person in charge who has direct responsibility for the mixing and
packaging operation; and
(c) maintaining a register of seed mixtures and their intended use.
3. The mixing and packaging operation of the seeds referred to in paragraph 1, point
(a), shall be carried out under the supervision of the competent authority.
The mixing operation shall be carried in a manner to ensure that there is no risk of
presence of seeds not intended for inclusion and that the resulting mixture is as
homogeneous as possible.
The weight of the seed in a single container, which consists of a mixture of both
small-seeded species and species of which the seed is larger than the size of wheat,
shall not exceed 40 kg.
4. The Commission may, by means of implementing acts, specify, on the basis of
technical and scientific developments and the experience gained from the application
of this Article, rules concerning:
(a) the mixing equipment and procedure;
(b) maximum lot sizes for particular species and varieties.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).

Article 22
Preservation mixtures

1. By way of derogation from Article 21(1), Member States may authorise the
production and marketing of a mixture of seeds of various genera or species listed in
Part A of Annex I, as well as of different varieties of those genera or species,
together with seeds of genera or species of other Parts of that Annex, or of genera or
species not listed in that Annex, if such a mixture fulfils all of the following
conditions:
(a) it contributes to the conservation of genetic resources, or the restoration of the
natural environment; and
(b) it is naturally associated with a particular area (‘source area’) contributing to
the conservation of genetic resources or the restoration of the natural
environment;
(c) it complies with the requirements of Annex V.
Such mixture constitutes a ‘preservation mixture’ and this shall be mentioned on its
label.
2. The Commission is empowered to adopt a delegated act, in accordance with Article
75, amending Annex V concerning the following elements:
(a) authorisation requirements for mixtures of seeds collected directly from a
natural place belonging to a defined source area, for the conservation and
restoration of the natural environment (directly harvested preservation
mixtures);
(b) authorisation requirements for crop-grown preservation mixtures;
(c) use and content of certain species;
(d) requirements on sealing and packaging;
(e) requirements for the authorisation of the professional operators.
Those amendments shall be based on the experience gathered by the implementation
of this Article, and any technical and scientific developments and the improvement
of the quality and identification of preservation mixtures. They may concern
particular genera or species only.
3. Professional operators shall report to the respective competent authorities, for each
production season, the amount of preservation mixtures produced and marketed by
them.
The Member States shall report on request to the Commission and to the other
Member States the amount of preservation mixtures produced and marketed in their
territory and, where applicable, the names of competent authorities responsible for
plant genetic resources or of organisations recognised for this purpose.

Article 23
Re-packaging and re-labelling of seed lots
1. Seed lots of pre-basic, basic and certified seed shall be repackaged and relabeled in
accordance with this Article, Articles 14 and 15, where this is necessary for splitting
or merging of lots.
2. The re-packaging and re-labelling of a seed lot shall be conducted by:

(a) the professional operator under the official supervision of the competent
authority; or
(b) a seed sampler, who is authorised and supervised for that purpose by, and
reports to, the competent authority.
In the case of point (b), the professional operator shall be notified in advance by the
competent authority so as to organise its co-operation with the seed sampler.
3. The professional operator and the seed sampler carrying out re-packaging and re-
labelling of seed lots, shall take all steps to ensure that during the operation of re-
packaging, the identity and varietal purity of the seed lot is maintained, no
contamination occurs, and the resulting seed lot is as homogeneous as possible.
4. The professional operators and the seed sampler shall keep records, when re-
packaging and re-labelling seed lots, for 3 years after the respective re-labelling and
re-packaging. The information contained in the records shall include:
(a) the reference number of the original seed lot;
(b) the reference number of the repackaged or relabeled seed lot;
(c) the weight of the original seed lot;
(d) the weight of the re-packaged or relabeled seed lot;
(e) the date of final disposal of the lot.
Those records shall be kept in a form allowing to identify and verify the authenticity
of the original seed lot, which is subject to re-packaging and re-labelling. They shall
be made available to the competent authority on request.
5. The original seals and labels shall be removed from the seed lot. The professional
operators or the seed sampler shall also keep the label, which was replaced, of each
component seed lot.
The new labels shall either state the original seed lot reference number or a new seed
lot reference number assigned by the competent authority.
6. Where the competent authority assigns a new seed lot reference number, it shall
either keep a record of the former seed lot reference number or ensure that this
former number is included on the new labels.
7. Repackaging of mixtures of certified seed may only be carried out where the
professional operator or the seed sampler has established that the ratio of the
different components within a mixture will be maintained during the repackaging
process.

Article 24
Control plot tests for pre-basic, basic and certified seeds
1. After the production of pre-basic, basic and certified seeds, the competent authorities
shall carry out annual field tests, immediately after, or during, the season following
the drawing of the samples, additionally to field inspection, in plots where the variety
is compared to an officially validated sample of seed of the variety to ascertain that
the characteristics of varieties have remained unchanged in the process of production
and to verify the varietal identity and purity of individual seed lots.
Those tests shall be used for assessing:

a) whether the requirements for the next categories or generations are fulfilled.
When, as a result of such tests of the immediately descending category or
generation, it is established that the varietal identity or purity of the seeds has
not been maintained, the competent authority shall not certify seed derived
from the lot concerned;
b) that such seed complies with the respective identity, quality and other
certification requirements. When, as a result of such test, it is established that
the requirements of Article 7 have not been fulfilled, the competent authority
shall withdraw the lot concerned from the market or ensure that it complies
with the applicable requirements.
2. The proportion of these control plot tests for pre-basic, basic and certified seed shall
be determined on the basis of a risk analysis concerning possible non-compliance of
the seeds with the respective requirements.
3. On the basis of the risk analysis referred to in paragraph 2, control plot tests shall be
carried out through samples taken by the competent authority from the harvested
seed.
4. The Commission is empowered to adopt delegated acts in accordance with Article
75, supplementing this Regulation by setting out rules for the control plot tests of
seeds per genera or species. Those rules shall adapt to the development of scientific
and technical knowledge and international standards, and may be established per
particular genera, species or categories. They may concern the following:
(a) criteria for the conduct of the risk analysis referred to in paragraph 2;
(b) the testing procedure;
(c) evaluation of results of the tests.
5. In the case of control of varietal identity and purity, the use of bio-molecular
techniques may be used as a supplementary tool where the results of the conrol plot
tests referred to in paragraph 1 are non conclusive

Article 25
Control plot tests for standard seeds
1. After the marketing of standard seeds, the competent authorities shall carry out
control plot tests to check whether the seeds comply with the respective varietal
identity and varietal purity requirements, and with other requirements, as appropriate.
2. The proportion of the control plot tests shall be determined on the basis of a risk
analysis concerning possible non-compliance of the respective seeds with those
requirements.
3. Based on the risk analysis of non-compliance with the respective rules, the control
plot tests referred to in paragraph 1 shall be carried out anually, by using samples
taken by the competent authority from homogeneous seed lots. Those tests shall
assess identity and varietal purity of the seed concerned, and its germination rate and
analitical purity.
4. In the case of control of varietal identity and purity, the use of bio-molecular
techniques may be use as a supplementary tool where the results of the conrol plot
tests referred to in paragraph 1 are non conclusive.

SECTION 7
DEROGATIONS FROM THE REQUIREMENTS OF ARTICLES 5 TO 25

Article 26
PRM belonging to conservation varieties
1. By way of derogation from Article 20, PRM belonging to a conservation variety
registered in a national variety register referred to in Article 44(1), point (b), may be
produced and marketed in the Union as standard seed or material, if it complies with
all the requirements concerning standard seed and material for the respective species,
as referred to in Article 8.
2. PRM referred to in paragraph 1 shall be accompanied by an operator’s label with the
indication ‘Conservation variety’.
3. A professional operator who uses this derogation shall annually notify to the
competent authority this activity, with regard to the species and quantities concerned.

