P9_TA(2024)0341 – Production and marketing of plant reproductive material – European Parliament legislative resolution of 24 April 2024 on the proposal for a regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC (Regulation on plant reproductive material) (COM(2023)0414 – C9-0236/2023 – 2023/0227(COD)) (Ordinary legislative procedure: first reading)
Date: 2024-04-24
Institutions: Committee on Agriculture and Rural Development, Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: agricultural production, market approval, marketing standard, plant health legislation, plant propagation, plantation, protection of plant life, seed, seedling




C_202503767EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/3767


17.9.2025






P9_TA(2024)0341
Production and marketing of plant reproductive material

European Parliament legislative resolution of 24 April 2024 on the proposal for a regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC (Regulation on plant reproductive material) (COM(2023)0414 – C9-0236/2023 – 2023/0227(COD))


(Ordinary legislative procedure: first reading)

(C/2025/3767)



The European Parliament,







—


having regard to the Commission proposal to Parliament and the Council (COM(2023)0414),










—


having regard to Article 294(2) and Article 43(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0236/2023),










—


having regard to Article 294(3) of the Treaty on the Functioning of the European Union,










—


having regard to the opinion of the European Economic and Social Committee of 13 December 2023
                   (1),










—


having regard to Rule 59 of its Rules of Procedure,










—


having regard to the opinion of the Committee on the Environment, Public Health and Food Safety,










—


having regard to the report of the Committee on Agriculture and Rural Development (A9-0149/2024),










1.


Adopts its position at first reading hereinafter set out;










2.


Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;










3.


Instructs its President to forward its position to the Council, the Commission and the national parliaments.







(1)  
            OJ C, C/2024/1583, 5.3.2024, ELI: http://data.europa.eu/eli/C/2024/1583/oj.






P9_TC1-COD(2023)0227


Position of the European Parliament adopted at first reading on 24 April 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031 and (EU)
, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC (Regulation on plant reproductive material) [Am. 1]

(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 (1),




Having regard to the United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas, adopted by the Human Rights Council on 28 September 2018, [Am. 2]



Acting in accordance with the ordinary legislative procedure,

Whereas:







(1)


Rules for the production and marketing of plant reproductive material (‘PRM’) of agricultural crops, vegetables, vine and fruit plants have been established at Union level since the 1960s. The production and marketing of PRM on the Union territory is regulated by Council Directives 66/401/EEC (2); 66/402/EEC (3); 68/193/EEC (4); 2002/53/EC (5); 2002/54/EC (6); 2002/55/EC (7); 2002/56/EC (8); 2002/57/EC (9); 2008/72/EC (10) and 2008/90/EC (11) (the ‘PRM marketing Directives’). These legal acts have formed the legal framework for the production and marketing of PRM and therefore have been of major importance for the creation of the internal market of PRM in the Union.












(2)


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












(3)


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












(4)


PRM constitutes the starting material for plant production in the Union. Therefore, it is critical for the production of raw material for food and feed purposes and for the efficient use of plant resources. It contributes

aims to contribute
 to environmental protection and the quality of the food chain and food supply in the Union as a whole. In this regard, the availability,

of high
 quality and diversity of PRM
, including locally adapted varieties that can have the benefit of having a higher tolerance to biotic and abiotic stress,
 appears to be of outmost importance to achieve the transition to sustainable food systems called for in the Farm to Fork Strategy (12), agriculture, horticulture, environmental protection, climate change mitigation and adaptation, food and feed security, and the economy in general. [Am. 3]













(5)


In order to achieve this transition to sustainable food systems, the Union legislation should therefore take account of the need to ensure 
at Member State and Union level
 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 
and promote
 biodiversity 
and ensure food security
 and to meet increasing farmers’ and consumers’ expectations related to quality
, safety, diversity
 and sustainability of PRM. 
This Regulation should stimulate innovation for the development of resilient PRM that would contribute to the enhancement of crops that promote soil health. [Am. 4]













(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 (13) (14).












(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 (15) still adequately covers the needs of that sector.












(12)


This Regulation should cover neither PRM exported to third countries, nor PRM used solely

sold or transferred in any way
 for official testing, breeding, inspections, exhibitions or scientific purposes
, including on-farm research
. 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. [Am. 5]













(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.














(13a)






This Regulation should not cover PRM accessed, sold or transferred in any way in limited quantities as defined in Annex VIIa, whether free of charge or not, for the purpose of dynamic conservation as that type of PRM does not require particular harmonised identity or quality standards and does not compromise the identity and quality of other PRM marketed in the Union. [Am. 6]













(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 (16) (‘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.














(18a)






Rules for the in vitro production of clones and their marketing should also be established. [Am. 7]













(19)


Specific rules should be established for the production and marketing of clones, selected clones, multiclonal mixtures and 
of
 polyclonal PRM, due to their

its
 increased importance and use in the PRM sector. In order to ensure transparency, informed choices for their users and effective official controls, the 
selected
 clones 
and polyclonal PRM
 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.
[Am. 8]













(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 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
, which are crucial for crop genetic diversity and essential for adaptation to environmental changes and future needs
. 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

satisfactory
 level of genetic and phenotypical diversity between individual reproductive units. Those varieties are referred to as ‘conservation varieties’
. It is appropriate to acknowledge that the conservation of genetic resources is a dynamic process and that newly bred varieties adapted to local conditions should be included
. 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 (17). As a party to the Treaty the Union has committed to support those objectives. [Am. 9]













(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

of dynamic conservation
. In order to facilitate their activity, it is appropriate to allow that PRM which is marketed to
, by, between and within

them, or among them, derogates from the established production and marketing requirements, and that instead it complies with less stringent rules. [Am. 10]













(36)


Farmers habitually exchange in kind 
or for monetary compensation
 small quantities of seeds in order to carry out dynamic management of their own seed

PRM
. It is thus appropriate that a derogation from the established requirements is provided for the exchanges of small quantities of seeds

PRM
 between farmers
, with maximum quantities to be set at Union level
. Such derogation could apply if those seeds

PRM
 do not belong to a variety for which plant variety rights have been granted in accordance with Council Regulation (EC) No 2100/94 (18). Member States

The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU)
 should be allowed to define those small quantities for specific species per year

delegated to the Commission in respect of supplementing this Regulation
, in order to ensure that there is no misuse of such derogation impacting the marketing of seeds

set up, for each species, the maximum quantity which may be exchanged
. [Am. 11]













(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
, with the exception of fodder plants,
 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. [Am. 12]















(38a)






Heterogeneous material should not consist of a GMO or a category 1 or category 2 NGT plant as defined in Regulation (EU).../... of the European Parliament and of the Council (19)
                            (+.) [NGT Regulation]. [Am. 13]













(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 (20), 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 
proportionate
 obligations should be introduced for professional operators active in the area of the production 
with a view to marketing
 and marketing of PRM, to ensure their accountability, more effective official controls and proper application of this Regulation. 
However, the specific characteristics and limitations of micro-enterprises should be taken into consideration. [Am. 14]













(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 
and the Member States where the varieties are to be cultivated,
 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. [Am. 15]













(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 
agronomic, use and environmental
 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 
cultivation, harvesting,
 storage, processing and

,
 distribution 
and use
; and quality
,
 or nutritional characteristics (‘value for sustainable cultivation and use’) 
or characteristics important for processing
. 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. 
Given the significant resources and preparation needed for that examination, for species listed in Parts B and C of Annex I it should be performed in a voluntary way. [Am. 16]













(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 
and for conservation varieties
, due to the longer time required for the completion of the productive cycle of those genera or species. [Am. 18]













(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 (21) 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 (22).












(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.
[Am. 19]













(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 (23). 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 (24).












(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

The power to adopt acts in accordance with Article 290 TFEU
 should be conferred

delegated
 to the Commission for deciding

in respect of supplementing this Regulation by specific rules
 on the organisation of temporary experiments to seek improved alternatives to the scope and certain provisions of this Regulation. [Am. 20]













(86)


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












(87)


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












(88)


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












(89)


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












(90)


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












(91)


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





HAVE ADOPTED THIS REGULATION:

CHAPTER I
GENERAL PROVISIONS

Article 1


Subject matter


This Regulation lays down rules for the production and

with a view to
 marketing in the Union of plant reproductive material (‘PRM’)
, and for the marketing in the Union of PRM
, and in particular requirements for the production of PRM in the field and other sites, categories of material, identy

identity
 and quality requirements, certification, labelling, packaging, imports, professional operators and the registration of varieties. [Am. 21]

This Regulation also lays down rules concerning the conditions of cultivation of certain varieties that 
are tolerant to herbicides or
 could have undesirable agronomic effects, including the cultivation for purposes beyond the production and marketing of PRM, for the production of food, feed and other products. [Am. 22]



Article 2


Scope and objectives



1.   This Regulation applies to the genera and species listed for the respective uses referred to in Parts A to E of Annex I.
Its requirements concern, respectively, all types of PRM, only seeds, or only material other than seeds.
The requirements concerning production 
or imports
 of PRM shall apply only to production with a view to its marketing 
within the Union
. [Am. 23]



2.   The objectives of this Regulation are the following:






(a)


to ensure quality
, safety
 and diversity of choice for PRM, and its availability for professional operators
, farmers
 and final users; [Am. 24]











(b)


to ensure a equal

fair
 conditions for the competition of the professional operators across the Union and the functioning of the internal market in PRM; [Am. 25]











(c)


to support innovation and competitiveness of the PRM sector in the Union;










(d)


to contribute to 
the dynamic
 conservation and sustainable use of plant genetic resources and agro-biodiversity; [Am. 26]











(e)


to contribute to sustainable agricultural production, adapted to current and future projected climatic 
and soil
 conditions; [Am. 27]











(f)


to contribute to food security 
and food sovereignty. [Am. 28]







3.   The Commission is empowered in accordance with Article 75 to adopt delegated acts, amend

amending
 Annex I, in order to adapt it

that Annex
 to the developments of technical and scientific knowledge, and the economic data concerning production and marketing of genera and species, by adding genera and species to or removing them from the list 
in
 that Annex. [Am. 29]

The delegated act

acts
 referred to in the first subparagraph shall add genera or species to the list in Annex I if they fulfil at least two of the following elements: [Am. 30]







(a)


represent a significant area of production of PRM and a significant value of marketed PRM in the Union










(b)


are of substantial importance for security of food and feed production in the Union, compared to other genera and species not listed in that Annex; and










(c)


are marketed in at least two Member States;












(ca)






present an interest in terms of environmental sustainability. [Am. 31]





The delegated act referred to in the first subparagraph shall remove genera or species from the list in Annex I if they no longer fulfil at least two of the elements set out in the second subparagraph.


4.   This Regulation does not apply to:






(a)


propagating material of ornamental plants as defined in Article 2 of Directive 98/56/EC
, and propagating material of genera or species listed in Annex I to this Regulation which are exclusively used for ornamental purposes
; [Am. 32]











(b)


forest reproductive material as defined in Article 3 of Regulation (EU).../… of the European Parliament and of the Council (25) (26)

and propagating material of genera or species listed in Annex I to this Regulation which are exclusively used for forestry purposes
; [Am. 33]











(c)


PRM produced 
solely
 for export to third countries; [Am. 34]











(d)


PRM sold or transferred in any way, whether free of charge or not, between final users for their own private use and outside their commercial activities;










(e)


PRM used solely

sold or transferred in any way, whether free of charge or not,
 for official testing, breeding, inspections, exhibitions or scientific purposes.

, including on-farm research and activities carried out by gene banks; [Am. 35]













(ea)






the production and marketing of PRM by conservation organisations and networks referred to in Article 29 in small quantities as defined in Annex VIIa, whether free of charge or not, for the purpose of dynamic conservation; [Am. 353]













(eb)






PRM produced by farmers for their own use. [Am. 37]








Article 3


Definitions


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






(1)


‘plant reproductive material’ (‘PRM’) means plants as defined in Article 2(1) of Regulation (EU) 2016/2031, capable of, and intended for, producing entire plants;










(2)


‘professional operator’ means any natural or legal person, involved professionally in one or more of the following activities in the Union concerning 
the commercial exploitation of
 PRM: [Am. 38]







(a)


production;










(b)


marketing;










(c)


maintenance 
or multiplication
 of varieties; [Am. 39]











(d)


provision of services for identity and quality;










(e)


preservation, storage, drying, processing, treating, packaging, sealing, labelling, sampling or testing;














(3)


‘marketing’ means the following 
commercial
 actions conducted by a professional operator: sale, holding, transfer for free, or offering for sale
, including online sale,
 or any other way of transferring or distribution within, or import into, the Union 
aimed at the commercial exploitation of the PRM; [Am. 40]











(4)


‘variety’ means a variety as defined in Article 5(2) of Regulation (EC) No 2100/94;










(5)


‘clone’ means
:








(a)


an individual plant progeny, originally derived from another single plant by vegetative reproduction, remaining genetically identical to that plant; 
or












(b)




the vegetative genetically uniform progeny of a single plant; [Am. 41]















(6)


‘selected clone’ means a clone that has been selected and chosen for some special intravarietal phenotypic traits and its phytosanitary status that give the selected clone a better performance, is true to the description of the variety 
of vines and those species of fruit trees in which such intravarietal variability has occurred,
 to which it belongs and, in the case of

the
 selected clones not belonging to a variety, it is true to the description of the species to which it

clone
 belongs; [Am. 42]











(7)


‘polyclonal plant reproductive material’ means 
propagating material obtained from a selection of
 a group of several distinct individual plant progenies derived from different

at least seven
 genotypes, each of which is true to the description of the

with the prediction of genetic gains, made through quantitative genetic tools, from the same experimental set of a specific ancient
 variety to which it belongs

, containing most of its intra-varietal diversity
; [Am. 43]












(8)





                              ‘multiclonal mixture’ means a mixture of selected clones, all belonging to the same variety or species, as appropriate, whereby each of them has been obtained through independent selection;
[Am. 44]











(9)


‘competent authority’ means the central or regional authority of a Member State, or, where applicable, the corresponding authority of a third country, responsible for the organisation of official controls, registration, certification and other official activities concerning the production and marketing of PRM, or any other authority to which that responsibility has been conferred in accordance with Union law;










(10)


‘official description’ means a description that has been established by a competent authority, includes the relevant characteristics of the variety and makes the variety identifiable as a result of the examination on its distinctness, uniformity and stability;










(11)


‘officially recognised description’ means a written description of a conservation variety, which has been recognised by a competent authority, includes the specific characteristics of the variety, and has been obtained by other means than the examination of its distinctness, uniformity and stability;










(12)


‘variety maintenance’ means the actions taken for controlling varietal purity and identity with the aim to ensure that a

the
 variety remains in accordance with its

characteristics remain true to their
 description over subsequent cycles of reproduction; [Am. 45]











(13)


‘seeds’ means seeds in the botanical sense;










(14)


‘pre-basic seed’ means seed that belongs to a generation preceding the generation of the basic seed, is intended for the production and certification of basic or certified seed, and has been found by means of official certification, or certification under official supervision, to satisfy the respective conditions laid down in Part

Parts
 A 
and D
 of Annex II; [Am. 46]











(15)


‘basic seed’ means seed that has been produced from pre-basic seed or preceding generations of basic seed, is intended for the production of further generations of basic seed or certified seed, and which has been found by means of official certification, or certification under official supervision, to satisfy the respective conditions laid down in Part

Parts
 A 
and D
 of Annex II; [Am. 47]











(16)


‘certified seed’ means seed that has been produced from pre-basic, basic or preceding generations of certified seed, and which has been found by means of official certification, or certification under official supervision, to satisfy the respective conditions laid down in Part

Parts
 A 
and D
 of Annex II; [Am. 48]











(17)


‘standard seed’ means seed, other than pre-basic, basic or certified seed, that is not intended for further multiplication, and satisfies the respective conditions laid down in Part

Parts
 A 
and D
 of Annex III; [Am. 49]











(18)


‘pre-basic material’ means PRM, other than seeds, that belongs to a generation preceding the generation of basic material, is intended for the production and certification of basic or certified material, and has been found by means of official certification or certification under official supervision to satisfy the respective conditions laid down in Part

Parts
 B
, C and E
 of Annex II; [Am. 50]











(19)


‘basic material’ means PRM, other than seed, that has been produced from pre-basic material or preceding generations of basic material, is intended for the production and certification of further generations of basic material or certified material, and has been found by means of official certification or certification under official supervision to satisfy the respective conditions laid down in Part

Parts
 B
, C and E
 of Annex II; [Am. 51]











(20)


‘certified material’ means PRM, other than seed, that has been produced from pre-basic, basic or preceding generations of certified material, and has been found by means of official certification or certification under official supervision to satisfy the respective conditions laid down in Part

Parts
 B
, C and E
 of Annex II; [Am. 52]











(21)


‘standard material’ means PRM other than seed, and other than pre-basic, basic or certified material, that is not intended for further multiplication, and satisfies the respective conditions laid down in Part

Parts
 B
, C and E
 of Annex III; [Am. 53]











(22)


‘official certification’ means official attestation by the competent authority of the compliance of pre-basic, basic or certified seed or material with the respective requirements of this Regulation, where all relevant inspections on site, sampling and testing including where appropriate control plot testing have been carried out by that authority, and if it has concluded that the seed or material concerned meets those requirements;










(23)


‘certification under official supervision’ means attestation by a specifically authorised professional operator that pre-basic, basic or certified seed or material complies with the applicable requirements, and where at least one or more of the relevant inspections, sampling, testing or label printing have been carried out by that professional operator, under the official supervision of the competent authority, and if it has concluded that the seed or material concerned meets those requirements;










(24)


‘category’ of PRM means a group or an individual unit of PRM that qualifies as pre-basic, basic, certified or standard seed or material and is identifiable by complying with specific identity and quality requirements;










(25)


‘genetically modified organism’ means a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council (27), excluding organisms obtained through the techniques of genetic modification listed in Annex I B to Directive 2001/18/EC;










(26)


‘lot’ means a unit of PRM, identifiable by its homogeneity of composition and origin;










(27)


‘heterogeneous material’ means a plant grouping within a single botanical taxon of the lowest known rank which:






(a)


presents common phenotypic characteristics;










(b)


is characterised by a high level of genetic and phenotypic diversity between individual reproductive units, so that that plant grouping is represented by the material as a whole, and not by a small number of units;










(c)


is not a variety; and










(d)


is not a mixture of varieties;














(28)


‘final user’ means any person acquiring, transferring and using PRM for purposes which are outside that person’s 
primary
 professional activities; [Am. 54]











(29)


‘conservation variety’ means a variety that is:






(a)




either a
 traditionally grown 
landrace
 or locally

a
 newly bred under specific

variety (modern landrace) derived from on-farm selection or bred for adaptation to
 local conditions in the Union, and adapted to those conditions

context of the sustainable use of plant genetic resources for food and agriculture
; and
[Am. 55]













(aa)






not an F1 hybrid variety; [Am. 56]











(b)


characterised by a high

satisfactory
 level of genetic and phenotypical diversity between individual reproductive units; [Am. 57]













(ba)






not subject, as a whole or in genetic components, to intellectual property rights that limit its use for conservation, research, breeding, education, including on farm by a farmer who uses the PRM grown on the farm, of that variety for those objectives; [Am. 58]















(30)


‘quality pests’ means pests fulfilling all of the following:






(a)


they are not Union quarantine pests, protected zone quarantine pests, or regulated non-quarantine pests (‘RNQPs’) within the meaning of Regulation (EU) 2016/2031, nor pests subject to the measures adopted pursuant to Article 30(1) of that Regulation;










(b)


they occur during PRM production or storage; and










(c)


their presence has an unacceptable adverse impact on the quality of the PRM, and an unacceptable economic impact as regards the use of that PRM in the Union; [Am. 59]















(31)


‘practically free from 
quality
 pests’ means completely free from pests, or a situation where the presence of quality pests on the respective PRM is so low that those pests do not affect adversely

excessively
 the quality of that PRM; [Am. 60]











(32)


‘seed potatoes’ means tubers of Solanum tuberosum L., used for the reproduction of other potatoes; [Am. 61]











(33)


‘farmer’ means farmer as defined in Article 3(1) of Regulation (EU) 2021/2115 of the European Parliament and of the Council (28);










(34)


‘off-type’ means, in relation with seed or other plants, a seed or other PRM not corresponding to the description of the variety or species to which it is supposed to belong pursuant to this Regulation;










(35)


‘hybrid variety’ means a variety produced as a result from the crossbreeding of two or more other varieties;












(35a)







                                 ‘dynamic conservation’ means the preservation of genetic diversity within and between cultivated plant species, and includes both in situ conservation and ex situ conservation, with the aim of a sustainable use of plant genetic resources and agro-biodiversity in a way and at a rate that does not lead to the long-term decline of biological diversity, thereby maintaining the potential to meet the needs and aspirations of present and future generations; [Am. 354]













(35b)







                                 ‘NGT plant’ means plants obtained by certain new genomic techniques as defined in Article 3, point 2 of Regulation (EU).../... [NGT Regulation] of the European Parliament and of the Council; [Am. 63]













(35c)






'commercial seed' means seed produced and marketed for mixtures referred to in Article 21 which is identifiable as belonging to a species, but not a variety, and which has been found by official certification or by certification carried out under official supervision to satisfy the conditions set out in this Regulation for certified seed with the exception of the requirement in Article 5; [Am. 64]













(35d)







                                 ‘small packages’ means packages containing seed or material up to a maximum of:










(a)






10 kg for cereals;














(b)






5 kg for fodder plants, beet, oil and fibre plants;














(c)






10 kg for seed potatoes;














(d)






500 g for legumes;














(e)






100 g for onions, chervil, asparagus, spinach beet or chard, red beet or beetroot, turnips, water melon, gourd, marrows, carrots, radishes, scorzonera or black salsify, spinach, corn salad or lamb's lettuce;














(f)






20 g for other species of vegetables;














(g)






10 individuals for fruit and vine cuttings. [Am. 355]











Article 4


Compliance with Regulation (EU) 2016/2031


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

CHAPTER II
REQUIREMENTS CONCERNING VARIETIES, CATEGORIES OF PRM, LABELLING, AUTHORISATIONS, HANDLING, IMPORTS AND DEROGATIONS
SECTION 1
General requirements for the production and marketing of PRM

Article 5


Belonging to a registered variety


Only PRM belonging to a variety registered in a national variety register referred to in Article 44 may be produced and marketed within the Union, except the following cases:






(a)


as rootstocks, if produced and marketed with a reference, contained in an appropriate labelling, to the species to which they belong;










(b)


as heterogeneous material in accordance with Article 27;










(c)


as PRM marketed to final users in accordance with Article 28;










(d)


as PRM produced and marketed for the purposes of conservation of genetic resources in accordance with Article 29;










(e)


as seed

PRM
 exchanged in kind between farmers in accordance with Article 30; [Am. 66]












(f)




as breeder’s seed, in accordance with Article 31;
[Am. 67]











(g)


as PRM of not yet registered varieties in accordance with Article 32;










(h)


in the event of supply difficulties of PRM in accordance with Article 33.






