Toelichting bij COM(2023)414 - Productie en het in de handel brengen van plantaardig teeltmateriaal in de Unie, tot wijziging van de Verordeningen (EU) 2016/2031, (EU) 2017/625 en (EU) 2018/848 van het Europees Parlement en de Raad en tot intrekking van de Richtlijnen 66/401/EEG, 66/402/EEG, 68/193/EEG, 2002/53/EG, 2002/54/EG, 2002/55/EG, 2002/56/EG, 2002/57/EG, 2008/72/EG en 2008/90/EG (verordening betreffende plantaardig teeltmateriaal) - Hoofdinhoud
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| dossier | COM(2023)414 - Productie en het in de handel brengen van plantaardig teeltmateriaal in de Unie, tot wijziging van de Verordeningen (EU) ... |
|---|---|
| bron | COM(2023)414  |
| datum | 05-07-2023 |
•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 seed 1 ,
●Council Directive 66/402/EEC on the marketing of cereal seed 2 ,
●Council Directive 68/193/EEC on the marketing of material for the vegetative propagation of the vine 3 ,
●Council Directive 2002/53/EC on the common catalogue of varieties of agricultural plant species 4 ,
●Council Directive 2002/54/EC on the marketing of beet seed 5 ,
●Council Directive 2002/55/EC on the marketing of vegetable seed 6 ,
●Council Directive 2002/56/EC on the marketing of seed potatoes 7 ,
●Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants 8 ,
●Council Directive 2008/72 on the marketing of vegetable propagating and planting material, other than seeds 9 , and
●Council Directive 2008/90/EC on the marketing of fruit plant propagating material and fruit plants intended for fruit production 10 .
Moreover, Council Directive 98/56/EC 11 regulates the marketing of propagating material of ornamental plants.
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 Deal 12 and the related strategies: the Farm to Fork Strategy 13 , the Biodiversity Strategy 14 and the EU Strategy on adaptation to climate change 15 .
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 Strategy 16 .
Inhoudsopgave
- 2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
- 3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
- 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;
- 4.the lack of a harmonised and risk-based framework for official controls causing a non-level playing field for official controls, and
- 4.BUDGETARY IMPLICATIONS
- 5.OTHER ELEMENTS
- Not applicable
•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 agricultural policy. Therefore, the legal basis for this proposal is Article 43 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.
•Ex-post evaluations/fitness checks of existing legislation
In 2019, the Council 17 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 material 18 . The study was supported by an external data gathering study 19 . 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;
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.
●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 Council 20 due to concerns over a potential increase in administrative burden. 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 assessment 21 . 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 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.
There are no budgetary implications.
•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)
•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.
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 Council 23 , 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 Council 24 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.