Article 27
PRM of heterogeneous material
1 By way of derogation from Article 5, PRM of heterogeneous material may be
produced and marketed within the Union without belonging to a variety. The
heterogeneous material shall be notified to and register by the competent authority
prior to its production and/or marketing, in accordance with the requirements set out
in Annex VI.
2. By way of derogation from Articles 7(1), (3) and Article 8(1), (3), the PRM of
heterogeneous material referred to in paragraph 1 shall be produced and marketed in
accordance with the requirements set out in Annex VI.
3. The Commission is empowered to adopt a delegated act in accordance with Article
75, amending Annex VI. Those amendments may concern all, or particular genera or
species only, and shall:
(a) improve the provision of information in notifications, description and
identification of heterogeneoys PRM, on the basis of experience gained by the
application of the respective rules;
(b) improve the rules concerning packaging and labelling of heterogeneous PRM,
on the basis of the experience gained from the checks carried out by the
competent authorities;
(c) improve the rules on maitenance of heterogenous PRM, on the basis of the
emergence of best practices.
Those amendments shall be adopted in order to adapt to the development of the
respective technical and scientific evidence, and the international standards, and to
follow up on the experience gained by the application of this Article concerning all
or certain genera or species only.
4. Any professional operator producing and/or intending to market PRM of
heterogeneous material shall submit a notification to the competent authority prior to
marketing. If no further information is requested by the national competent authority

within a time determined by the competent authority, the PRM of heterogeneous
material may be marketed.
5. The professional operator shall ensure the traceability of the PRM of heterogeneous
material by keeping information allowing to identify the professional operators
which have supplied them with the initial material used for the production (parental
material) of heterogeneous material.
The professional operator shall keep that information for 5 years.
The professional operator producing PRM of heterogeneous material intended for
marketing shall also record and keep the following information:
(a) the name of the species and denomination used for each notified heterogeneous
material;
(b) the type of technique used for the production of heterogeneous material as
referred to in paragraph 1;
(c) the characterisation of the notified heterogeneous material;
(d) the breeding location of the PRM of heterogeneous material and production
location;
(e) the surface area for the production of PRM of heterogeneous material and
quantity produced.
The competent authorities shall have access to the information referred to in this
paragraph.
6. Article 54 shall apply accordingly for the suitability of the denomination of
heterogeneous material.
7. Heterogeneous material as notified pursuant to paragraph 1, shall be registered by the
competent authorities in a dedicated register (‘heterogeneous material register’).
The competent authorities shall keep, update and publish that register, and notify
immediately its content and updates to the Commission.

Article 28
PRM marketed to final users
1. By way of derogation from Articles 5 - 12, 14, 15 and 20, PRM may be marketed to
final users, if it complies with all of the following requirements:
(a) to bear an operator’s label with the denomination of the PRM and the
indication ‘Plant reproductive material for final users – not officially certified’
or, in the case of seeds, ‘Seeds for final users – not officially certified’;
(b) in case not belonging to a variety registered in a national variety register
referred to in Article 44, to have a description made publicly available, on the
basis of a private documentation, in a commercial catalogue kept by the
professional operator. This private documentation shall be made available by
the professional operator upon request to the competent authority;
(c) to be practically free from quality pests and any defects likely to impair its
quality as reproductive material, and shall have satisfactory vigour and
dimensions in respect of its usefulness as PRM, and, in the case of seeds, shall
have satisfactory germination capacity; and

(d) to be marketed as individual plants, or, in the case of seeds and tubers, in small
packages.
A professional operator who uses this derogation shall annually notify this activity to
the competent authority, with regard to the species and quantities concerned
2. The Commission shall, by means of implementing acts, adopt rules concerning the
size, form, sealing and handling requirements concerning the small packages referred
to in paragraph 1 point (d).
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).

Article 29
PRM marketed to and between gene banks, organisations and networks
1. By way of derogation from Articles 5 to 25, PRM may be marketed to, or between,
gene banks, organisations and networks with a statutory objective, or an objective
official notified to the competent authority, to conserve plant genetic resources,
whereby any of the activities are carried out for non-profit purposes.
It can be marketed as well from those gene banks, organisations and networks to
persons who carry out conservation of that PRM as final consumers, for non-profit
purposes.
In the cases provided for in the first and the second subparagraphs, PRM shall fulfil
the following requirements:
(a) be listed in a register kept by those gene banks, organisations and networks
with an appropriate description of that PRM;
(b) be conserved by those gene banks, organisations and networks, and samples of
that PRM be made available by them to the competent authorities upon request;
and
(c) be practically free from quality pests and any defects likely to impair its quality
as a reproductive material, and have satisfactory vigour and dimensions in
respect of its usefulness as PRM, and, in the case of seeds, have satisfactory
germination capacity.
2. The gene banks, organisations and networks shall notify the competent authority of
the use of the derogation referred to in paragraph 1 and the species concerned.

Article 30
Seed exchanged in kind between farmers
1. By way of derogation from Articles 5 - 25, farmers may exchange seeds in kind, if
such seeds fulfill all of the following conditions:
(1) are produced in the respective farmer’s own premises;
(2) are derived from the respective farmer’s own harvest;
(3) are not subject to a service contract conducted by the respective farmer with a
professional operator performing seed production; and
(4) the seed is used for dynamic management of farmer’s own seed for the purpose
of contributing to agro-diversity.

2. Such seeds shall fulfil all of the following requirements:
(a) not to belong to a to variety for which plant variety rights have been granted in
accordance with Regulation (EU) 2100/94;
(b) to be limited to small quantities, defined by the competent authorities for
specific species per year and per farmer, without using commercial
intermediaries or public offer of marketing; and
(c) to be practically free from quality pests and any defects likely to impact their
quality as seeds, and shall have satisfactory germination capacity.
3. Member States shall annually notify to the Commission and the other Member States
the amounts per species defined in accordance with paragraph 2, point (b).

Article 31
Breeder’s seed
1. By way of derogation from Articles 5 -25, a competent authority may authorise
operators to market seed of generations preceeding the pre-basic category to another
operator, for the purpose of breeding new varieties (breeders’ seed).
The competent authority shall determine the duration of the authorisation and
quantities per species, when granting that authorisation.
2. The PRM referred to in paragraph 1 shall be accompanied by a label issued by the
professional operator, with the indication ‘breeder’s seed’, that shall be affixed, as
applicable, on the container, bundle or package of that material.
It shall be sealed and bear a lot number to be used for identification purposes and
control plot testing before it is used as pre-basic seed.

Article 32
PRM of not yet registered varieties
1. By way of derogation from Article 5, a competent authority may authorise
professional operators to produce and market, for the purposes of multiplication, pre-
basic seeds, pre-basic material, basic seeds and basic material belonging to a variety
not yet registered in a national variety register, referred to in Article 44, if all of the
following requirements are fulfilled:
(a) the respective marketing sectors need to acquire that material or seeds in
advance, so as to have sufficient stocks available, when the respective variety
will be registered; and
(b) there is no risk that such an authorisation will lead to insufficient identification
or quality of the marketed PRM; and
(c) the respective PRM belongs to a variety for which an application has been
submitted for registration in a national variety register pursuant to Article 55.
Such authorisation may be granted for a maximum period of 3 3years in the case of
seeds, and 5 years in the case of PRM other than seeds, and for small quantities per
species as specified by the competent authority.
2. By way of derogation from Articles 5, 7, 10 -12, 15, 20, 23 and 24, a competent
authority may authorise professional operators for a maximum period of 3 years in

the case of seeds, and 5 years in the case of PRM other than seeds, and for small
quantities per species as determined by the competent authority, to produce and
market PRM belonging to a variety not yet registered in a national variety register
referred to in Article 44, if all of the following requirements are fulfilled:
(a) the authorised PRM is only used for tests or trials carried out by professional
operators, in order to gather information on the cultivation or use of the variety
concerned on farms;
(b) the marketing is made to those professional operators only, with no further
marketing thereafter, who produces a report on results of the tests or trials, in
relation to the information on the cultivation or use of that variety;
(c) there is no risk that such an authorisation will lead to insufficient identification
or quality of the marketed PRM; and
(d) the authorised PRM complies with the requirements of standard PRM for the
respective species.
3. In order to obtain the authorisation referred to in paragraphs 1 and 2, the professional
operator shall submit to the competent authorities a request, indicatingthe
information about the following:
(a) the production of the stock of pre-basic seeds and material, and basic seeds and
material, and certified seeds and material available before the variety
registration and the envisaged tests and trials for the standard seeds and
material;
(b) the breeder’s reference of the variety indicated in the application for
registration;
(c) the procedure for the variety maintenance, where applicable;
(d) the authority before which the application for the registration of the variety is
pending, and the reference assigned to that application;
(e) the site where production will take place; and
(f) 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 paragraphs 1 and 2 shall annually inform the other Member States and
the Commission thereof.
5. PRM referred to in paragraphs 1 and 2 shall be accompanied by a label, issued by the
professional operator, with the indication ‘Not yet listed variety’.

Article 33
Authorisation in cases of temporary difficulties in the supply
1. In order to remove temporary difficulties in the general supply of PRM that may
occur in the Union due to adverse climatic conditions or other unforeseen
circumstances, the Commission, by means of an implementing act, may authorise
Member States for a maximum period of 1 year, to allow the marketing of the
categories of pre-basic, basic or certified material or seed, which fulfils one of the
following conditions:
(a) belongs to a variety not included in a national variety register; or

(b) complies with less stringent requirements than the requirements referred to in
Article 7(1).
Point (a) shall apply by way of derogation from Articles 5, and point (b) shall apply
by way of derogation from Articles 7(1).
That implementing act may set out the maximum quantities, which may be marketed
per genera or species.
That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 76(2).
2. PRM referred to in paragraph 1 shall be accompanied by a label that states, as
applicable, that the PRM in question belongs to a non-registered variety or fulfils less
stringent quality requirements than the ones referred to in Article 7(1).
3. The Commission may decide, by means of an implementing act, that the
authorisation concerned has to be repealed or amended, if it concludes that is no
longer necessary or proportionate to the objective of removing the temporary
difficulties in the general supply of the PRM concerned. That implementing act shall
be adopted in accordance with the examination procedure referred to in Article 76(2).
4. Member States may, without obtaining the authorisation of the Commission referred
to in paragraph 1, allow, for a maximum period of 1 year, and for a limited amount
of quantities per genera or species as necessary for supply difficulties in question, the
production and marketing of seeds that fulfill germination rates reduced up to 15
percentage points compared to the ones set out pursuant to the implementing act
referred to in Article 7(3).

