EG (verordening betreffende plantaardig teeltmateriaal) - Hoofdinhoud

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dossier	COM(2023)414 - Productie en het in de handel brengen van plantaardig teeltmateriaal in de Unie, tot wijziging van de Verordeningen (EU) ...
document	COM(2023)414
datum	5 juli 2023

(1)Rules for the production and marketing of plant reproductive material (‘PRM’) of agricultural crops, vegetables, vine and fruit plants have been established at Union level since the 1960s. The production and marketing of PRM on the Union territory is regulated by Council Directives 66/401/EEC( 26 ); 66/402/EEC( 27 ); 68/193/EEC( 28 ); 2002/53/EC( 29 ); 2002/54/EC( 30 ); 2002/55/EC( 31 ); 2002/56/EC( 32 ); 2002/57/EC( 33 ); 2008/72/EC( 34 ) and 2008/90/EC( 35 ) (the ‘PRM marketing Directives’). These legal acts have formed the legal framework for the production and marketing of PRM and therefore have been of major importance for the creation of the internal market of PRM in the Union.

(2)The impact assessments carried out by the Commission in 2013 and 2023 confirmed that those Directives have had a significant impact on the free movement, availability and high quality of PRM on the Union market and have thus facilitated the trade of PRM within the Union.

(3)However, the rules on production and marketing of PRM need to be adapted to the scientific and technical developments in the areas of agricultural and horticultural production techniques and plant breeding. Moreover, the legislation needs to be updated on the basis of changes in international standards and experience gained by the application of the PRM Directives. Those rules need to be clarified in order to facilitate a more harmonised implementation. Therefore, the PRM marketing Directives should be replaced by a single Regulation on the production and marketing of PRM within the Union.

(4)PRM constitutes the starting material for plant production in the Union. Therefore, it is critical for the production of raw material for food and feed purposes and for the efficient use of plant resources. It contributes to environmental protection and the quality of the food chain and food supply in the Union as a whole. In this regard, the availability, quality and diversity of PRM appears to be of outmost importance to achieve the transition to sustainable food systems called for in the Farm to Fork Strategy 36 , agriculture, horticulture, environmental protection, climate change mitigation and adaptation, food and feed security, and the economy in general.

(5)In order to achieve this transition to sustainable food systems, the Union legislation should therefore take account of the need to ensure the adaptability of the PRM production to the changing agricultural, horticultural and environmental conditions, to face the challenges of climate change, to protect and restore biodiversity and to meet increasing farmers’ and consumers’ expectations related to quality and sustainability of PRM.

(6)The scope of this Regulation should only cover the PRM of certain genera and species of increased economic and social importance. That importance should be assessed depending on whether such genera and species represent a significant area of production and value in the Union, on their role for the security of food and feed production in the Union, and on whether they are marketed in at least two Member States. That area of production and value may concern several technical aspects. Depending on the circumstances, it may be calculated on the basis of factors such as the total size of productive land in several different areas of the Union, the marketing value of PRM in relation to specific sectors, or the demands for those species by farmers, final users and industry.

(7)Those genera and species should be listed and classified by their intended use, namely as agricultural crops, vegetables, fruit plants or vine. That classification is necessary to ensure a proportionate approach, as some species are only important for certain uses.

(8)Furthermore, some varieties may have certain characteristics that, when cultivated under certain conditions, could have undesirable agronomic effects that would undermine the objective of the Regulation to contribute to the sustainability of agricultural production. This objective can only be achieved if such varieties are subject to appropriate cultivation conditions under which those undesirable agronomic effects are avoided. Those conditions should apply to the cultivation of those varieties for the production of food, feed or industrial materials and not only when intended for the production and marketing of PRM. Therefore, this Regulation should cover the conditions under which those varieties are cultivated, also for the production of food, feed or other products.

(9)PRM should be defined in a comprehensive manner, including all plants capable of, and intended for, producing entire plants. This Regulation should, therefore, cover seeds, as well as all other forms of plants at any growth stage, capable of and intended for producing entire plants.