Article 6


Belonging to certain categories of PRM



1.   Only PRM belonging to one of the following categories may be produced and marketed within the Union, except in the cases provided for in paragraph 2:






(a)


pre-basic material or seed;










(b)


basic material or seed;










(c)


certified material or seed;










(d)


standard material or seed.




Where a reference is made in this Regulation to lower or higher categories concerning identity and quality of PRM, that determination shall be based on the ranking the order of points (a) - (d), with point (a) indicating the highest rank and point (d) the lowest one.


2.   By way of derogation from paragraph 1, PRM may be produced and marketed without belonging to a category listed in (a) - (d) in the following cases:






(a)


marketing of PRM of heterogeneous material in accordance with Article 27;










(b)


marketing to a final user in accordance to Article 28;










(c)


marketing to and between conservation networks as referred to in Article 29;










(d)


as seed

PRM
 exchanged in kind between farmers in accordance with Article 30. [Am. 68]












(e)




breeder’s seed as referred to in Article 31.
[Am. 69]







SECTION 2
Requirements for the production and marketing of pre-basic, basic, certified and standard material and seed

Article 7


Requirements for the production and marketing of pre-basic, basic and certified seed and material



1.   Pre-basic, basic and certified seed may only be produced and marketed within the Union, if all the following conditions are fulfilled:






(a)


the pre-basic, basic or certified seed is practically free from quality pests;










(b)


it is produced and marketed:






(i)


following official certification by the competent authorities, or certification by the professional operator under official supervision;










(ii)


in accordance with the requirements set out in Part

Parts
 A 
and D
 of Annex II, and its compliance with those requirements is attested by the official label referred to in Article 15(1). [Am. 70]











2.   Pre-basic, basic and certified material may only be produced and marketed within the Union, if all the following conditions are fulfilled:






(a)


the pre-basic, basic or certified material is practically free from quality pests;










(b)


it is produced and marketed:






(i)


following official certification by the competent authorities, or certification by the professional operator under official supervision;










(ii)


in accordance with the requirements set out in Part

Parts
 B 
and E
 of Annex II, and its compliance with those requirements is attested by the official label referred to in Article 15(1). [Am. 71]











3.   The Commission is empowered to adopt delegated acts in accordance with Article 75, in order to amend Annex II. Those amendments shall adapt to the developments of international technical and scientific standards and may

shall only
 concern the requirements for the following: [Am. 72]







(a)


sowing and planting, and production in the field, of pre-basic, basic and certified seed;










(b)


harvesting and post-harvesting of pre-basic, basic and certified seed;










(c)


marketing of seeds;










(d)


sowing and planting, and production in the field, of pre-basic, basic and certified material;










(e)


harvesting and post-harvesting of pre-basic, basic and certified material;










(f)


marketing of pre-basic, basic and certified material;










(g)




production and marketing of
 pre-basic, basic and certified material of clones, selected clones, multiclonal mixtures and polyclonal PRM; [Am. 73]











(h)


production of pre-basic, basic and certified material produced by in vitro propagation;










(i)


marketing of pre-basic, basic and certified material produced by in vitro propagation.






4.   The Commission may adopt implementing acts specifying the production and marketing requirements referred to in Part A and Part B of Annex II for certain genera, species or categories of PRM, and, where appropriate, for certain grades, classes, generations or other sub-divisions of the category concerned. Those requirements shall concern one or more of the following elements
: [Am. 74]







(a)


specific uses of the genera, species or the types of the PRM concerned;










(b)


production methods of PRM, including sexual and asexual reproduction and in vitro propagation;










(c)


conditions for sowing or planting;










(d)


field cultivation;










(e)


harvesting and post-harvesting;










(f)


germination rates, purity and content of other PRM, moisture, vigour, presence of earth or extraneous matter; [Am. 75]











(g)


certification methods of PRM, including the application of bio-molecular or other technical methods, as well as their approval and use, and the listing of approved methods in the Union;










(h)


the conditions for rootstocks and other parts of plants of genera or species other than those listed in Annex I, or their hybrids, if propagating material of the genus or species listed in Annex I or their hybrids is grafted onto them;










(i)


conditions for the production of seeds from fruit plants or vine;










(j)


conditions for the production of fruit plants, vine or seed potatoes from seeds.




Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 76(2), in order to adapt to the developments of the relevent

relevant
 international technical and scientific standards 
and taking into account the possible implications for PRM production and availability and for small operators
. 
Those implementing acts shall be proportionate to the category of PRM. [Am. 76]




Article 8


Requirements for the production and marketing of standard seed and material



1.   Standard seed may only be produced and marketed within the Union, if all the following conditions are fulfilled:






(a)


it is practically free from quality pests;










(b)


it is produced and marketed:






(i)


under the responsibility of the professional operator;










(ii)


in accordance with the requirements set out in Part

Parts
 A 
and D
 of Annex III, and its compliance with those requirements is attested by the operator’s label referred to in Article 16. [Am. 77]











2.   Standard material may only be produced and marketed within the Union, if all the following conditions are fulfilled:






(a)


it is practically free from quality pests;










(b)


it is produced and marketed:






(i)


under the responsibility of the professional operator;










(ii)


in accordance with the requirements set out in Part

Parts
 B 
and E
 of Annex III, and its compliance with those requirements is attested by the operator’s label referred to in Article 16. [Am. 78]












3.   Once a year, professional operators shall submit to the competent authority a declaration concerning the quantities per species of standard seed and material they produced.
[Am. 79]



4.   The Commission is empowered to adopt delegated acts, in accordance with Article 75, in order to amend Annex III, to adapt the requirements referred to in paragraphs 1 and 2 to the scientific and technical developments and to the applicable international standards. Those amendments shall concern the following:






(a)


requirements for sowing and planting, and production in the field, of standard seeds;










(b)


requirements for harvesting and post-harvesting of standard seeds;










(c)


requirements for marketing of standard seeds;










(d)


requirements for sowing and planting, and production in the field, of standard material;










(e)


requirements for harvesting and post-harvesting of standard material;










(f)


requirements for the marketing of standard material;










(g)


requirements for clones, selected clones, multiclonal mixtures and

production and marketing of
 polyclonal PRM of standard material; [Am. 80]











(h)


requirements for the production of standard material produced by in vitro propagation;










(i)


requirements for the marketing of standard material produced by in vitro propagation.








4a.
   
Before adopting the delegated acts referred to in paragraph 4, concerning the requirements referred to in points (a) to (i) thereof, the Commission shall assess the implementation of those requirements, taking into account the possible implications for PRM production and availability and for small operators. Those delegated acts shall be proportionate to the category of PRM. [Am. 81]



5.   The Commission may adopt implementing acts specifying the production and marketing requirements referred to in Part A and Part B of Annex III for certain genera or species of standard seed or material. Those requirements shall concern one or more of the following elements: [Am. 82]







(a)


specific uses of the genera, species or the types of the PRM concerned;










(b)


production methods of PRM, including sexual and asexual reproduction and in vitro propagation;










(c)


conditions for sowing or planting;










(d)


field cultivation;










(e)


harvesting and post-harvesting;










(f)


germination rates, purity and content of other PRM, moisture, vigour, presence of earth or extraneous matter; [Am. 83]











(g)


the application of 
internationally recognised
 bio-molecular or other technical methods, as well as their approval and use, and the listing of approved methods in the Union; [Am. 84]











(h)


the conditions for rootstocks and other parts of plants of genera or species other than those listed in Annex I, or their hybrids, if propagating material of the genus or species listed in Annex I or their hybrids is grafted onto them;










(i)


conditions for the production of seeds from fruit plants or vine;










(j)


conditions for the production of fruit plants, vine or seed potatoes from seeds.




Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 76(2), in order to adapt to the developments of the relevent

relevant
 international technical and scientific standards 
and taking into account the possible implications for PRM production and availability and for small operators
. 
Those implementing acts shall be proportionate to the category of PRM. [Am. 85]




Article 9



Requirements for the production, and
 marketing and registration of clones,
of selected clones, multiclonal mixtures and polyclonal PRM
[Am. 86]



1.   In addition to the requirements referred to in Articles 4 to 43, Pre-basic, basic,

and
 certified 
material of selected clones
 and standard material of clones, selected clones, multiclonal mixtures and polyclonal PRM shall be produced and marketed in accordance with paragraphs 2 and 3 and the requirements set out respectively in Annex II, Part C, and Annex III, Part C. [Am. 87]



2.   Clones, Selected clones, multiclonal mixtures and polyclonal PRM may only be produced and marketed if they are registered by a competent authority in at least one official register for 
selected
 clones 
and polyclonal PRM
 established by a Member State. [Am. 88]

That register shall include all elements referred to in the application for the registration of a clone, selected clone, multiclonal mixture and polyclonal PRM, as set out in Annex II, Part B, Part C point 2

Article 53a
. [Am. 89]



3.   Clones, Selected clones, multiclonal mixtures and polyclonal PRM shall be maintained for the purpose of preserving their identity. The persons responsible for maintenance of the clones, selected clones, multiclonal mixtures and polyclonal PRM shall take all measures to be able to make them verifiable by the competent authorities or any other person, on the basis of kept records. [Am. 90]





3a.
   
Polyclonal PRM, registered in the register referred to in paragraph 2 of this Article, shall be produced and marketed only if it complies with all the requirements concerning standard material as referred to in Part C of Annex III. Polyclonal PRM shall be accompanied by a professional operator’s label with the indication ‘Polyclonal material’, in accordance with Article 17. [Am. 91]



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

Article 10


Authorisation of professional operators to carry out certification under official supervision



1.   A professional operator may, upon application, be authorised by the competent authority to perform all or certain activities required for certification of PRM under official supervision of the competent authority for pre-basic, basic and certified material or seeds, and to issue

print
 an official label for them. [Am. 92]

In order to be granted such authorisation and depending on the activities to be authorised for, the professional operator shall:






(a)


possess the necessary knowledge for complying with the requirements referred to in Article 7;










(b)


be qualified to carry out the inspections referred to in Annex II or employ personnel qualified for such inspections;










(c)


employ qualified personnel for carrying out the sampling referred to in Annex II, or conclude contracts with companies 
or associations of professional operators
 employing qualified personnel for those activities; [Am. 93]











(d)


employ specialised personnel and equipment to carry out the testing referred to in Annex II, or use 
PRM testing
 laboratories employing qualified personnel for those activities; [Am. 94]











(e)


have identified, and have the capability to monitor, the critical points of the production process which may influence the quality and identity of the PRM, and keep records of the results of that monitoring;










(f)


have in place systems to ensure the fulfilment of the requirements concerning the identification of lots pursuant to Article 13;










(g)


have in place systems to ensure the fulfilment of the traceability requirements set out in Article 42.






2.   The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing paragraph 1 as regards one or more of the following elements:
[Am. 95]








(a)




procedure for the application submitted by the professional operator;
[Am. 96]












(b)



specific actions to be taken by the competent authority, in order to confirm the compliance with paragraph 1, points (a) to (g). [Am. 97]








Article 11


Withdrawal or modification of the authorisation of a professional operator


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


Article 12


Official supervision by the competent authorities



1.   For the purposes of the certification under official supervision, the competent authorities shall 
conduct regular audits
, at least once per year, conduct audits

every 18 months,
 to ensure that the professional operator fulfils the requirements referred to in Article 10(1). [Am. 98]

They shall also organise training and examinations of the personnel carrying out field inspections, sampling and testing provided for in this Regulation.


2.   For the purposes of the certification under official supervision, the competent authorities shall carry out official inspections, sampling and testing on a portion of the crops on the site of production and on lots of the PRM in order to confirm compliance of that material with the requirements referred to in Article 7.
That portion shall be determined on the basis of the assessment of the potential risk of non-compliance of the PRM with those requirements.


3.   The Commission may, by means of implementing acts, specify

is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation by specifying
 the requirements for the audits, training, examinations, inspections, sampling and testing, as referred to in paragraphs 1 and 2, with regard to particular genera or species. [Am. 99]

Those implementing

delegated
 acts may specify one or more of the following elements: [Am. 100]







(a)


the risk criteria as referred to in paragraph 2 and minimum portion of the crops and the lots of PRM, to be subject to inspections, sampling and testing, as referred to in paragraph 2;










(b)


monitoring activities to be carried out by the competent authorities;










(c)


use of particular accreditation schemes by the professional operator, and the possibility for the competent authorities to reduce the inspections, sampling and testing, and monitoring activities referred to in this Article due to the use of those schemes
, as referred to in paragraph 2
. [Am. 101]






Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).
[Am. 102]



SECTION 4
Handling requirements

Article 13


Lots



1.   PRM shall be marketed in lots. The content of the varieties and species of each lot shall be sufficiently homogeneous regarding

homogeneously mixed
 and identifiable by its users as distinct from other lots of PRM. [Am. 103]



2.   During processing, packaging, storage, or at delivery, lots of PRM may be merged into a new lot only if they belong to the same variety and harvest year. [Am. 104]

Where lots consisting of different certification categories are merged, the new lot shall belong to the category of the component of the lowest category. The merging operation may only be undertaken in a facility and by persons authorised by the competent authority for this specific purpose.


3.   During processing, packaging, storage, or at delivery, lots of PRM may be split into two or more lots.


4.   In cases of merging or splitting of the lots of PRM, as referred to in paragraphs 2 and 3, the professional operator shall keep records concerning the origin of the new lots.


5.   The Commission may, by means of implementing acts, adopt specific requirements for all or certain species of PRM, concerning the maximum size of lots, their identification and labelling, the merging or splitting of lots in relation to the origin of the PRM lots, recording of those operations and labelling following the merging or splitting. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).



Article 14


Packages, bundles and containers



1.   PRM shall be marketed in fastened packages, bundles or containers, bearing a sealing device and marking. In the case of PRM other than seeds 
and seed potatoes
, it may also be marketed in the form of individual plants. [Am. 105]



2.   The packages, bundles and containers referred to in paragraph 1 shall be fastened in such a way, that they cannot be opened without destroying that fastening or leaving traces demonstrating that the package, bundle or container has been opened. The effectiveness of the fastening device shall be ensured, either by incorporating the labels provided for in Articles 15 and 16 in the device or by use of a seal. Packages and containers shall be exempted from this requirement if the fastening cannot be reused.


3.   In the case of pre-basic, basic or certified PRM, those packages, bundles and containers shall be fastened by the competent authority, or by the professional operator under the official supervision of the competent authority. Those packages and containers shall not be refastened unless this is done by the competent authority or by the professional operator under the official supervision of the competent authority. If a package, bundle or a container is refastened, the date of refastening and the details of the responsible competent authority shall be stated on the label referred to in Article 15.


4.   Lots of pre-basic, basic or certified PRM may be repackaged, re-labelled, and re-sealed only under official control or

by the competent authority, or by the professional operator
 under the official supervision of the competent authority. [Am. 106]



5.   By way of derogation from paragraph 1, seeds 
and seed potatoes
 may be marketed from a professional operator directly to a farmer in bulk. [Am. 107]

That professional operator shall be authorized for that purpose by the competent authority. It shall inform the competent authority in advance of such activity and of the lot from which such seed 
and seed potato
 comes. [Am. 108]

Where seed 
and seed potato
 is loaded directly into the farmer’s machinery or trailer, the professional operator and the farmer concerned shall ensure traceability of that seed 
and seed potato
 by issuing and retaining documents indicating the species and variety, quantity, the time of transfer and lot identification. [Am. 109]





5a.
   
                        
The competent authority or the professional operator shall keep a record of the following:










(a)






authorisation, purchase, load and transport of the PRM; and














(b)






quality, identification and traceability of the PRM. [Am. 110]







6.   The Commission may, by means of implementing acts, adopt specific requirements concerning sealing, fastening, size and form of packages, bundles and containers of specific species of PRM, and specify conditions for the marketing of seeds 
and seed potato
 in bulk. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2). [Am. 111]



SECTION 5
Labelling requirements

Article 15


Official label



1.   Pre-basic, basic and certified material and seeds shall be identified, and their compliance with this Regulation shall be attested, through an official label, issued after the conclusion by the competent authority that the requirements referred to in Article 7 have been fulfilled.


2.   The official label shall be issued by the competent authority and bear a serial number given by the competent authority.
It shall be printed by:






(a)


the competent authority 
that issued the official label
, if so requested by the professional operator, or if the professional operator is not authorised to carry out certification under official supervision, by the competent authority in accordance with Article 10; or [Am. 112]











(b)


the professional operator 
or associations of professional operators
, under the official supervision of the competent authority, where the professional operator is authorised to carry out certification under official supervision in accordance with Article 10. [Am. 113]







3.   The official label shall be affixed to the outside of the bundle, package or container by the professional operator under the official supervision of the competent authority, or by a person acting under the responsibility of the professional operator.


4.   The official label shall be newly issued. Adhesive official labels may be used, if so authorised by the competent authority where there is no risk that they can be re-used.


5.   The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Article by establishing the following rules on:






(a)


the digital recording of all actions taken by the professional operators and the competent authorities in order to issue the official label;










(b)


the establishment of a centralised platform that connects the Member States and the Commission to facilitate the processing of, access to, and use of those records;










(c)


the technical arrangements for the issuance of electronic official labels.




Following the adoption of such delegated act, the official label may also be issued in an electronic form (‘electronic official label’).


6.   By way of derogation from paragraphs 1 to 5 
of this Article
, pre-basic, basic material and seed basic material and seed and certified material and seed, imported from third countries pursuant to Article 39, shall be marketed in the Union with the respective OECD label that was accompanying them at import. [Am. 114]




Article 16


Operator’s label


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

operator. The information to be included
 on the outside of a

professional operator’s label may also be printed directly on the plant
 bundle, package or container 
by the professional operator, or by a person acting under the responsibility of the professional operator
. [Am. 115]



Article 17


Content of labels



1.   The official label and the operator’s label, shall be written in at least one of the official Union languages.


2.   The official label and the operator’s label shall be legible, indelible, not modifiable if tampered with, printed on one side, 
made of untearable material unless it is an adhesive label,
 not having been used previously, and easily visible. 
It shall include, where applicable, a reference to the plant variety right and a reference to the register referred to in Article 46 in the case of further intellectual property rights. [Am. 116]



3.   Any space of the official label or the operator’s label apart from the elements mentioned in paragraph 4, may

shall, where relevant,
 be used for additional information by the competent authority. Such information shall be presented in letters not larger than those used for the content of the official label or the operator’s label as referred to in paragraph 4. That additional information shall be strictly factual, it shall not represent advertising material, and shall be related only to the production and marketing requirements or to labelling requirements for genetically modified organisms or category 1 NGT plants as defined in Article 3(7) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation...). [Am. 117]



4.   The Commission shall, by means of implementing acts, specify the content, size, colour and form of the official or operator’s label, as applicable, in relation to the respective categories or types of PRM, for:






(a)


the official label referred to in Article 15(1);










(b)


the operator’s label referred to in Article 16;










(c)


the label for mixtures referred to in Article 21(1);










(d)


the label for preservation mixtures referred to in Article 22(1);










(e)


the label for repackaged and relabelled seeds referred to in Article 23(5);










(f)


the label for PRM belonging to conservation varieties referred to in Article 26(2);










(g)


the label for PRM marketed to final users referred to in Article 28(1), point (a);











(h)




the label for the PRM marketed by certain gene banks, organisations and networks referred to in Article 29;
[Am. 118]












(i)




the label for breeder’s material referred to in Article 31(2);
[Am. 119]











(j)


the label for PRM of not yet registered varieties referred to in Article 32(5);










(k)


the label for PRM authorised in cases of temporary difficulties in the supply referred to in Article 33(2); and










(l)


the label for seeds with a provisional authorisation for marketing referred to in Article 34(3);










(m)


the label for seeds which are not finally certified referred to in Article 35(3);










(n)


the label for PRM imported from third countries referred to in Article 40(1) and (2);












(na)






the label for polyclonal material referred to in Article 9(4). [Am. 120]





That implementing act shall be adopted in accordance with the examination procedure referred to in Article 76(2).


5.   The competent authority may authorise the professional operator to indicate information other than the content referred to in paragraph 4, and other than advertising material, placed at the periphery of the official label, in an area of a size not larger than 20 % of the total area of the official label, bearing the title ‘Non official information’. Such information shall be in letters not larger than those used for the content of the official label as referred to in paragraph 4.



Article 18


Reference to lots


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


Article 19


Non-compliance of PRM with production and marketing requirements


In the case where official controls carried out during the marketing of PRM show that pre-basic, basic, certified seeds or material, or standard seeds or material, have

it has
 not been produced or marketed within the Union in compliance with the respective requirements referred to in Articles 7 or 8, or in the case where the varietal identity and purity of the PRM were not confirmed in the control plot testing in accordance with Article 24

applicable to that PRM
, the competent authorities shall ensure that the professional operator concerned takes the necessary corrective actions concerning the PRM concerned and

,
 its premises and production methods, as appropriate. Those actions shall aim at achieving one or more of the following elements: [Am. 121]







(a)


the PRM concerned complies with the respective requirements;










(b)


the PRM concerned is withdrawn from the market or is used as material other than PRM;










(c)


with the exception of standard seed or standard material, 
heterogeneous seed or heterogeneous material and PRM marketed under the derogations provided for in Articles 27 to 30,
 the PRM concerned is produced or marketed under a lower category, in accordance with the requirements applicable for that category; [Am. 122]











(d)




where applicable,
 the professional operator is

may be
 sanctioned by additional means to the withdrawal or modification of the authorisation referred to in Article 11. [Am. 123]







Article 20


PRM to be only produced and marketed as pre-basic, basic or certified seeds or material



1.   PRM belonging to the genera or species as listed in Annex IV may only be produced and marketed as pre-basic, basic or certified seeds or material.