Article 34
Provisional authorisation in urgency cases for marketing of seeds not certified as
complying with applicable quality requirements
1. Competent authorities may authorise, for a maximum period of 1 month, the
marketing of seeds as pre-basic, basic or certified seeds, before they have been
certified to comply with the requirements referred to in Article 7 concerning
germination, maximum content of other species or purity, if it is necessary to make
that seed rapidly available on the market to address urgent needs of supply.
2. The authorisation referred to in paragraph 1 shall be granted on the basis of a an
analytical report on the seed, issued by the professional operator, attesting its
compliance with the requirements concerning germination, content of other species
or purity, adopted pursuant to Article 7(1).
The name and address of the first recipient of the seeds shall be submitted to the
competent authority by the professional operator. The professional operator shall
keep the information on the provisional analytical report at the disposition of the
competent authority.
3. The seeds referred to in paragraph 1 shall bear a label indicating ‘Provisional
authorisation for marketing’marketing’.

Article 35
PRM which is not yet certified

1. PRM which has been produced in the Union, but has not yet been certified as pre-
basic, basic or certified seed pursuant to Article 7, may be marketed with a reference
to any of those categories, if all of the following requirements are fulfilled:
(a) prior to the harvesting, a field inspection has been carried out by the competent
authority, or the professional operator under the official supervision of the
competent authority, and that inspection has confirmed compliance of that
PRM with the production requirements referred to in Article 7(1);
(b) it is in the process of being certified by the competent autority, or by the
professional operator under the official supervision of the competent authority;
and
(c) the requirements set out in paragraphs 2 to 5 are fulfilled.
2. PRM referred to in paragraph 1 may be marketed only by the professional operator
who has produced that PRM to the professional operator who is to carry out the
certification. Such PRM may not be further transferred to any other person before its
final certification.
3. PRM referred to in paragraph 1, shall be accompanied by a label, issued by the
professional operator, with the indication ‘Seeds/Material not yet finally certified’.
4. If the competent authority, where the PRM has been harvested (‘competent authority
of production’), and the competent authority where the PRM is certified pursuant to
Article 7 (‘competent authority of certification’) are different, they shall exchange
the relevant information concerning the production and marketing of that PRM.
5. PRM which has been harvested in a third country, but has not yet been certified as
pre-basic, basic or certified material pursuant to Article 7, may be marketed in the
Union by reference to any of those categories, if:
(a) a decision on equivalence has been adopted pursuant to Article 39 concerning
that third country;
(b) the requirements set out in paragraph 1, points (a) and (b), paragraphs 2 and 3,
are fulfilled, and the professional operators of the third county concerned have
been subject to the official supervision of their competent authorities;
(c) the competent authorities of the Member State and the third country concerned
exchange between themselves the relevant information concerning the
marketing of that material; and
(d) on request, the competent authorities of the third country concerned provide all
relevant production information to the competent authority of the Member
State of certification.
For the purposes of this paragraph, references made in paragraphs 1 - 5 to the
competent authority of production shall be construed as references made to the
competent authority of the third country concerned, and references made therein to
the requirements set out pursuant to Article 7(1) shall be construed as references
made to equivalent requirements of the third country, as recognised pursuant to
Article 39(2).

Article 36
More stringent production and requirements

1. The Commission, by means of implementing acts, may authorise the Member States
to impose, with regards to production and marketing of PRM, more stringent
production or marketing requirements than those referred to in Articles 7 and 8, in all
or part of the territory of the Member State concerned, provided that those more
stringent requirements correspond to specific production conditions in, and agro-
climatic needs, of that Member State in regard to the respective PRM.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).
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; and
(b) a justification on the necessity and proportionality of such requirements.
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 paragraph 2, point
(a), ensures the improvement of the identity and quality of the PRM concerned,
and it is justified by the specific agricultural or climatic conditions of the
Member State concerned; and
(b) the draft provisions are necessary and proportionate to the objective of the
measure referred to in paragraph 2, point (a).
4. Where applicable, each Member State shall, by ... [one year after date of application
of this Regulation], review the measures it has adopted pursuant to Article 5 of
Directive 66/401/EEC, Article 5 of Directive 66/402/EEC, Article 7 of Directive
2002/54/EC, Article 24 of Directive 2002/55/EC, Article 5 of Directive 2002/56/EC
and Article 7 of Directive 2002/57/EC, and either repeal those measures or amend
them to comply with the production and marketing requirements set out in, and
adopted pursuant to, Articles 7 and 8.
The Member State concerned shall inform the Commission and the other Member
States of those actions.
The Commission may, by means of implementing acts, decide that the measures, as
referred to in the first subparagraph, are to be repealed or amended, in case they are
considered to be unnecessary and/or disproportionate to their objective. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 76(2).

Article 37
Emergency measures
1. Where the production or marketing of PRM is likely to constitute a serious risk to
human, animal or plant health, environment or cultivation of other species, 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. Such measures
shall be limited in time. They may include provisions restricting or prohibiting the
marketing of the PRM concerned or laying down appropriate conditions for its
production or marketing, depending on the gravity of the situation.

Such measures may be taken on the Commission’s own initiative or at the request of
a Member State. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 76(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 76(3).
2. 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 the appropriate interim emergency
measures. Those measures may include provisions restricting, prohibiting or laying
down appropriate conditions for the production or marketing of PRM within the
territory of that Member State, 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.
3. The Commission may decide, by means of implementing acts, that the national
interim emergency measures referred to in paragraph 2 are to be repealed or
amended, if it considers that those measures are not justified in view of the respective
risk as referred to in paragraph 1. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 76(2). The Member
State concerned may maintain its national interim emergency measures until the date
of application of the implementing act(s) referred to in this paragraph.

Article 38
Temporary experiments to seek improved alternatives to provisions of this Regulation
1. By way of derogation from Articles 2, 5, 6, 7, 8 and 20, the Commission may, by
means of implementing acts, decide on the organisation of temporary experiments to
seek improved alternatives to provisions of this Regulation concerning the genera
and species it applies to, the requirements for belonging to a registered variety, the
production and marketing requirements for pre-basic, basic, certified and standard
material or seed, and the obligation to belong to pre-basic, basic and certified
material or seed.
Those experiments may take the form of technical or scientific trials examining the
feasibility and appropriateness of new requirements compared to the ones set out in
Articles 2, 5, 6, 7, 8 and 20 of this Regulation.
2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with
the examination procedure referred to in Article 76(2) and shall specify one or more
of the following elements:
(a) the genera or species concerned;
(b) the conditions of the experiments per genera or species;
(c) the duration of the experiment;
(d) the monitoring and reporting obligations of the participating Member States.
Those acts shall adapt to the evolution of techniques for production of the PRM
concerned, as shall be based on any comparative trials carried out by the Member
States.

3. The Commission shall review the results of those experiments and summarise them
in a report, indicating, if necessary, the need to amend Articles 2, 5, 6, 7, 8 or 20.