(10)This Regulation should not cover forest reproductive material due to its particular characteristics, and very different concepts and applicable terminology. For this reason, forest reproductive material is subject to a separate legal act, and namely Regulation (EU) .../… of the European Parliament and of the Council 37 +.

(11)This Regulation should not cover propagating material of ornamental plants, because after consultations with Member States and stakeholders it has been concluded that Council Directive 98/56/EC ( 38 ) still adequately covers the needs of that sector.

(12)This Regulation should cover neither PRM exported to third countries, nor PRM used solely for official testing, breeding, inspections, exhibitions or scientific purposes. This is because such categories of PRM do not require particular harmonised identity or quality standards and do not compromise the identity and quality of other PRM marketed in the Union.

(13)This Regulation should not cover PRM sold or transferred in any other way, whether free of charge or not, between any persons for their own private use and outside their trade. It would be disproportionate to set out rules for such use of PRM, as this kind of transfer is usually limited to very small amounts, has no commercial purposes and is restricted to private activities.

(14)In order to allow for informed choices by the users, PRM should be produced and marketed only if it belongs to varieties registered in national a variety register.

(15)However, it is appropriate to exempt, where necessary, rootstocks from the requirement to belong to a variety, as although of a significant value, they frequently do not fall under the definition of a variety.

(16)In order to ensure the identity, quality and transparency and to enable informed choices by the users, PRM should as a general rule be produced or marketed under predefined categories. Those categories should reflect different generation stages and quality levels, and, on the basis of the internationally established terminology, be named ‘pre-basic’, ‘basic’, ‘certified’ and ‘standard’ seed, and ‘pre-basic’, ‘basic’, ‘certified’ and ‘standard’ material, in the case of PRM other than seeds, and .

(17)PRM of each of those categories should be produced and marketed in accordance with the applicable international standards, in order to ensure the highest possible level of its identification and quality, and to be in line with the latest technical and scientific developments. Those standards should include, as applicable, the Schemes for the Varietal Certification or the Control of Seed Moving in International Trade ( 39 ) (‘OECD Seed Schemes’), the seed potato standards of the United Nations Economic Commission for Europe (UNECE) and the rules on seed sampling and testing of the International Seed Testing Association (ISTA).

(18)In accordance with those standards, compliance of PRM with the requirements for the categories pre-basic, basic or certified should be confirmed by inspections, sampling, testing and official control plot testing carried out by the competent authorities (‘official certification’) and should be attested by an official label.

(19)Specific rules should be established for the production and marketing of clones, selected clones, multiclonal mixtures and polyclonal PRM, due to their increased importance and use in the PRM sector. In order to ensure transparency, informed choices for their users and effective official controls, the clones should be registered in a special public register established by the competent authorities. Rules for the maintenance of the clones should also be established to ensure their preservation and identification.

(20)Professional operators should be authorised by the competent authority to perform certification under official supervision of PRM belonging to certain species and categories and print the official label. Rules should be set out for the respective official supervision by the competent authority and the withdrawal of that authorisation or its modification. Those rules are necessary to ensure that the entire certification system functions effectively.

(21)In order to ensure the maximum possible purity and homogeneity of PRM, PRM should be kept in separate lots, and separate from other material different to PRM, such as grain for food or feed.

(22)In view of the large diversity of PRM, professional operators should be able to market the PRM lots in the form of individual plants, packages, bundles or containers, or in bulk.

(23)Rules should be adopted for the labelling of PRM to ensure the appropriate identification of that material per category through the attestation of compliance with the respective requirements concerning pre-basic, basic, certified and standard seed and material.

(24)In the case of pre-basic, basic and certified seed and material, an official label should be issued by the competent authority, while for standard seed or material an operator’s label should be issued. This is necessary to make a distinction between PRM subject to certification (official certification or certification under official supervision) and PRM produced under the responsibility of the professional operator. Issuing of a specific label aims at facilitating informed choices by the professional operators and consumers who may wish to select PRM of different standards. It would also facilitate the work of the competent authorities in designing their official controls in accordance with the respective requirements of each category.