2.   The Commission is empowered to adopt a delegated act in accordance with Article 75 in order to amend Annex IV.
The delegated act referred to in the first subparagraph shall add a genus or a species to Annex IV, if both the following conditions are fulfilled:






(a)


there is a need for higher guarantees for the quality of seeds belonging to that genus or species; and.










(b)


the costs of the certification activities, necessary to produce and market the respective seed as pre-basic, basic and certified seed are proportionate:






(i)


to the purpose of ensuring food and feed security, or ensuring high value of industrial processing; and










(ii)


to the economic benefits deriving from the highest standards concerning identity and quality of the seed, resulting from the compliance with the requirements for pre-basic, basic and certified seed compared to those for standard seed.








That proportionality shall be based on an overall assessment of the following elements in combination: the importance of the respective genus or species for the Union food and feed security; the volume of its production in the Union; its demand by the professional operators and operators of the food/feed industry; the costs of the production of pre-basic, basic and certified seed compared to the cost of production of other seed of the same genus or species; and the economic benefits derived from the production and marketing of pre-basic, basic and certified seed compared to other seed of the same genus or species.
The delegated act referred to in the first subparagraph shall remove a genus or a species from Annex IV, if one of the conditions set out in the second subparagraph, point (b), points (i) and (ii), is no longer fulfilled.




2a.
   
Upon application by a Member State, the Commission may, by means of implementing acts, authorise a Member State to be released from the obligation to apply the provisions laid down in this Article for the production and marketing of PRM within its territory, specifically pertaining to a genus or species listed in Annex IV, which is not normally reproduced or marketed within its territory. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).




The authorisation referred to in the first subparagraph of this paragraph shall be based on an assessment of the conditions laid down in paragraph 2, second subparagraph, points (a) and (b).




The authorisation referred to in the first subparagraph of this paragraph shall be subject to regular review. The Commission may decide, by means of implementing acts, that the authorisation is to be repealed, if it considers that it is no longer justified in view of the conditions referred to in paragraph 2, second subparagraph, points (a) and (b). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2). [Am. 124]



SECTION 6
Specific requirements for mixtures of seeds, re-packaging of seeds and control plot tests for seeds

Article 21


Mixtures of seeds



1.   Mixtures of certified seed or mixtures of standard seed of various genera or species listed in Part

Parts
 A 
and B
 of Annex I and complying with the requirements of Articles 5 to 8
, whether or not in combination with commercial seed
, as well as of different varieties of those genera or species, may be produced and marketed in the Union, if they fullfill

fulfil
 the requirements of this Article. [Am. 125]

The seeds included in those mixtures shall be accompanied by:






(a)


an official label, where the mixture consists only of certified seeds; or










(b)


an operator’s label, in the case where the mixture consists only of standard seed, or of certified and standard seed

all other cases
. [Am. 126]





For the purposes of the second subparagraph, point (a), the professional operators shall submit to the competent authority the list of constituent varieties 
and commercial seed components
 of the mixture and their ratios, for verification of eligibility of those varieties. [Am. 127]



2.   Μixtures of seeds referred to in paragraph 1 may only be produced by professional operators, which are authorised for that purpose by the competent authority. In order to receive an authorisation for the production of such mixtures, professional operators shall fulfil the following requirements:






(a)


having installed suitable mixing equipment and appropriate procedures ensuring that the finished mixture is uniform and the stated ratio between the component varieties in each container can be achieved;










(b)


having a person in charge who has direct responsibility for the mixing and packaging operation; and










(c)


maintaining a register of seed mixtures and their intended use.






3.   The mixing and packaging operation of the seeds referred to in paragraph 1, point (a), shall be carried out under the supervision of the competent authority.
The mixing operation shall be carried in a manner to ensure that there is no risk of presence of seeds not intended for inclusion and that the resulting mixture is as homogeneous as possible.
The weight of the seed in a single container, which consists of a mixture of both small-seeded species and species of which the seed is larger than the size of wheat, shall not exceed 40 kg.


4.   The Commission may, by means of implementing acts, specify, on the basis of technical and scientific developments and the experience gained from the application of this Article, rules concerning:






(a)


the mixing equipment and procedure;










(b)


maximum lot sizes for particular species and varieties.




Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).



Article 22


Preservation mixtures



1.   By way of derogation from 
Articles 5 to 8 and
 Article 21(1), Member States may authorise the production and marketing of a mixture of seeds of various genera or species listed in Part

Parts
 A
, B and C
 of Annex I, as well as of different varieties of those genera or species, together with seeds of

and
 genera or species of other Parts of that Annex, or of genera or species not listed in that Annex, if such a mixture fulfils

mixtures fulfil
 all of the following conditions: [Am. 128]







(a)



it contributes

they contribute
 to the conservation of genetic resources, or the restoration of the natural environment; and [Am. 129]











(b)



it is

they are
 naturally associated with a particular area (‘source area

region of origin
’) contributing to the conservation of genetic resources or the restoration of the natural environment; [Am. 130]











(c)



it complies

they comply
 with the requirements of Annex V;.
[Am. 131]













(ca)






they do not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) …/… [NGT Regulation] or of a category 1 or 2 NGT plant as defined in Article 3(8) of that Regulation. [Am. 132]





Such mixture constitutes a

mixtures constitute
‘preservation mixture

mixtures
’ and this shall be mentioned on its

their
 label. [Am. 133]



2.   The Commission is empowered to adopt a delegated act, in accordance with Article 75, amending Annex V concerning the following elements:






(a)


authorisation requirements for mixtures of seeds collected directly from a natural place belonging to a defined source area

region of origin
, for the conservation and restoration of the natural environment (directly harvested preservation mixtures); [Am. 134]











(b)


authorisation requirements for crop-grown preservation mixtures;










(c)


use and content of certain species;










(d)


requirements on sealing and packaging;










(e)


requirements for the authorisation of the professional operators.




Those amendments

delegated acts
 shall be based on the experience gathered by the implementation of this Article, and any technical and scientific developments and the improvement of the quality and identification of preservation mixtures. They may concern particular genera or species only. [Am. 135]



3.   Professional operators shall report to the respective competent authorities, for each production season, the amount of preservation mixtures produced and marketed by them.
The Member States shall report on request to the Commission and to the other Member States the amount of preservation mixtures produced and marketed in their territory and, where applicable, the names of competent authorities responsible for plant genetic resources or of organisations recognised for this purpose.



Article 23


Re-packaging and re-labelling of seed
PRM lots
[Am. 136]



1.   Seed

PRM
 lots of pre-basic, basic and certified seed shall be repackaged and relabeled in accordance with this Article, Articles 14 and 15, where this is necessary for splitting or merging of lots. [Am. 137]



2.   The re-packaging and re-labelling of a seed

PRM
 lot shall be conducted by: [Am. 138]







(a)


the professional operator under the official supervision of the competent authority; or










(b)


a seed sampler, who is authorised and supervised for that purpose by, and reports to, the competent authority.




In the case of point (b), the professional operator shall be notified in advance by the competent authority so as to organise its co-operation with the seed sampler.


3.   The professional operator and the seed sampler carrying out re-packaging and re-labelling of seed lots, shall take all steps to ensure that during the operation of re-packaging, the identity and varietal purity of the seed lot is maintained, no contamination occurs, and the resulting seed lot is as homogeneous as possible.


4.   The professional operators and the seed sampler shall keep records, when re-packaging and re-labelling seed lots, for 3 years after the respective re-labelling and re-packaging. The information contained in the records shall include:






(a)


the reference number of the original seed lot;










(b)


the reference number of the repackaged or relabeled seed lot;










(c)


the weight of the original seed lot;










(d)


the weight of the re-packaged or relabeled seed lot;










(e)


the date of final disposal of the lot.




Those records shall be kept in a form allowing to identify and verify the authenticity of the original seed lot, which is subject to re-packaging and re-labelling. They shall be made available to the competent authority on request.


5.   The original seals and labels shall be removed from the seed lot. The professional operators or the seed sampler shall also keep the label, which was replaced, of each component seed lot.
The new labels shall either state the original seed lot reference number or a new seed lot reference number assigned by the competent authority.


6.   Where the competent authority assigns a new seed lot reference number, it shall either keep a record of the former seed lot reference number or ensure that this former number is included on the new labels.


7.   Repackaging of mixtures of certified seed may only be carried out where the professional operator or the seed sampler has established that the ratio of the different components within a mixture will be maintained during the repackaging process.



Article 24


Control plot tests for pre-basic, basic and certified seeds



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






a)


whether the requirements for the next categories or generations are fulfilled. When, as a result of such tests of the immediately descending category or generation, it is established that the varietal identity or purity of the seeds has not been maintained, the competent authority shall not certify seed derived from the lot concerned;










b)


that such seed complies with the respective identity, quality and other certification requirements. When, as a result of such test, it is established that the requirements of Article 7 have not been fulfilled, the competent authority shall withdraw the lot concerned from the market or ensure that it complies with the applicable requirements.






2.   The proportion of these control plot tests for pre-basic, basic and certified seed shall be determined on the basis of a risk analysis concerning possible non-compliance of the seeds with the respective requirements.


3.   On the basis of the risk analysis referred to in paragraph 2, control plot tests shall be carried out through samples taken by the competent authority from the harvested seed.


4.   The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation by setting out rules for the control plot tests of seeds per genera or species. Those rules shall adapt to the development of scientific and technical knowledge and international standards, and may be established per particular genera, species or categories. They may concern the following:






(a)


criteria for the conduct of the risk analysis referred to in paragraph 2;










(b)


the testing procedure;










(c)


evaluation of results of the tests.






5.   In the case of control of varietal identity and purity, the use of bio-molecular techniques may be used as a supplementary tool where the results of the control plot tests referred to in paragraph 1 are non conclusive



Article 25


Control plot tests for standard seeds



1.   After the marketing of standard seeds, the competent authorities shall
, if indicated by the risk analysis,
 carry out control plot tests to check whether the seeds comply with the respective varietal identity and varietal purity requirements, and with other requirements

set out in Article 8 and in Annex III
, as appropriate. [Am. 139]



2.   The proportion of the control plot tests shall be determined on the basis of a risk analysis concerning possible non-compliance of the respective seeds with those requirements. 
Such a risk analysis shall be carried out by the competent authority on the basis of territorial characteristics, the existence of plant health risks in the region, and the track record of the professional operator. [Am. 140]



3.   Based on the risk analysis of non-compliance with the respective rules, the control plot tests referred to in paragraph 1 shall be carried out annually, by using samples taken by the competent authority from homogeneous seed lots. Those tests shall assess identity and varietal purity of the seed concerned, and its germination rate and analytical purity.


4.   In the case of control of varietal identity and purity, the use of bio-molecular techniques may be use as a supplementary tool where the results of the control plot tests referred to in paragraph 1 are non conclusive.


SECTION 7
Derogations from the requirements of Articles 5 to 25

Article 26


PRM belonging to conservation varieties



1.   By way of derogation from Article 20, PRM 
of genera and species listed in Annex IV and
 belonging to a conservation variety registered in a national variety register referred to in Article 44(1), point (b), may be produced and marketed in the Union as standard seed or material, if it complies with all the requirements concerning standard seed and material for the respective species, as referred to in Article 8. [Am. 141]



2.   PRM referred to in paragraph 1 shall be accompanied by an operator’s label with the indication ‘Conservation variety’.


3.   A professional operator who uses this derogation shall annually notify to the competent authority this activity, with regard to the species and quantities concerned. [Am. 142]




Article 27


PRM of heterogeneous material



1.   By way of derogation from Article 5, PRM of heterogeneous material
, with the exclusion of the production and marketing of fodder plants listed in Annex I,
 may be produced and marketed within the Union without belonging to a variety. The

PRM of
 heterogeneous material shall be notified to and register

registered
 by the competent authority prior to its production and/or marketing, in accordance with the requirements set out in Annex VI. [Am. 143]



2.   By way of derogation from Articles 7(1), (3) and

Article 7, Article 8,
 Article 8(1), (3)

13(2) and (5) and Articles 18 and 20
, the PRM of heterogeneous material referred to in paragraph 1 shall be produced and marketed in accordance with the requirements set out in Annex VI. [Am. 144]



3.   The Commission is empowered to adopt a delegated act in accordance with Article 75, amending Annex VI. Those amendments may concern all, or particular genera or species only, and shall:






(a)


improve the provision of information in notifications, description and identification of heterogeneous PRM, on the basis of experience gained by the application of the respective rules;










(b)


improve the rules concerning packaging and labelling of heterogeneous PRM, on the basis of the experience gained from the checks carried out by the competent authorities;










(c)


improve the rules on maitenance

maintenance
 of heterogenous PRM
, where applicable
, on the basis of the emergence of best practices. [Am. 145]





Those amendments shall be adopted in order to adapt to the development of the respective technical and scientific evidence, and the international standards, and to follow up on the experience gained by the application of this Article concerning all or certain genera or species only.


4.   Any professional operator producing and/or intending to market PRM of heterogeneous material shall submit a notification to the competent authority prior to marketing. If no further information is requested by the national competent authority within a time determined

three months
 by the competent authority, the PRM of heterogeneous material may be marketed. [Am. 146]



5.   The professional operator shall ensure the traceability of the PRM of heterogeneous material by keeping information allowing to identify the professional operators which have supplied them with the initial material used for the production (parental material) of heterogeneous material.
The professional operator shall keep that information for 5 years.
The professional operator producing PRM of heterogeneous material intended for marketing shall also record and keep the following information:






(a)


the name of the species and denomination used for each notified heterogeneous material;










(b)


the type of technique used for the production of heterogeneous material as referred to in paragraph 1;










(c)


the characterisation of the notified heterogeneous material;










(d)


the breeding 
or production
 location of the PRM of heterogeneous material and production location; [Am. 147]











(e)


the surface area for the production of PRM of heterogeneous material and quantity produced.




The competent authorities shall have access to the information referred to in this paragraph
, in the context of post-marketing controls
. [Am. 148]



6.   Article 54 shall apply accordingly for the suitability of the denomination of heterogeneous material.


7.   Heterogeneous material as notified pursuant to paragraph 1, shall be registered by the competent authorities in a dedicated register (‘heterogeneous material register’). 
The registration shall be free of charge to the professional operator. [Am. 149]

The competent authorities shall keep, update and publish that register, 
make it accessible online
 and notify immediately its content and updates to the Commission. [Am. 150]




Article 28


PRM marketed to final users



1.   By way of derogation from Articles 5 - 12, 14, 15 and 20, PRM may be marketed to final users, if it complies with all of the following requirements:






(a)


to bear an operator’s label with the denomination of the PRM and the indication ‘Plant reproductive material for final users – not officially certified’ or, in the case of seeds, ‘Seeds for final users – not officially certified’;










(b)


in case not belonging to a variety registered in a national variety register referred to in Article 44, to have a description made publicly available, on the basis of a private documentation, in a commercial catalogue kept by the professional operator. This private documentation shall be made available by the professional operator upon request to the competent authority;










(c)


to be practically free from quality pests and any defects likely to impair its quality as reproductive material, and shall have satisfactory vigour and dimensions in respect of its usefulness as PRM, and, in the case of seeds, shall have satisfactory germination capacity; and










(d)


to be marketed as individual plants, or, in the case of seeds and tubers, in small packages.




A professional operator who uses this derogation shall annually notify this activity to the competent authority, with regard to the species and quantities concerned

. [Am. 151]




2.   The Commission shall, by means of implementing acts, adopt rules concerning the size, form, sealing and handling requirements concerning the small packages referred to in paragraph 1 point (d).


Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).
[Am. 152]




Article 29


PRM marketed to,
by,
and between gene banks,
and within organisations and networks dedicated to dynamic conservation

[Am. 153]



1.   By way of derogation from Articles 5 to 25, PRM may be marketed to, or

by,
 between, gene banks,

and within
 organisations and networks with a statutory objective, or an objective official notified to the competent authority, to conserve plant genetic resources,

including farmers, dedicated to dynamic conservation,
 whereby any of the activities are carried out for non-profit purposes. [Am. 154]

It can

may also
 be marketed as well from those gene banks,

conservation
 organisations and networks 
or their members
 to persons who carry out 
dynamic
 conservation of that PRM as final consumers, for non-profit

or for farming
 purposes. [Am. 155]

In the cases provided for in the first and the second subparagraphs, PRM shall fulfil the following requirements:






(a)


be listed in a register kept by those gene banks,

conservation
 organisations and networks with an appropriate

a basic
 description of that PRM
, in the event that it does not belong to a variety registered in a national variety register referred to in Article 44
; [Am. 156]











(b)


be conserved by those gene banks,

conservation
 organisations and networks, and
, where quantities allow it,
 samples of that PRM be made available by them to the competent authorities upon request; and [Am. 157]











(c)


be practically free from quality pests and any defects likely to impair its quality as a reproductive material, and have satisfactory vigour and dimensions in respect of its usefulness as PRM, and, in the case of seeds, have satisfactory germination capacity. [Am. 158]







2.   The gene banks,

conservation
 organisations and networks shall notify the competent authority of the use of the derogation referred to in paragraph 1 and the species concerned. [Am. 159]




Article 30



Seed
PRM exchanged in kind between farmers
[Am. 160]



1.   By way of derogation from Articles 5 -

to
 25, farmers may exchange seeds

PRM
 in kind 
or for monetary compensation
, if such seeds fulfill

PRM fulfils
 all of the following conditions: [Am. 161]







(1)



are

is
 produced in the respective farmer’s own premises; [Am. 162]











(2)



are

is
 derived from the respective farmer’s own harvest

crops
; [Am. 163]











(3)



are

in the case of seeds, is
 not subject to a service contract conducted by the respective farmer with a professional operator performing seed production; and [Am. 164]











(4)


the seed

PRM
 is used for dynamic management 
and conservation
 of 
the
 farmer’s own seed

PRM
 for the purpose of contributing to agro-diversity. [Am. 165]







2.   Such seeds

PRM
 shall fulfil all of the following requirements: [Am. 166]







(a)


not to belong to a to variety for which plant variety rights have been granted in accordance with Regulation (EC) No 2100/94;










(b)


to be limited to small

in
 quantities, defined by the competent authorities for specific species per year and per farmer, without using commercial intermediaries or public offer of marketing; and [Am. 167]











(c)


to be practically free from quality pests and any defects likely to impact their quality as

and for
 seeds, and shall have satisfactory germination capacity. [Am. 168]








3.   Member States shall annually notify to the Commission and the other Member States the amounts per species defined in accordance with paragraph 2, point (b).
[Am. 169]





Article 30a




Maximum quantity of each species which may be exchanged





The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation, in order to set up, for each species, the maximum quantity which may be exchanged, referred to in Article 30(2), point (b). That quantity shall be set taking into consideration the needs of small-scale professional farmers as well as plant health risks, while promoting the development and maintenance of diverse farming systems. [Am. 170]




Article 31




Breeder’s seed





1.   By way of derogation from Articles 5 -25, a competent authority may authorise operators to market seed of generations preceeding the pre-basic category to another operator, for the purpose of breeding new varieties (breeders’ seed).


The competent authority shall determine the duration of the authorisation and quantities per species, when granting that authorisation.




2.   The PRM referred to in paragraph 1 shall be accompanied by a label issued by the professional operator, with the indication ‘breeder’s seed’, that shall be affixed, as applicable, on the container, bundle or package of that material.


It shall be sealed and bear a lot number to be used for identification purposes and control plot testing before it is used as pre-basic seed.
[Am. 171]




Article 32


PRM of not yet registered varieties



1.   By way of derogation from Article 5, a competent authority may authorise professional operators to produce and market, for the purposes of multiplication, pre-basic seeds, pre-basic material, basic seeds and basic material
, standard seed and standard material
 belonging to a variety not yet registered in a national variety register, referred to in Article 44, if all of the following requirements are fulfilled: [Am. 172]







(a)


the respective marketing sectors need to acquire that material or seeds in advance, so as to have sufficient stocks available, when the respective variety will be registered; and










(b)


there is no risk that such an authorisation will lead to insufficient identification or quality of the marketed PRM; and










(c)


the respective PRM belongs to a variety for which an application has been submitted for registration in a national variety register pursuant to Article 55.




Such authorisation may be granted for a maximum period of 3 3years

years
 in the case of seeds, and 5 years in the case of PRM other than seeds, and for small

limited
 quantities per species as specified by the competent authority 
in correlation with the volume of production at Member State level
. [Am. 173]



This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC. [Am. 174]



2.   By way of derogation from Articles 5, 7, 10 -12, 15, 20, 23 and 24, a competent authority may authorise professional operators for a maximum period of 3 years in the case of seeds, and 5 years in the case of PRM other than seeds, and for small

limited
 quantities per species as determined by the competent authority
, in correlation with the volume of production at Member State level
, to produce and market PRM belonging to a variety not yet registered in a national variety register referred to in Article 44, if all of the following requirements are fulfilled: [Am. 175]







(a)


the authorised PRM is only used for tests or trials carried out by professional operators, in order to gather information on the cultivation or use of the variety concerned on farms;










(b)


the marketing is made to those professional operators only, with no further marketing thereafter, who produces a report on results of the tests or trials, in relation to the information on the cultivation or use of that variety;










(c)


there is no risk that such an authorisation will lead to insufficient identification or quality of the marketed PRM; and










(d)


the authorised PRM complies with the requirements of standard PRM for the respective species.






3.   In order to obtain the authorisation referred to in paragraphs 1 and 2, the professional operator shall submit to the competent authorities a request, indicating the information about the following:







(a)




the production of the stock of pre-basic seeds and material, and basic seeds and material, and certified seeds and material available before the variety registration and the envisaged tests and trials for the standard seeds and material;
[Am. 176]











(b)


the breeder’s reference of the variety indicated in the application for registration;










(c)


the procedure for the variety maintenance, where applicable;










(d)


the authority before which the application for the registration of the variety is pending, and the reference assigned to that application.











(e)




the site where production will take place; and
[Am. 177]












(f)




the quantities of the material to be made available on the market.
[Am. 178]







4.   The Member States whose competent authorities have granted the authorisation referred to in paragraphs 1 and 2 shall annually inform the other Member States and the Commission thereof.


5.   PRM referred to in paragraphs 1 and 2 shall be accompanied by a label, issued by the professional operator, with the indication ‘Not yet listed variety’.