SECTION 8
IMPORTS FROM THIRD COUNTRIES

Article 39
Imports on the basis of Union equivalence
1. PRM may only be imported from third countries, if it is established, pursuant to
paragraph 2, that it fulfils requirements equivalent to those applicable to PRM
produced and marketed in the Union.
However, no such import shall be allowed, and no such equivalence shall be
recognised pursuant to paragraph 2, for the preservation mixtures such as those
referred to in Article 22, and for PRM such as that subject to the derogations of
Articles 26 - 30.
2. The Commission may recognise, by means of implementing acts, that PRM 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 PRM
produced and marketed in the Union, on the basis of all of the following:
(a) a thorough examination of the information and data provided by the third
country concerned;
(b) an audit carried out by the Commission in the third country concerned,
showing that the PRM concerned fulfils requirements equivalent to those
applicable to PRM produced and marketed in the Union, where that audit has
been considered necessary by the Commission; and
(c) in the case of seeds, the fact that this the country concerned participates in the
OECD Schemes for the Varietal Certification of Seed moving in International
Trade and implements the methods of the International Seed Testing
Association (ISTA), or, where applicable, complies with the rules of the
Association of Official Seed Analysts (AOSA).
For that purpose, the Commission shall examine:
(a) the third country’s legislation on the species concerned;
(b) the structure of the competent authorities of the third country and its control
services, the powers available to them, the guarantees that can be provided with
regard to the application and enforcement of the legislation of the third country
applicable to the sector concerned, and the reliability of the official
certification procedures;
(c) the performance by the competent authorities of the third country of adequate
official controls concerning the identification and quality of the PRM of the
species concerned;
(d) the guarantees given by the third country that:
(i) the conditions applied to the production sites from which PRM are
exported to the Union comply with requirements that are equivalent to
those referred to in this Article; and

(ii) those production sites are subject to regular and effective controls by the
competent authorities of the third country.
The Commission may also carry out audits to verify the compliance with points (b)
to (d) of the second subparagraph.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).
3. The implementing act referred to in paragraph 2 may provide for one or more of the
following elements, as appropriate for the respective PRM:
(a) conditions relating to inspections in the production site, carried out in third
countries;
(b) in the case of seeds, conditions relating to the issuance by the third country of a
certificate provided by the International Seed Testing Association;
(c) conditions relating to seed not yet finally certified;
(d) conditions relating to packaging, sealing and marking of PRM;
(e) conditions relating to the production, identity and marketing of PRM, in
addition to the ones provided for by the third country’s legislation, if so needed
to address particular aspects concerning the identity and quality of that PRM;
(f) requirements to be fulfilled by the professional operators producing and
marketing that PRM.
4. The Commission may, by means of implementing acts, recognise that the controls on
variety maintenance carried out in the third country afford the same guarantees as
those provided for in Article 72(1), (2) and (4), if varieties registered in a national
variety register or in the Union variety register are to be maintained in the third
country concerned.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).

Article 40
Labelling and information to be provided for the PRM imported from third countries
1. Pre-basic, basic and certified seeds referred to in Article 39 may only be imported
from third countries, if they are accompanied by an OECD label.
Pre-basic, basic and certified material referred to in Article 39 may only be imported
from third countries if it is accompanied by an official label issued by the competent
authority of the third country concerned.
Those labels shall contain all of the following information:
(a) the indication ‘meets EU rules and standards’;
(b) the species, variety, category and lot number of the PRM concerned;
(c) the date of closure, in case of marketing in containers or packages;
(d) the third country of production and the respective competent authority;
(e) where applicable, the last third country from which the PRM is imported and
the last third country where the PRM has been produced;

(f) in the case of seeds, the declared net or gross weight of the imported seeds or
declared number of imported lots of seeds;
(g) the name of the person importing the PRM.
2. Standard seed and material referred to in Article 39 may only be imported from third
countries, if it is accompanied by an operator’s label containing all of the following
information:
(a) the indication ‘meets EU rules and standards’;
(b) the species, variety, category and lot number of the PRM concerned;
(c) the date of closure, in case of marketing in containers or packages;
(d) the third country of production;
(e) where applicable, the last third country from which the PRM is imported and
the last third country where the PRM has been produced;
(f) in the case of seeds, the declared net or gross weight of the imported seeds or
declared number of imported lots of seeds;
(g) the name of the person importing the PRM.
3. PRM may only be imported into the Union after the electronic submission of the
information referred to in paragraph 1 or 2 by the importer to the competent authority
of the Member State of import.
4. Member States shall immediately notify the Information management system for
official controls (IMSOC), referred to in Article 131 of Regulation (EU) 2017/625,
of all established non-compliances of the imported PRM concerning the
requirements of paragraphs 1 and 2.

CHAPTER III
REQUIREMENTS FOR PROFESSIONAL OPERATORS

Article 41
Obligations of professional operators producing PRM
Professional operators, which produce PRM, shall:
(a) be established in the Union;
(b) be registered in the register referred to Article 65 of Regulation (EU) 2016/2031, in
accordance with Article 66 of that Regulation;
(c) be available personally, or designate another person, to liaise with the competent
authorities for facilitating the official controls;
(d) identify and monitor the critical points of the production process, or of the marketing,
which may influence the identity and quality of PRM;
(e) keep records of the monitoring of the critical points referred to in point (b) and
provide them for examination when requested by the competent authorities;
(f) ensure that lots of PRM remain separately identifiable;
(g) keep updated information on the address of the premises and other locations used for
the production of PRM;

(h) make sure that competent authorities have access to the premises and other locations
of production, including premises and fields of third contracting parties, and to the
records of the monitoring and all related documents;
(i) take measures, where appropriate, for the maintenance of the identity of the PRM in
accordance with the requirements of this Regulation;
(j) make available on request of the competent authorities any contracts with third
parties.

Article 42
Traceability
1. Professional operators shall ensure that PRM is traceable at all stages of production
and marketing.
2. For the purposes of paragraph 1, professional operators shall keep information
allowing them to identify:
(a) the professional operators, which have supplied them with the seeds and the
material concerned;
(b) the persons to whom they have supplied PRM and the PRM concerned, except
in case of final users.
On request, they shall make such information available to the competent authorities.
3. Professional operators shall keep records of the PRM and the professional operators
and persons referred to in paragraph 2 for 3 years after that material has been
respectively supplied to or by them.

Article 43
Annual notification of the intended production and certification of pre-basic, basic and certified seed and material
Every year, professional operators shall notify the competent authorities about:
(a) their intention to produce pre-basic, basic and certified material or pre-basic, basic
and certified seed, at least one month before the beginning of that production; and
(b) the production of pre-basic, basic and certified material that started in pevious years
and continues in the year concerned.
That notification shall state the plant species, varieties and categories concerned and the exact
location of production.

CHAPTER IV
VARIETY REGISTRATION

SECTION 1
VARIETY REGISTERS

Article 44
Establishment of national variety registers

EN 64 EN
1. Each Member State shall establish and publish, in electronic format, and shall keep
updated a single national register of varieties (‘national variety register’) containing:
(a) all varieties registered pursuant to the procedure set out in Articles 55 - 68;
(b) the conservation varieties referred to in Article 26 and registered pursuant to
Article 53.
2. PRM belonging to a variety registered in at least one national variety register may be
produced and marketed in the Union, in accordance with this Regulation.
3. Following the establishment of their national variety registers, as well as following
any of their updates, Member States shall immediately notify them to the
Commission for inclusion in the Union variety register referred to in Article 45.
4. This Article, and Articles 45 to 74, may not apply to varieties which are bred solely
as components of hybrid varieties.

Article 45
Establishment of a Union variety register
1. The Commission shall establish, publish, in an electronic format, and keep updated a
single register of varieties (‘the Union variety register’).
2. The Union variety register shall include the varieties, registered in national variety
registers and notified in accordance with Article 44.
The Union variety register may be accessible by an electronic portal containing other
registers of plant variety rights, forest reproductive material or other plants.

Article 46
Contents of the national and Union variety registers
1. The national variety registers and Union variety register shall contain all the
elements set out in Annex VII, concerning the varieties referred to in Article 44(1),
point (a).
In the case of the conservation varieties referred to in Article 44(1), point (b), those
registers shall indicate at least a brief summary of the officially recognised
description, the initial region of their origin, their denomination and the person that
maintains them.
2. The Commission is empowered to adopt a delegated act in accordance with Article
75, in order to amend Annex VII, taking into account the technical and scientific
developments, and on the basis of gained experience indicating the need of
competent authorities or professional operators to obtain more precise information
about the registered varieties.

SECTION 2
REQUIREMENTS FOR REGISTRATION OF VARIETIES

Article 47
Requirements for registration in national variety registers

1. Varieties shall be registered in a national variety register in accordance with Articles
55 to 68, only if:
(a) they have:
(i) an official description showing compliance with the requirements of
distinctness, uniformity and stability set out in Articles 48, 49 and 50,
and fulfil the requirements for satisfactory value for sustainable
cultivation and use, as set out in Article 52; or
(ii) an officially recognised description pursuant to Article 53, if they are
conservation varieties;
(b) they bear a denomination deemed suitable pursuant to Article 54;
(c) where the varieties contain or consist of genetically modified organisms, the
organism is authorised for cultivation in the respective Member State pursuant
to Article 19 of Directive 2001/18/EC or Articles 7 and 19 of Regulation (EC)
1829/2003, or, where applicable, in the respective Member State in accordance
with Article 26b of Directive 2001/18/EC;
(d) where the varieties contain or consist of a category 1 NGT plant as defined in
Article 3(7) of Regulation (EU) .../... (Office of Publications, please insert
reference to NGT Regulation ...), that plant has obtained a declaration of
category 1 NGT plant status pursuant to Article 6 or 7 of that Regulation or is
progeny of such plants;
(e) where the varieties contain or consist of a category 2 NGT plant as defined in
Article 3(8) of Regulation (EU) .../... (Office of Publications, please insert
reference to NGT Regulation), that plant has been authorised pursuant to
Chapter III of that Regulation;
(f) where the varieties are tolerant to herbicides, they are subject to cultivation
conditions for the production of PRM and for any other purpose, adopted
pursuant to paragraph 3 or, in the case they have not been adopted, as adopted
by the competent authorities responsible for registration, to avoid the
development of herbicide resistance in weeds due to their use;
(g) where the varieties have particular characteristics other than the ones referred
to in point (f) that may lead to undesirable agronomic effects, they are subject
to cultivation conditions for the production of PRM and any other purpose,
adopted pursuant to paragraph 3 or, in the case they have not been adopted, as
adopted by the competent authorities responsible for their registration, to avoid
those particular undesirable agronomic effects, such as the development of
resistance of pests to the respective varieties or undesirable effects on
pollinators.
A variety may not be registered with both an official description and an officially
recognised description.
2. The Commission shall adopt, by means of implementing acts, specific requirements
concerning:
(a) distinctness, uniformity and stability per genera or species of varieties, as
referred to in paragraph 1, point (a), based on the applicable protocols of the
International Union for the Protection of new Varieties of Plants (UPOV),