(25)The official label should be printed and affixed by authorised professional operators and under the official supervision of the competent authorities. However, and since certain professional operators may not have the resources to carry out all the certification activities and print official labels, it should be provided that any certification steps may also be carried out by the competent authorities upon request of professional operators.

(26)Rules should be set out concerning the contents and form of the official label and operator’s label, to ensure a uniform application of the respective production and marketing requirements for each category and the identification of those labels.

(27)Each official label and operator’s label should contain a serial number, so as to guarantee the appropriate identification and traceability of the PRM concerned and the effectiveness of the official controls.

(28)The PRM marketing Directives and international practice and standards require that seeds belonging to certain species are only produced and marketed as pre-basic, basic or certified seeds, due to their importance for food security and industrial processing, and for the protection of the interests of the farmers using them. For this reason, certain seeds should only be produced and marketed as pre-basic, basic or certified seeds, if the costs for their production and marketing are proportionate to the purpose of ensuring quality seed for the farmers, food and feed security, or are proportionate to the purpose of ensuring high value of industrial processing. Those costs should also be proportionate to the achievement of the highest standards concerning the identity and quality of the seed, in line with the requirements for pre-basic, basic and certified seed. A list of those species of seeds for which seed may only be produced and marketed as pre-basic, basic or certified seeds should thus be established.

(29)Seeds are frequently marketed in varietal mixtures of same species or species mixtures. However seeds of genera or species, covered by this Regulation, should be allowed to be produced and marketed in mixtures only with seeds of the genera or species covered by this Regulation. This is necessary to ensure that the respective production and marketing standards are respected. However, Member States should have the possibility to allow the production and marketing of a mixture of seeds covered by this Regulation, with seeds not belonging to genera or species covered by this Regulation, for the purposes of conservation of genetic resources and preservation of the natural environment. This is is because those species are the ones most appropriate for the purpose of that preservation. Rules should be set out concerning those mixtures to ensure their identity and quality.

(30)Requirements should be established concerning the re-packaging and re-labelling of pre-basic, basic and certified seed, in order to guarantee that the identity and the quality of the respective PRM will not be subject to change during those operations.

(31)Control plot tests should be conducted to verify the varietal identity and purity of individual seed lots. Specific rules should be set out concerning those tests on pre-basic, basic, certified and standard seed, on the basis of the applicable international standards and the experience gained by the application of the PRM marketing Directives.

(32)Certain types of varieties do not fulfil the established requirements concerning distinctness, uniformity and stability. However, they are important for the conservation and sustainable use of plant genetic resources. They are traditionally grown or new locally produced varieties under specific local conditions and adapted to those conditions. They are characterised, in particular, by reduced uniformity due to a high level of genetic and phenotypical diversity between individual reproductive units. Those varieties are referred to as ‘conservation varieties’. The production and marketing of those varieties contribute to the objectives of the International Treaty on Plant Genetic Resources for Food and Agriculture to promote the conservation and sustainable use of plant genetic resources for food and agriculture ( 40 ). As a party to the Treaty the Union has committed to support those objectives.

(33)In view of those special characteristics of the conservation varieties, and by way of derogation from the established requirements for production and marketing, the production and marketing of PRM belonging to them should be allowed under less stringent requirements. That objective is in line with the principles of the European Green Deal, and in particular, with the principle of protection of the biodiversity. It is thus appropriate to allow for that material to comply with the requirements for standard material for the species concerned. That PRM belonging to conservation varieties should therefore be labelled with the indication ‘Conservation varieties’. Those varieties should also be registered, to enable their control by the competent authorities and guarantee the informed choices for their users and the effectiveness of official controls.