Article 33


Authorisation in cases of temporary difficulties in the supply



1.   In order to remove temporary difficulties in the general supply of PRM that may occur in the Union due to adverse climatic conditions or other unforeseen circumstances, the Commission, by means of an implementing act, may

is empowered to adopt delegated acts in accordance with Article 75, amending this Regulation, in order to
 authorise Member States for a maximum period of 1 year, to allow the marketing of the categories of pre-basic, basic or certified material or seed, which fulfils one of the following conditions: [Am. 179]







(a)


belongs to a variety not included in a national variety register; or










(b)


complies with less stringent requirements than the requirements referred to in Article 7(1).




Point (a) shall apply by way of derogation from Articles 5, and point (b) shall apply by way of derogation from Articles 7(1).
That implementing act may

delegated act shall
 set out the maximum quantities, which may be marketed per genera or species. [Am. 180]


That implementing act shall be adopted in accordance with the examination procedure referred to in Article 76(2).
[Am. 181]



2.   PRM referred to in paragraph 1 shall be accompanied by a label that states, as applicable, that the PRM in question belongs to a non-registered variety or fulfils less stringent quality requirements than the ones referred to in Article 7(1).


3.   The Commission may

is empowered to adopt delegated acts in accordance with Article 75, amending this Regulation, in order to
 decide, by means of an implementing act, that the authorisation concerned has to be repealed or amended, if it concludes that 
it
 is no longer necessary or proportionate to the objective of removing the temporary difficulties in the general supply of the PRM concerned. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 76(2).
[Am. 182]



4.   Member States may, without obtaining the authorisation of the Commission referred to in paragraph 1, allow, for a maximum period of 1 year, and for a limited amount of quantities per genera or species as necessary for supply difficulties in question, the production and marketing of seeds that fulfil germination rates reduced up to 15 percentage points compared to the ones set out pursuant to the implementing act referred to in Article 7(3).




4a.
   
The Member State that uses the derogation referred to in paragraph 4 shall notify it to the Commission. [Am. 183]





4b.
   
This exceptional authorisation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC. [Am. 184]




Article 34


Provisional authorisation in urgency cases for marketing of seeds not certified as complying with applicable quality requirements



1.   Competent authorities may authorise, for a maximum period of 1 month, the marketing of seeds as pre-basic, basic or certified seeds, before they have been certified to comply with the requirements referred to in Article 7 concerning germination, maximum content of other species or purity, if it is necessary to make that seed rapidly available on the market to address urgent needs of supply.


2.   The authorisation referred to in paragraph 1 shall be granted on the basis of a an analytical report on the seed, issued by the professional operator, attesting its compliance with the requirements concerning germination, content of other species or purity, adopted pursuant to Article 7(1).
The name and address of the first recipient of the seeds shall be submitted to the competent authority by the professional operator. The professional operator shall keep the information on the provisional analytical report at the disposition of the competent authority.


3.   The seeds referred to in paragraph 1 shall bear a label indicating ‘Provisional authorisation for marketing’.



Article 35


PRM which is not yet certified



1.   PRM which has been produced in the Union, but has not yet been certified as pre-basic, basic or certified seed pursuant to Article 7, may be marketed with a reference to any of those categories, if all of the following requirements are fulfilled:






(a)


prior to the harvesting, a field inspection has been carried out by the competent authority, or the professional operator under the official supervision of the competent authority, and that inspection has confirmed compliance of that PRM with the production requirements referred to in Article 7(1);










(b)


it is in the process of being certified by the competent authority, or by the professional operator under the official supervision of the competent authority; and










(c)


the requirements set out in paragraphs 2 to 5

5a
 are fulfilled. [Am. 185]







2.   PRM referred to in paragraph 1 may be marketed only by the professional operator who has produced that PRM to the professional operator who is to carry out the certification. Such PRM may not be further transferred to any other person before its final certification.


3.   PRM referred to in paragraph 1, shall be accompanied by a label, issued by the professional operator, with the indication ‘Seeds/Material not yet finally certified’.


4.   If the competent authority, where the PRM has been harvested (‘competent authority of production’), and the competent authority where the PRM is certified pursuant to Article 7 (‘competent authority of certification’) are different, they shall exchange the relevant information concerning the production and marketing of that PRM.


5.   PRM which has been harvested in a third country, but has not yet been certified as pre-basic, basic or certified material pursuant to Article 7, may be marketed in the Union by reference to any of those categories, if:






(a)


a decision on equivalence has been adopted pursuant to Article 39 concerning that third country;










(b)


the requirements set out in paragraph 1, points (a) and (b), paragraphs 2 and 3, are fulfilled, and the professional operators of the third county concerned have been subject to the official supervision of their competent authorities;










(c)


the competent authorities of the Member State and the third country concerned exchange between themselves the relevant information concerning the marketing of that material; and










(d)


on request, the competent authorities of the third country concerned provide all relevant production information to the competent authority of the Member State of certification.




For the purposes of this paragraph, references made in paragraphs 1 - 5 to the competent authority of production shall be construed as references made to the competent authority of the third country concerned, and references made therein to the requirements set out pursuant to Article 7(1) shall be construed as references made to equivalent requirements of the third country, as recognised pursuant to Article 39(2).




5a.
   
This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC. [Am. 186]




Article 36


More stringent production and requirements



1.   The Commission, by means of implementing acts, may authorise the Member States to impose, with regards to production and marketing of PRM, more stringent production or marketing requirements than those referred to in Articles 7 and 8, in all or part of the territory of the Member State concerned, provided that those more stringent requirements correspond to specific production conditions in, and agro-climatic needs, of
,
 that Member State in regard to the respective PRM 
and do not prohibit, impede or restrict the free movement of PRM that is in conformity with this Regulation
. [Am. 187]

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).


2.   In order to obtain the authorisation referred to in paragraph 1, Member States shall submit to the Commission a request setting out:






(a)


the draft provisions containing the proposed requirements; and










(b)


a justification on the necessity and proportionality of such requirements 
in light of possible additional costs of production and marketing
. [Am. 188]







3.   The authorisation referred to in paragraph 1 shall be granted only if the following conditions are fulfilled:






(a)


the implementation of the draft provisions, as referred to in paragraph 2, point (a), ensures the improvement of the identity and quality of the PRM concerned, and it is justified by the specific agricultural or climatic conditions of the Member State concerned; and










(b)


the draft provisions are necessary and proportionate to the objective of the measure referred to in paragraph 2, point (a).






4.   Where applicable, each Member State shall, by … [one year after date of application of this Regulation], review the measures it has adopted pursuant to Article 5 of Directive 66/401/EEC, Article 5 of Directive 66/402/EEC, Article 7 of Directive 2002/54/EC, Article 24 of Directive 2002/55/EC, Article 5 of Directive 2002/56/EC and Article 7 of Directive 2002/57/EC, and either repeal those measures or amend them to comply with the production and marketing requirements set out in, and adopted pursuant to, Articles 7 and 8.
The Member State concerned shall inform the Commission and the other Member States of those actions.
The Commission may, by means of implementing acts, decide that the measures, as referred to in the first subparagraph, are to be repealed or amended, in case they are considered to be unnecessary and/or disproportionate to their objective. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).



Article 37


Emergency measures



1.   Where the production or marketing of PRM is likely to constitute a serious risk to human, animal or plant health, environment or cultivation of other species, and such risk cannot be contained satisfactorily by means of measures taken by the Member State concerned, the Commission shall take, without delay, by means of implementing acts, any appropriate interim emergency measures. Such measures shall be limited in time. They may include provisions restricting or prohibiting the marketing of the PRM concerned or laying down appropriate conditions for its production or marketing, depending on the gravity of the situation.


By way of derogation from the first subparagraph, in the case of lack of compliance with refuge requirements or with other requirements imposed on cultivation of varieties containing or consisting of genetically modified organisms, the measures restricting or prohibiting the marketing of the PRM concerned shall be put in place until full compliance is restored. [Am. 189]

Such measures may be taken on the Commission’s own initiative or at the request of a Member State. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).
On duly justified imperative grounds of urgency to address a serious risk to human health, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 76(3).


2.   Where a Member State officially informs the Commission of the need to take emergency measures and the Commission has not acted in accordance with paragraph 1, that Member State may adopt the appropriate
, proportionate and time-limited
 interim emergency measures. Those measures may include provisions restricting, prohibiting or laying down appropriate conditions for the production or marketing of PRM within the territory of that Member State, depending on the gravity of the situation. The Member State concerned shall immediately inform the other Member States and the Commission of the measures adopted 
and the time period they cover
, stating the grounds for its decision. 
That approach permits a Member State to act quickly and effectively in emergency situations to protect health, the environment and economic interests. [Am. 190]



3.   The Commission may decide, by means of implementing acts, that the national interim emergency measures referred to in paragraph 2 are to be repealed or amended, if it considers that those measures are not justified in view of the respective risk as referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2). The Member State concerned may maintain its national interim emergency measures until the date of application of the implementing act(s) referred to in this paragraph.



Article 38


Temporary experiments to seek improved alternatives to provisions of this Regulation



1.   By way of derogation from Articles 2, 5, 6, 7, 8 and

, 9,
 20, 
26, 27 and 47 to 53
, the Commission may, by means of implementing acts, decide on the organisation of

is empowered to adopt delegated acts in accordance with Article 75 in order to supplement this Regulation by organising
 temporary experiments to seek improved alternatives to provisions of this Regulation concerning the genera and species it applies to, the requirements for belonging to a registered variety,

PRM or
 the production and marketing requirements for pre-basic, basic, certified and standard material or seed, and the obligation to belong to pre-basic, basic and certified material or seed
, production and marketing requirements for heterogeneous material, and the obligation to belong to pre-basic, basic and certified material or seed
. [Am. 191]

Those experiments may take the form of technical or scientific trials examining the feasibility and appropriateness of new requirements compared to the ones set out in Articles 2, 5, 6, 7, 8 and

, 9,
 20
, 26, 27 and 47 to 53
 of this Regulation. [Am. 192]



2.   The implementing

delegated
 acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 76(2) and shall specify one or more of the following elements: [Am. 193]







(a)


the genera or species concerned;










(b)


the conditions of the experiments per genera or species;










(c)


the duration of the experiment;










(d)


the monitoring and reporting obligations of the participating Member States.




Those 
delegated
 acts shall adapt to the evolution of techniques for production of the PRM concerned, as

and
 shall be based on any comparative trials carried out by the Member States. [Am. 194]



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

to 9,
 20
, 26, 27 and 47 to 53
. [Am. 195]



SECTION 8
Imports from third countries

Article 39


Imports on the basis of Union equivalence



1.   PRM may only be imported from third countries, if it is established, pursuant to paragraph 2, that it fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union.
However, no such import shall be allowed, and no

not be authorised, nor shall
 such equivalence shall be recognised pursuant to

under
 paragraph 2, for the preservation mixtures such as those

PRM
 referred to in Article 22, and for PRM such as that subject to the derogations of Articles 26 - 30

22 to 29, except where it originates in neighbouring countries
. [Am. 196]



2.   The Commission may recognise, by means of implementing acts, that PRM of specific genera, species οr categories produced in a third country, or particular areas of a third country, fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union, on the basis of all of the following:






(a)


a thorough examination of the information and data provided by the third country concerned;










(b)


an audit carried out by the Commission in the third country concerned, showing that the PRM concerned fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union, where that audit has been considered necessary by the Commission; and










(c)


in the case of seeds, the fact that this the country concerned participates in the OECD Schemes for the Varietal Certification of Seed moving in International Trade and implements the methods of the International Seed Testing Association (ISTA), or, where applicable, complies with the rules of the Association of Official Seed Analysts (AOSA).




For that purpose, the Commission shall examine:






(a)


the third country’s legislation on the species concerned;










(b)


the structure of the competent authorities of the third country and its control services, the powers available to them, the guarantees that can be provided with regard to the application and enforcement of the legislation of the third country applicable to the sector concerned, and the reliability of the official certification procedures;










(c)


the performance by the competent authorities of the third country of adequate official controls concerning the identification and quality of the PRM of the species concerned;










(d)


the guarantees given by the third country that:






(i)


the conditions applied to the production sites from which PRM are exported to the Union comply with requirements that are equivalent to those referred to in this Article; and










(ii)


those production sites are subject to regular and effective controls by the competent authorities of the third country.








The Commission may also carry out audits to verify the compliance with points (b) to (d) of the second subparagraph.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).


3.   The implementing act referred to in paragraph 2 may provide for one or more of the following elements, as appropriate for the respective PRM:






(a)


conditions relating to inspections in the production site, carried out in third countries;










(b)


in the case of seeds, conditions relating to the issuance by the third country of a certificate provided by the International Seed Testing Association;










(c)


conditions relating to seed not yet finally certified;










(d)


conditions relating to packaging, sealing and marking of PRM;










(e)


conditions relating to the production, identity and marketing of PRM, in addition to the ones provided for by the third country’s legislation, if so needed to address particular aspects concerning the identity and quality of that PRM;










(f)


requirements to be fulfilled by the professional operators producing and marketing that PRM.






4.   The Commission may, by means of implementing acts, recognise that the controls on variety maintenance carried out in the third country afford the same guarantees as those provided for in Article 72(1), (2) and (4), if varieties registered in a national variety register or in the Union variety register are to be maintained in the third country concerned.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).



Article 40


Labelling and information to be provided for the PRM imported from third countries



1.   Pre-basic, basic and certified seeds referred to in Article 39 may only be imported from third countries, if they are accompanied by an OECD label.
Pre-basic, basic and certified material referred to in Article 39 may only be imported from third countries if it is accompanied by an official label issued by the competent authority of the third country concerned.
Those labels shall contain all of the following information:






(a)


the indication ‘meets EU rules and standards’;










(b)


the species, variety, category and lot number of the PRM concerned;










(c)


the date of closure, in case of marketing in containers or packages;










(d)


the third country of production and the respective competent authority;










(e)


where applicable, the last third country from which the PRM is imported and the last third country where the PRM has been produced;










(f)


in the case of seeds, the declared net or gross weight of the imported seeds or declared number of imported lots of seeds;










(g)


the name of the person

final user, farmer or professional operator
 importing the PRM. [Am. 197]







2.   Standard seed and material referred to in Article 39 may only be imported from third countries, if it is accompanied by an operator’s label containing all of the following information:






(a)


the indication ‘meets EU rules and standards’;










(b)


the species, variety, category and lot number of the PRM concerned;










(c)


the date of closure, in case of marketing in containers or packages;










(d)


the third country of production;










(e)


where applicable, the last third country from which the PRM is imported and the last third country where the PRM has been produced;










(f)


in the case of seeds, the declared net or gross weight of the imported seeds or declared number of imported lots of seeds;










(g)


the name of the person

final user, farmer or professional operator
 importing the PRM. [Am. 198]







3.   PRM may only be imported into the Union after the electronic submission of the information referred to in paragraph 1 or 2 by the importer to the competent authority of the Member State of import.


4.   Member States shall immediately notify the Information management system for official controls (IMSOC), referred to in Article 131 of Regulation (EU) 2017/625, of all established non-compliances of the imported PRM concerning the requirements of paragraphs 1 and 2.


CHAPTER III
REQUIREMENTS FOR PROFESSIONAL OPERATORS

Article 41


Obligations of professional operators producing PRM


Professional operators, which produce PRM 
with the aim of commercial exploitation
, shall: [Am. 199]







(a)


be established in the Union;










(b)


be registered in the register referred to Article 65 of Regulation (EU) 2016/2031, in accordance with Article 66 of that Regulation;










(c)


be available personally, or designate another person, to liaise with the competent authorities for facilitating the official controls;










(d)


identify and monitor the critical points of the production process, or of the marketing, which may influence the identity and quality of PRM;










(e)


keep records of the monitoring of the critical points referred to in point (b)

(d)
 and provide them for examination when requested by the competent authorities; [Am. 200]











(f)


ensure that lots of PRM remain separately identifiable;










(g)


keep updated information on the address of the premises and other locations used for the production of PRM;










(h)


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










(i)


take measures, where appropriate, for the maintenance of the identity of the PRM in accordance with the requirements of this Regulation;










(j)


make available on request of the competent authorities any contracts with third parties.






The requirements laid down in paragraph 1, points (d) and (e), shall not apply to micro-enterprises. [Am. 201]



The activities referred to in Articles 29 and 30 shall not be subject to the provisions of this Article. [Am. 202]



Article 42


Traceability



1.   Professional operators shall ensure that PRM is traceable at all stages of production and marketing.


2.   For the purposes of paragraph 1, professional operators shall keep information allowing them to identify:






(a)


the professional operators, which have supplied them with the seeds and the material concerned;










(b)


the persons to whom they have supplied PRM and the PRM concerned, except in case of final users.




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


3.   Professional operators shall keep records of the PRM and the professional operators and persons referred to in paragraph 2 for 3 years after that material has been respectively supplied to or by them.




3a.
   
The activities referred to in Articles 29 and 30 shall not be subject to the provisions of this Article. [Am. 203]




Article 43


Annual notification of the intended production and certification of pre-basic, basic and certified seed and material


Every year, professional operators shall notify the competent authorities about:






(a)


their intention to produce pre-basic, basic and certified material or pre-basic, basic and certified seed, at least one month before the beginning of that production; and [Am. 204]











(b)


the production of pre-basic, basic and certified material that started in previous years and continues in the year concerned.




That notification shall state the plant species, varieties and categories concerned and the exact location of production.

CHAPTER IV
VARIETY REGISTRATION
SECTION 1
Variety registers

Article 44


Establishment of national variety registers



1.   Each Member State shall establish and publish, in electronic format, and shall keep 
permanently
 updated a single national register of varieties (‘national variety register’) containing: [Am. 205]







(a)


all varieties registered pursuant to the procedure set out in Articles 55 - 68;










(b)


the conservation varieties referred to in Article 26 and registered pursuant to Article 53.






2.   PRM belonging to a variety registered in at least one national variety register may be produced and marketed in the Union, in accordance with this Regulation.


3.   Following the establishment of their national variety registers, as well as following any of their updates, Member States shall immediately notify them to the Commission for inclusion in the Union variety register referred to in Article 45.


4.   This Article, and Articles 45 to 74, may not apply to varieties which are bred solely as components of hybrid varieties.



Article 45


Establishment of a Union variety register



1.   The Commission shall establish, publish, in an electronic format, and keep updated a single register of varieties (‘the Union variety register’).


2.   The Union variety register shall include the varieties, registered in national variety registers and notified in accordance with Article 44
, and shall be updated monthly
. [Am. 206]

The Union variety register may be accessible by an electronic portal containing other registers of plant variety rights, forest reproductive material or other plants.



Article 46


Contents of the national and Union variety registers



1.   The national variety registers and Union variety register shall contain all the elements set out in Annex VII, concerning the varieties referred to in Article 44(1), point (a).
In the case of the conservation varieties referred to in Article 44(1), point (b), those registers shall indicate at least a brief summary of the officially recognised description, the initial region of their origin, their denomination and the person that maintains them.


2.   The Commission is empowered to adopt a delegated act in accordance with Article 75, in order to amend Annex VII 
by adding elements that need to be included in the variety registers
, taking into account the technical and scientific developments, and on the basis of gained experience indicating the need of competent authorities or professional operators to obtain more precise information about the registered varieties. [Am. 207]



SECTION 2
Requirements for registration of varieties

Article 47


Requirements for registration in national variety registers



1.   Varieties shall be registered in a national variety register in accordance with Articles 55 to 68, only if:






(a)


they have:






(i)


an official description showing compliance with the requirements of distinctness, uniformity and stability set out in Articles 48, 49 and 50, and
, in the case of species listed in Part A except turf grasses, and in Parts D and E of Annex I,
 fulfil the requirements for satisfactory value for sustainable cultivation and use, as set out in Article 52; or [Am. 208]











(ii)


an officially recognised description pursuant to Article 53, if they are conservation varieties;














(b)


they bear a denomination deemed suitable pursuant to Article 54;










(c)


where the varieties contain or consist of genetically modified organisms, the organism is authorised for cultivation in the respective Member State pursuant to Article 19 of Directive 2001/18/EC or Articles 7 and 19 of Regulation (EC) 1829/2003, or, where applicable, in the respective Member State in accordance with Article 26b of Directive 2001/18/EC;










(d)


where the varieties contain or consist of a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation...), that plant has obtained a declaration of category 1 NGT plant status pursuant to Article 6 or 7 of that Regulation or is progeny of such plants;










(e)


where the varieties contain or consist of a category 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation), that plant has been authorised pursuant to Chapter III of that Regulation;










(f)


where the varieties are tolerant to herbicides, they are subject to cultivation conditions for the production of PRM and for any other purpose, adopted pursuant to paragraph 3 or, in the case

event that
 they have not been adopted, as adopted by the competent authorities responsible for registration, 
and, in the event that the varieties are to be cultivated in another Member State, those conditions shall be adopted by the respective competent authority, in order
 to avoid the development of herbicide resistance in weeds due to their use; 
when a plan for cultivation conditions has already been established by a Member State, those conditions shall, where appropriate, be extended to the registrations of subsequent varieties with similar characteristics within that Member State; [Am. 209]











(g)


where the varieties have particular characteristics other than the ones referred to in point (f) that may lead to undesirable agronomic effects, they are subject to cultivation conditions for the production of PRM and any other purpose, adopted pursuant to paragraph 3 or, in the case

event that
 they have not been adopted, as adopted by the competent authorities responsible for their registration, 
and, in the event that the varieties are to be cultivated in another Member State, adopted by the respective competent authority in that Member State, in order
 to avoid those particular undesirable agronomic effects, such as the development of resistance of pests to the respective varieties or undesirable effects on pollinators
; when cultivation conditions have already been established by a Member State, those conditions shall, where appropriate, be extended to the registrations of subsequent varieties with similar characteristics within that Member State
. [Am. 210]





A variety may not be registered with both an official description and an officially recognised description.