protocols established by the CPVO, or other relevant technical and scientific
evidence; and
(b) specific requirements concerning the distinctness, uniformity and stability per
genera and species, as referred to in point (a), for organic varieties suitable for
organic production, as defined in Article 3 of Regulation (EU) 2018/848, based
on the applicable protocols established by UPOV or the CPVO, and in
particular by adjusting the requirements concerning uniformity;
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).
They shall adapt the respective requirements to the development, where applicable,
of international standards, and the new scientific and technical knowledge.
Until the requirements referred to in point 2(b) are established, the assessment of
uniformity of varieties suitable for organic production, other than the varieties
referred to in Article 68(1), shall be carried out on the basis of off-types. For self-
pollinating species, a population standard of 10% and an acceptance probability of at
least 90 % shall be applied. For open pollinated out-crossing species, a population
standard of 20% shall be applied and an acceptance probability of at least 80 % shall
be applied.
3. The Commission is empowered to adopt delegated acts in accordance with Article
75, supplementing this Regulation with the minimum cultivation conditions to be
adopted by the competent authorities pursuant to paragraphs 1(f) and (g),
concerning:
(i) measures in the field, including crop rotation;
(ii) monitoring measures;
(iii) the mode of notification of the conditions referred to in point (i) to the
Commission and the other Member States;
(iv) rules for reporting from professional operators to the competent authorities
concerning the application of the conditions referred to in point (i);
(v) the indication of the conditions referred to in point (i) in the national variety
registers.
Those conditions shall be based on the latest scientific and technical knowledge.
4. For the purpose of registering a variety in its national variety register, a competent
authority shall accept, without any further examination, an official description or an
official examination of the requirements for value for sustainable cultivation and use,
as referred to in paragraph 1, point (a)(i), which has been produced by a competent
authority of another Member State.

Article 48
Distinctness
1. For the purposes of the official description, referred to in Article 47(1), point (a), 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 submission of the application established in accordance
with Article 58.
2. The existence of another variety, as referred to in paragraph 1, shall be deemed to be
commonly known, if one or more of the following conditions are complied with:
(a) the variety is included in a national variety register;
(b) an application for registration of the variety, or an application for granting a
plant variety right in respect of that variety, has been filed in the Union; or
(c) an official description of that variety exists in the Union, it is commonly known
worldwide, or the technical examination has been conducted pursuant to
Article 59.
3. Where paragraph 2, point (c) applies, the person(s) responsible for the technical
examinations shall make available to the competent authorities the official
description of the variety examined by them.

Article 49
Uniformity
For the purposes of the official description, 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 the characteristics included in the examination
for distinctness, as well as in the expression of any other characteristics used for its official
description.

Article 50
Stability
For the purposes of the official description, a variety shall be deemed to be stable if the
expression of the characteristics included in the examination for distinctness, as well as of 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 51
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 purposes of the official description and to have a
suitable denomination for the purposes of Article 47(1), point (b).

Article 52
Value for sustainable cultivation and use
1. For the purposes of Article 47(1), point (c), the value of a variety for sustainable
cultivation and use of a variety shall be considered as satisfactory if, compared to
other varieties of the same species registered in the national variety register of the
respective Member State, its characteristics, taken as a whole, offer a clear
improvement for the sustainable cultivation and the uses which can be made of the
crops, other plants or the products derived therefrom.

The characteristics referred to in the first subparagraph are the following, as
appropriate for the species, regions, agro-ecological conditions and uses concerned:
(a) yield, including yield stability and yield under low-input conditions;
(b) tolerance/resistance to biotic stresses, including plant diseases caused by
nematodes, fungi, bacteria, viruses, insects and other pests;
(c) tolerance/resistance to abiotic stresses, including adaptation to climate change
conditions;
(d) more efficient use of natural resources, such as water and nutrients;
(e) reduced need for external inputs, such as plant protection products and
fertilisers;
(f) characteristics that enhance the sustainability of storage, processing and
distribution;
(g) quality or nutritional characteristics.
2. For the prupose of paragraph 1, Member States may collaborate with other Member
States with similar agro-ecological conditions. Those Member States may establish
shared facilities for carrying out the examination for value for sustainable cultivation
and use.
3. The Commission is empowered to adopt delegated acts in accordance with Article
75, supplementing this Regulation by:
(a) establishing the minimum requirements for carrying out the examination
referred to under paragraph 1;
(b) establishing the methodologies for assessing the characteristics listed under
paragraph 1, points (a) to (g);
(c) establishing the standards for the evaluation and the reporting of the results of
the examination of the value for sustainable cultivation and use.
Those delegated acts shall adapt the requirements, methodologies and standards of
points (a) to (c) to the applicable technical or scientific developments, and to any
new Union policies or rules on sustainable agriculture.
Where those rules are not yet established, Member States may adopt such rules for
their respective territories. They shall notify them to the Commission and to the other
Member States.
The Commission may adopt, by means of implementing acts, a decision requesting a
Member State to repeal or modify those rules, if they are deemed, on the basis of the
available scientific and technical evidence, to be inappropriate for the examination of
value for sustainable cultivation and use of a variety. Those implementing acts shall
be adopted in accordance with the examination procedure referred to in Article 76(2).
4. For the purposes of registration of organic varieties suitable for organic production as
defined in Article 3(19) of Regulation (EU) 2018/848, the examination of the value
for sustainable cultivation and use shall be conducted under organic conditions, in
accordance with that Regulation, and in particular Article 5, points (d), (e), (f) and
(g), and Article 12 thereof and Part I of Annex II to that Regulation.
Where competent authorities are not able to carry out an examination under organic
conditions, or the examination of certain characteristics, including disease

susceptibility, testing may be carried out under low-input conditions and with only
the absolutely necessary for the completion of the testing treatments with pesticides
and other external inputs.

Article 53
Registration of conservation varieties
1. By way of derogation from Articles 48, 49, 50, 52, 55(2), 56, 57, and 59 to 65, a
conservation variety shall be registered in a national variety register if it complies
with the following conditions:
(a) it has an officially recognised description, specifying the characteristics that
qualify it as a conservation variety, in accordance with the definition in Article
3, point (29);
(b) it has an indication of its initial region of origin;
(c) it bears a denomination complying with Article 54;
(d) it is maintained in the Union.
2. A conservation variety shall be registered in the national variety register upon
application by a professional operator established in the Union. That application shall
include all the elements referred to in paragraph 1, points (a) to (d).
The competent authority shall accept or reject the registration of a conservation
variety, after checking its compliance with paragraph 1.
3. A variety shall not be listed in the national variety register as conservation variety, if:
(a) it is already listed in the Union variety register with an official description,
pursuant to Article 44(1), point (a), or it was deleted from the Union variety
register as a variety with an official description within the last 2 years, or
within 2 years from the expiry of the period granted pursuant to Article 71(2),
or
(b) it is protected by a Community plant variety right as provided for in Regulation
(EC) No 2100/94, or by a national plant variety right, or an application for such
a right is pending.
4. The officially recognised description referred to in paragraph 1, point (a), shall be
based on results of unofficial tests, knowledge gained from practical experience
during cultivation, reproduction and use, or other information, in particular from the
plant genetic resource authorities or from organisations recognised for this purpose
by Member States.
The Commission may, by means of implementing acts, specify the characteristics
and information that that description should cover if appropriate for specific species.
Such implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 76(2).
5. The person responsible for the maintenance of a conservation variety shall keep
samples of it and, upon request, make them available to the competent authorities.

