EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

Plant reproductive material is a fundamental input for the productivity, the diversity, and the health and quality of agriculture, horticulture and food and feed production and our environment. Forests cover a large area of the Union and fulfil multiple social, economic, environmental, ecological and cultural functions. The current EU legislation for making available on the market of plant reproductive material is based on two main pillars, namely the registration of varieties/material and the certification of individual plant reproductive material lots of plant species as identified in the Directives ('EU listed species').

The draft proposal consolidates and updates the legislation on marketing of plant reproductive material by repealing and replacing the following 12 Directives: Council Directive 66/401/EEC on the marketing of fodder plant seed, Council Directive 66/402/EEC on the marketing of cereal seed, Council Directive 2002/53/EC on the common catalogue of varieties of agricultural plant species, Council Directive 2002/54/EC on the marketing of beet seed, Council Directive 2002/55/EC on the marketing of vegetable seed, Council Directive 2002/56/EC on the marketing of seed potatoes, Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants, Council Directive 68/193/EEC on the marketing of material for the vegetative propagation of the vine, Council Directive 1998/56/EC on the marketing of propagating material of ornamental plants, Council Directive 92/33/EEC on the marketing of vegetable propagating and planting material, other than seed, Council Directive 2008/90/EC on the marketing of fruit plant propagating material and fruit plants intended for fruit production and Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material.

The majority of Council Directives for making available on the market of plant reproductive material have first been adopted between 1966 and 1971 and some Directives are more recent. The old Directives have been updated both frequently and substantially, creating the need for clarity and transparency. As a consequence of this history, the Directives are quite diverse in the technical backgrounds they are based on, but also in their approaches, ranging from official controls on products to official supervision of processes. In particular, the product control is very demanding for competent authorities.

Furthermore, the complexity and fragmentation of the existing legislation is likely to perpetuate existing uncertainties and discrepancies in its implementation between the Member States. This creates an uneven playing field for professional operators on the single market. There is a need to harmonise implementation of the legislation, reduce cost and administrative burdens and support innovation. It is also important to adapt to the technical progress in plant breeding, and to the rapid evolution of the European and global market of plant reproductive material. All those needs make the update and modernisation of the legislative framework imperative. The aim of in situ conservation of agro-biodiversity should be further strengthened. In addition, the weak horizontal coordination with other EU legislation, policies and strategies is an obstacle to their more efficient implementation. In the past years, agricultural policy in the EU has come to be seen as strategically important for food security and safety, the nutritional value of food, the environment, biodiversity and climate change. "Sustainable intensification" and greening of food crop production, in which yields are increased without adverse environmental impact and without the cultivation of more land, have become a central concern. Plant reproductive material legislation is critically important for reaching this aim. The EU Forest Strategy emphasises the importance of the multifunctional role of forest and its sustainable management.

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

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

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

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

The Impact Assessment identified the following main axes along which the system has to change in order to be fit for the changing economic, environmental, social, scientific circumstances: (i) Simplification of the basic legal acts (from 12 Directives to one Regulation), (ii) Cost recovery and improvement of the effectiveness and efficiency of the system and (iii) Horizontal coordination with recent, already adopted EU policies. Various ways – increased flexibility, deregulation or centralisation – are explored for improving the efficiency of the system, while maintaining the assurances for high quality plant reproductive material, competitiveness and addressing new challenges such as biodiversity. Based on these 3 axes, 5 policy options were identified, where legal simplification and cost recovery are constant for all options. In the various options, issues regarding SMEs and micro-enterprises have been addressed throughout, especially in order to ensure access for these enterprises to public services for the execution of certain tasks they cannot perform themselves and to support and further develop their flexibility to gain improved access to the plant reproductive material market. Specific attention is given to trade-offs between transferring operational work and keeping of quality of plant reproductive material.

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

3. LEGAL ELEMENTS OF THE PROPOSAL

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

3.1. Part I – General provisions

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

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

As regards definitions, the main change is the introduction of a common term to cover all the plant reproductive material, either in the form of seeds or other types of plant propagating material. Plant reproductive material is defined to mean plants or parts of plant capable of and intended for producing or reproducing entire plants. This includes also young plants. All those types of plant reproductive material are subject to common principles with regard to their production with a view to making available on the market and with regard to making them available on the market.

3.2. Part II – Professional operators

As under this Regulation the definition of operator does not include private persons, the term 'professional operator' is used. Professional operators are defined by a single definition and shall be registered to ease the control activities. This register shall be combined with the register established under [title of the new Plant Health Regulation]. Basic obligations will be introduced for professional operators concerning the identification of the plant reproductive material they are producing or making available on the market, keeping of records, facilitation of controls and maintenance of the material. The traceability of any plant reproductive material is ensured by the obligation for the professional operators to have information one step before and one step after their commercial activities.

3.3. Part III – Plant reproductive material other than forest reproductive material

Title I General provisions

Definitions of variety and its maintenance, variety with official description or variety with officially recognised description, clone as well as of the different marketing categories are laid down.

Title II Production and making available on the market of listed species

In general, the basic approach on registration of varieties/material and certification/inspection of lots before making available on the market will be maintained. However, more flexibility will be given to the professional operators so that they may decide to carry out the necessary examination for variety registration or inspections, sampling and analysis of plant reproductive material for certification under the official supervision of the competent authorities. In addition, secondary acts will be adopted setting out the specific requirements for the production and making available on the market of particular species and their categories (pre-basic, basic, certified and standard material). This is important to increase flexibility for changes due to technical and scientific developments and at the same time respecting proportionality and sustainability in regulatory approach.

The requirements for making available on the market of plant reproductive material may be summarised as follows:

– it belongs to a variety or clone registered in accordance the provisions of this Regulation;

– it complies with the specific requirements adopted for the marketing category concerned per genera and species;

– it bears an official label for pre-basic, basic or certified material, or an operator's label in case of standard material;

– it complies with the handling requirements;

– it complies with the requirements for certification and identification.

The obligation of variety registration shall not apply to rootstocks which do not fulfil the conditions of a variety. In addition, in order to introduce flexibility for future technical and scientific developments, heterogeneous material, which does not fulfil the definition of a variety, could be exempted under certain conditions from the requirement that that material belongs to a registered variety. Furthermore, a specific derogation for niche market plant reproductive material is laid down.

Certain genera and species of plant reproductive material, which are listed in the current Directives, should continue to be subject to enhanced requirements relating to their production and making available on the market (listed species). However, there is a need to set criteria to decide on these plant species. Genera or species of plants which represent a significant area and value of production, are produced and made available on the market by a significant number of professional operators or they contain substances requiring specific rules to protect human, animal health or the environment should be included in the list.

Plant reproductive material should only be produced and made available on the market as pre-basic, basic, certified or standard material, in order to ensure transparency and informed choices for users. Detailed criteria need to be established to decide which genera and plant species shall not be made available on the market as standard material to ensure enhanced quality and health, identity and traceability of plant reproductive material as well as food and feed security. Specific requirements should be adopted per genera and species for each of those categories. The requirements on identity, purity, health and other quality requirements, labelling, lots, packaging including small packages, post-certification control tests, comparative tests and trial and mixtures will continue to be applied.