2.   The Commission shall adopt, by means of implementing acts, specific requirements 
for carrying out the examinations in respect of trial design and growing conditions
 concerning: [Am. 211]







(a)


distinctness, uniformity and stability per genera or species of varieties, as referred to in paragraph 1, point (a), based on the applicable protocols of the International Union for the Protection of new Varieties of Plants (UPOV), protocols established by the CPVO, or other relevant technical and scientific evidence; and










(b)


specific requirements concerning the distinctness, uniformity and stability per genera and species, as referred to in point (a), for organic varieties suitable for organic production, as defined in Article 3 of Regulation (EU) 2018/848, based on the applicable protocols established by UPOV or the CPVO, and in particular by adjusting the requirements concerning uniformity;




Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).
They shall adapt the respective requirements to the development, where applicable, of international standards, and the new scientific and technical knowledge.
Until the requirements referred to in point 2(b) are established, the assessment of uniformity of varieties suitable for organic production, other than the varieties referred to in Article 68(1), shall be carried out on the basis of off-types. For self-pollinating species, a population standard of 10 % and an acceptance probability of at least 90 % shall be applied. For open pollinated out-crossing species, a population standard of 20 % shall be applied and an acceptance probability of at least 80 % shall be applied.


3.   The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation with the minimum 
requirements for the
 cultivation conditions to be adopted by the competent authorities pursuant to paragraphs 1(f) and (g),

paragraph 1, points (f) and (g),
 concerning: [Am. 212]








(i)

(a)




measures in the field, including crop rotation; [Am. 213]












(ii)

(b)




monitoring measures; [Am. 214]












(iii)

(c)




the mode of notification of the conditions referred to in point (i)

(a)
 to the Commission and the other Member States; [Am. 215]












(iv)

(d)




rules for reporting from professional operators to the competent authorities concerning the application of the conditions referred to in point (i)

(a)
; [Am. 216]












(v)

(e)




the indication of the conditions referred to in point (i)

(a)
 in the national variety registers. [Am. 217]





Those conditions shall be based on the latest scientific and technical knowledge.


4.   For the purpose of registering a variety in its national variety register, a competent authority shall accept, without any further examination, an official 
description, an officially recognised
 description or an official examination of the requirements for value for sustainable cultivation and use, as referred to in paragraph 1, point (a)(i), which has been produced by a competent authority of another Member State 
if equivalent recognition measures exist between the two competent authorities
. [Am. 218]




Article 48


Distinctness



1.   For the purposes of the official description, referred to in Article 47(1), point (a), a variety shall be deemed to be distinct, if it is clearly distinguishable, by reference to the expression of the characteristics that results from a particular genotype or combination of genotypes, from any other variety whose existence

which
 is commonly known on the date of the submission of the application established in accordance with Article 58. [Am. 219]



2.   The existence of another variety, as referred to in paragraph 1, shall be deemed to be commonly known, if one or more of the following conditions are complied with:






(a)


the variety is included in a national variety register 
or documentation provided to the competent authority by natural or legal persons involved in selling PRM to final users or in dynamic conservation
; [Am. 220]











(b)


an application for registration of the variety, or an application for granting a plant variety right in respect of that variety, has been filed in the Union; or










(c)


an official description of that variety exists in the Union, it is commonly known worldwide, or the technical examination has been conducted pursuant to Article 59.






3.   Where paragraph 2, point (c) applies, the person(s) responsible for the technical examinations shall make available to the competent authorities the official description of the variety examined by them.



Article 49


Uniformity


For the purposes of the official description, a variety shall be deemed to be uniform if, subject to the variation that may be expected from the particular features of its reproduction and type, it is sufficiently uniform in the expression of the characteristics included in the examination for distinctness, as well as in the expression of any other characteristics used for its official description.


Article 50


Stability


For the purposes of the official description, a variety shall be deemed to be stable if the expression of the characteristics included in the examination for distinctness, as well as of any other characteristics used for the variety description, remains unchanged after repeated reproduction or, in the case of cycles of reproduction, at the end of each such cycle.


Article 51


Granted plant variety rights


If a variety has been granted a plant variety right pursuant to Article 62 of Regulation (EC) No 2100/1994 or pursuant to the legislation of a Member State, that variety shall be deemed to be distinct, uniform and stable for the purposes of the official description and to have a suitable denomination for the purposes of Article 47(1), point (b).


Article 52


Value for sustainable cultivation and use



1.   For the purposes of Article 47(1), point (c), the value of a variety for sustainable cultivation and use of a variety shall be considered as satisfactory if, compared to other varieties of the same species registered in the national variety register of the respective Member State, its characteristics, taken as a whole, offer a clear improvement for the sustainable cultivation and the uses which can be made of the crops, other plants or the products derived therefrom.
The characteristics referred to in the first subparagraph are the following, as appropriate for the species, regions, agro-ecological conditions and uses concerned:






(a)


yield, including yield stability and yield under low-input conditions;










(b)


tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses, insects and other pests;










(c)


tolerance/resistance to abiotic stresses, including adaptation to climate change conditions;










(d)


more efficient use of natural resources, such as water and nutrients;










(e)


reduced need for external inputs, such as plant protection products and fertilisers;










(f)


characteristics that enhance the sustainability of 
cultivation, harvesting,
 storage, processing and

,
 distribution 
and use
; [Am. 221]











(g)


quality
,
 or nutritional characteristics.

or characteristics important for processing; [Am. 222]













(ga)






pre- or post-harvest waste reduction. [Am. 223]









1a.
   
Examination of the value for sustainable cultivation and use shall be made possible for the species listed in Parts B and C of Annex I on a voluntary basis. Where the examination of the sustainable cultivation and use has been carried out by an official competent authority or under the official supervision and guidance of the competent authority pursuant to Article 61, it shall allow the inclusion of claim on the area of the label mentioned in Article 17(5). That claim shall only concern the characteristics that have been shown to offer a clear improvement compared to other varieties of the same species during the examination tests. The voluntary system shall allow competent authorities to develop methodologies to assess the characteristics listed under paragraph 1, second subparagraph, points (a) to (g). [Am. 224]



2.   For the purpose of paragraph 1, Member States may collaborate with other Member States with similar agro-ecological conditions. Those Member States may establish shared facilities for carrying out the examination for value for sustainable cultivation and use.


3.   The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation by:






(a)


establishing the minimum requirements for carrying out the examination referred to under paragraph 1;










(b)


establishing the methodologies for assessing the characteristics listed under paragraph 1, 
second subparagraph,
 points (a) to (g)

(ga)
; [Am. 225]











(c)


establishing the standards for the evaluation and the reporting of the results of the examination of the value for sustainable cultivation and use.




Those delegated acts shall adapt the requirements, methodologies and standards of points (a) to (c) to the applicable technical or scientific developments, and to any new Union policies or rules on sustainable agriculture.
Where those rules are not yet established, Member States may adopt such rules for their respective territories. They shall notify them to the Commission and to the other Member States.


Those delegated acts shall ensure that the minimum requirements, methodologies and standards referred to in points (a) to (c) of the first subparagraph that apply to Parts D and E of Annex I, are adapted to the specific features of those species and their end-uses, as well as to the objectives of diversity and innovation. [Am. 226]


The Commission may adopt, by means of implementing acts, a decision requesting a Member State to repeal or modify those rules, if they are deemed, on the basis of the available scientific and technical evidence, to be inappropriate for the examination of value for sustainable cultivation and use of a variety. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).
[Am. 227]



4.   For the purposes of registration of organic varieties suitable for organic production as defined in Article 3(19) of Regulation (EU) 2018/848, the examination of the value for sustainable cultivation and use shall be conducted under organic conditions, in accordance with that Regulation, and in particular Article 5, points (d), (e), (f) and (g), and Article 12 thereof and Part I of Annex II to that Regulation.
Where competent authorities are not able to carry out an examination under organic conditions, or the examination of certain characteristics, including disease susceptibility, testing may be carried out under 
in-conversion or
 low-input conditions and with only the absolutely necessary for the completion of the testing treatments with pesticides and other external inputs 
for the completion of the examination
. 
Where applicable, the Member States shall report yearly to the Commission on the reasons behind not testing under organic conditions and implementation of testing under non-organic conditions. [Am. 228]





4a.
   
Competent authorities may include testing of conventional seed under low input conditions, organic in-conversion, or organic conditions. [Am. 229]





4b.
   
By... [10 years from the date of entry into force of this Regulation] the Commission shall evaluate the results of the voluntary system referred to in paragraph 1a, and shall summarise the results of that evaluation in a report to the European Parliament and the Council. [Am. 230]




Article 53


Registration of conservation varieties



1.   By way of derogation from Articles 48, 49, 50, 52, 55(2), 56, 57, and 59 to 65, a conservation variety shall be registered in a national variety register if it complies with the following conditions:






(a)


it has an officially recognised description, specifying the characteristics that qualify it as a conservation variety, in accordance with the definition in Article 3, point (29);










(b)


it has an indication of its initial region of origin
, when known, or the local conditions under which it has been newly bred
; [Am. 231]











(c)


it bears a denomination complying with Article 54;










(d)


it is maintained in the Union.






The registration under this Article shall be free of charge for the applicant. [Am. 232]



2.   A conservation variety shall be registered in the national variety register upon application by a professional operator established in the Union. That application shall include all the elements referred to in paragraph 1, points (a) to (d).
The competent authority shall accept or reject the registration of a conservation variety, after checking its compliance with paragraph 1. 
The competent authority shall communicate to the applicant its decision. In the event of rejection of the registration, it shall state the reasons justifying such rejection. [Am. 233]



3.   A variety shall not be listed in the national variety register as conservation variety, if:






(a)


it is already listed in the Union variety register with an official description, pursuant to Article 44(1), point (a), or it was deleted from the Union variety register as a variety with an official description within the last 2 years, or within 2 years from the expiry of the period granted pursuant to Article 71(2), or










(b)


it is protected by a Community plant variety right as provided for in Regulation (EC) No 2100/94, or by a national plant variety right, or an application for such a right is pending.






4.   The officially recognised description referred to in paragraph 1, point (a), shall be based on results of unofficial tests, knowledge gained from practical experience during cultivation, reproduction and use, or other information, in particular from the plant genetic resource authorities or from organisations recognised for this purpose by Member States.

The Commission may, by means of implementing acts, specify the characteristics and information that that description should cover if appropriate for specific species. Such implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).
[Am. 234]



5.   The person responsible for the maintenance of a conservation variety shall keep samples of it and, upon request, make them available to the competent authorities.




Article 53a




Requirements for the registration of a selected clone and polyclonal PRM in the Member State’s register






1.
   
                        
The applicant shall submit an application to the competent authority indicating:










(a)






species and, as applicable, variety to which the selected clone or polyclonal PRM belongs, whereby the variety shall be registered in a national variety register referred to in Article 44;














(b)






proposed denomination and synonyms;














(c)






where applicable, description of the polyclonal PRM;














(d)






the maintainer of the selected clone or polyclonal PRM;














(e)






reference to the description of the main characteristics of the variety to which the selected clone or polyclonal PRM belongs;














(f)






description of the main value for sustainable cultivation and use characteristics of the selected clone or polyclonal PRM;














(g)






the estimated genetic gains of the selected clone or polyclonal PRM in relation to the overall performance of the relevant variety;














(h)






information on whether the selected clone or polyclonal PRM is already registered in a register of another Member State.










2.
   
                        
The selected clone shall fulfil the following requirements in order to be registered in the Member State's register:










(a)






it shall be selected within the variety it belongs to for some special intravarietal phenotypic traits and its phytosanitary status that give the selected clone a better performance, in accordance with internationally accepted methods based on methods from the International Organisation of Vine and Wine;














(b)






the trueness of the selected clone to the identity of the variety shall be ensured through the observation of the phenotypic characteristics and, where appropriate, through molecular analysis pursuant to internationally accepted standards.










3.
   
                        
The polyclonal PRM shall fulfil the following requirements in order to be registered in the Member State's register:










(a)






it shall be selected in a single field trial containing a representative sample of the overall genetic diversity of the variety according to an experimental design based on internationally accepted methods; that design shall be based on methods prescribed by the International Organisation of Vine and Wine and shall be composed of seven to 20 distinct genotypes (29);














(b)






the trueness of the polyclonal PRM to the identity of the variety shall be ensured through the observation of the phenotypic characteristics and, where appropriate, through molecular analysis pursuant to internationally accepted standards.










4.
   
The competent authority shall decide on the registration in the Member State’s register only after it concludes that the conditions set out in paragraphs 2 and 3, as applicable for the type of material, are fulfilled. [Am. 235]




Article 54


Suitability of variety denominations



1.   For the purposes of Article 47(1), point (b), the denomination of a variety shall not be deemed suitable if:






(a)


its use in the territory of the Union is precluded by the prior right of a third party;










(b)


it may commonly cause its users difficulties as regards recognition or reproduction;










(c)


it is identical to, or may be confused with, a variety denomination:






(i)


under which another variety of the same or of a closely related species is entered in a national variety register or in the Union variety register; or 
in documentation provided to the competent authority by a natural or legal person involved in the dynamic conservation; [Am. 236]











(ii)


under which material of another variety has been made available on the market in a Member State or in a Member of the International Union for the Protection of New Varieties of Plants,





unless variety referred to in point (i) or (ii) no longer remains in existence and its denomination has acquired no special significance;
[Am. 237]











(d)


it is identical to, or may be confused with, other designations which are commonly used for making available on the market goods or which have to be kept free pursuant to Union legislation;










(e)


it is liable to give offence in one of the Member States or is contrary to the public order;










(f)


it is liable to mislead or to cause confusion concerning the characteristics, the value or the identity of the variety, or the identity of the breeder.






2.   Without prejudice to paragraph 1, if a variety is already registered in other national variety registers, the denomination shall be deemed suitable, only if it is identical to that appearing in those registers.
This paragraph shall not apply if:






(a)


the denomination is likely to mislead or cause confusion concerning the relevant variety in one or more Member States; or










(b)


the rights of third parties impede the free use of that denomination in connection with the variety in question.






3.   Where, after the registration of a variety, it is established by the competent authority that at the time of the registration the denomination of the variety was not suitable within the meaning of paragraphs 1 and 2, the applicant shall submit an application for a new denomination. The competent authority shall decide on that application upon consultation with CPVO.
The competent authority may permit the previous denomination to be used temporarily.


4.   The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation by setting out specific criteria concerning the suitability of variety denominations as regards:






(a)


their relation to trade marks;










(b)


their relation to geographical indications or designations of origin for agricultural products;










(c)


written consents of holders of prior rights to remove impediments to the suitability of a denomination;










(d)


determination of whether a denomination is misleading or confusing as referred to in paragraph 1, point (f); and










(e)


the use of a denomination in the form of a code.






SECTION 3
Procedure for registration of varieties in the national variety registers

Article 55


Submission of application


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


Article 56


Contents of the application for registration of a variety



1.   The application for registration of a variety in a national variety register shall consist of the following:






(a)


a request for registration;










(b)


the identification of the botanical taxon to which the variety belongs;










(c)


where applicable, the registration number of the applicant, its name and address or, where appropriate, the names and addresses of the joint applicants, and the credentials of any procedural representative;










(d)


a proposed denomination

provisional designation
; [Am. 238]













(da)






a variety denomination proposed by the applicant which may accompany the application; [Am. 239]











(e)


the name and address of the person responsible for the variety maintenance, and, where applicable, the registration number of that person;










(f)


a description of the main characteristics of the variety, information on whether it is adapted only for particular seasons of the year, and, if available, a completed technical questionnaire;










(g)


a description of the procedure of variety maintenance;










(h)


the place of breeding of the variety and, if applicable, its particular region of origin;










(i)


information on whether the variety is registered in another national variety register in and on whether it is known to the applicant that an application for registration in one of those registers is pending;










(j)


where the variety contains or consists of a genetically modified organism, evidence that the genetically modified organism in question is authorised for cultivation in the Union, in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003, or, where applicable, in the respective Member State in accordance with Article 26b of Directive 2001/18/EC;

, and the evidence of compliance with the cultivation and monitoring requirements in the given growing season
; [Am. 240]












(k)




where the application concerns conservation varieties, information related to the production of an officially recognised description of the variety, a proof of that description and any document or publication supporting it;
[Am. 241]











(l)


in the case of an application concerning varieties with a granted plant variety right pursuant to Regulation (EC) No 2100/94 or the legislation of a Member State, the proof that the variety is protected by such right, with the corresponding official description;










(m)


in case the variety contains or consists of a category 1 NGT as defined in Article 3(7) of Regulation (EU) …/… of the European Parliament and of the Council (30) (Office of Publications, please insert reference to NGT Regulation), evidence that the plant has obtained a declaration of category 1 NGT plant status pursuant to Article 6 or 7 of that Regulation or is progeny of such plant(s);










(n)


in case the variety contains or consists of a category 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation), indication of that fact;










(o)



the intended use or conditions of cultivation, if applicable pursuant to Article 47(2), of

in the event that
 the variety.

is tolerant to herbicides as referred to in Article 47(1), point (f), or has particular characteristics that may lead to undesirable agronomic effects as referred to in Article 47(1), point (g), an indication of that fact; [Am. 242]













(oa)






the breeding techniques used for the development of the variety; [Am. 243]













(ob)






the existence of any intellectual property rights covering the variety, its components, and characteristics, within the limits of the rights applied for or granted for that variety to the applicant, including where the applicant has signed a contractual licence or has obtained a compulsory licence for the use of a patent owned by another operator. [Am. 244]







2.   The application for registration of a variety in a national variety register shall be accompanied by a sample to be used for the examination of that variety. The competent authority of the respective Member State shall set a deadline for the submission of that sample and specify its quality and quantity.



Article 57


Formal examination of application



1.   The competent authority of the respective Member State shall register and examine each application referred to in Article 55 in order to establish whether it complies with the requirements laid down in Article 56.


2.   If the application does not comply with the requirements laid down in Article 56, the competent authority shall give the applicant a possibility to rectify the application accordingly within a given time. If the application does not meet these requirements by the expiry of that given time, the competent authority shall reject the application and terminate the variety registration.



Article 58


Date of application for registration


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


Article 59


Technical examination of the variety



1.   Where, as a result of the formal examination, the application is found to comply with the requirements laid down in Article 56, a technical examination of the variety shall be carried out.
The technical examination shall be carried out by growing the variety, taking into account the intended use and conditions for cultivation of the variety. Other means, including the use of bio-molecular techniques, may be used as a supplementary tool, as appropriate for the purposes of the technical examination, the species concerned or the characteristics to be checked, as established pursuant to the implementing act referred to in Article 47(2) concerning distinctness, uniformity and stability.
The technical examination referred shall verify:






(a)


the compliance with the requirements for distinctness, uniformity and stability of the variety, as laid down in Articles 48 to 50;










(b)


whether the variety has value for sustainable cultivation and use, in accordance with Article 52, in the case of the varieties referred to in Article 47(1), point (a)(ii).






2.   The technical examination referred to in paragraph 1 shall be carried out by the competent authorities in accordance with Article 60, unless the derogation referred to in Article 61(1) applies.


3.   In case a formal report on the distinctness, uniformity and stability of the variety, produced by CPVO or another competent authority, is already available, the competent authority shall take into consideration the conclusions of that report for the purposes of concluding the technical examination.


4.   The conduct of the technical examination referred to in paragraph 1 may be subject to a fee paid by the applicant, as established by the competent authority.



Article 60


Audit of the competent authority’s premises


The competent authority of the respective Member State may carry out the technical examination as regards compliance with the requirements for distinctness, uniformity and stability referred to in Articles 48 to 50 only after its premises and working arrangements, dedicated to this purpose, have been found suitable for carrying out this examination pursuant to an audit conducted by the CPVO or the Commission.
On the basis of the audit referred to in the first subparagraph, the Commission may recommend to the competent authority, if appropriate, actions to ensure the suitability of the premises and organisation of the competent authorities. The Commission may carry out additional audits and, where applicable, recommend to the competent authorities corrective actions to ensure the suitability of their premises and organisation.


Article 61


Authorisation of the applicant to carry out technical examination for value for sustainable cultivation and use



1.   By way of derogation from Article 59(2), 
and only for operators under the voluntary system referred to in Article 52(1a), the competent authority may authorise the applicant to carry out
 the technical examination of whether the variety has a sustainable value for cultivation and use, in accordance with Article 52, or part of it, may be carried out by the applicant if: [Am. 245]








(a)




that applicant has been authorised by the competent authority of the respective Member State;
[Am. 246]











(b)


the examination is carried out under the official supervision and guidance of the competent authority concerned; and










(c)


the examination is carried out in the premises dedicated to that purpose;












(ca)






the examination does not replace the risk assessment required to apply for marketing authorisation under Directive 2001/18/EC on genetically modified organisms. [Am. 247]







2.   Prior to granting the authorisation to carry out the technical examination on breeders’ premises, the competent authority shall audit the premises, the resources and the organisational capacities of the applicant. That audit shall verify whether the premises, the laboratory facilities, the organisation and the carrying out of the growing trials are suitable for realising the technical examination on breeders’ premises as regards compliance with the requirements of a value for sustainable cultivation and use referred to in Article 52.


3.   The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation by setting out the rules concerning the audit referred to in paragraph 2.


4.   On the basis of the audit referred to in paragraph 2, the competent authority may recommend to the applicant, if appropriate, actions to ensure the suitability of the applicant’s premises and organisation of the examination.


5.   The competent authority may carry out additional audits to the one referred to in paragraph 2 and, where applicable, recommend to the applicant to perform, within a specific period of time, corrective actions concerning the its premises and the working arrangements. In case the competent authority concludes, following that period, that the applicant’s premises and working arrangements are not suitable, it may withdraw or modify the authorisation referred to in paragraph 1.



Article 62


Additional rules on technical examination



1.   The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing the requirements on the technical examination laid down in Article 59. Those delegated acts may concern:






(a)


qualification, training and activities of staff of the competent authority or of the applicant, for the purposes of the technical examination referred to in Article 61;










(b)


the necessary equipment, including laboratories for testing, necessary to carry out the technical examination;










(c)


the establishment of a variety reference collection to compare the examined variety with other varieties to assess distinctness, and the storage management of such reference collection;










(d)


the establishment of quality management systems, including record of activities and protocols or guidelines, to be used for the technical examination;










(e)


the carrying out of growing trials and laboratory tests for particular genera or species, including bio-molecular techniques.




Those delegated acts adapt to the available international technical and scientific protocols.


2.   Where no requirements have been adopted pursuant to paragraph 1, technical examinations shall be carried out in accordance with national protocols as regards the elements referred in paragraph 1, points (a) - (e).



Article 63


Confidentiality



1.   Where, during the technical examination provided for in Article 59, an examination of the genealogical components appears to be necessary, the results of that examination and the description of the genealogical components shall be treated as confidential, if the applicant requests so.