(34)Experience from the application of the marketing Directives has shown that final users of PRM (amateur gardeners and others) are often interested in using more diverse PRM that responds to different needs, without necessarily having the same quality demands as the professional operators. It is therefore appropriate to allow, by way of derogation from certain rules, that PRM may be marketed to final users without having to comply with the requirements for variety registration and without having to comply with the certification requirements or with the requirements for standard material. That derogation is necessary to ensure a wider variety for consumer offer, while respecting the general quality requirements. Moreover, for reasons of transparency and better control, rules should be set out for the packaging and labelling of PRM intended for final users only. For the same reason, professional operators using this derogation for marketing to final users should notify that activity to the competent authorities.

(35)Many gene banks, organisations and networks operate in the Union with an objective to conserve plant genetic resources. In order to facilitate their activity, it is appropriate to allow that PRM which is marketed to them, or among them, derogates from the established production and marketing requirements, and that instead it complies with less stringent rules.

(36)Farmers habitually exchange in kind small quantities of seeds in order to carry out dynamic management of their own seed. It is thus appropriate that a derogation from the established requirements is provided for the exchanges of small quantities of seeds between farmers. Such derogation could apply if those seeds do not belong to a variety for which plant variety rights have been granted in accordance with Council Regulation (EU) 2100/94( 41 ). Member States should be allowed to define those small quantities for specific species per year, in order to ensure that there is no misuse of such derogation impacting the marketing of seeds.

(37)According to the PRM marketing Directives, derogations from the established requirements are allowed for the marketing of PRM belonging to not yet registered varieties; of varieties that have not yet been fully tested; of seed not complying with the applicable requirements to be made rapidly available on the market; of seed not yet finally certified; of PRM to be temporarily authorised to address temporary difficulties in the supply; and of PRM for the conduct of temporary experiments to seek improved alternatives to certain provisions of the applicable legislation concerning the requirements for the PRM to belong to a registered variety and to fulfil certain identity and quality requirements. Those derogations have been useful and necessary for the professional operators and the competent authorities, without creating problems for the internal market of PRM. Therefore, they should be maintained. Conditions should be set out concerning those derogations, to ensure that they are not misused and that they do not affect adversely the internal market of PRM.

(38)The use of PRM that does not belong to a variety pursuant to this Regulation, but rather belongs to a plant grouping within a single botanical taxon, with a high level of genetic and phenotypic diversity between individual reproductive units (‘heterogeneous material’), could have benefits especially in organic production and low input agriculture, through improving resilience and increasing the within-species genetic diversity of cultivated plants. Therefore, PRM of heterogeneous material should be allowed to be produced and marketed without having to comply with the requirements for variety registration and the other production and marketing requirements of this Regulation. Specific requirements for the production and marketing of that material should be set out.

(39)Union production and marketing of PRM needs to comply with the highest possible standards. Therefore, the import of PRM from third countries should only be allowed if an assessment of their applicable identity and quality standards and certification system establishes that such PRM fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union. Such assessment should be based on a thorough examination of the information provided by the third country and its relevant legislation. It should also be based on the satisfactory outcome of an audit carried out by the Commission in the respective third country, where that audit is considered necessary by the Commission.

(40)Rules should be set out concerning labelling and information to be provided for the imported PRM for the purposes of its proper identification, traceability, and informed choices by its users and for enabling official controls.

(41)In order to ensure transparency and more effective controls on the production and marketing of PRM, professional operators should be registered. It is appropriate that they register in the registers established by Member States pursuant to Regulation (EU) 2016/2031 of the European Parliament and of the Council ( 42 ), in order to reduce the administrative burden for those professional operators. This is also proportionate because the vast majority of professional operators producing and marketing PRM are already registered in the professional operators’ registers of that Regulation.

(42)Specific obligations should be introduced for professional operators active in the area of the production and marketing of PRM, to ensure their accountability, more effective official controls and proper application of this Regulation.

(43)Experience has shown that the reliability and quality of the marketed PRM can be jeopardised where it is impossible to trace material not complying with the applicable standards. It is therefore necessary to establish a comprehensive traceability system allowing withdrawals from the market or the submission of information to users of PRM or competent authorities. For that reason, the keeping of information and records on transfers from and to professional users should be mandatory for the professional operators. However, such record keeping is not appropriate for marketing in retail.