Derogations

The existing permanent derogations on making available on the market to a limited extent not-yet registered varieties for testing on farm and not finally certified material and authorisation of more stringent national requirements should be maintained. This should also concern the important temporary derogations on emergency measures, temporary difficulties in supply and temporary experiments.

Derogation on niche market plant reproductive material

In addition, proportionate and sustainable rules for small scale activities concerning plant reproductive material, which is adapted to local conditions, and made available on the market in small quantities, should be established. Such varieties should be exempted from the requirements on registration and making available on the market. This material is defined as niche market plant reproductive material. The exemption should concern e.g. farmer-breeders or gardener-breeders whether being professional operators or not. However, some basic rules on labelling and traceability of the material should be laid down. In order to prevent an abuse of the exemption the material should only be made available on the market in a defined size of packages.

Imports and exports

The EU equivalence system is maintained as a basic condition for imports from third countries. However, exports are included in the scope of the Regulation. Exports should take place in line with legislation, standards, code of practice or any other legal or administrative procedure in place in the importing third country. Where a bilateral or multilateral agreement between the Union and the third country exists, the exports from the Union shall comply with the agreement. Furthermore, in the absence of the latter, an agreement conducted between the professional operators shall apply.

Title III Production and making available on the market of plant reproductive material belonging to non-listed genera or species

Plant reproductive material not belonging to the listed genera and species shall also be subject to a few basic requirements with regard to its health status, fitness for purpose, appropriate reference to varieties, where applicable, and identification of the respective material and imports.

Title IV Registration of varieties in national and Union registers

Variety registers

The varieties, in order to be made available on the market throughout the Union, shall be included in a national register or in the Union register via direct application procedure to the CVPO. CPVO will keep the updated information on all plant varieties that can be made available on the market in the Union, including the varieties registered in national registers (Union plant variety database).

For new improved varieties the basic requirement of DUS (distinct, uniform and stable) will be maintained. The uniformity examination should take into account the type of variety and type of reproduction. In addition, by secondary act it can be decided for which plant species additional requirements on value for cultivation and use (VCU) can be laid down. The Member States shall adopt more detailed criteria for the VCU examination of these plant species as regards their yield, quality characteristics, resilience and suitability for low input production systems including organic production. Thus, given the specific characteristics required for organic farming, the methodology and requirements established for variety examination should take due account of the specific needs.

Rules on a sustainable value for cultivation will be laid down and harmonised in the EU by adopting specific requirements concerning resistance to specific pests, reduced need for input of resources, decreased content of undesirable substances or increased adaptation to divergent agro-climatic environment. This is an important tool to guide the breeding process to a more sustainable direction.

If a variety has been granted a Union Plant Variety Right pursuant to Regulation (EC) No 2100/1994, or pursuant to national rules, that variety should be deemed to be distinct, uniform and stable and to have a suitable denomination for the purposes of variety registration under this Regulation.

The basic principle of the use of a single denomination throughout the Union for one variety is kept. In certain specific cases synonyms will be allowed. The CPVO is best made available to have an overview of applicable denominations of varieties throughout the Union. Therefore, and in order to ensure coherence regarding the assignment of denominations throughout the Union, the competent authorities should consult CPVO to check a denomination, before the respective variety is registered in a national variety register.

The Regulation establishes the detailed requirements for the variety registration procedure regarding conditions for registration, submission and content of applications, formal and technical examinations, examination reports, decisions on registration, period of validity and its renewal, revocation/deletion of registration and maintenance of varieties. For coherence, the same rules shall also apply to direct variety applications to the CPVO for registration in the Union variety register.

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

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

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

Old traditional varieties

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

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

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

3.5. Part V – Procedural provisions

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

3.6. Part VI – Final provisions

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

The necessary rules on penalties are laid down.

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

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

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

4. BUDGETARY IMPLICATION

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

5. OPTIONAL ELEMENTS

2013/0137 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

On the production and making available on the market of plant reproductive material (plant reproductive material law)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the opinion of the European Economic and Social Committee,

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure[1],

Whereas:

(1) The following Directives set out rules for the production and marketing of seeds and propagating material of agricultural crops, vegetables, vine, fruit plants, forest reproductive material and ornamental plants:

(a) Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed[2];

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

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

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

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

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

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

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

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

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

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

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

(2) The basic objective of the above Directives is sustainable agricultural, horticultural and forestry production. In order to ensure productivity, the health, quality and diversity of plant reproductive material is of outmost importance for agriculture, horticulture, food and feed security, and the economy in general. Moreover, to ensure sustainability, legislation should take account of the need to meet consumers' expectations, to ensure the adaptability of production to manifold agricultural, horticultural and environmental conditions, to face the challenges of climate change and to foster the protection of agro-biodiversity.

(3) Evolution in the areas of agriculture, horticulture, forestry, plant breeding and making available on the market of plant reproductive material has shown that the legislation needs to be simplified and further adapted to the developments of the sector. Therefore, the above Directives should be replaced by a single Regulation on the production, with a view to making available on the market, and the making available on the market, of plant reproductive material within the Union.

(4) Plant reproductive material, should be defined in a comprehensive manner, including all plants capable of, and intended for, producing (including reproducing at any further stage of production) entire plants. This Regulation should, therefore, cover seeds, as well as all other forms of plant at any growth stage, intended for and capable of producing entire plants.

(5) This Regulation should also cover plant reproductive material used for the production of agricultural raw materials intended for industrial purposes, since that material represents a major part of several sectors and should fulfil certain quality standards.

(6) In order to determine the scope of the several provisions of this Regulation it is necessary to define the concepts of “professional operator” and “making available on the market”. In particular, in view of the marketing developments of the sector, the definition of 'making available on the market' should be as wide as possible to ensure all forms of transactions of plant reproductive material. That definition should include inter alia persons concluding sales through distance contracts (e.g. electronically) and persons who collect basic forest material.

(7) Given the needs of producers and the requirements for flexibility and proportionality, this Regulation should not apply to reproductive material intended solely for testing, scientific and breeding purposes, to gene banks, organisations and networks devoted to the exchange and conservation of genetic resources (including on-farm conservation), or to reproductive material exchanged in kind between persons other than professional operators.

(8) Directive 94/62/EC of 20 December 1994 on packaging and packaging waste[14], Regulation (EC) No 338/97/EC of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein[15], Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC[16], Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed[17], Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC[18] and Regulation (EU) No …/… [Office of publications, please add number of Regulation on protective measures against pests of plants], should also apply for the production and making available on the market of plant reproductive material.

(9) In order to ensure transparency and more effective controls on the production and making available on the market of plant reproductive material, professional operators should be registered. However, in order to reduce the administrative burden for professional operators, by allowing them to register only once in a single register, it is appropriate that they register in the public registers established by the Member States pursuant to Regulation (EU) No …/… (Office of Publication, please insert number of Regulation on protective measures against pests of plants).