2.   In the case of varieties of PRM intended exclusively for the production of agricultural raw materials for industrial purposes, certain elements of the technical examination and the intended uses of those varieties, whose public disclosure may affect the competitive position of the applicant, shall be treated as confidential, if that applicant requests so.


3.   This Article shall apply without prejudice to Article 8 of Regulation (EU) 2017/625. 
The competent authorities shall take due account of the respect of confidentiality of commercial or industrial information where such confidentiality is provided for by Union or national law to protect a legitimate economic interest. [Am. 248]




Article 64


Provisional examination report and provisional official description



1.   Following the technical examination provided for in Article 59, the competent authority shall produce a provisional examination report, as to the compliance with the distinctness, uniformity and stability requirements, and the characteristics of value for sustainable cultivation and use, as applicable, as referred to in Articles 48, 49, 50 and 52, and shall issue a provisional official description of the variety on the basis of that report.


2.   The provisional examination report may refer to findings of other examination reports, produced on the relevant variety, by the competent authority concerned, other competent authorities or the CPVO.


3.   The competent authority shall communicate the provisional examination report and the provisional official description of the variety to the applicant. The applicant may comment on these documents within 15 calendar days.


4.   Where the competent authority does not consider that the provisional examination report constitutes a sufficient basis for a decision on the registration of the variety, it shall request from the applicant additional information, examinations or other actions, as appropriate, to ensure compliance of the variety with the requirements concerning distinctness, uniformity, stability and value for sustainable cultivation and/or use, as set out respectively in Articles 48, 49, 50 and 52.



Article 65


Examination report and final official description


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


Article 66


Examination of the denomination of a variety


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


Article 67


Decision on the registration of a variety in the national variety register



1.   If, on the basis of the procedure set out in Articles 55 to 66, it is concluded that the variety complies with the requirements set out in Article 47(1), the competent authority of the respective Member State shall decide to register the variety in the national variety register.


2.   The competent authority shall adopt a decision refusing registration in the national variety register, if:






(a)


it establishes that the respective requirements set out in Article 47(1) 
and Article 48
 are not fulfilled; or [Am. 249]











(b)


the applicant has failed to comply with any of the obligations set out for it in Articles 55 to 64.






3.   Decisions refusing the registration of a variety in the national variety register shall state the reasons justifying such refusal.


4.   The competent authority shall communicate to the applicant the decision referred to in paragraphs 1 and 2.


5.   The decisions referred to in paragraph 1 and 2 may be appealed, in accordance with the administrative rules of the Member State concerned. Any appeal against a decision referred to in paragraph 1 shall have a suspensory effect on the registration of the respective variety.


6.   The adoption of the decision referred to in paragraph 1 may be subject to a fee paid by the applicant, as established by the competent authority.



Article 68


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



1.   By way of derogation from Articles 54 to 67, the competent authorities shall immediately register in their national variety registers all varieties officially accepted or registered before … [the date of the entry into force of this Regulation], in the catalogues, lists or registers established by their Member States pursuant to Article 5 of Directive 68/193/EEC, Article 3 of Directive 2002/53/EC, Article 3(2) of Directive 2002/55/EC and 
varieties with an official description pursuant to
 Article 7(4)

7
 of Directive 2008/90/EC, without applying the registration procedure set out by those Articles. [Am. 250]



2.   By way of derogation from Article 53, varieties accepted in accordance with Article 3 of Directive 2008/62/EC and Article 3(1) 
and Article 21(1)
 of Directive 2009/145/EC
, and varieties with an officially recognised description pursuant to Article 7 of Directive 2008/90/EC
 before… [OJ, please, insert the date of the entry into force of this Regulation] shall be immediately registered in the national variety registers as conservation varieties provided with an officially recognised description without applying the registration procedure set out by that Article. [Am. 251]



SECTION 4
Registration period and variety maintenance

Article 69


Period of registration



1.   The period of registration of a variety in a national variety register (‘period of registration’) shall be 10 years.
However, that period of registration shall be 30 years for 
conservation varieties and
 varieties of species of fruit plants and vine propagating material, as listed respectively in Parts C and D of Annex I. [Am. 252]

In the case of varieties consisting of, or containing, a genetically modified organism, the period of registration shall be limited to the period for which that genetically modified organism is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003.
In the case of varieties consisting of, or containing, a category 2 NGT plant as defined in Article 3(8), of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation...), the period of registration shall be limited to the period for which that plant is authorised pursuant to that Regulation.


2.   The period of registration of a variety in a national variety register may be renewed for a further period of 10 years, or respectively 30 years, in accordance with the procedure and the conditions laid down in Article 70.
In the case of a variety consisting of or containing a genetically modified organism, the renewal of the period of registration shall be limited to the period for which that genetically modified organism is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003.


3.   The registration of a variety may be subject to an annual fee paid by the applicant, as established by the competent authority.



Article 70


Procedure and conditions for registration renewal



1.   Any person intending to renew the registration of a variety shall submit an application, no earlier than 12 months, and no later than 6 months, before the expiration of the period of registration as referred to in Article 69(1).


2.   The application shall be submitted electronically. It shall be accompanied by evidence showing that the conditions set out in paragraph 3 are fulfilled.


3.   The renewal of the registration of a variety in a national variety register may only be granted, if:






(a)


the applicant has submitted sufficient evidence that the variety continues to comply with the respective requirements of Article 47(1); and










(b)


the competent authority of the respective Member State has established that there is a person responsible for the variety maintenance in accordance with Article 72.






4.   The competent authority may, on its own initiative, renew the registration of a variety, if it is still in large demand by the professional operators and farmers concerned, or it should be retained in the interest of conserving plant genetic resources
, provided that the variety is no longer protected by a plant breeders’ right title in accordance with Regulation (EC) No 2100/94, and provided that the variety is off the list for a minimum of two years
. [Am. 253]




Article 71


Removal from national variety registers



1.   The competent authority of the respective Member State shall remove a variety from the national variety register, if:






(a)


it concludes, on the basis of any new evidence, that the requirements for registration, as set out in Article 47(1) are no longer fulfilled;










(b)


the applicant does not pay the fee that the competent authority has established in accordance with Articles 55, 59(4), 67(6) and 69(3);










(c)


the person responsible for the variety maintenance, as referred to in Article 72, so requests, or that person has ceased to maintain the variety and no other person has become responsible for its maintenance;










(d)


the variety is no longer maintained pursuant to requirements of Article 72;










(e)


the variety is maintained in a third country, which has not provided assistance on the controls of that maintenance pursuant to Article 72(7);










(f)


at the time of the application, false or fraudulent data were supplied on the basis of which the registration was decided;










(g)


no application for renewal has been submitted by the deadline referred to in Article 70(1) and the validity period of registration referred to in Article 69(1) has expired.






2.   On request by the applicant, the competent authority may allow that a variety removed from the national variety register in accordance with paragraph 1, point (g), continues to be made available on the market until 30 June of the third year following the removal from the register.
That request shall be submitted no later than the date of the expiration of the validity period of registration.


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



Article 72


Variety maintenance



1.   Varieties registered in a national variety register shall be maintained by the applicant, or by any other person notified by the applicant to the competent authority. The competent authority shall authorise that other person to carry out the maintenance of the variety, if that person proves its capacity for that task, and the competent authority shall withdraw that authorisation if that person is no longer capable for that. The name and registration number of that person shall be notified by the applicant to the competent authority of the Member State.


2.   Variety maintenance shall take place in accordance with accepted practices concerning, as appropriate, genera, species or particular types of varieties.


3.   The persons referred to in paragraph 1 shall keep records concerning the variety maintenance. It shall at all times be possible for the competent authority to check the variety maintenance from those records. Those records shall also cover the production of pre-basic, basic, certified and standard material, and the stages of production prior to pre-basic material.
A standard sample of the variety concerned shall be provided to the competent authority on request.


4.   The competent authority shall carry out controls on the manner in which the variety maintenance is carried out and may, to this purpose, take samples of the varieties concerned. The frequency of those controls shall be based on the likelihood of non-compliance with paragraphs 1 to 3.


5.   Where a competent authority finds that the person responsible for variety maintenance does not comply with paragraphs 1 to 3, it shall give that person appropriate time to take corrective action or request another person to carry out the variety maintenance. If no such action is taken within that time limit, the competent authority shall remove the variety from the national variety register in accordance with Article 71.


6.   Where variety maintenance takes place in a Member State other than the Member State in whose national variety register the variety has been registered, the competent authorities of the two Member States concerned shall assist each other in the controls on variety maintenance. If no such assistance is provided within a reasonable period of time, or if it is concluded that the variety maintenance is not carried out in accordance with this Article, the respective competent authority shall remove the variety from the national variety register in accordance with Article 71.


7.   Where variety maintenance takes place in a third country, the competent authorities of the Member State, in whose national variety register the variety has been registered, shall request the third country’s authorities assistance in the controls on variety maintenance, if such a maintenance has been subject to the recognition of equivalence referred to in Article 39(5). If no such assistance is provided within a reasonable period of time, or if it is concluded that the variety maintenance is not carried out in accordance with this Article, the respective competent authority shall remove the variety from the national variety register in accordance with Article 71.


SECTION 5
Keeping of documentation and samples

Article 73


Documentation on the national variety registers


The competent authority of the respective Member State shall keep a file on each variety registered in the national variety register, containing:






(a)


the official description or the officially recognised description of the variety;










(b)


the examination report; and










(c)


any complementary examination report pursuant to Article 64(4).




In the case of an officially recognised description, the file shall only contain that description and the documents supporting it.


Article 74


Samples of the registered varieties


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

CHAPTER V
PROCEDURAL PROVISIONS

Article 75


Exercise of delegation



1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.


2.   The delegation of power 
to adopt delegated acts
 referred to in Articles 2(3), 7(3), 8(4), 10(2), 
12(3),
 15(5), 20(2), 22(2), 24(4), 27(3)
, 30a, 33(1) and (3), 38(1) and (2)
, 46(2), 47(3), 52(3), 54(4), 61(3), and 62(1) shall be conferred on the Commission for 5

five
 years from 
... [
the date of the entry into force of this Regulation
]
. [Am. 254]

The delegation of power shall be tacitly extended for periods of 5 years, unless the European Parliament or the Council opposed such extension not later than three months before the end of each period. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the first 5-year period.


3.   The delegation of power referred to in Articles 2(3), 7(3), 8(4), 10(2), 
12(3),
 15(5), 20(2), 22(2), 24(4), 27(3)
, 30a, 33(1) and (3), 38(1) and (2)
, 46(2), 47(3), 52(3), 54(4), 61(3), and 62(1) may be revoked at any time by the European Parliament or by the Council. A decision of revocation

to revoke
 shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. [Am. 255]



4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.


5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.


6.   A delegated act adopted pursuant to Articles 2(3), 7(3), 8(4), 10(2), 
12(3),
 15(5), 20(2), 22(2), 24(4), 27(3)
, 30a, 33(1) and (3), 38(1) and (2)
, 46(2), 47(3), 52(3), 54(4), 61(3), and 62(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of the notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council. [Am. 256]




Article 76


Committee procedure



1.   The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (31). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.


2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee decides so or a simple majority of committee members requests it.


3.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof shall apply.


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

Article 77


Reporting



1.   By … [5 years after the date of application of this Regulation], and every five years thereafter, Member States shall transmit to the Commission a report on the following:






(a)


quantities of certified and standard PRM and areas used for their production per year and species with a specification of the quantities used for organic varieties suitable for organic production; [Am. 257]











(b)


quantities of marketed PRM of heterogeneous material and areas used for their production per year and species;










(c)


quantities of marketed PRM of conservation varieties per year and species;










(d)


number of professional operators using the derogations for marketing to final users in accordance with Article 28, the species concerned and total quantities of PRM per species; [Am. 258]











(e)


number of gene banks,

conservation
 organisations and networks with a statutory or other declared objective to conserve plant genetic resources, in accordance with Article 29 and the species concerned; [Am. 259]












(f)




the quantities as defined per species for the seeds exchanged in kind between farmers, in accordance with Article 30;
[Am. 260]












(g)




the quantities authorised per species for PRM intended for tests and trials for the breeding of new varieties, in accordance with Article 31;
[Am. 261]











(h)


quantities of PRM per genera and species for which Article 33(4) has been applied;










(i)


quantities of PRM per genera and species imported from third countries, in accordance with Article 39;










(j)


penalties imposed in accordance with Article 78;










(k)


number of professional operators established in their territory;












(ka)






progress made in the conservation and sustainable use of plant genetic resources for food and agriculture, i.e. through the number of entities having notified their use of Article 29 and other related data. [Am. 331]







2.   The Commission shall, by means of implementing acts, specify the technical formats for reporting made pursuant to paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).



Article 78


Penalties



1.   Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate
, preventive
 and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and of any subsequent amendment affecting them. [Am. 262]



2.   Member States shall ensure that financial penalties for violations of this Regulation, perpetrated through fraud are equal, in accordance with national law, at least either to the acquired economic advantage for the professional operator or to a percentage of the professional operator’s turnover.



Article 79


Amendments of Regulation (EU) 2016/2031


In Article 37 of Regulation (EU) 2016/2031, paragraph 4 is replaced by the following:

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



Article 80


Amendments of Regulation (EU) 2017/625


Regulation (EU) 2017/625 is amended as follows:






(1)


in Article 1, paragraph 2, the following point is added:






‘(k)


production and marketing of plant reproductive material.;’














(2)


in Article 3, the following point is added:






‘(52)


“plant reproductive material” means plant reproductive material as defined in Article 3(1) of Regulation (EU) …/… of the European Parliament and the Council (*1)
 (+)’;





(*1)  Regulation (EU) …/… of the European Parliament and of the Council …. (OJ …, p…). [footnote that will be in that regulation goes here]"
                        

(+)  OJ: Please insert in the text the number of this Regulation and insert the number, date, title and OJ reference of this Regulation in the footnote.]’
                                             "
                        










(3)


the following article is inserted after Article 22:

‘Article 22a


Specific rules on official controls and for action taken by the competent authorities in relation to plant reproductive material


1.   Official controls to verify compliance with the rules referred to in Article 1(2), point (k), shall include official controls on plant reproductive material, operators and other persons subject to those rules.


2.   The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation by laying down rules for the performance of official controls on plant reproductive material in order to verify compliance with Union rules referred to in Article 1(2), point (k), applicable to those goods and for action taken by the competent authorities following the performance of those official controls.
Those delegated acts shall lay down rules on specific requirements for the performance of such official controls on:






(a)


the import into, and marketing within, the Union of particular plant reproductive material subject to the rules referred to in Article 1(2), point (k), concerning its identification and quality, and










(b)


specific requirements for the performance of such official controls on the activities of operators during the production of particular plant reproductive material subject to the rules referred to in Article 1(2), point (k).






3.   The Commission shall, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of official controls on plant reproductive material in order to verify compliance with Union rules referred to in Article 1(2), point (k), applicable to those goods and for action taken by the competent authorities following such official controls on:






(a)


uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to recognised uniform risks of non-compliance with the rules on plant reproductive material of a particular origin or provenance;










(b)


uniform frequency of official controls performed by competent authorities on operators authorised to carry out certification under official supervision in accordance with Article 12(1) of Regulation (EU) …/… (++)





Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).


4.   For the purposes of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.;’



(++)  OJ: Please insert in the text the number of this Regulation."
                        










(4)


in Article 40(1), the following point is added:






‘(c)


laboratories which are accredited by the International Seed Testing Association to carry out analyses, tests and diagnoses on seed samples.’











Article 81




Amendment of Regulation (EU) 2018/848




Regulation (EU) 2018/848 is amended as follows:








(1)




Article 3 is amended as follows:








(a)




point (17) is replaced by the following:









                                                         ‘(17)





                                                         “plant reproductive material” means plant reproductive material as defined in Article 3(1) of Regulation (EU) …/… of the European Parlament and Council (*2)
 (+);’;






(*2)  
                                                               Regulation (EU) …/… of the European Parliament and of the Council …. (OJ …, p…). [footnote that will be in that regulation goes here]
                                                            "
                        

(+)  
                                                               OJ: Please insert in the text the number of this Regulation and insert the number, date, title and OJ reference of this Regulation in the footnote.]’
                                                            "
                        











(b)




point (18) is replaced by the following:









                                                         ‘(18)





                                                         “organic heterogeneous material” means heterogeneous material as defined in Article 3(27) of Regulation (EU) …/… (*3)
 (++), produced in accordance with this Regulation;’






(*3)  
                                                               Regulation (EU) …/… of the European Parliament and of the Council …. (OJ …, p…). [footnote that will be in that regulation goes here]
                                                            "
                        

(++)  
                                                               OJ: Please insert in the text the number of this Regulation.]
                                                               ’
                                                            "
                        















(2)




Article 13 is deleted.












(3)




The second paragaph of Point 1.8.4. of Part I of Annex II to Regulation (EU) 2018/848 is replaced by the following: ‘All multiplication practices, except plant tissue cultures, cell cultures, germplasm, meristems, chimaeric clones, micro-propagated material, shall be carried out under certified organic management’.
[Am. 263]






CHAPTER VII
FINAL PROVISIONS

Article 82


Repeals


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


Article 83


Entry into force and application


This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from … [36 months from the date of the entry into force of this Regulation].
However,






(a)


Article 40(4) shall apply from three days after the entry into force of this Regulation;










(b)


Article 52 shall apply from... [60 months from the date of the entry into force of this Regulation] for the species

, provided that the respective examination requirements, methodologies and standards for assessing the characteristics
 listed in Parts B and C of Annex I

Article 52(1), second subparagraph, points (a) to (gb), exist
. It shall be binding in its entirety and directly applicable in all Member States. [Am. 264]








Done at …,


For the European Parliament


The President




For the Council


The President






(1)  
            OJ C, C/2024/1583, 5.3.2024, ELI: http://data.europa.eu/eli/C/2024/1583/oj.

(2)  Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (OJ 125, 11.7.1966, p. 2298).

(3)  Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (OJ 125, 11.7.1966, p. 2309).

(4)  Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (OJ L 93, 17.4.1968, p. 15).

(5)  Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ L 193, 20.7.2002, p. 1).

(6)  Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (OJ L 193, 20.7.2002, p. 12).

(7)  Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (OJ L 193, 20.7.2002, p. 33).

(8)  Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (OJ L 193, 20.7.2002, p. 60).

(9)  Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L 193, 20.7.2002, p. 74).

(10)  Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and planting material, other than seed (OJ L 205, 1.8.2008, p. 28).

(11)  Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (OJ L 267, 8.10.2008, p. 8).

(12)  Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system (COM(2020) 381 final).

(13)  Regulation (EU).../… of the European Parliament and of the Council …. (OJ…., p….).

(14)  OJ: Please insert in the text the number of the Regulation contained in document (… (COD)) and insert the number, date, title and OJ reference of that Regulation in the footnote.

(15)  Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental plants (OJ L 226, 13.8.1998, p. 16).

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

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

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

(19)  
            
Regulation (EU).../… of the European Parliament and of the Council …. (OJ…., p….).



(+.)  
            
OJ: Please insert in the text the number of the Regulation contained in document (… (COD)) and insert the number, date, title and OJ and ELI reference of that Regulation in the footnote.



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

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

(22)  Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

(23)  
            OJ L 123, 12.5.2016, p. 1.

(24)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers, OJ L 55, 28.2.2011, p. 13–18.

(25)  Regulation (EU).../… of the European Parliament and of the Council …. (OJ…., p….).

(26)  OJ: Please insert in the text the number of the Regulation contained in document (… (COD)) and insert the number, date, title and OJ reference of that Regulation in the footnote.

(27)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

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

(29)  
            
International Organisation of Vine and Wine, resolution OIV-VITI 564B[1]2019.



(30)  Regulation (EU) …./…. of the European Parliament and of the Council of … (….., p….).