(44)It is important to ensure that, as a general rule, all PRM of the genera and species within the scope of this Regulation are subject to the registration of the variety to which that PRM belongs, the description of the variety and the corresponding rules.

(45)Varieties should be registered in a national variety register, to ensure informed choices by their users and more effective official controls.

(46)The national variety register should include two types of varieties: varieties registered on the basis of an official description, if they fulfil the requirements of distinctness, uniformity and stability (‘DUS’), and varieties registered on the basis of an officially recognised description in the case of conservation varieties. The existence of those two different descriptions is necessary to separate the two categories of varieties, whereby the first one is based on DUS testing results, while the other one is based on historical data concerning the use of the variety and practical experience. In addition, such approach can offer the necessary information about the characteristics of the varieties and their identity.

(47)The registered varieties should be further notified by the competent authorities via the EU Plant Variety Portal to the Union variety register, to ensure an overview of all varieties allowed for marketing in the Union.

(48)Herbicide tolerant varieties are varieties that have been bred to be intentionally tolerant to herbicides, in order to be cultivated in combination of the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides, spread of such resistance genes in the environment or to the need to increase of quantities of herbicides applied. As this Regulation aims to contribute to the sustainability of agricultural production, the competent authorities of Member States responsible for the registration of varieties should be able to subject the cultivation of those varieties in their territory to cultivation conditions appropriate for avoiding those undesirable effects. Moreover, where varieties have particular characteristics, other than tolerance to herbicides, that could have undesirable agronomic effects, they should also be subject to cultivation conditions, in order to address those agronomic effects. Those conditions should apply to the cultivation of those varieties for any purpose, including food, feed and other products, and not only for purposes of production and marketing of PRM. This is necessary to achieve the objectives of this Regulation to contribute to sustainable agricultural production beyond the stage of production and marketing of PRM.

(49)In order to contribute to the sustainability of agricultural production and serve economic, environmental and broader societal needs, new varieties of all genera or species should show an improvement compared to the other varieties of the same genera or species registered in the same national variety register, concerning certain aspects. Among those aspects are their yield, including yield stability and yield under low input conditions; tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses, insects and other pests; tolerance/resistance to abiotic stresses, including adaptation to climate change conditions; more efficient use of natural resources, such as water and nutrients; reduced need for external inputs, such as plant protection products and fertilisers; characteristics that enhance the sustainability of storage, processing and distribution; and quality or nutritional characteristics (‘value for sustainable cultivation and use’). For the purpose of deciding on the variety registration and in order to provide sufficient flexibility to register varieties with the most desirable characteristics, those aspects should be considered for a given variety as a whole.

(50)As organic varieties suitable for organic production as defined in Article 3 of Regulation (EU) 2018/848 are characterised by a high level of genetic and phenotypical diversity between individual reproductive units, it is appropriate that their registration is subject to adjusted DUS, and in particular as regards the requirements concerning uniformity. Furthermore, in order for that such varieties to be better adapted to the specific needs of organic production, their examination of the value for sustainable cultivation and use should be conducted under organic conditions.

(51)For reasons of efficiency and reduction of the administrative burden, varieties that have been granted a plant variety right pursuant to Article 62 of Regulation (EC) No 2100/94, or pursuant to the legislation of a Member State, should be deemed to be distinct, uniform and stable and to have a suitable denomination for the purposes of this Regulation.

(52)The procedure of variety registration should be precisely defined, in order to ensure legal certainty for the applicants and the competent authorities, and a level playing field for all applicants. For this reason, rules should be set out concerning the submission, content, formal examination and date of submission of the applications, technical examinations, audit of the competent authority’s premises and organisation, additional rules on technical examination, confidentiality, provisional examination report and provisional official description, examination report and final official description, examination of the denomination of a variety and decision on the registration of a variety in the national variety register.