(10) Basic obligations should be introduced for professional operators active in the production and making available on the market of plant reproductive material area to ensure the proper application of this Regulation.

(11) Experience has shown that the reliability and quality of reproductive material made available on the market can be jeopardised where it is impossible to trace reproductive material not complying with applicable standards. It is therefore necessary to establish a comprehensive system of traceability allowing withdrawals to be undertaken or information to be given to consumers or competent authorities. For that reason, the keeping of the necessary information and records on transfers from and to professional users should be mandatory. On the basis of the principle of proportionality, that rule should not apply in case that supply is part of making available on the market in retail.

(12) Certain genera and species of plant reproductive material should be subject to enhanced requirements concerning their production and making available on the market due to their increased economic, health or environmental importance. That importance should be determined through the area or value of production of those genera or species, the number of professional operators or the content of substances which present a potential risk for health or the environment. The majority of those genera and species is currently regulated by the above Directives. Those genera and species should be inserted in a specific list (hereinafter: 'listed genera and species').

(13) In order to ensure transparency and enable informed choices by consumers, plant reproductive material belonging to listed genera and species should only be produced or made available on the market under predefined categories. Those categories should reflect different quality levels and production stages and be named “pre-basic”, “basic”, “certified” and “standard”,

(14) In order to ensure the widest possible availability of plant reproductive material and choices by its users, professional operators should, in principle, be able to make available on the market plant reproductive material belonging to listed genera or species under any of the categories. However, in order to ensure food and feed security, and to achieve a high level of identity, quality and health of plant reproductive material, plant reproductive material should not be made available on the market as standard material if the certification costs are proportionate to those objectives.

(15) Plant reproductive material belonging to varieties with officially recognised description, as well as heterogeneous material and niche market material, should be subject to minimum requirements. Therefore, such material should in all cases be produced and made available on the market only as standard material.

(16) In order to allow for informed choices by users concerning its identity and characteristics, plant reproductive material belonging to listed genera and species should only be produced and made available on the market if it belongs to varieties registered in national variety registers or in the Union variety register.

(17) In order to facilitate adaptation to developments in plant breeding, and to possible new techniques, heterogeneous plant reproductive material, which does not fulfil the definition of a variety in the meaning of this Regulation, should be allowed to be produced or made available on the market, under certain conditions, without belonging to a registered variety, and even if it does not comply with the requirements concerning registration of varieties, namely distinctiveness, uniformity or stability, or the requirements concerning the satisfactory value for cultivation or those concerning the sustainable value for cultivation. The registration of such material should take into account its contribution to increase the genetic variability of agricultural crops, the genetic resource basis and biodiversity in the Union, as well as to the sustainability of agriculture and thus to the adaptation to climate change. The methodology for the registration should particularly take into account those specific characteristics and it should be based on the minimum possible burden for operators who wish to register such material. It would also be appropriate and proportionate to exempt from the same requirement rootstocks, as they have a significant commercial and practical value for the sectors where they are used, but they frequently do not fulfil the definition of a variety.

(18) Rules should be set out for the certification of plant reproductive material, as well as for the activities aiming at verifying the reliability of certification at the post-certification stage, to ensure the fulfilment of the applicable quality requirements. Those rules should be adapted to the technical and scientific developments.

(19) The quality requirements and certification schemes should take into account international recommendations, such as the Seed Scheme Rules and Regulations of the Organisation for Economic Co-operation and Development (OECD), the seed potato standards of the United Nations Economic Commission for Europe (UNECE) and the rules on sampling and testing of the International seed testing association (ISTA).

(20) Given the thresholds established for the presence of quality pests by Regulation (EU) No …/… (Office of Publication, please insert number of Regulation on protective measures against pests of plants) on protective measures against pests of plants[19], it is appropriate to establish detailed inspection and examination procedures leading to a single certification as regards compliance with the requirements adopted pursuant to this Regulation and to Regulation (EU) No. .../… (Office of Publication, please insert number of Regulation on protective measures against pests of plants).

(21) In order to ensure the maximum possible purity of the material and the homogeneity of production, plant reproductive material belonging to listed genera or species should be kept in separate lots.

(22) In view of the diversity of plant reproductive material, professional operators should have the option to produce and make available on the market plant reproductive material in the form of individual plants, packages, containers or bundles.

(23) Rules should be adopted for the labelling of plant reproductive material of listed genera or species to ensure the appropriate identification of that material. In the case of material of the categories subject to certification, the label (hereinafter: 'official label') should be produced and affixed by authorised professional operators and under the official supervision of the competent authorities. However, and since certain professional operators may not have the resources to carry out the certification activities and issue official labels, it should be provided that official labels may be issued by competent authorities upon request of professional operators.

(24) For the preservation of the natural environment in the context of the conservation of genetic resources, it is desirable to allow the mixture of plant reproductive material belonging to listed genera or species with non-listed genera or species. Those mixtures should be permitted only if their composition is naturally linked to a certain region. In order to ensure transparency and better control concerning the quality of the mixtures concerned, the production and making available on the market of those mixtures should be subject to the authorisation by the competent authorities.

(25) Rules should be adopted for the import of plant reproductive material of listed genera or species into the Union, only allowing the import of plant reproductive material fulfilling the same production and quality requirements as for material produced and made available on the market in the Union.

(26) To ensure flexibility, and facilitate adaptation of the professional operators and the markets to specific circumstances, or in cases of temporary supply difficulties, it is appropriate to provide for certain derogations from the general rules of this Regulation. Those derogations should be granted under specific conditions to avoid abuses and to ensure that the overall purposes of this Regulation are respected. They should concern plant reproductive material belonging to varieties, the registration of which is pending, plant reproductive material which is not finally certified or not certified as complying with applicable germination requirements. The possibility should also exist to adopt emergency measures to address risks for human, animal and plant health, and the environment.

(27) Plant reproductive material which is made available on the market only in limited quantities by small producers (“niche market plant reproductive material”) should be exempted from the requirement of belonging to a registered variety. That derogation is necessary to prevent undue constraints to the making available on the market of plant reproductive material, which is of lesser commercial interest, but is important for the maintenance of genetic diversity. However, it should be ensured that that derogation is not regularly used by a wide range of professional operators and it is only used by professional operators which cannot afford the costs and administrative burden of variety registration. This is important to avoid abuses of that derogation and to ensure the application of the rules of this Regulation. Therefore, niche market material should only be made available on the market by professional operators employing a small number of persons and with a small annual turnover.

(28) It is desirable to organise temporary experiments for the purpose of seeking improved alternatives to any measures adopted for listed genera or species. In the organisation of those experiments the evolution of techniques relating to the production and control of plant reproductive material should be taken into account.

(29) Exported plant reproductive material of listed genera or species to third countries should comply with the rules on plant reproductive material produced and made available on the market in the Union, unless the material concerned is subject to bilateral or multilateral agreements or rules of third countries.