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





Annex I

GENERA AND SPECIES, AND THEIR RESPECTIVE USES, AS REFERRED TO IN ARTICLE 2

PART A
Genera and species to be used for the production of agricultural crops, other than vegetables
Agrostis canina L.
Agrostis capillaris L.
Agrostis gigantea Roth
Agrostis stolonifera L.
Alopecurus pratensis L.
Arachis hypogaea L.
Arrhenatherum elatius (L.) P. Beauv. ex J. Presl & C. Presl
Avena nuda L.
Avena sativa L. (includes A. byzantina K. Koch)
Avena strigosa Schreb.
Beta vulgaris L. partim
Biserrula pelecinus L.
Brassica juncea (L.) Czern.
Brassica napus L. var. napobrassica (L.) Rchb.
Brassica napus L. var. napus
Brassica nigra (L.) W.D.J. Koch
Brassica oleracea L. convar. acephala (DC.) Alef. var. medullosa Thell. + var. varidis L.
Brassica rapa L. var. silvestris (Lam.) Briggs
Bromus catharticus Vahl
Bromus sitchensis Trin.
Cannabis sativa L.
Carthamus tinctorius L.
Carum carvi L.
Cynodon dactylon (L.) Pers.
Dactylis glomerata L.
Festuca arundinacea Schreber
Festuca filiformis Pourr
Festuca ovina L.
Festuca pratensis Huds.
Festuca rubra L.
Festuca trachyphylla (Hack.) Krajina
Galega orientalis Lam.
Glycine max (L.) Merr. partim
Gossypium spp.
Hedysarum coronarium L.
Helianthus annuus L.
Hordeum vulgare L.
Lathyrus cicera L.
Linum usitatissimum L.
Lolium multiflorum Lam.
Lolium perenne L.
Lolium x hybridum Hausskn
Lotus corniculatus L.
Lupinus albus L.
Lupinus angustifolius L.
Lupinus luteus L.
Medicago doliata Carmign.
Medicago italica (Mill.) Fiori
Medicago littoralis Rohde ex Loisel.
Medicago lupulina L.
Medicago murex Willd.
Medicago polymorpha L.
Medicago rugosa Desr.
Medicago sativa L.
Medicago sativa L. nothosubsp. varia (Martyn) Arcang.
Medicago scutellata (L.) Mill.
Medicago truncatula Gaertn.
Onobrychis viciifolia Scop.
Ornithopus compressus L.
Ornithopus sativus Brot.
Oryza sativa L.
Papaver somniferum L.
Phacelia tanacetifolia Benth.
Phalaris aquatica L.
Phalaris canariensis L.
Phleum nodosum L.
Phleum pratense L.
Pisum sativum L. partim
Plantago lanceolata L.
Poa annua L.
Poa nemoralis L.
Poa palustris L.
Poa pratensis L.
Poa trivialis L.
Raphanus sativus L. var. oleiformis Pers.
Secale cereale L.
Sinapis alba L.
Sorghum bicolor (L.) Moench subsp. bicolor
Sorghum bicolor (L.) Moench subsp. bicolor x Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse
Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse
Trifolium alexandrinum L. Berseem
Trifolium fragiferum L.
Trifolium glanduliferum Boiss.
Trifolium hirtum All.
Trifolium hybridum L.
Trifolium incarnatum L.
Trifolium isthmocarpum Brot.
Trifolium michelianum Savi
Trifolium pratense L.
Trifolium repens L.
Trifolium resupinatum L.
Trifolium squarrosum L.
Trifolium subterraneum L.
Trifolium vesiculosum Savi
Trigonella foenum-graecum L.
Trisetum flavescens (L.) P. Beauv.
Triticum aestivum L. subsp. aestivum
Triticum aestivum L. subsp. spelta (L.) Thell.
Triticum turgidum L. subsp. durum (Desf.) van Slageren
Vicia benghalensis L.
Vicia faba L. partim
Vicia pannonica Crantz
Vicia sativa L.
Vicia villosa Roth
xFestulolium Asch. &amp; Graebn
xTriticosecale Wittm. ex A. Camus
Zea mays L. partim


Cicer arietinum




Camelina sativa




Fagopyrum esculentu




Lens culinaris




Triticum monococcum




Chenopodium quinoa




Vicia ervilia




Vicia narbonensis




Tritordeum




Lathyrus sativus




Eragrostis tef




Ceratonia siliqua [Am. 265]

PART B
Genera and species to be used for the production of vegetables
Allium cepa L.
Allium fistulosum L.
Allium porrum L.
Allium sativum L.
Allium schoenoprasum L.
Anthriscus cerefolium (L.) Hoffm.
Apium graveolens L.
Asparagus officinalis L.
Beta vulgaris L. partim
Brassica oleracea L. partim
Brassica rapa L. partim
Capsicum annuum L.
Cichorium endivia L.
Cichorium intybus L.
Citrullus lanatus (Thunb.) Matsum. et Nakai
Cucumis melo L.
Cucumis sativus L.
Cucurbita maxima Duchesne
Cucurbita pepo L.
Cynara cardunculus L.
Daucus carota L.
Foeniculum vulgare Mill.
Lactuca sativa L.
Petroselinum crispum (Mill.) Nyman ex A. W. Hill
Phaseolus coccineus L.
Phaseolus vulgaris L.
Pisum sativum L. partim
Raphanus sativus L. partim
Rheum rhabarbarum L.


Salvia hispanica. [Am. 266]

Scorzonera hispanica L.
Solanum lycopersicum L.
Solanum melongena L.
Spinacia oleracea L.
Valerianella locusta (L.) Laterr.
Vicia faba L. partim
Zea mays L. partim
Hybrids resulting from the crossing of species referred in this Part.
PART C
Genera and species to be used for the production of fruit plants
Castanea sativa Mill.
Citrus L.
Corylus avellana L.
Cydonia oblonga Mill.
Ficus carica L.
Fortunella Swingle
Fragaria L.
Juglans regia L.
Malus Mill.
Olea europaea L.
Pistacia vera L.
Poncirus Raf.
Prunus amygdalus Batsch
Prunus armeniaca L.
Prunus avium (L.) L.
Prunus cerasus L.
Prunus domestica L.
Prunus persica (L.) Batsch
Prunus salicina Lindley
Pyrus L.
Ribes L.
Rubus L.
Vaccinium L.
PART D
Genera and species to be used for the production of vine
Vitis L.
PART E
Genera and species to be used for the production of potatoes
Solanum tuberosum L.





Annex II

REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED SEEDS AND MATERIAL AS REFERRED TO IN ARTICLE 7

PART A
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED SEEDS OF AGRICULTURAL AND VEGETABLE SPECIES
1.   General requirements for the production of pre-basic, basic and certified seeds
A.   Sowing or planting:






(a)


The variety of the seed sown, including where applicable mother plants, shall be identified through an official label or a label issued by the professional operator, and shall be recorded to ensure its traceability. The label, or the records on the mother plant, shall be retained by the professional operator until the issuance of the official label of the marketed seed.










(b)


The previous cropping of the field shall be compatible with the production of seed of the species, variety and category of the crop, and the field shall be sufficiently free from such plants, which may have remained from previous cropping (volunteers).










(c)


The mother plants or seed shall be planted and/or sowed in a way, which assures:






(i)


sufficient distance from pollen sources of the same species and/or different varieties, from any undesirable foreign pollination, so as to avoid cross pollination with other crops, where applicable; and










(ii)


an appropriate source and level of pollination to ensure the subsequent reproduction, where applicable.














(d)


The quality of soil, substrates, mother plants and the immediate environment shall be inspected to avoid presence of pests or their vectors, in accordance with Regulation (EU) 2016/2031.










(e)


The machines and any equipment used shall be inspected, and weed or seed from other species or varieties shall be removed.










(f)


Where appropriate, the production of seeds shall take place separately from the cultivation of seeds belonging to the same genera or species intended for the production of food or feed, to ensure the fulfilment of the requirements applicable only for the PRM concerned.










(g)


Where applicable, in vitro propagation may also be used for the reproduction of seeds.




B.   Field cultivation:






(a)


It shall be ensured that plants of other species, other varieties, appearing as varietal impurity, obviously differing from the variety in one or more characteristics from the variety description (‘off-type’), in the field, are absent. Where this is not possible due to the characteristics of the species concerned, they shall be present up to the lowest possible level.
In the case of presence of off-types or other plant species or varieties during the cultivation stage, or during seed processing, appropriate treatment and/or elimination shall be applied to ensure varietal identity and purity of the seed, and to avoid the presence of any undesirable species.










(b)


The plants shall be treated or excluded as a source of PRM in case of positive test results or visual symptoms of pests, in accordance with Regulation (EU) 2016/2031, or defects.










(c)


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










(d)


The mother plants shall be maintained in all phases of production, under conditions to enable the production of seeds, and permit their identification with the official description of their variety.










(e)


All crops in the field shall be inspected officially or under official supervision at their relevant growth stage(s), at the relevant frequency and with the relevant methods, as appropriate, for the species concerned to verify the respective requirements. The methods for inspections shall be in accordance with the applicable international standards. If it is not possible to remove or separate non-compliant plants during the growing phase, the entire field shall be discarded for seed production, unless the undesirable seeds can be mechanically separated at a later stage.




C.   Harvesting and post-harvesting:






(a)


The seed shall be harvested in bulk or as individual plants, as appropriate, to ensure its identity and purity and a correct traceability.










(b)


A sample of seed shall be taken from each sealed lot. The sample size and the sampling intensity, equipment and method shall be appropriate for the species concerned and in accordance with the applicable international standards.










(c)


All seed samples shall be subjected to laboratory testing, to ensure the fulfilment of the quality requirements for the respective species. Laboratory testing shall be carried out in accordance with methods, equipment and growing media appropriate for the species concerned, and in accordance with the applicable international standards. Testing shall include, where appropriate, retesting of germination rate after a certain period appropriate to the species concerned.










(d)


All the seed lots belonging to the pre-basic, basic category, or certified category if it will be used for the production of further seed generations, and at least 5 % of the seed lots belonging to a certified category that will be no longer multiplied, are subject to control plot-testing by the operator, under official supervision, to verify the compliance with:






(i)


their varietal identity;










(ii)


the standards of the minimum varietal purity; and










(iii)


the plant health requirements.




Seed lots belonging to the pre-basic, basic, or certified category shall be subject to risk-based official post-control testing to verify the compliance with the previous requirements. The samples used for the official post-control tests shall be taken officially.
Control plot-testing shall be carried out in accordance with the applicable international standards.
Appropriate bio-molecular methods may be utilised.




2.   Requirements for the marketing of seeds
The seed shall fulfil all of the following quality requirements, depending on the characteristics of each genus or species and the category concerned:






(a)


have a minimum germination to allow an appropriate number of plants per square metre after sowing, and consequently to secure the yield and quality of the production;










(b)


have a maximum content of hard seed to allow an appropriate number of plant per square metre;










(c)


have a minimum purity to secure the highest level of varietal identity;










(d)


have a maximum moisture content to ensure the preservation of the material during processing, storage and making available on the market;










(e)


have a maximum content of seeds of other genera or species to ensure the lowest presence of undesirable plants in the lot;










(f)


have a minimum vigour, defined dimension and specific grading to ensure the appropriateness of the material and the sufficient homogeneity of the lot for sowing or planting;










(g)


have a maximum presence of earth or extraneous matter to prevent fraudulent practices and technical impurities; and










(h)


be free from specific defects and damages to ensure the quality and health of the material.




PART B
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED MATERIAL OF AGRICULTURAL AND VEGETABLE SPECIES
, FRUIT PLANTS [Am. 267]

1.   Requirements for the production of pre-basic, basic and certified material
A.   Sowing or planting:






(a)


The identity of the material, including, where applicable, mother plants or seed sown, shall be determined through an official label or a label issued by the professional operator, and recorded by the professional operator to ensure its traceability. The label of the material after the marketing of that material, or the records on the mother plant, shall be kept by the professional operator.










(b)


The material shall be planted in a way that:






(i)


the pre-basic material is maintained in facilities that ensure freedom from infection through aerial vectors and any other possible sources throughout the production process;










(ii)


there is sufficient distance from other plants of the same genera or species, determined on the basis of botanical characteristics and breeding techniques of each species, and as appropriate for the category of the material, to ensure protection from any undesirable foreign pollination and to avoid cross pollination with other crops; and










(iii)


planting densities are adequate to allow plants to be observed individually.














(c)


Where appropriate, the cultivation of material shall take place separately from the cultivation of material belonging to the same genera or species intended for food or feed purposes.




B.   Field cultivation:






(a)


During all stages of cultivation, propagating and planting material shall be kept separate from each other.










(b)


PRM satisfying the requirements for a given category shall not be mixed with material of other categories.










(c)


Off-types and deformed or damaged plants shall be disposed of at all stages of cultivation.










(d)


Mother plants shall be treated or excluded as a source of PRM in case of positive test results or visual symptoms of pests, in accordance with Regulation (EU) 2016/2031 or defects.










(e)


Mother plants shall be maintained in all phases of cultivation, under conditions to enable the production of PRM, and to permit their identification and verification of compliance with the official description or the officially recognised description of their variety. In the case of mother plants not belonging to a variety, that verification of compliance with the official description or the officially recognised description shall concern the species to which those mother plants belong.










(f)


Mother plants shall be inspected at their relevant growth stage(s), at the relevant frequency and with the relevant methods as appropriate for the genera or species concerned.










(g)


The sample to be drawn from a lot shall have the appropriate minimum size for determining the fulfilment of the quality requirements for the respective genera or species. The intensity, equipment and method of sampling shall be appropriate for the genera or species concerned and in accordance with the applicable international standards.










(h)


Testing shall be carried out in accordance with the methods, equipment and growing media appropriate for the genera or species concerned, and in accordance with the applicable international standards, to ensure that the quality requirements have been fulfilled.




C.   Harvesting and post-harvesting for species and genera belonging to Part E of Annex I (seed potatoes):






(a)


The material shall be harvested in bulk or as individual plants, as appropriate, to ensure its identity, health and traceability.










(b)


A sample of tubers shall be taken from each sealed lot. The sample size and the sampling intensity, equipment and method shall be appropriate for the species concerned and in accordance with the applicable international standards.










(c)


All tubers samples shall be subjected to laboratory testing, to ensure the fulfilment of the quality and phytosanitary requirements for the respective species. Laboratory testing shall be carried out in accordance with methods, equipment and growing media appropriate for the species concerned, and in accordance with the applicable international standards.










(d)


All the lots belonging to the pre-basic or basic category, and at least 5 % of the lots belonging to a certified category, shall be subject to control plot-testing by the operator, under official supervision of the competent authority, to verify the compliance with:






(i)


their varietal identity;










(ii)


the standards of the minimum varietal purity;










(iii)


their germination capacity;










(iv)


the plant health requirements.








Lots belonging to the pre-basic, basic, or certified category shall be subject to risk-based official post-control testing to verify the compliance with the previous requirements. The samples used for the official post-control tests shall be taken officially.
Control plot-testing shall be carried out in accordance with the applicable international standards.
Appropriate bio-molecular methods may be utilised.
2.   Requirements for the marketing of pre-basic, basic and certified material
The material shall fulfil all of the following requirements, depending on the characteristics of each genus or species and the category concerned:






(a)


have minimum vigour or germination rate, defined dimension, and, where applicable, specific grading, to ensure the appropriateness of the material and sufficient homogeneity of the lot for planting;










(b)


be practically free from specific defects.




PART C
REQUIREMENTS FOR THE PRODUCTION, REGISTRATION AND MARKETING OF SELECTED CLONES, MULTICLONAL MIXTURES AND POLYCLONAL PRM OF PRE-BASIC, BASIC AND CERTIFIED MATERIAL AS REFERRED TO IN ARTICLE 9(1) [Am. 268]

1.   Requirements for the production of pre-basic, basic and certified selected clones, multiclonal mixtures and polyclonal PRM
[Am. 269]

A.   Planting:






(a)


The identity of the selected clone, multiclonal mixture or polyclonal PRM shall be determined through an official label or a label issued by the professional operator and recorded by the professional operator to ensure its traceability. The label of the material or the records, on the respective mother plants for the production of each selected clone and the respective genotypes for the production of the polyclonal PRM, shall be kept by the professional operator after the marketing of that PRM. [Am. 270]











(b)


The material shall be planted in a way that:







(i)




there is sufficient distance from other plants of the same genera or species, determined on the basis of botanical characteristics for each species and as appropriate for the category of the material, to ensure protection from any undesirable foreign pollination and to avoid cross pollination with other crops;
[Am. 271]











(ii)


planting densities are adequate to allow each plant to be observed individually.














(c)


Where appropriate, the cultivation of material shall take place separately from the cultivation of material belonging to the same genera or species intended for food or feed purposes.




B.   Field cultivation:






(a)


During all stages of cultivation, propagating and planting material shall be kept separate from each other.










(b)


Reproductive material satisfying the requirements of a given category shall not be mixed with material of other categories.










(c)


Off-types and deformed or damaged plants shall be disposed of at all stages of cultivation in order to ensure varietal identity and purity, or, in the case of rootstocks not belonging to a variety, trueness to the identity of the species, and efficient production.










(d)


The respective mother plants and the respective genotypes shall be excluded as a source of PRM in case of defects. [Am. 272]











(e)


The respective mother plants and the respective genotypes shall be maintained in all phases of cultivation, under conditions to enable the production of PRM, and to permit their identification and verification of compliance with the official description or the officially recognised description of their variety. In the case of mother plants not belonging to a variety, that verification of compliance with the official description or the officially recognised description shall concern the species to which those mother plants belong. [Am. 273]











(f)


Mother plants shall be inspected at their relevant growth stage(s), at the relevant frequency and with the relevant methods as appropriate for the genera or species concerned.










(g)


The sample to be drawn from a lot shall have the appropriate minimum size for determining the fulfilment of the quality requirements for the respective genera or species. The intensity, equipment and method of sampling shall be appropriate for the genera or species concerned and in accordance with the applicable international standards.










(h)


Testing shall be carried out in accordance with the methods, equipment and growing media appropriate for the genera or species concerned, and in accordance with the applicable international standards, to ensure that the quality requirements have been fulfilled.











(i)




In the case of multiclonal mixtures, the mixture of selected clones constituting the multiclonal mixture shall be made before the final packaging of that PRM and shall include identical proportions of all selected clones that constitute the multiclonal mixture.
[Am. 274]












(j)




In the case of polyclonal PRM, the mixture of genotypes constituting the polyclonal PRM shall be made before the final packaging of that PRM and shall include identical proportions of all genotypes that constitute the polyclonal PRM.
[Am. 275]






2.   Requirements for the registration of a selected clone, multiclonal mixture and polyclonal PRM








(a)




The applicant shall submit an application to the competent authority indicating:








(i)




species and, as applicable, variety to which the selected clone, multiclonal mixture or polyclonal PRM belongs, whereby the variety shall be registered in a national variety register referred to in Article 44;












(ii)




proposed denomination and synonyms;












(iii)




where applicable, description of the composition of the multiclonal mixture or polyclonal PRM;












(iv)




the maintainer of the selected clone, multiclonal mixture or polyclonal PRM;












(v)




reference to the description of the main characteristics of the variety to which the selected clone, multiclonal mixture or polyclonal PRM belongs;












(vi)




description of the main VSCU characteristics of the selected clone, multiclonal mixture or polyclonal PRM;












(vii)




the estimated genetic gain of the selected clone, multiclonal mixture or polyclonal PRM in relation to the overall performance of the relevant variety;












(viii)




information on whether the selected clone, multiclonal mixture or polyclonal PRM is already registered in a register of another Member State.
















(b)




The selected clone, multiclonal mixture or polyclonal PRM shall fulfil the following requirements as appropriate for the type of material concerned in order to be registered:








(i)




the polyclonal PRM shall be selected in a single field trial containing a representative sample of the overall genetic diversity of the variety according to an experimental design based on internationally accepted methods. In the case of polyclonal PRM of vine that design shall be based on methods prescribed by the International organisation of vine and wine;












(ii)




in the case of vine propagating material, the polyclonal PRM shall be composed of 7 to 20 distinct genotypes;












(iii)




the trueness of the selected clone, each selected clone of the multiclonal mixture, each genotype of the polyclonal PRM to the identity of the variety shall be ensured through the observation of the phenotypic characteristics and, where appropriate, through molecular analysis pursuant to internationally accepted standards.






The competent authority shall decide on the registration only after it concludes that the points (i) - (iii) as applicable for the type of material are fulfilled.












(c)




The requirements for the marketing of pre-basic, basic and certified material as set out in Part B point 2 shall apply accordingly.
[Am. 276]





PART D
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED SEED OF FRUIT PLANTS, VINE AND SEED POTATOES [Am. 277]

1.   Requirements for the production of pre-basic, basic and certified seed of fruit plants, vine and seed potatoes [Am. 278]

A.   Sowing or planting:






(a)


The mother plants and, where appropriate, the pollinator plants shall be planted in a way that:






(i)


there is sufficient distance from other plants of the same genera or species, determined by the botanical characteristics and breeding techniques and as appropriate for the category of the material, to ensure protection from any undesirable foreign pollination and to avoid cross pollination with other crops; and










(ii)


planting densities are adequate to allow plants to be observed individually.














(b)


Where appropriate, the cultivation of material shall take place separately from the cultivation of material belonging to the same genera or species intended for food or feed purposes.




B.   Field cultivation:






(a)


During all stages of cultivation, propagating and planting material shall be kept separate from each other.










(b)


Reproductive material satisfying the requirements of a given category shall not be mixed with material of other categories.










(c)


The flowering mother plant shall be subject to self-pollination or cross-pollination with pollen from the surrounding pollinator plants, as appropriate for the genera or species concerned.










(d)


Off-types and deformed or damaged plants shall be disposed of at all stages of cultivation in order to ensure trueness to the identity of the variety, or for plants not belonging to a variety, to ensure the trueness to the identity of the species to which they belong, their sufficient purity and efficient production.










(e)


Mother plants and pollinator plants shall be excluded as a source of seeds in case of defects.










(f)


Mother plants shall be maintained in all phases of cultivation, under conditions to enable the production of seeds. Mother plants and pollinator plants shall be maintained in all phases of cultivation, under conditions permitting their identification and verification of compliance with the official description or the officially recognised description of their variety. In the case of mother plants and pollinator plants not belonging to a variety, that verification of compliance with the official description or the officially recognised description shall concern the species to which those mother plants and pollinator plants belong.










(g)


Mother plants and pollinator plants shall be inspected at their relevant growth stage(s), at the relevant frequency and with the relevant methods as appropriate for the genera or species concerned.










(h)


The sample to be drawn from a lot shall have the appropriate minimum size for determining the fulfilment of the quality requirements for the respective genera or species. The intensity, equipment and method of sampling shall be appropriate for the genera or species concerned and in accordance with the applicable international standards.










(i)


Testing shall be carried out in accordance with the methods, equipment and growing media appropriate for the genera or species concerned, and in accordance with the applicable international standards, to ensure that the quality requirements have been fulfilled.




2.   Requirements for the marketing of pre-basic, basic and certified seed of fruit plants, vine and seed potatoes
The seed shall fulfil all of the following quality requirements, depending on the characteristics of each genus or species and the category concerned:






(a)


belong to the variety and, in the case of seeds not belonging to a variety, to the species;










(b)


have minimum vigour, defined dimension, and, where applicable, specific grading, to ensure the appropriateness of the material and sufficient homogeneity of the lot for planting; and










(c)


be practically free from specific defects and damages to ensure the quality of the seeds.




PART E
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED MATERIAL PRODUCED BY IN VITRO PROPAGATION
1.   Requirements for the production of pre-basic, basic and certified material produced by in vitro propagation
A.   In vitro culture






(a)


The identity of the in vitro or in vivo material, as applicable, shall be determined through a label and recorded to ensure its traceability. The label of the material shall be kept.










(b)


Material that has been sampled from in vivo material shall be sanitised.




B.   In vitro production






(a)


The clone(s) that originate from the material referred to under point A.(a) shall be produced by in vitro propagation.










(b)


During all stages of cultivation, propagating and planting material shall be kept separate from each other.










(c)


Clone(s) satisfying the requirements of a given PRM category shall not be mixed with clone(s) of other categories.










(d)


The number of successive propagation cycles by in vitro propagation shall be restricted, as appropriate, for the genera or species concerned.










(e)


Clone(s) shall be maintained in all phases of production, under conditions to enable the production of PRM, and permitting their identification and verification of compliance with the official description or the officially recognised description of their variety. In the case of clone(s) not belonging to a variety, that verification of compliance with the official description or the officially recognised description shall concern the species to which those clone(s) belong.










(f)


Clone(s) shall be inspected at their relevant growth stage(s), at the relevant frequency and with the relevant methods as appropriate for the genera or species concerned.