(53)For reasons of efficiency and in order to reduce administrative burden for competent authorities and applicants, the competent authorities should register in their national variety registers all varieties officially accepted or registered, before the entry into force of this Regulation, in the catalogues, lists or registers established by their respective Member States pursuant to Directives 2002/53/EC, 2002/55/EC, 2008/90/EC and 68/193/EEC. As those varieties are already marketed in the Union and used by farmers and other professional operators, they should not be subject to a new registration procedure.

(54)Rules should be set out concerning the technical examination of varieties, in order to conclude whether they are distinct, uniform and stable. Due to the importance of that examination for the variety breeding sector and the fact that it leads to the production of an official description, that technical examination should be carried out only by the competent authority.

(55)However, there should be the possibility to carry out the technical examination for the satisfactory value for sustainable cultivation and use of a variety on the premises of the applicant and under the official supervision of the competent authority. This is necessary in order to ease the administrative burden, ensure the availability of testing facilities and reduce costs for the competent authorities. However, the competent authority should be in charge of the testing arrangements. Moreover, professional operators involved in the breeding of new varieties, and on the basis of their co-operation with the competent authorities, have proven qualified to carry out such examinations as they possess the respective expertise, knowledge and appropriate resources.

(56)In order to ensure the credibility and high quality of the examinations on distinctness, uniformity and stability, the premises of the competent authorities where they take place should be audited by the Community Plant Variety Office (‘CPVO’).The premises of the applicants where the examination for the satisfactory value for sustainable cultivation and use takes place under official supervision, should be audited by the respective competent authorities, to ensure compliance with the applicable requirements.

(57)The period of the registration of a variety should be 10 years, so as to encourage innovation in the breeding sector, and the removal from the market of old varieties and their replacement by new ones. However, that period should be 30 years for varieties of genera or species of fruit plants and vine, due to the longer time required for the completion of the productive cycle of those genera or species.

(58)Upon a request of any interested person, the period of registration of a variety should be subject to renewal, in order to allow for the continuation of marketing of certain varieties if a need is established and they still fulfil applicable requirements.

(59)Rules should be set out concerning variety maintenance in accordance with accepted practices. This is necessary to ensure the varietal identity during the period of its registration, which can only be ensured if the maintenance of the respective variety is carried out by the applicant, or other persons notified by the applicant to the competent authority, pursuant to certain requirements and subject to official controls by the competent authorities.

(60)Rules should be set out concerning the content of the national variety registers and the Union variety register, and the keeping of samples of the registered varieties (‘official sample’ or ‘standard sample’) which is a living description of the variety. This is important to ensure accessibility to the necessary information on the variety, its identification during the period of its registration and the availability of standard samples for control plot testing in the context of PRM certification.

(61)The PRM marketing Directives should be repealed, as this Regulation replaces them. As a consequence, Regulation (EU) 2016/2031 should be amended to remove references to those Directives and to ensure that Regulated Non-Quarantine Pests (‘RNQPs’) are exclusively regulated by that Regulation.

(62)Regulation (EU) 2017/625 of the European Parliament and of the Council 43 should be amended to include in its scope the production and marketing of PRM in line with this Regulation. This is important in order to guarantee a uniform approach as regards official controls for the entire plant production and food chain, since Regulation (EU) 2017/625 also applies to the scope of Regulation (EU) 2016/2031, and Regulation (EU) 2018/848 of the European Parliament and of the Council 44 .

(63)In this respect, the Commission should be empowered to adopt specific rules on official controls and on actions taken by the competent authorities in relation to PRM, in particular for laying down rules for the performance of official controls on PRM for verifying compliance with Union rules, for the import into, and marketing within, the Union of PRM, and on the activities of operators during the production of PRM.

(64)Regulation (EU) 2018/848 should be amended to align the definitions of ‘plant reproductive material’ and ‘heterogeneous material’ with the definitions provided for by this Regulation. Moreover, the empowerment for the Commission to adopt specific provisions for the marketing of PRM of organic heterogeneous material should be excluded from Regulation (EU) 2018/848, as all rules concerning the production and marketing of PRM should be set out in this Regulation for reasons of legal clarity.