(30) Basic requirements should be set for plant reproductive material not belonging to listed genera or species, to ensure minimum quality and identification standards for their production and making available on the market.

(31) In order to ensure that all varieties have access to registration and are subject to common rules and conditions rules should be established for the registration of varieties and should apply to varieties of listed genera or species as well as to varieties of non-listed species.

(32) Experience so far has shown that some breeders are interested in making available on the market their varieties in the entire Union market, or in the bigger part of it. It is therefore appropriate to offer the breeders the option of registering their varieties either in a national variety register or in a Union variety register. The task of establishing , publishing and updating the Union variety register should be assigned to the European Agency on Plant Varieties (hereinafter: 'the Agency'), previously titled 'Community Plant Variety Office' as established pursuant to Article 4 of Regulation (EC) No 2100/1994 of the Council, which is currently in charge of granting plant variety rights. The activities of the Agency should thus cover all aspects of plant variety management.

(33) Varieties should, in principle, be registered on the basis of an official description produced by a competent authority or the Agency. However, in order to reduce the burden for the competent authorities and the Agency and ensure flexibility, it is appropriate to provide for the possibility that the examinations necessary to produce the official description may also be carried out by the applicants.

(34) Further to the basic registration requirements, varieties belonging to species with particular importance for the development of agriculture and horticulture in the Union should be subject to the additional requirements ensuring satisfactory and sustainable value for cultivation or use.

(35) The requirements ensuring sustainable value for cultivation should be established at Union level in order to support sustainable development, direct plant breeding and meet breeders', producer and consumer demands concerning that type of development. The requirements ensuring satisfactory value for cultivation and use may be only developed by Member States according to their agro-climatic and agricultural conditions. Therefore, the respective varieties should only be registered in the national variety registers. The requirements ensuring satisfactory value for cultivation and use should concern yields and quality characteristics. When Member States develop and apply such requirements, they should consider the constraints characterising specific agricultural management practices. In particular, they should duly take into account the specific needs of organic farming as regards resilience and low input conditions.

(36) In the context of the Convention on Biological Diversity to which the Union is a party, the Union has committed to maintain the genetic diversity of cultivated plants, and of wild relatives, and to minimise genetic erosion. That commitment complements the objective of the Union to halt biodiversity loss by 2020. In that context, certain varieties should be allowed to be produced and made available on the market even if they do not comply with the requirements concerning distinctiveness, uniformity or stability, to ensure their conservation and sustainable use and thus contribute to the sustainability of agriculture and the adaptation to climate change. Therefore, those varieties should only be registered on the basis of an officially recognised description.

(37) However, the varieties registered on the basis of an officially recognised description should be produced in the region where they have been historically grown and adapted, to ensure their authenticity and their added value for the conservation of genetic diversity and the protection of the environment. Therefore, they should only be included in national variety registers. For the same reason, those varieties should have been available on the market and/or collected e.g. in gene banks before the entry into force of this Regulation, or, should have been deleted for more than five years from the national variety register or Union variety register, in case they have been registered there on the basis of a technical examination concerning their distinctness, uniformity and stability.

(38) Rules should be established concerning the procedures for the registration of varieties and clones in the national variety registers to ensure uniform conditions for all applications and a transparent framework for all interested parties.

(39) Certain varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion, or which have no intrinsic value for commercial crop production but have been developed for growing under particular conditions, are already accepted in national catalogues, lists or registers of varieties pursuant to Article 3 of Directive 2008/62/EC of the Commission of 20 June 2008 providing for certain derogations for acceptance of agricultural landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion and for marketing of seed and seed potatoes of those landraces and varieties[20], and pursuant to Article 3(1) of Directive 2009/145/EC of the Commission of 26 November 2009 providing for certain derogations, for acceptance of vegetable landraces and varieties which have been traditionally grown in particular localities and regions and are threatened by genetic erosion and of vegetable varieties with no intrinsic value for commercial crop production but developed for growing under particular conditions and for marketing of seed of those landraces and varieties[21]. Those varieties have not been subject to complete technical examination concerning their distinctiveness, uniformity or stability. It is therefore appropriate that those varieties be registered directly in the national variety registers without any further proceedings as varieties with an officially recognised description.

(40) The Union variety register should also include all varieties that are registered in the national variety registers. In this way, it will be ensured that the Union variety register offers a transparent overview of all varieties registered in the Union.

(41) Rules should be adopted for the registration of varieties and clones in the Union variety register. For the purposes of consistency, those rules should be similar to the rules on registration in national variety registers.

(42) The competent national authorities and the Agency should charge fees for the processing of applications, the formal and technical examinations and for each year of the registration period. This would be necessary to ensure the necessary resources for the overall system of registration of varieties, and that the main beneficiaries of that registration bear the costs for the functioning of that system. Rules concerning the fixing of those fees should be set out in this Regulation.

(43) In order to facilitate the registration of varieties which serve at combating genetic erosion in the Union, Member States should apply a reduced fee for varieties with officially recognised description and for heterogeneous material. Such reduced fees should be sufficiently low as not to constitute a deterrent or a barrier to the making available on the market of those varieties. In order to provide support to micro-enterprises, they should be fully exempted from the payment of fees.

(44) In order to protect the commercial interests and intellectual property of professional operators, the results of the examination and the description of the genealogical components should be treated as confidential, if the breeder so requests. For the sake of transparency, all descriptions of varieties listed in the national variety registers or in the Union variety register should be made publicly available.

(45) Forests cover a large area of the Union and fulfil social, economic, environmental, ecological and cultural functions. There is, therefore, a need for specific approaches and actions for the different types of forests, considering the wide range of conditions characterising the forests in the Union.

(46) Forest reproductive material of tree species and artificial hybrids which are important for forestry purposes should be genetically suited to local conditions and of high quality. The conservation and enhancement of biodiversity of forests, including the genetic diversity of the trees, are essential to sustainable forest management.

(47) Requirements should be set for forest reproductive material as regards basic material, categories under which the material may be made available on the market, lots, labelling, small packages, to ensure the appropriate quality and marketing standards, and to adapt to the technical and scientific developments of the sector.

(48) In order to ensure flexibility and adaptation to particular circumstances, derogations should be provided, under conditions, for the production and making available on the market of forest reproductive material. Those derogations should concern the possibility for Member States to adopt more stringent requirements, the case of temporary difficulties of supply, the need of making seed rapidly available on the market, the conduct of temporary experiments and the adoption of emergency measures.

(49) In order to serve the interest of conservation and sustainable use of forestry plant genetic resources, Member States should be allowed to adopt less stringent requirements on forest reproductive material which is naturally adapted to the local and regional conditions and threatened by genetic erosion.

(50) The competent authorities should charge fees for the registration/approval of basic forest material and the issuance of master certificates for the forest material derived from registered/approved basic forest material. This would be necessary to ensure the necessary resources for the certification of forest reproductive material, and that the main beneficiaries of that certification bear the respective costs. In order to provide support to micro-enterprises, they should be fully exempted from the payment of fees. The rules concerning those fees should be set out in this Regulation, as they concern the effective production, registration and making available on the market of forest reproductive material.