Article 54
Suitability of variety denominations

1. For the purposes of Article 47(1), point (b), 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:
(i) 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
(ii) 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 variety referred to in point (i) or (ii) 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 making available on the market goods or which have to be
kept free pursuant to Union legislation;
(e) it is liable to give offence in one of the Member States or is contrary to the
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, the denomination shall be deemed suitable, only if it is identical to
that appearing in those registers.
This paragraph 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.
3. 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 paragraphs 1 and 2, the applicant shall submit an application
for a new denomination. The competent authority shall decide on that application
upon consultation with CPVO.
The competent authority may permit the previous denomination to be used
temporarily.
4. The Commission is empowered to adopt delegated acts in accordance with Article
75, supplementing this Regulation by setting out specific criteria concerning the
suitability of variety denominations as regards:
(a) their relation to 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) determination of whether a denomination is misleading or confusing as referred
to in paragraph 1, point (f); and
(e) the use of a denomination in the form of a code.

SECTION 3
PROCEDURE FOR REGISTRATION OF VARIETIES IN THE NATIONAL
VARIETY REGISTERS

Article 55
Submission of application
Any professional operator established in the Union may electronically submit to the
competent authority an application for registration of a variety in the national variety register.
The submission of that application may be subject to a fee paid by the applicant, as
established by the competent authority.

Article 56
Contents of the application for registration of a variety
1. The application for registration of a variety in a national variety register shall consist
of the following:
(a) a request for registration;
(b) the identification of the botanical taxon to which the variety belongs;
(c) where applicable, the registration number of the applicant, its name and
address or, where appropriate, the names and addresses of the joint applicants,
and the credentials of any procedural representative;
(d) a proposed denomination;
(e) the name and address of the person responsible for the variety maintenance,
and, where applicable, the registration number of that person;
(f) a description of the main characteristics of the variety, information on whether
it is adapted only for particular seasons of the year, and, if available, a
completed technical questionnaire;
(g) a description of the procedure of variety maintenance;
(h) the place of breeding of the variety and, if applicable, its particular region of
origin;
(i) information on whether the variety is registered in another national variety
registerin 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 in the Union, in accordance with Directive 2001/18/EC or
Regulation (EC) No 1829/2003, or, where applicable, in the respective
Member State in accordance with Article 26b of Directive 2001/18/EC;;

(k) where the application concerns conservation varieties, information related to
the production of an officially recognised description of the variety, a proof of
that description and any document or publication supporting it;
(l) in the case of an application concerning varieties with a granted plant variety
right pursuant to Regulation (EC) No 2100/94 or the legislation of a Member
State, the proof that the variety is protected by such right, with the
corresponding official description;
(m) in case the variety contains or consists of a category 1 NGT as defined in
Article 3(7) of Regulation (EU) .../... of the European Parliament and of the
Council26 (Office of Publications, please insert referrence to NGT Regulation),
evidence that the plant has obtained a declaration of category 1 NGT plant
status pursuant to Article 6 or 7 of that Regulation or is progeny of such
plant(s);
(n) in case the variety contains or consists of a category 2 NGT plant as defined in
Article 3(8) of Regulation (EU) .../... (Office of Publications, please insert
reference to NGT Regulation), indication of that fact;
(o) the intended use or conditions of cultivation, if applicable pursuant to Article
47(2), of the variety.
2. The application for registration of a variety in a national variety register shall be
accompanied by a sample to be used for the examination of that variety. The
competent authority of the respective Member State shall set a deadline for the
submission of that sample and specify its quality and quantity.

Article 57
Formal examination of application
1. The competent authority of the respective Member State shall register and examine
each application referred to in Article 55 in order to establish whether it complies
with the requirements laid down in Article 56.
2. If the application does not comply with the requirements laid down in Article 56, the
competent authority shall give the applicant a possibility to rectify the application
accordingly within a given time. If the application does not meet these requirements
by the expiry of thatgiven time, the competent authority shall reject the application
and terminate the variety registration.

Article 58
Date of application for registration
The date of the submission of the application for registration shall be the date on which the
application, fully complying with the requirements laid down in Article 56, is received by the
competent authority of the respective Member State.
The competent authorities shall immediately send to the applicant a confirmation of the
successful submission of the application, including information on the date of that
submission.

-------------------------------
26 Regulation (EU) ..../.... of the European Parliament and of the Council of ... (....., p....).

Article 59
Technical examination of the variety
1. Where, as a result of the formal examination, the application is found to comply with
the requirements laid down in Article 56, a technical examination of the variety shall
be carried out.
The technical examination shall be carried out by growing the variety, taking into
account the intended use and conditions for cultivation of the variety. Other means,
including the use of bio-molecular techniques, may be used as a supplementary tool,
as appropriate for the purposes of the technical examination, the species concerned or
the characteristics to be checked, as established pursuant to the implementing act
referred to in Article 47(2) concerning distinctness, uniformity and stability.
The technical examination referred shall verify:
(a) the compliance with the requirements for distinctness, uniformity and stability
of the variety, as laid down in Articles 48 to 50;
(b) whether the variety has value for sustainable cultivation and use, in accordance
with Article 52, in the case of the varieties referred to in Article 47(1), point
(a)(ii).
2. The technical examination referred to in paragraph 1 shall be carried out by the
competent authorities in accordance with Article 60, unless the derogation referred to
in Article 61(1) applies.
3. In case a formal report on the distinctness, uniformity and stability of the variety,
produced by CPVO or another competent authority, is already available, the
competent authority shall take into consideration the conclusions of that report for
the purposes of concluding the technical examination.
4. The conduct of the technical examination referred to in paragraph 1 may be subject
to a fee paid by the applicant, as established by the competent authority.

Article 60
Audit of the competent authority’s premises
The competent authority of the respective Member State may carry out the technical
examination as regards compliance with the requirements for distinctness, uniformity and
stability referred to in Articles 48 to 50 only after its premises and working arrangements,
dedicated to this purpose, have been found suitable for carrying out this examination pursuant
to an audit conducted by the CPVO or the Commission.
On the basis of the audit referred to in the first subparagraph, the Commission may
recommend to the competent authority, if appropriate, actions to ensure the suitability of the
premises and organisation of the competent authorities. The Commission 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 61
Authorisation of the applicant to carry out technical examination for value for
sustainable cultivation and use

1. By way of derogation from Article 59(2), the technical examination of whether the
variety has a sustainable value for cultivation and use, in accordance with Article 52,
or part of it, may be carried out by the applicant if:
(a) that applicant has been authorised by the competent authority of the respective
Member State;
(b) the examination is carried out under the official supervision and guidance of
the competent authority concerned; and
(c) the examination is carried out in the premises dedicated to that purpose.
2. Prior to granting the authorisation to carry out the technical examination on breeders’
premises, the competent authority shall audit the premises, the resources and the
organisational capacities of the applicant. That audit shall verify whether the
premises, the laboratoriy facilities, the organisation and the carrying out of the
growing trials are suitable for realising the technical examination on breeders’
premises as regards compliance with the requirements of a value for sustainable
cultivation and use referred to in Article 52.
3. The Commission is empowered to adopt delegated acts in accordance with Article
75, supplementing this Regulation by setting out the rules concerning the audit
referred to in paragraph 2.
4. On the basis of the audit referred to in paragraph 2, the competent authority may
recommend to the applicant, if appropriate, actions to ensure the suitability of the
applicant’s premises and organisation of the examination.
5. The competent authority may carry out additional audits to the one referred to in
paragraph 2 and, where applicable, recommend to the applicant to perform, within a
specific period of time, corrective actions concerning the its premises and the
working arrangements. In case the competent authority concludes, following that
period, that the applicant’s premises and working arrangements are not suitable, it
may withdraw or modify the authorisation referred to in paragraph 1.

Article 62
Additional rules on technical examination
1. The Commission is empowered to adopt delegated acts in accordance with Article
75, supplementing the requirements on the technical examination laid down in
Article 59. 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
61;
(b) the necessary equipment, including laboratories for testing, necessary to carry
out the technical examination;
(c) the establishment of a variety reference collection to compare the examined
variety with other varieties 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 carrying out of growing trials and laboratory tests for particular genera or
species, including bio-molecular techniques.
Those delegated acts adapt to the available international 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 paragraph 1, points (a) - (e).

Article 63
Confidentiality
1. Where, during the technical examination provided for in Article 59, an examination
of the genealogical components appears to be necessary, the results of that
examination and the description of the genealogical components shall be treated as
confidential, if the applicant requests so.
2. In the case of varieties of PRM intended exclusively for the production of
agricultural raw materials for industrial purposes, certain elements of the technical
examination and the intended uses of those varieties, whose public disclosure may
affect the competitive position of the applicant, shall be treated as confidential, if that
applicant requests so.
3. This Article shall apply without prejudice to Article 8 of Regulation (EU) 2017/625.

Article 64
Provisional examination report and provisional official description
1. Following the technical examination provided for in Article 59, the competent
authority shall produce a provisional examination report, as to the compliance with
the distinctness, uniformity and stability requirements, and the characteristics of
value for sustainable cultivation and use, as applicable, as referred to in Articles 48,
49, 50 and 52, and shall issue 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 CPVO.
3. The competent authority shall communicate the provisional examination report and
the provisional official description of the variety to the applicant. The applicant may
comment on these documents within 15 calendar days.
4. Where the competent authority does not consider that the provisional examination
report constitutes a sufficient basis for a decision on the registration of the variety, it
shall request from the applicant additional information, examinations or other
actions, as appropriate, to ensure compliance of the variety with the requirements
concerning distinctness, uniformity, stability and value for sustainable cultivation
and/or use, as set out respectively in Articles 48, 49, 50 and 52.