(65)In order to adapt the list of genera and species of PRM, subject to the scope of this Regulation, to the developments related to the significance of area and value of production, food/feed security and number of Member States where it is cultivated, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending that list.

(66)In order to adapt the rules on the production and marketing of PRM to the technical and scientific developments and the applicable international standards, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the requirements of this Regulation concerning the production and marketing of pre-basic, basic, certified and standard material and seeds.

(67)In order to adapt the rules on the production and marketing of PRM of heterogeneous material to the technical and scientific developments, and take into account the experience gained from the application of the rules of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the requirements concerning the production and marketing of heterogeneous material.

(68)In order to adapt the content of variety registers to the technical developments and follow up to the experience gained from variety registration, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the requirements concerning that content.

(69) In order to adapt the cultivation of varieties to the development of technical and scientific knowledge, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adopting conditions of cultivation of varieties that are herbicide-tolerant or have other characteristics that could lead to undesirable agronomic effects. Those conditions should include measures in the field, such as crop rotation; monitoring measures; the notification of those measures by Member States to the Commission and the other Member States; reporting by professional operators to the competent authorities concerning the application of those measures; and the indications of those conditions in the national variety registers.

(70)In order to adapt testing and requirements for the sustainable value of cultivation and use requirements to the potential technical and scientific developments, and the possible development of international standards, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation with certain elements. Those consist of the necessary methodologies for the growing trials to be carried out with a view to assessing, and adopting further requirements for, sustainable value of cultivation and use for certain genera or species.

(71)In order to adapt the rules on variety denomination to the technical and scientific developments, and follow up on the experience gained from the application of those rules, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation by setting out specific criteria concerning the suitability of variety denominations.

(72)In order to adapt the provisions of this Regulation concerning technical examinations of varieties to the technical and scientific developments and the practical needs of competent authorities and professional operators, and follow up on the experience gained from the application of the respective rules, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation by setting out the rules concerning the audit of the premises of professional operators to carry out technical examinations for the satisfactory value for sustainable cultivation and use.

(73)In order to adapt the provisions of this Regulation concerning the examination for sustainable cultivation and use to the technical or scientific developments, and to any new Union policies or rules on sustainable agriculture, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation by establishing the minimum requirements for carrying out this examination, establishing the methodologies for assessing the characteristics examined, establishing the standards for the evaluation and the reporting of the results of this examination and amending the characteristics examined.

(74)It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making 45 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(75)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 46 .

(76)In order to ensure uniform conditions for the implementation of this Regulation, and to improve the performance of professional operators and the identity and quality of PRM produced and marketed by them, implementing powers should be conferred to the Commission with respect to specifying the requirements for the audits, training, examinations, inspections, sampling and testing, with regard to particular genera or species, for the official supervision of the professional operators by the competent authorities.

(77)In order to ensure uniform conditions for the implementation of this Regulation concerning handling and marketing of PRM, and adapt the respective rules to the experience gained from the application of the provisions of this Regulation, implementing powers should be conferred to the Commission for adopting specific requirements for all or certain species of PRM, concerning the merging or splitting of lots in relation to the origin of PRM lots, their identification, records on that operation and labelling following the merging or splitting of PRM lots.

(78)In order to ensure uniform conditions for the implementation of this Regulation, follow up on the practical experience gained by the application of its provisions, and improve the integrity of the marketed PRM, implementing powers should be conferred to the Commission for adopting specific requirements concerning the sealing, fastening, size and form of packages, bundles and containers of specific species of PRM.

(79)In order to ensure uniform conditions for the implementation of this Regulation, and in particular concerning the legibility, recognisability and security of labels, implementing powers should be conferred to the Commission for adopting specific provisions concerning the official labels, labels used for certain derogations and, labels used for some specific types of PRM, and set out the content, size, colour and form of those labels for the respective categories or types of PRM.