(51) Regulation (EC) No 2100/1994 needs to be amended to include variety registration in the mission of the Agency and to amend its former title 'Community Plant Variety Office'.

(52) In order to ensure that the Annexes of this Regulation are adapted to the technical and scientific developments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the Annexes of this Regulation.

(53) In order to follow the technical and economic developments of the sector, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of listing the genera or species whose plant reproductive material may not be placed on the market as standard material.

(54) In order to follow the technical and economic developments of the sector, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out the plant reproductive material which may be produced and made available on the market without belonging to a registered variety, and the requirements for its production and making available on the market.

(55) In order to ensure that plant reproductive material of listed genera or species, and certain types of forest reproductive material, fulfils the highest possible identity, quality and health requirements, as appropriate for the characteristics of the genera, species or categories concerned, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adopting production and quality requirements, and certification schemes, for those genera or species, and in respect of adopting quality requirements for making available on the market specific parts of plants and planting stock of species and artificial hybrids of forest reproductive material.

(56) In order to ensure that plant reproductive material is made available on the market under conditions adapted to the specific characteristics of particular genera or species to which it belongs, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the maximum size, composition and identification of lots, and the requirements concerning small packages, of plant reproductive material belonging to particular genera or species.

(57) In order to adapt the rules concerning the official labels and operators' labels to the characteristics of certain types of plant reproductive material, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out additional rules concerning the label for specific categories and other groups of plant reproductive material, indications concerning a label number, indications of generations of pre-basic, basic, certified and standard material, the indication of variety types including intraspecific or interspecific hybrids, the indication of subdivisions of categories satisfying different conditions, in case of mixtures, the indication of the percentage by weight of the various components by species and, where appropriate, by variety, and indications concerning the intended use of the material.

(58) In order to ensure the ability of the professional operators to properly carry out a reliable certification of the plant reproductive material concerned, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out more detailed requirements concerning the qualification of professional operators and of the inspectors which may be entrusted with certification activities, suitability of premises and availability of particular equipment to be used by the professional operators and laboratories.

(59) In order to ensure updated standards for the official supervision of certification carried out by operators as appropriate for the characteristics of particular genera or species, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out more detailed requirements concerning the way competent authorities must supervise the certification.

(60) In order to ensure updated standards for post-certification as appropriate for the characteristics of particular genera or species, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out requirements concerning proportion of samples to be submitted to tests and concerning testing procedures.

(61) In order to ensure that mixtures of plant reproductive material are produced and made available on the market pursuant to the appropriate quality requirements per genera and species, and in order to ensure informed choices for their users, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adopting rules concerning the production and making available on the market of mixtures of plant reproductive material belonging to different genera or species listed in Annex I, or different varieties of those genera or species, and in respect of adopting rules concerning mixture of plant reproductive material belonging to genera or species listed in Annex I, with plant reproductive material belonging to genera or species not listed in Annex I.

(62) In order to ensure that plant reproductive material belonging to varieties, registration of which is pending, is made available on the market in a transparent manner and to a limited extent only, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out requirements concerning labelling of packages and the maximum authorised quantities which may be made available on the market for specific genera or species.

(63) In order to ensure that niche market material is made available on the market in a limited and transparent manner, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out the maximum size of packages, containers or bundles, and requirements concerning traceability, lots, and labelling of the niche market material concerned.

(64) It is important to ensure that plant reproductive material not finally certified, and seed not confirmed as complying with germination requirements, can be produced and made available on the market under particular conditions. Therefore, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out specific rules for plant reproductive material concerning the packages, containers and bundles, rules on small packages and containers, the labelling of that material, the duration of period in which such seed may be made available on the market, and the content of the provisional analytical reports concerning germination.

(65) It is important to ensure that plant reproductive material imported from third countries fulfils the requirements of this Regulation. Therefore, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission, in respect of deciding whether plant reproductive material of specific genera, species οr categories produced in a third country, or particular areas of a third country, fulfils requirements equivalent with those applicable to plant reproductive material produced and made available on the market in the Union.

(66) It is important to ensure that the production and making available on the market of plant reproductive material of particular genera or species responds to increased requirements of the society concerning their agricultural performance and quality characteristics for processing. In order to follow the technical and economic developments of the sector, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of listing the genera or species with particular importance for the satisfactory and sustainable development of agriculture in the Union.

(67) In order to ensure updated standards for the registration of varieties as appropriate for the characteristics of genera or species with particular importance for the sustainable development of agriculture in the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out rules for the registration of varieties of those genera or species concerning resistance to pests, reduced need for input of specific resources, decreased content of undesirable substances and increased adaptation to divergent agro-climatic environment.

(68) In order to ensure updated conditions for the suitability of variety denominations in particular cases, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out rules concerning the relation of denominations to trade marks, their relation to geographical indications or designations of origin for agricultural products, written consents of holders of prior rights to remove impediments to the suitability of a denomination, specific criteria to determine whether a denomination is misleading or confusing, and the use of a denomination in the form of a code.

(69) It is important to ensure that plant reproductive material belonging to clones may only be produced and placed on the market if it fulfils particular quality and health requirements, and also belongs to genera or species which have a particular value for particular market sectors. Therefore, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adopting quality and health requirements for clones of particular genera or species, and in respect of listing the genera or species, to which the clones must belong in order to be made available on the market.

(70) In order to ensure that the information provided in the applications for registration of varieties remain up to date to the developments of the sector, and is relevant to the particular features of the varieties belonging to those genera or species, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out additional items to be included in the application for particular genera or species.

(71) In order to ensure updated standards for the audits by the Agency and the competent authorities of premises of technical examinations and of the organisation of those examinations, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out rules concerning those audits.

(72) In order to ensure updated standards for the technical examinations of varieties, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out rules concerning obligations for the qualification and training of the staff of competent authorities or the applicants, the equipment necessary to carry out the technical examination, the establishment of variety reference collections, the establishment of quality management systems, and the conduct of growing trials and laboratory tests for particular genera or species.

(73) In order to ensure proportionate, fair and updated amounts for the fees to be paid by the applicants for the registration of a variety in the Union variety register, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out the amount of the fees to be paid by the applicant.

(74) In order to ensure a comprehensive submission of information for particular categories or species of forest reproductive material, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out conditions under which the operator's label be supplemented by another document produced by the professional operator.

(75) In order to avoid risks in relation to quality and health of the forest reproductive material concerned, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing the requirements set out in this Regulation concerning clones and clonal mixtures, by determining the maximum number of years or the maximum number of ramets to which the approval of clones or clonal mixtures should be restricted.

(76) In order to ensure that the exemption of small quantities of seeds of forest reproductive material, from the information requirements concerning germination or viability, is applied in a proportionate manner, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out the maximum quantities of those small quantities for particular types of forest reproductive material.

(77) In order to ensure that the cost items for the fees charged by the competent authorities on the registration of approved basic forest material and the issuance of master certificates are appropriate to the conducted work and updated, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out those items.