Article 65
Examination report and final official description

After taking into account any comments on the provisional examination report and the
provisional official description provided by the applicant, the competent authority shall issue
a final examination report and a final official description on the distinctness, uniformity and
stability of the variety and including a summary of the examantion results on value for
sustainable cultivation and use.
Competent authorities shall, on reasoned request, make available the examination reports and
the official description to third parties, subject to national or Union law on data protection and
to rules on confidentiality.

Article 66
Examination of the denomination of a variety
After the formal examination of the application provided for in Article 57, and prior to the
registration of a variety in a national variety register pursuant to Article 67, the competent
authority shall consult the CPVO on the variety denomination proposed by the applicant.
Thet CPVO shall submit to the competent authority a recommendation on the suitability of
the variety denomination proposed by the applicant, in accordance with Article 54. The
competent authority shall inform the applicant on that recommendation.

Article 67
Decision on the registration of a variety in the national variety register
1. If, on the basis of the procedure set out in Articles 55 to 66, it is concluded that the
variety complies with the requirements set out in Article 47(1), the competent
authority of the respective Member State 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 respective requirements set out in Article 47(1) are not
fulfilled; or
(b) the applicant has failed to comply with any of the obligations set out for it in
Articles 55 to 64.
3. Decisions refusing the registration of a variety in the national variety register shall
state the reasons justifying such refusal.
4. The competent authority shall communicate to the applicant the decision referred to
in paragraphs 1 and 2.
5. The decisions referred to in paragraph 1 and 2 may be appealed, in accordance with
the administrative rules of the Member State concerned. Any appeal against a
decision referred to in paragraph 1 shall have a suspensory effect on the registration
of the respective variety.
6. The adoption of the decision referred to in paragraph 1 may be subject to a fee paid
by the applicant, as established by the competent authority.

Article 68
Varieties registered pursuant to Directives 68/193/EEC, 2002/53/EC, 2002/55/EC and 2008/90/EC

1. By way of derogation from Articles 54 to 67, the competent authorities shall
immediately register in their national variety registers all varieties officially accepted
or registered before ... [the date of the entry into force of this Regulation], in the
catalogues, lists or registers established by their Member States pursuant to Article 5
of Directive 68/193/EEC, Article 3 of Directive 2002/53/EC, Article 3(2) of
Directive 2002/55/EC and Article 7(4) of Directive 2008/90/EC, without applying
the registration procedure set out by those Articles.
2. By way of derogation from Article 53, varieties accepted in accordance with Article
3 of Directive 2008/62/EC and Article 3(1) of Directive 2009/145/EC before... [OJ,
please, insert the date of the entry into force of this Regulation] shall be immediately
registered in the national variety registers as conservation varieties provided with an
officially recognised description without applying the registration procedure set out
by that Article.

SECTION 4
REGISTRATION PERIOD AND VARIETY MAINTENANCE

Article 69
Period of registration
1. The period of registration of a variety in a national variety register (‘period of
registration’) shall be 10 years.
However, that period of registration shall be 30 years for varieties of species of fruit
plants and vine propagating material, as listed respectively in Parts C and D of
Annex I.
In the case of varieties consisting of, or containing, a genetically modified organism,
the period of 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.
In the case of varieties consisting of, or containing, a category 2 NGT plant as
defined in Article 3(8), of Regulation (EU) .../... (Office of Publications, please
insert reference to NGT Regulation ...), the period of registration shall be limited to
the period for which that plant is authorised pursuant to that Regulation.
2. The period of registration of a variety in a national variety register may be renewed
for a further period of 10 years, or respectively 30 years, in accordance with the
procedure and the conditions laid down in Article 70.
In the case of a variety consisting of or containing a genetically modified organism,
the renewal of the period of 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.
3. The registration of a variety may be subject to an annual fee paid by the applicant, as
established by the competent authority.

Article 70
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 6 months, before the
expiration of the period of registration as referred to in Article 69(1).
2. The application shall be submitted electronically. It shall be accompanied by
evidence showing that the conditions set out in paragraph 3 are fulfilled.
3. The renewal of the registration of a variety in a national variety register may only be
granted, if:
(a) the applicant has submitted sufficient evidence that the variety continues to
comply with the respective requirements of Article 47(1); and
(b) the competent authority of the respective Member State has established that
there is a person responsible for the variety maintenance in accordance with
Article 72.
4. The competent authority may, on its own initiative, renew the registration of a
variety, if it is still in large demand by the professional operators and farmers
concerned, or it should be retained in the interest of conserving plant genetic
resources.

Article 71
Removal from national variety registers
1. The competent authority of the respective Member State shall remove a variety from
the national variety register, if:
(a) it concludes, on the basis of any new evidence, that the requirements for
registration, as set out in Article 47(1) are no longer fulfilled;
(b) the applicant does not pay the fee that the competent authority has established
in accordance with Articles 55, 59(4), 67(6) and 69(3);
(c) the person responsible for the variety maintenance, as referred to in Article 72,
so requests, or that person has ceased to maintain the variety and no other
person has become responsible for its maintenance;
(d) the variety is no longer maintained pursuant to requirements of Article 72;
(e) the variety is maintained in a third country, which has not provided assistance
on the controls of that maintenance pursuant to Article 72(7);
(f) at the time of the application, false or fraudulent data were supplied on the
basis of which the registration was decided;
(g) no application for renewal has been submitted by the deadline referred to in
Article 70(1) and the validity period of registration referred to in Article 69(1)
has expired.
2. On request by the applicant, the competent authority may allow that a variety
removed from the national variety register in accordance with paragraph 1, point (g),
continues to be made available on the market until 30 June of the third year
following the removal from the register.
That request shall be submitted no later than the date of the expiration of the validity
period of registration.

3. Following its removal from a national variety register, as referred to in paragraph 1,
the variety concerned shall be immediately removed from the Union variety register,
if it is not registered in any other national variety register.

Article 72
Variety maintenance
1. Varieties registered in a national variety register shall be maintained by the applicant,
or by any other person notified by the applicant to the competent authority. The
competent authority shall authorise that other person to carry out the maintenance of
the variety, if that person proves its capacity for that task, and the competent
authority shall withdraw that authorisation if that person is no longer capable for that.
The name and registration number of that person shall be notified by the applicant to
the competent authority of the Member State.
2. Variety maintenance shall take place in accordance with accepted practices
concerning, as appropriate, genera, species or particular types of varieties.
3. The persons referred to in paragraph 1 shall keep records concerning the variety
maintenance. It shall at all times be possible for the competent authority to check the
variety maintenance 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.
A standard sample of the variety concerned shall be provided to the competent
authority on request.
4. The competent authority shall carry out controls on the manner in which the variety
maintenance is carried out and may, to this purpose, take samples of the varieties
concerned. The frequency of those controls shall be based on the likelihood of non-
compliance with paragraphs 1 to 3.
5. Where a competent authority finds that the person responsible for variety
maintenance does not comply with paragraphs 1 to 3, it shall give that person
appropriate time to take corrective action or request another person to carry out the
variety maintenance. If no such action is taken within that time limit, the competent
authority shall remove the variety from the national variety register in accordance
with Article 71.
6. 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. If no such assistance is provided within a reasonable period
of time, or if it is concluded that the variety maintenance is not carried out in
accordance with this Article, the respective competent authority shall remove the
variety from the national variety register in accordance with Article 71.
7. 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, shall request the third country’s authorities assistance in the controls on
variety maintenance, if such a maintenance has been subject to the recognition of
equivalence referred to in Article 39(5). If no such assistance is provided within a
reasonable period of time, or if it is concluded that the variety maintenance is not

carried out in accordance with this Article, the respective competent authority shall
remove the variety from the national variety register in accordance with Article 71.

SECTION 5
KEEPING OF DOCUMENTATION AND SAMPLES

Article 73
Documentation on the national variety registers
The competent authority of the respective Member State shall keep a file on each variety
registered in the national variety register, containing:
(a) the official description or the officially recognised description of the variety;
(b) the examination report; and
(c) any complementary examination report pursuant to Article 64(4).
In the case of an officially recognised description, the file shall only contain that description
and the documents supporting it.

Article 74
Samples of the registered varieties
The competent authorities shall keep samples of the varieties registered in the national variety
registers and make them accessible to any third party upon request.
The Commission may, by means of implementing acts, specify the size of those samples, the
rules for their replacement, in the case where the quantity of the original sample is too limited
or it is no longer adequate due to its use in other examinations, and their submission to other
competent authorities. That implementing act shall be adopted in accordance with the
examination procedure referred to in Article 76(2).