(80)In order to ensure uniform conditions for the implementation of this Regulation and follow up on any practical experience gained by the application of the respective rules, implementing powers should be conferred to the Commission for adopting specific provisions concerning mixtures of seeds.

(81)In order to ensure uniform conditions for the implementation of this Regulation with respect to retail marketing of PRM, and make the marketing of PRM as practical and suitable for each species as possible, implementing powers should be conferred to the Commission for adopting rules concerning the size, form, sealing and handling requirements of the small packages for seeds and the packages and bundles for other PRM marketed to final users.

(82)In order to ensure uniform conditions for the implementation of this Regulation and to address urgent supply difficulties of PRM, implementing powers should be conferred to the Commission for authorising, in the case of temporary difficulties in the supply of PRM, for a maximum period of 1 year, the marketing of PRM of the categories of pre-basic, basic or certified material or seed subject to less stringent requirements, or to derogate from the requirement to belong to a variety, and with respect to repealing and amending that authorisation.

(83)In order to ensure uniform conditions for the implementation of this Regulation, and ensure some flexibility to Member States to adopt national measures adapted to their agro-climatic conditions and higher quality standards, implementing powers should be conferred to the Commission for authorising the Member States to adopt, with regards to production and marketing of PRM, more stringent production or marketing requirements, in all or part of the territory of the Member State concerned, and with respect to repealing or amending such measures adopted pursuant to the PRM marketing Directives.

(84)In order to ensure uniform conditions for the implementation of this Regulation, and ensure a swift response to sudden risks, implementing powers should be conferred to the Commission for taking emergency measures, where the production or marketing of PRM is likely to constitute a serious risk to human, animal or plant health, the environment or cultivation of other species, and such risk cannot be contained satisfactorily by measures taken by the Member State concerned, and with respect to repealing or amending any such measure taken by a Member State.

(85)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred to the Commission for deciding on the organisation of temporary experiments to seek improved alternatives to the scope and certain provisions of this Regulation.

(86)In order to ensure uniform conditions for the implementation of this Regulation with regard to the import of PRM, and ensure compliance of the third country requirements with the equivalent Union requirements, implementing powers should be conferred to the Commission with respect to recognising whether PRM of specific genera, species οr categories produced in a third country, or particular areas of a third country, fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union, in order to be imported.

(87)In order to ensure uniform conditions for the implementation of this Regulation and to ensure appropriate maintenance of the registered varieties in third countries too, implementing powers should be conferred to the Commission with respect to recognising that the controls on variety maintenance carried out in the third country afford the same guarantees as those set out in the Union.

(88)In order to ensure uniform conditions for the implementation of this Regulation, and to adapt its provisions to the evolving applicable protocols of the International Union for the Protection of new Varieties of Plants (UPOV) or protocols established by the CPVO, and the relevant technical and scientific developments, implementing powers should be conferred to the Commission for adopting specific requirements concerning distinctness, uniformity and stability per genera or species of varieties.

(89)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred to the Commission for adopting specific rules as regards the size of the standard sample of registered varieties used for the official post controls of PRM, the rules for the renewal of those samples and the provision of those samples to other Member States.

(90)Since the objective of this Regulation, namely to ensure a harmonised approach with regard to the production and marketing of PRM, cannot be sufficiently achieved by the Member States but can rather, by reason of its effects, complexity and international character, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not exceed what is necessary in order to achieve that objective. In this view, and as necessary, it introduces derogations or specific requirements for certain types of PRM and professional operators.

(91)This Regulation should apply from 3 years after its entry into force, in order to allow the competent authorities and the professional operators to adapt to its provisions and also to provide the necessary time for the adoption of the respective delegated and implementing acts. The rules concerning the satisfactory value for sustainable cultivation and use of varieties of vegetables and fruit plants should however apply from 5 years after its entry into force. That additional time period is needed for the competent authorities and professional operators to make the necessary preparations and carry out the first tests in the fields complying with those new rules.