(78) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work for the adoption of delegated acts, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(79) Implementing powers should be conferred on the Commission in order to ensure uniform conditions for the implementation of the provisions of this Regulation concerning the following:

(a) authorisation of Member States to adopt more stringent requirements than those adopted pursuant to this Regulation concerning plant reproductive material of listed genera or species and forest reproductive material of listed species and artificial hybrids,

(b) adoption of emergency measures,

(c) authorisation of Member States to permit, for a maximum period of one year, the production and making available on the market of plant reproductive material belonging to a variety of listed genera or species not yet included in a national variety register or in the Union register,

(d) authorisation of Member States to permit, for a maximum period of one year, the making available on the market of plant reproductive material of listed genera or species complying with lower requirements that those adopted pursuant to this Regulation,

(e) the organisation of temporary experiments,

(f) the format of the national variety registers and the Union variety register,

(g) the format for the application for the registration of varieties,

(h) modalities concerning the submission of notifications concerning the registration of varieties,

(i) the form of national lists concerning forest reproductive material,

(j) the format of the notification of inclusion of forest reproductive material in the national list, and

(k) the format of master certificates for forest reproductive material.

(80) Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers.

(81) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably respect for private and family life, the right to property, the protection of personal data, freedom to conduct business and the freedom of art and science. This Regulation should be applied by the Member States in accordance with those rights and principles.

(82) Since the objective of this Regulation, namely to establish the rules concerning production and making available on the market of plant reproductive material to ensure quality of the material and informed choices for the users, cannot be sufficiently achieved by the Member States and can therefore, by reason of its effect, complexity, trans-border and international character, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not exceed what is necessary in order to achieve that objective,

HAVE ADOPTED THIS REGULATION:

PART I GENERAL PROVISIONS

Article 1 Scope

This Regulation lays down rules on:

(a) the production, with a view to making available on the market, of plant reproductive material; and

(b) the making available on the market of plant reproductive material.

Article 2 Exclusions

This Regulation shall not apply to plant reproductive material:

(a) intended solely for testing or scientific purposes;

(b) intended solely for breeding purposes;

(c) intended solely for, and maintained by, gene banks, organisations and networks of conservation of genetic resources, or persons belonging to those organisations or networks;

(d) exchanged in kind between persons other than professional operators.

Article 3 Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) 'plants' means plants as defined in Article 2(1) of Regulation (EU) No …/… (Office of Publications, please insert number of Regulation on protective measures against pests of plants) on protective measures against pests of plants;

(2) 'plant reproductive material' means plant(s) capable of, and intended for, producing entire plants;

(3) 'mother plant' means an identified plant from which plant reproductive material is taken for reproduction of new plants;

(4) 'generation' means a group of plants constituting a single step in the line of descent of plants;

(5) ‘making available on the market’ means the holding for the purpose of sale within the Union, including offering for sale or for any other form of transfer, and the sale, distribution, import into, and export out of, the Union and other forms of transfer, whether free of charge or not;

(6) 'professional operator' means any natural or legal person carrying out, as a profession, at least one of the following activities with regard to plant reproductive material:

(a) producing;

(b) breeding;

(c) maintaining;

(d) providing services;

(e) preserving, including storing; and

(f) making available on the market.

(7) 'competent authorities' means competent authorities as defined in accordance with Article 2(5) of Regulation (EU) No …/…. [Office of Publication, please insert number of Regulation on Official Controls];

(8) 'genetically modified organism' means a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC;

(9) 'forest reproductive material' means plant reproductive material intended for forestry purposes;

(10) 'lot' means a unit of plant reproductive material, identifiable by its homogeneity of composition and origin.

Article 4 Free circulation

Plant reproductive material shall be subject to no restrictions concerning its production and making available on the market, other than those laid down in this Regulation, in Directive 94/62/EC, Regulation (EC) No 338/97, Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1830/2003, Regulation (EU) No …/… [Office of Publication, please insert number of Regulation on protective measures against pests of plants] and in Union legislation restricting the production or making available on the market of invasive alien species.

PART II PROFESSIONAL OPERATORS

Article 5 Registers of professional operators

Professional operators shall be registered in the registers referred to in Article 61 of Regulation (EC) No …/… (Office of Publication, please insert number of Regulation on protective measures against pests of plants) in accordance with the provisions of Article 62 of that Regulation.

Article 6 General responsibilities of professional operators

Professional operators shall ensure that plant reproductive material produced and made available on the market under their control fulfils the requirements of this Regulation.

Article 7 Specific responsibilities of professional operators producing plant reproductive material

Professional operators producing plant reproductive material shall:

(a) be available personally, or designate a person, to liaise with the competent authorities for the purpose of facilitating the official controls;

(b) identify and monitor the critical points of the production process, or of the making available on the market, which may influence the quality of the plant reproductive material;

(c) keep records of the monitoring of the critical points referred to in point (b), which shall be available for examination when requested by the competent authorities;

(d) ensure that lots remain separately identifiable;

(e) keep updated information on the premises and other locations used for the production of plant reproductive material;

(f) make sure that competent authorities have access to the premises of production, including premises and fields of third contracting parties, and to the records of the monitoring and all related documents;

(g) take measures, where appropriate, for the maintenance of the identity of the plant reproductive material in accordance with the applicable requirements of this Regulation;

(h) make available to the competent authorities, on request, any contracts with third parties.

Article 8 Traceability

1. Professional operators shall ensure that plant reproductive material is traceable at all stages of production and making available on the market.

2. For the purpose of paragraph 1, professional operators shall keep information allowing them to identify the professional operators, which have supplied them with plant reproductive material, and the material concerned.

On request, they shall make such information available to the competent authorities.

3. For the purpose of paragraph 1, professional operators shall keep information allowing them to identify the persons to whom they have supplied plant reproductive material and the material concerned, unless that material has been supplied in retail.

On request, they shall make such information available to the competent authorities.

4. In the case of plant reproductive material, other than forest reproductive material, professional operators shall keep records of the plant reproductive material referred to in paragraphs 2 and 3 for three years after that material has been respectively supplied to or by them.

In the case of forest reproductive material, the respective period shall be ten years.

PART III PLANT REPRODUCTIVE MATERIAL OTHER THAN FOREST REPRODUCTIVE MATERIAL

TITLE I General Provisions

Article 9 Scope

This Part shall apply to the production, with a view to making available on the market, and to the making available on the market of plant reproductive material other than forest reproductive material.