CHAPTER V
PROCEDURAL PROVISIONS

Article 75
Exercise of delegation
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 2(3), 7(3), 8(4), 10(2), 15(5), 20(2),
22(2), 24(4), 27(3), 46(2), 47(3), 52(3), 54(4), 61(3), and 62(1) shall be conferred on
the Commission for 5 years from the date of the entry into force of this Regulation.
The delegation of power shall be tacitly extended for periods of 5 years, unless the
European Parliament or the Council opposed such extension not later than three
months before the end of each period.The Commission shall draw up a report in
respect of the delegation of power no later than nine months before the end of the
first 5-year period.
3. The delegation of power referred to in Articles 2(3), 7(3), 8(4), 10(2), 15(5), 20(2),
22(2), 24(4), 27(3), 46(2), 47(3), 52(3), 54(4), 61(3), and 62(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. Before adopting a delegated act, the Commission shall consult experts designated by
each Member State in accordance with the principles laid down in the
Interinstitutional Agreement on Better Law-Making of 13 April 2016.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to
the European Parliament and to the Council.
6. A delegated act adopted pursuant to Articles 2(3), 7(3), 8(4), 10(2), 15(5), 20(2),
22(2), 24(4), 27(3), 46(2), 47(3), 52(3), 54(4), 61(3), and 62(1) shall enter into force
only if no objection has been expressed either by the European Parliament or the
Council within a period of 2 months of the 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 2 months at the initiative of the European
Parliament or the Council.

Article 76
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 Council27. That committee shall be a committee
within the meaning of Regulation (EU) No 182/2011.
2. 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 decides so or a simple majority of
committee members requests it.
3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No
182/2011, in conjunction with Article 5 thereof shall apply.

CHAPTER VI
REPORTING, PENALTIES AND AMENDMENTS OF
REGULATIONS (EU) 2016/2031, 2017/625 AND 2018/848

Article 77
Reporting

-------------------
27 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying
down the general principles and requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

1. By ... [5 years after the date of application of this Regulation], and every five 5
years there after, Member States shall transmit to the Commission a report on the
following:
(a) quantities of certified and standard PRM and areas used for their production
per year and species with a specification of the quantities used for organic
varieties suitable for organic production;
(b) quantities of marketed PRM of heterogeneous material and areas used for their
production per year and species;
(c) quantities of marketed PRM of conservation varieties per year and species;
(d) number of professional operators using the derogations for marketing to final
users in accordance with Article 28, the species concerned and total quantities
of PRM per species;
(e) number of gene banks, organisations and networks with a statutory or other
declared objective to conserve plant genetic resources, in accordance with
Article 29 and the species concerned;
(f) the quantities as defined per species for the seeds exchanged in kind between
farmers, in accordance with Article 30;
(g) the quantities authorised per species for PRM intended for tests and trials for
the breeding of new varieties, in accordance with Article 31;
(h) quantities of PRM per genera and species for which Article 33(4) has been
applied;
(i) quantities of PRM per genera and species imported from third countries, in
accordance with Article 39;
(j) penalties imposed in accordance with Article 78;
(k) number of professional operators established in their territory.
2. The Commission shall, by means of implementing acts, specify the technical formats
for reporting made pursuant to paragraph 1. Those implementing acts shall be
adopted in accordance with the examination procedure referred to in Article 76(2).

Article 78
Penalties
1. 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 shall be effective, proportionate and
dissuasive. Member States shall, without delay, notify the Commission of those rules
and of those measures and of any subsequent amendment affecting them.
2. Member States shall ensure that financial penalties for violations of this Regulation,
perpetrated through fraud are equal, in accordance with national law, at least either to
the acquired economic advantage for the professional operator or to a percentage of
the professional operator’s turnover.

Article 79
Amendments of Regulation (EU) 2016/2031

In Article 37 of Regulation (EU) 2016/2031, paragraph 4 is replaced by the following:
‘4. The Commission shall, by means of an implementing act, where appropriate, set out
measures to prevent the presence of Union regulated non-quarantine pests on the
plants for planting concerned, as referred to in Article 36, point (f). Those measures
shall, where appropriate, concern the introduction into, and the movement within, the
Union of those plants.’.

Article 80
Amendments of Regulation (EU) 2017/625
Regulation (EU) 2017/625 is amended as follows:
(1) in Article 1, paragraph 2, the following point is added:
‘(k) production and marketing of plant reproductive material.’;
(2) in Article 3, the following point is added:
‘(52) ‘plant reproductive material’ means plant reproductive material as defined in
Article 3(1) of Regulation (EU) .../... of the European Parliament and the
Council(*)+’;
_________
(*) Regulation (EU) .../... of the European Parliament and of the Council .... (OJ
..., p...). [footnote that will be in that regulation goes here]
[+ OJ: Please insert in the text the number of this Regulation and insert the
number, date, title and OJ reference of this Regulation in the footnote.]
(3) the following article is inserted after Article 22:
‘Article 22a
Specific rules on official controls and for action taken by the competent authorities in relation to plant reproductive material
1. Official controls to verify compliance with the rules referred to in Article 1(2),
point (k), shall include official controls on plant reproductive material,
operators and other persons subject to those rules.
2. The Commission is empowered to adopt delegated acts in accordance with
Article 144 to supplement this Regulation by laying down rules for the
performance of official controls on plant reproductive material in order to
verify compliance with Union rules referred to in Article 1(2), point (k),
applicable to those goods and for action taken by the competent authorities
following the performance of those official controls.
Those delegated acts shall lay down rules on specific requirements for the
performance of such official controls on:
(a) the import into, and marketing within, the Union of particular plant
reproductive material subject to the rules referred to in Article 1(2), point
(k), concerning its identification and quality, and
(b) specific requirements for the performance of such official controls on the
activities of operators during the production of particular plant

reproductive material subject to the rules referred to in Article 1(2), point
(k).
3. The Commission shall, by means of implementing acts, lay down rules on
uniform practical arrangements for the performance of official controls on
plant reproductive material in order to verify compliance with Union rules
referred to in Article 1(2), point (k), applicable to those goods and for action
taken by the competent authorities following such official controls on:
(a) uniform minimum frequency of such official controls, where a minimum
level of official control is necessary to respond to recognised uniform
risks of non-compliance with the rules on plant reproductive material of a
particular origin or provenance;
(b) uniform frequency of official controls performed by competent
authorities on operators authorised to carry out certification under official
supervision in accordance with Article 12(1) of Regulation (EU) .../...++
Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 145(2).
_________
++ OJ: Please insert in the text the number of this Regulation.
4. For the purposes of Article 30, the delegation of certain official control tasks,
referred to in this Article, to one or more natural persons shall be allowed.’;
(4) in Article 40(1), the following point is added:
‘(c) laboratories which are accreditated by the International Seed Testing
Association to carry out analyses, tests and diagnoses on seed
samples’samples’.

Article 81
Amendment of Regulation (EU) 2018/848
Regulation (EU) 2018/848 is amended as follows:
(1) Article 3 is amended as follows:
(a) point (17) is replaced by the following:
‘(17) ‘plant reproductive material’ means plant reproductive material as
defined in Article 3(1) of Regulation (EU) .../... of the European
Parlament and Council(*)+;’;
____________
(*) Regulation (EU) .../... of the European Parliament and of the Council
.... (OJ ..., p...). [footnote that will be in that regulation goes here]
[+ OJ: Please insert in the text the number of this Regulation and insert the
number, date, title and OJ reference of this Regulation in the footnote.]
(b) point (18) is replaced by the following:
‘(18) ‘organic heterogeneous material’ means heterogeneous material as
defined in Article 3(27) of Regulation (EU) .../...(*)++ , produced in
accordance with this Regulation;’

____________
(*) Regulation (EU) .../... of the European Parliament and of the Council
.... (OJ ..., p...). [footnote that will be in that regulation goes here]
[++ OJ: Please insert in the text the number of this Regulation.]
(2) Article 13 is deleted.
(3) The second paragaph of Point 1.8.4. of Part I of Annex II to Regulation (EU)
2018/848 is replaced by the following: “ All multiplication practices, except plant
tissue cultures, cell cultures, germplasm, meristems, chimaeric clones, micro-
propagated material, shall be carried out under certified organic management”.

CHAPTER VII
FINAL PROVISIONS

Article 82
Repeals
Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC,
2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC are repealed.
References to those repealed acts shall be construed as references to this Regulation and shall
be read in accordance with the correlation table in Annex VIII.

Article 83
Entry into force and application
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 ... [36 months from the date of the entry into force of this Regulation ].
However,
(a) Article 40(4) shall apply from three days after the entry into force of this Regulation;
(b) Article 52 shall apply from ... [60 months from the date of the entry into force of this
Regulation] for the species listed in Parts B and C of Annex I. It 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