Article 10 Definitions

For the purposes of this Part, the following definitions shall apply:

(1) 'variety' means a plant grouping within a single botanical taxon of the lowest known rank, which fulfils all of the following requirements:

(a) it is defined by the expression of the characteristics that results from a given genotype or combination of genotypes;

(b) it is distinguished from any other plant grouping by the expression of at least one of the characteristics referred to in point (a); and

(c) it is considered as a unit with regard to its suitability for being reproduced unchanged;

(2) 'official description' means a variety description that has been produced by a competent authority, includes the specific characteristics of the variety and makes the variety identifiable by examination of its distinctiveness, uniformity and stability;

(3) 'officially recognised description' means a description of a variety, which has been recognised by a competent authority, includes the specific characteristics of the variety, makes it identifiable and has been obtained by means other than examination of the variety's distinctiveness, uniformity and stability pursuant to the rules applicable at the time of registration of that variety in accordance with Article 79;

(4) 'clone' means an individual progeny, originally derived from another plant by vegetative reproduction, which remains genetically identical to the latter;

(5) 'variety maintenance' means the actions to ensure that a variety remains consistent with its description;

(6) 'pre-basic material' means plant reproductive material which is at the first step of production and is intended for the production of other categories of plant reproductive material;

(7) 'basic material' means plant reproductive material which has been produced from pre-basic material, and is intended for the production of certified material;

(8) 'certified material" means plant reproductive material which has been produced from pre-basic or basic material;

(9) 'standard material' means plant reproductive material other than pre-basic, basic or certified material;

(10) 'category' means pre-basic material, basic material, certified material or standard material.

TITLE II Production and making available on the market of plant reproductive material belonging to genera and species listed in Annex I

CHAPTER I Introductive Provisions

Article 11 Scope

1. This Title shall apply to the production and making available on the market of plant reproductive material belonging to genera and species which comply with one or more of the following criteria:

(a) they represent a significant area of production;

(b) they represent a significant value of production;

(c) they are produced or made available on the market by a significant number of professional operators in the Union;

(d) they contain substances which, for all or particular uses, must be subject to particular rules concerning the protection of human and animal health, and the environment.

2. The genera and species referred to in paragraph 1 are listed in Annex I.

3. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, amending Annex I in order to adapt it to the developments of technical knowledge, scientific knowledge and economic data.

4. This Title shall also apply to rootstocks and other parts of plants (hereinafter jointly referred to as "rootstocks"), which belong to genera and species not listed in Annex I, if material of one of the genera or species listed in Annex I, or their hybrids, is grafted on them.

Article 12 Categories of plant reproductive material

1. Plant reproductive material may only be produced and made available on the market, under one of the following categories:

(a) pre-basic material,

(b) basic material,

(c) certified material,

(d) standard material.

2. Plant reproductive material may not be produced and made available on the market as standard material, if it belongs to genera or species for which the costs and certification activities necessary to produce and make available on the market plant reproductive material as pre-basic, basic and certified material are proportionate:

(a) to the purpose of ensuring food and feed security; and

(b) to the higher level of identity, health and quality of the plant reproductive material which result from the fulfilment of the requirements for pre-basic, basic and certified material compared to those for standard material.

3. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, listing the genera or species whose plant reproductive material may not be placed on the market as standard material, as referred to in paragraph 2.

4. By way of derogation to paragraph 2 and 3, plant reproductive material shall only be produced and made available on the market as standard material if one or more of the following cases apply:

(a) it belongs to a variety provided with an officially recognised description;

(b) it is heterogeneous material in the meaning of Article 14(3);

(c) it is niche market material in the meaning of Article 36(1).

CHAPTER II Requirements for the production and making available on the market

Section 1 List of requirements

Article 13 Production and making available on the market of pre-basic, basic, certified and standard material

1. Plant reproductive material produced and made available on the market shall comply with:

(a) the registration requirements set out in Section 2;

(b) the production and quality requirements set out in Section 3 for the relevant category;

(c) the handling requirements set out in Section 4;

(d) the identification, and, where applicable, certification requirements set out in Section 5.

2. Paragraph 1(b) shall not apply to production requirements of plant reproductive material referred to in Article 14(3) and Article 36.

Article 14 Requirement to belong to registered varieties

1. Plant reproductive material may be produced and made available on the market only if it belongs to a variety registered in a national variety register referred to in Article 51 or in the Union variety register referred to in Article 52.

2. By way of derogation to paragraph 1 of this Article, rootstocks may be produced and made available on the market without belonging to a variety registered in a national variety register or in the Union variety register.

3. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, setting out that, by way of derogation to paragraph 1 of this Article, plant reproductive material may be produced and made available on the market without belonging to a variety in the meaning of point (1) of Article 10 ('hereafter 'heterogeneous material') and not fulfilling the requirements on distinctiveness, uniformity and stability as set out in articles 60, 61 and 62 and satisfactory value for cultivation and/or use or sustainable value for cultivation and/or use as set out in articles 58 and 59.

Those delegated acts may set out one or more of the following for heterogeneous material:

(a) rules on labelling and packaging;

(b) rules concerning description of the material, including the breeding methods and parental material used, description of the production scheme for the plant reproductive material and availability of standard samples;

(c) rules relating to information and samples of production to be kept by the professional operators and the maintenance of the material;

(d) establishment by the competent authorities of registers for heterogeneous material, modalities for registration and content of those registers;

(e) establishment of fees, and cost items for the calculation of those fees, concerning the registration of heterogeneous material referred to in point (d) in a manner ensuring that the fee does not constitute a barrier to the registration of the heterogeneous material concerned.

Those delegated acts shall be adopted by [Office of Publications, please insert date of application of this Regulation…]. They may be adopted per particular genera or species.

Article 15 Requirement to belong to registered clones

Plant reproductive material belonging to a clone may be produced and made available on the market only if that clone is registered in a national variety register referred to in Article 51 or in the Union variety register referred to in Article 52.

Section 2 Production and quality requirements

Article 16 Production and quality requirements for plant reproductive material

1. Plant reproductive material shall be produced in accordance with the production requirements set out in Part A of Annex II and shall be made available on the market only if it fulfils the quality requirements set out in Part B of Annex II.

2. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, supplementing the requirements referred to in paragraph 1. Where appropriate, those delegated acts may specify those requirements set out in Part D of Annex II.

3. Those delegated acts shall take into account the relevant international technical and scientific standard recommendations:

(a) the Seed Scheme Rules and Regulations of the Organisation for Economic Co-operation and Development (hereinafter: 'OECD');

(b) the seed potato standards of the United Nations Economic Commission for Europe (hereinafter: 'UNECE');

(c) the rules on sampling and testing of the International Seed Testing Association (hereinafter 'ISTA'); and

(d) the rules of the European and Mediterranean Plant Protection Organisation (EPPO).

4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, amending Part A and Part B of Annex II to adapt them to the technical and scientific developments.

Section 3 Handling requirements

Article 17 Lots

1. Plant reproductive material shall be made available on the market in lots. Those lots shall be sufficiently homogeneous and identified as distinct from other lots of plant reproductive material.

2. During processing, packaging, storage, transport or at delivery, lots of plant reproductive material of different origins may be merged into a new lot. In that case the professional operator shall keep records including data about the origin of the individual components of the new lot.

3. During processing, packaging, storage, transport or at delivery, lots of plant reproductive material may be split into two or more lots. In that case the professional operator shall keep records concerning the origin of the new lots.

4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, establishing additional rules for particular genera or species in relation to one or more of the following elements:

(a) maximum size of lots to ensure homogeneity of the plant reproductive material concerned;

(b) composition of lots to ensure the maintenance of the identity of the plant reproductive material concerned;

(c) identification of lots to ensure the traceability of the plant reproductive material concerned.

Article 18 Packages, containers and bundles, and rules on small packages and containers

1. Plant reproductive material shall be made available on the market as individual plants, or in packages, containers or bundles.

2. Packages and containers shall be closed in such a way that they cannot be opened without damaging the closure and, in the case of packaging, without the packaging showing signs of tampering.

3. Bundles shall be tied up in such a way that the material forming parts of the bundles cannot be separated without damaging the tie or ties.

4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, setting out rules for specific genera or species one or more of the following elements:

(a) the closure, including sealing or resealing, of packages, containers or bundles to ensure the identity of the plant reproductive material concerned and to avoid uncontrolled mixtures of lots;

(b) the establishment of a requirement that plant reproductive material is to be made available on the market only in packages, containers or bundles in order to facilitate the traceability of the lots concerned.

5. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, setting out specific rules for the production and making available on the market of particular genera or species in small packages, containers or bundles. Those rules may concern one or more of the following elements:

(a) maximum size and volume of the small packages, containers or bundles;

(b) colour and content of labels, and methods of labelling, of the small packages, containers or bundles;

(c) examination of the small packages, containers or bundles and the contained plant reproductive material;

(d) closure of the small packages.

Section 4 Certification, identification and labelling requirements

Article 19 Certification and identification of pre-basic, basic or certified material, and identification of standard material

1. Pre-basic, basic or certified material shall be certified and identified through an official label ('official label').

2. Official labels shall certify that pre-basic, basic or certified material complies with the relevant production and quality requirements as referred to in Article 16.

3. The certification referred to in paragraphs 1 and 2 shall be based on field inspections, sampling and testing carried out in accordance with the rules referred to in Article 20 (hereinafter: 'certification schemes') and with the provisions of Articles 22 to 26.

4. Standard material shall be identified through an operator's label ('operator's label').

5. Operators' labels shall attest that standard material complies with the relevant quality requirements as referred to in Article 16.

Article 20 Certification schemes

1. The certification schemes for pre-basic, basic or certified material are set out in Part C of Annex II.

2. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, supplementing the certification schemes. Where appropriate, those delegated acts may specify those schemes, as set out in Part D of Annex II.

3. Those delegated acts shall take into account the applicable international technical and scientific standard recommendations such as:

(a) the Seed Scheme Rules and Regulations of OECD;

(b) the seed potato standards of UNECE;

(c) the rules on sampling and testing of ISTA; and

(d) the rules of EPPO.

3. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, amending Part C and Part D of Annex II to adapt them to the technical and scientific developments.

Article 21 Content of the official label and operator's label

1. The official label and the operator's label shall contain the information set out in Part A of Annex III.

2. The official label and the operator’s label shall be written in one of the official Union languages. They shall be legible, indelible, printed on one side, not previously been used and easily visible.

3. The official label shall have a distinct colour per category of plant reproductive material.

4. In case the issuance of a plant passport is required pursuant to Article 74(1) and Article 75(1) of Regulation (EU) No …/… [Office of Publication, please insert number of Regulation on protective measures against pests of plants], the official label shall include the plant passport as set out in Article 78(3) of that Regulation.

5. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, setting out requirements, further to the requirements referred to in paragraphs 1 and 2, for official labels and operators' labels. Those requirements shall concern one or more of the following elements:

(a) the colours of the label for specific categories and other groups of plant reproductive material;

(b) indications concerning a label number;

(c) indications of generations of pre-basic, basic, certified and standard material;

(d) the indication of variety types including intraspecific or interspecific hybrids;

(e) the indication of subdivisions of categories satisfying different conditions;

(f) in case of mixtures, the indication of the percentage by weight of the various components by species and, where appropriate, by variety;

(g) indications concerning the intended use of the material.

6. This Article shall apply without prejudice to Article 49(4) of Regulation (EC) No 1107/2009 concerning the label and the documents accompanying treated seeds in the meaning of that Regulation.

7. The Commission shall, by means of implementing acts, adopt the format(s) of the official label and operator's label. Those formats may be adopted per genera or species. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141(3).

Article 22 Responsibility to produce and affix official labels

The official labels shall be produced and affixed by:

(a) the professional operator, under the official supervision of the competent authority; or

(b) the competent authority, if requested so by the professional operator, or if the professional operator concerned is not authorised pursuant to Article 23.

Article 23 Authorisation of professional operators to carry out certification and produce official labels

1. Professional operators may be authorised by the competent authority to carry out the certification and produce the official labels under official supervision, as referred to in point (a) of Article 22, only if they fulfil all of the following conditions:

(a) they possess the necessary knowledge to fulfil the production and quality requirements and comply with the certification schemes adopted pursuant to Articles 16(2) and 20(2), and, where applicable, fulfil the requirements adopted pursuant to point (a) of paragraph 3 of this Article;

(b) they possess, or have access to, adequate equipment and laboratories to apply correctly and efficiently the requirements referred to in Articles 16(2) and 20(2), in particular equipment and laboratories complying with the requirements adopted pursuant to point (b) and (c) of paragraph 3;

(c) they have identified, and have the capability to monitor, the critical points of the production process which may influence the quality and identity of the plant reproductive material, and keep records of the results of that monitoring;

(d) they are capable to ensure that lots remain identifiable as referred to in Article 7;

(e) they have in place systems and provisions to ensure the fulfilment of the traceability requirements set out in Article 8;

(f) they use appropriately qualified inspection and laboratory staff, in particular inspection and laboratory staff, complying with the requirements adopted pursuant to point (c) of paragraph 3.

2. The authorisation referred to in paragraph 1 may be granted for particular or all genera or species.

3. The Commission shall be empowered to adopt delegated acts, in accordance with Article 140, supplementing the provisions of paragraph 1, to ensure the ability of the professional operators to properly carry out a reliable certification of the plant reproductive material concerned. Those delegated acts may concern one or more of the following elements:

(a) qualification, training and activities of professional operators, and of other persons which may be entrusted, by the professional operators, with field inspections, sampling and testing;

(b) suitability of premises and availability of particular equipment to be used by the professional operators concerned;

(c) requirements for laboratories which may be entrusted with testing by the professional operators.

Article 24 Official supervision by the competent authorities

1. For the purposes of the official supervision referred to in point (a) of Article 22, competent authorities shall, at least once per year, conduct audits to ensure that the professional operator fulfils the requirements referred to in Article 23.

2. For the purposes of the official supervision referred to in point (a) of Article 22, competent authorities shall furthermore carry out official inspection, sampling and testing on a proportion of the crops in the fields and the lots of plant reproductive material, to confirm compliance of that material with the production and quality requirements referred to in Article 16(2). That proportion shall be determined on the basis of the potential risk of non-compliance with those requirements.

3. In addition to the inspection, sampling and testing referred to in paragraph 2, the competent authorities may car