(g)


The sample to be drawn from a lot shall have the appropriate minimum size for determining the fulfilment of the quality requirements for the respective genera or species. The intensity, equipment and method of sampling shall be appropriate for the genera or species concerned and in accordance with the applicable international standards.










(h)


Testing shall be carried out in accordance with the methods, equipment and growing media appropriate for the genera or species concerned, and in accordance with the applicable international standards, to ensure that the quality requirements have been fulfilled.




2.   Requirements for the marketing of pre-basic, basic and certified material produced by in vitro propagation
The in vitro or in vivo material shall fulfil all of the following requirements, depending on the characteristics of each genus or species and the category concerned:






(a)


belong to the variety and, in the case of material not belonging to a variety, belong to the species indicated on the label by:






(i)


observing the phenotypic characteristics of the in vivo material referred to under point A.(a);










(ii)


producing in vivo plants from the in vitro material referred to under point A.(a) and observing the phenotypic characteristics of those plants;










(iii)


producing in vivo plants from the clone(s) referred to under point B.(a) and observing the phenotypic characteristics of those plants; and










(iv)


where appropriate, molecular analysis of the in vitro material referred to under point A.(a) and/or the clone(s) referred to under point B.(a);














(b)


have minimum vigour, defined dimension, and, where applicable, specific grading, to ensure the appropriateness of the material and sufficient homogeneity of the lot for planting;










(c)


be practically free from specific defects and damages.









Annex III

REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD SEED AND MATERIAL AS REFERRED TO IN ARTICLE 8

PART A
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD SEED OF AGRICULTURAL AND VEGETABLE SPECIES
1.   General requirements for the production of standard seed
A.   Sowing or planting:






(a)


The variety of the seed sown, including where applicable, mother plants, shall be determined to ensure its traceability. The label of the material, or the records on the mother plant, shall be kept at least for 2 years.










(b)


The previous cropping of the field shall not have been incompatible with the production of seed of the species and variety of the crop, and the field shall be sufficiently free from such plants, which may have remained from previous cropping (volunteers).










(c)


The mother plants or seed shall be planted and /or sowed in a way that there is:






(i)


sufficient distance from pollen sources of the same species and/or the different varieties, in accordance with isolation rules determined on the basis of botanical characteristics for each species and breeding techniques, to ensure protection from any undesirable foreign pollination and to avoid cross pollination with other crops, where applicable; and










(ii)


an appropriate source and level of pollination to ensure the subsequent reproduction, where applicable.














(d)


The quality of soil, substrates, mother plants and the immediate environment shall be inspected to avoid presence of pests or their vectors, in accordance with Regulation (EU) 2016/2031.










(e)


Appropriate attention shall be paid to the machines and any equipment used to ensure absence of weed or other species, which are difficult to distinguish in laboratory tests.










(f)


Where appropriate, the production of seeds shall take place separately from the cultivation of seeds belonging to the same genera or species intended for the production of food or feed, to ensure health of the material concerned.










(g)


Where applicable, in vitro propagation may also be used for the reproduction of seeds.




B.   Field production:






(a)


It shall be ensured that off-types, in the field, are absent. Where this is not possible due to the characteristics of the species concerned, they shall be present up to the lowest possible level.
In the case of presence of off-types or other plant species, or varieties, during the cultivation stage, or during seed processing, appropriate treatment and/or elimination shall be applied to ensure varietal identity and purity of the seed, and to avoid the presence of any undesirable species.










(b)


The plants shall be treated or excluded as a source of PRM in case of positive test results or visual symptoms of pests, in accordance with Regulation (EU) 2016/2031 or defects.










(c)


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










(d)


The mother plants shall
, where applicable,
 be maintained in all phases of production, under conditions to enable the production of seeds, and permitting their identification and verification of compliance with the official description of their variety. [Am. 279]











(e)


All crops in the field shall be inspected at their relevant growth stage(s), at the relevant frequency and with the relevant methods, as appropriate, for the species concerned to verify the respective requirements. The methods for inspections shall be such to ensure the reliability of the observations. If it is not possible to remove or separate non-compliant plants during the growing phase, the entire field shall be discarded for seed production, unless the undesirable seeds can be mechanically separated at a later stage.




C.   Harvesting and post-harvesting:






(a)


The seed shall be harvested in bulk or as individual plants, as appropriate, to ensure its identity, purity and traceability.










(b)


A sample of seed shall be taken from each lot and tested in a laboratory to ensure the fulfilment of the quality requirements for the respective species, including germination. Testing shall include, where appropriate, retesting of germination rate after a certain period appropriate to the species concerned.










(c)


Seed lots shall be subject to risk-based official post-control-testing to verify the compliance with:






(i)


their varietal identity;










(ii)


the standards of the minimum varietal purity;










(iii)


their germination capacity; and










(iv)


the plant health requirements.




The samples used for the official post-control tests shall be taken officially.
Appropriate bio-molecular methods may be utilised.




2.   Requirements for marketing of standard seed
The seed shall fulfil all of the following quality requirements, depending on the characteristics of each genus or species:






(a)


have at least a minimum germination, to allow an appropriate number of plants per square metre after sowing, and consequently to secure the yield and quality of the production;










(b)


have at most a maximum content of hard seed, to allow an appropriate number of plants per square metre;










(c)


have at least a minimum purity, to secure the highest level of varietal identity;










(d)


have at most a maximum moisture content, to ensure the preservation of the material during processing, storage and making available on the market;










(e)


have at most a maximum content of seeds of other genera or species, to ensure the lowest presence of undesirable plants in the lot;










(f)


have sufficient vigour, defined dimension and specific grading, to ensure appropriateness of the material and sufficient homogeneity of the lot for sowing or planting;










(g)


have a maximum presence of earth or extraneous matter, to prevent fraudulent practices and technical impurities; and










(h)


be free from specific defects and damage to ensure the quality and health of the material.




PART B
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD MATERIAL OF AGRICULTURAL AND VEGETABLE SPECIES
, FRUIT PLANTS AND VINE [Am. 280]


With the exception of point (b)(i) thereof, Part B

Part A
 of Annex II

III
 shall apply accordingly for the production and marketing of standard material
, including for conservation varieties placed on the market in accordance with Article 26
. [Am. 281]



Vine rootstocks may not be marketed as standard material. [Am. 282]

PART C
REQUIREMENTS FOR THE REGISTRATION, PRODUCTION AND MARKETING OF SELECTED CLONES, MULTICLONAL MIXTURES AND POLYCLONAL PRM OF STANDARD MATERIAL AS REFERRED TO IN ARTICLE 9(1) [Am. 283]









1.



Vine rootstocks may not be marketed as standard material.

Planting




Part C, point 1 of Annex II shall apply accordingly to the planting of polyclonal PRM. [Am. 284]













2.



Part C of Annex II shall apply accordingly for the registration, production and marketing of selected clones, multiclonal mixtures and polyclonal PRM of standard material.

Field cultivation:










(a)






During all stages of cultivation, propagating and planting material shall be kept separate from each other.














(b)






Off-types and deformed or damaged plants shall be disposed of at all stages of cultivation in order to ensure varietal identity and purity, or, in the case of rootstocks not belonging to a variety, trueness to the identity of the species, as well as deformed or damaged plants and for efficient production.














(c)






The respective mother plants shall be excluded as a source of PRM in the case of defects.














(d)






The respective mother plants shall be maintained in all phases of cultivation, under conditions to enable the production of PRM, and to permit their identification and verification of compliance with the official description or the officially recognised description of their variety.














(e)






Mother plants shall be inspected visually at their relevant growth stage(s), at the relevant frequency and with the relevant methods as appropriate for the genera or species concerned. [Am. 285]



















2a.






Requirements for the marketing of polyclonal PRM




The material shall fulfil all of the following requirements, depending on the characteristics of each genus or species concerned:










(a)






have minimum vigour, defined dimension, and, where applicable, specific grading, to ensure the appropriateness of the material and sufficient homogeneity of the lot for planting;














(b)






be practically free from specific defects;














(c)






the mixture of genotypes constituting the polyclonal PRM shall be made before the final packaging of that PRM and shall include identical proportions of all genotypes that constitute the polyclonal PRM; however, a tolerance is admissible, the frequency of any single genotype shall never exceed twice that of the least frequent genotype. [Am. 286]









PART D
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD SEED OF FRUIT PLANTS, VINE AND SEED POTATOES [Am. 287]

Part D of Annex II shall apply accordingly for the production and marketing of standard seed of fruit plants, vine and seed potatoes. [Am. 288]

PART E
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD MATERIAL PRODUCED BY IN VITRO PROPAGATION
Part E of Annex II shall apply accordingly for the production and marketing of standard material produced by in vitro propagation.





Annex IV

GENERA AND SPECIES WHICH MAY ONLY BE PRODUCED AND MARKETED AS PRE-BASIC, BASIC OR CERTIFIED SEED OR MATERIAL, IN ACCORDANCE WITH ARTICLE 20(1)

PART A
GENERA AND SPECIES TO BE USED FOR THE PRODUCTION OF AGRICULTURAL CROPS, OTHER THAN VEGETABLES WHICH MAY ONLY BE PRODUCED AND MARKETED AS PRE-BASIC, BASIC OR CERTIFIED SEED
Agrostis canina L.
Agrostis capillaris L.
Agrostis gigantea Roth.
Agrostis stolonifera L.
Alopecurus pratensis L.
Arachis hypogaea L.
Arrhenatherum elatius (L.) P. Beauv. ex J. Presl & C. Presl.
Avena nuda L.
Avena sativa L.(including A. byzantina K. Koch.)
Avena strigosa Schreb.
Beta vulgaris L.
Brassica juncea (L.) Czern.
Brassica napus L. var. napobrassica (L.) Rchb.
Brassica napus L. var. napus
Brassica nigra (L.) W.D.J. Koch
Brassica oleracea L. convar. acephala (DC.) Alef. var. medullosa Thell. + var. varidis L.
Brassica rapa L.
Bromus catharticus Vahl
Bromus sitchensis Trin.
Cannabis sativa L.
Carthamus tinctorius L.
Carum carvi L.
Cynodon dactylon (L.) Pers.
Dactylis glomerata L.
Festuca arundinacea Schreb.
Festuca filiformis Pourr.
Festuca ovina L.
Festuca pratensis Huds.
Festuca rubra L.
Festuca trachyphylla (Hack.) Krajina
xFestulolium Asch. et Graebn.
Galega orientalis Lam.
Glycine max (L.) Merrill
Gossypium L.
Hedysarum coronarium L.
Helianthus annuus L.
Hordeum vulgare L.
Linum usitatissimum L.
Lolium × boucheanum Kunth
Lolium multiflorum Lam.
Lolium perenne L.
Lotus corniculatus L.
Lupinus albus L.
Lupinus angustifolius L.
Lupinus luteus L.
Medicago lupulina L.
Medicago sativa L.
Medicago × varia T. Martyn
Onobrychis viciifolia Scop.
Oryza sativa L.
Papaver somniferum L.
Phacelia tanacetifolia Benth.
Phalaris aquatica L.
Phalaris canariensis L.
Phleum nodosum L.
Phleum pratense L.
Pisum sativum L.
Poa annua L.
Poa nemoralis L.
Poa palustris L.
Poa pratensis L.
Poa trivialis L.
Raphanus sativus L.
Secale cereale L.
Sinapis alba L.
Solanum tuberosum L.
Sorghum bicolor (L.) Moench
Sorghum bicolor (L.) Moench × Sorghum sudanense (Piper) Stapf.
Sorghum sudanense (Piper) Stapf.
Trifolium alexandrinum L.
Trifolium hybridum L.
Trifolium incarnatum L.
Trifolium pratense L.
Trifolium repens L.
Trifolium resupinatum L.
Trigonella foenum-graecum L.
Trisetum flavescens (L.) P. Beauv.
xTriticosecale Wittm. ex A. Camus.
Triticum aestivum L.
Triticum durum Desf.
Triticum spelta L.
Vicia faba L.
Vicia pannonica Crantz.
Vicia sativa L.
Vicia villosa Roth.
Zea mays L.
PART B
GENERA AND SPECIES WHICH MAY ONLY BE PRODUCED AND MARKETED AS PRE-BASIC, BASIC OR CERTIFIED MATERIAL
Solanum tuberosum L.







Annex IVa




SPECIES WHICH MAY BE PRODUCED AND MARKETED AS COMMERCIAL SEED




Arachis hypogaea L.




Biserrula pelecinus




Brassica nigra (L.) W.D.J. Koch




Cynodon dactylon L.




Festuca trachyphylla (Hack.) Krajina)




Festuca filiformis Pour




Hedysarum coronarium L.




Lathyrus cicera




Medicago × varia T. Martyn Sand




Medicago doliata Carmingn




Medicago italica (Mill.) Fiori




Medicago littoralis




Medicago murex




Medicago polymorpha




Medicago rugosa




Medicago scutellata




Medicago truncatula




Medicago x varia Martyn Sand




Onobrychis viciifolia Scop




Ornithopus compressus




Ornithopus sativus




Phalaris aquatica L.




Plantago lanceolata




Poa annua




Poa nemoralis




Trifolium fragiferum




Trifolium glanduliferum




Trifolium hirtum




Trifolium isthmocarpum




Trifolium michelianum




Trifolium squarrosum




Trifolium subterraneum




Trifolium vesiculosum




Trigonella foenum-graecum L.




Vicia bengahalensis L.




Vicia pannonica Crantz




xFestulolium Asch. & Graebn. [Am. 289]






Annex V

PRODUCTION AND MARKETING REQUIREMENTS FOR PRESERVATION MIXTURES AS REFERRED TO IN ARTICLE 22

1.   Source area

Region of origin [Am. 290]

Competent authorities may designate specific source areas

regions of origin
 for the preservation mixtures, with which such mixtures are naturally associated. For that purpose, they shall take into account information from plant genetic resource authorities or organisations recognised for this purpose by the Member States. [Am. 291]

Where the source area

region of origin
 is located in more than one Member State, it shall be identified by a common agreement of all Member States concerned. [Am. 292]

2.   Species
The species and, where relevant, subspecies, used in preservation mixtures shall be:






(a)


typical for the habitat type of the source area

region of origin
; [Am. 293]











(b)


of importance for the preservation of the natural environment in the context of conservation of genetic resources, as components of the mixture;










(c)


adequate for the purpose of recreating the habitat type of the source area

region of origin
. [Am. 294]





The preservation mixture shall not contain the species Avena fatua, Avena sterilis and Cuscuta spp.
The maximum content of Rumex spp., other than Rumex acetosella and Rumex maritimus, 
Rumex acetosa, R. thyrsiflorus and R. sanguineus
 shall not exceed 0,05 % by weight. [Am. 295]

3.   Authorisation of professional operators
Professional operators shall be authorised prior to the production of preservation mixtures.
The professional operator shall submit an application for the authorisation referred to in Article 22(1), including all of the following elements:






(a)


name and address of the professional operator;










(b)


harvesting method: whether the mixture is directly harvested or multiplied;










(c)


components as species and, where relevant, subspecies and varieties of the preservation mixture; which are typical for the habitat type of the source area site

region of origin
 and which are, as components of the mixture, of importance for the preservation of the natural environment in the context of the conservation of genetic resources; [Am. 296]












(d)




quantity of the mixture to which the authorisation is to apply;
[Am. 297]











(e)



source are a

region of origin
 of the mixture; [Am. 298]











(f)


collection site, and in the case of a multiplied preservation mixture, in addition, the multiplication site;










(g)


habitat type of the source area

region of origin
 of the mixture; and [Am. 299]











(h)


year of collection.




The application shall be accompanied by the information necessary to verify compliance with requirements set out in point

paragraph
 4 in the case of directly harvested preservation mixtures, or point

paragraph
 5 in the case of multiplied preservation mixtures. [Am. 300]

Competent authorities may issue an authorisation which shall include the authorisation date and the scope of the authorisation, according to the operator application and the compliance of the requirements, and the restriction to marketing in the source area.
Professional operators before the beginning

at the end
 of each production season

calendar or fiscal year, as appropriate,
 shall notify the quantity of seed of

authorised
 preservation mixtures, for which the authorisation is intended, together with size and location of the intended collection site or sites and the date or dates of collection

to the competent authority
. [Am. 301]

4.   Production of directly harvested preservation mixtures
Directly harvested preservation mixtures shall comply the following requirements:






(a)


a seed mixture that has been collected at the source area

region of origin
 (‘directly harvested preservation mixture’) shall be collected at a site which has not been sown in the 40 years previous to the date of the authorisation; [Am. 302]











(b)


the percentage of the components of the directly harvested preservation mixture that are species and, where relevant, subspecies, shall be adequate for the purpose of recreating the habitat type of the source area;










(c)


the maximum content of species and, where relevant, subspecies which do not comply with point (b) shall not exceed 1 % by weight;










(d)


the competent authorities may carry out visual inspections on the collection site during the period of growth at intervals appropriate, and during the collection activities, to ensure that the mixture complies with the requirements provided for this preservation mixtures; they shall document the results thereof.










(e)


tests shall be carried out officially, or under the official supervision of the competent authority, to check that the preservation mixture complies with the requirements provided; such tests shall be carried out in accordance with current international methods, or, where such methods do not exist, in accordance with any appropriate methods;










(f)


samples shall be drawn from homogenous lots, and shall be sufficient to carry out the test referred to in point (e).




5.   Production of multiplied preservation mixtures
Preservation mixtures seeds may be also multiplied by an authorized operator in accordance with the following process:






(a)


seed of individual species is taken at the source area

region of origin
, or is a directly harvested preservation mixtures purchased to other operator; [Am. 303]












(b)




the seed referred to in point (a) is multiplied outside the source area as single species. Multiplication may take place for five generations;
[Am. 304]











(c)


the seeds of those species are then mixed to create a mixture which is composed of those genera, species and, where relevant, subspecies which are typical for the habitat type of the source area;











(d)




this mixture may also include seed from species listed in Part A of Annex I that has been produced conventionally, if it complies with point (c);
[Am. 305]











(e)


the collected seed from which the preservation mixture is multiplied shall have been collected in its source area at a collection site which has not been sown in the 40 years previous to the date of the authorization by the operator, referred to in point 3.










(f)


the seed of the multiplied preservation mixture shall be of species and, where relevant, subspecies which are typical for the habitat type of the source area and which are, as components of the mixture, of importance for the preservation of the natural environment in the context of conservation of genetic resources;










(g)


the germination rate of the components referred to in point (f) shall be sufficient for the purpose of recreating the habitat type of the source area;










(h)


the maximum content of species and, where relevant, subspecies which do not comply with point (g)

(f)
 shall not exceed 1 % by weight; [Am. 306]











(i)


components of a multiplied preservation mixture which are seeds of species listed in Part A of Annex I shall, before mixing, comply at least with the requirements for standard seed for the concerned species;










(j)


tests shall be carried out officially or under official supervision of the Member State to check that the preservation mixture complies with the requirements provided. Such tests shall be carried out in accordance with current international methods, or, where such methods do not exist, in accordance with any appropriate methods;










(k)


samples shall be drawn from homogenous lots, and shall be sufficient to carry out the test referred to in point (j).









Annex VI

REQUIREMENTS FOR PRODUCTION AND MARKETING OF PRM OF HETEROGENEOUS MATERIAL AS REFERRED TO IN ARTICLE 27(2)

A.   Notification of heterogeneous material
PRM of heterogeneous material as referred to in Article 27(2) may be marketed following a notification of the heterogeneous material by the professional operator to the competent authorities, made my means of a dossier containing:






(a)


the contact details of the applicant;










(b)


the species and denomination of the heterogeneous material;










(c)


the description of the heterogeneous material as referred in point B;










(d)


a declaration by the applicant concerning the truth of the elements in points (a), (b) and (c);










(e)


a representative sample.




The notification shall be sent by registered letter or by any other means of communication accepted by the competent authorities with confirmation of receipt requested. Three months after the date shown on the return receipt provided that no additional information was requested or that non formal refusal for reasons of incompleteness of the notification was communicated to the supplier, the competent authority shall be deemed to have acknowledged the notification and its content, and the heterogeneous material shall be included in the heterogeneous material register. 
That register shall remain free of charge to the official operator. [Am. 307]

B.   Description of the heterogeneous material








1.


The description of heterogeneous material shall include all of the following elements:






(a)


a description of its characteristics, including:






(i)


the phenotypic characterisation of the key characters which are common to the material, together with the description of the heterogeneity of the material, by characterising the phenotypic diversity observable between individual reproductive units;










(ii)


documentation of its relevant characteristics, including agronomic aspects such as yield, yield stability, suitability for low input systems, performance, resistance to abiotic stress, disease resistance, quality parameters, taste or colour;










(iii)


any available results from tests concerning the characteristics referred to in point (ii);














(b)


a description of the type of technique used for the breeding or production method of the heterogeneous material;










(c)


a description of the parental material used to breed or produce the heterogeneous material and own production control programme used by the operator concerned with a reference to the practices as referred to in point B.2.(a) and, if applicable, in point B.2.(c);










(d)


a description of the on-farm management and selection practices with a reference to point B.2.(b) and, if applicable, of the parental material with a reference to point B.2.(c);










(e)


a reference to the country of breeding or production, with information on the year of production and description of the pedo-climatic conditions.
















2.


The heterogeneous material may be generated by

originate from
 one of the following techniques: [Am. 308]







(a)


crossing of several different types of parental material, using crossing protocols to produce diverse heterogeneous material by bulking of the progeny, repeatedly re-sowing and exposing the stock to natural and/or human selection, provided that this material shows a high level of genetic diversity;










(b)


on-farm-management practices, including selection, establishing or maintaining material, which is characterized by a high level of genetic diversity;










(c)


any other technique used for breeding or production of heterogeneous material, taking into account particular features of propagation.








C.   Requirements concerning the identity of PRM lots of heterogeneous material
PRM of heterogeneous material shall be identifiable on the basis of all of the following elements:






(a)


the initial material and the production scheme used in the crossing for creation of the heterogeneous material, as provided for in point B.2.(a) or, if applicable, in point B.2.(c), or the history of the material and the on-farm management practices, including whether the selection has occurred naturally and/or through human intervention, in the cases of points B.2.(b) and point B.2.(c);










(b)


the country of breeding or production; and










(c)


characterisation of the common key characters and of the phenotypic heterogeneity of the material.




D.   Requirements concerning the sanitary quality, analytical purity and germination of PRM of heterogeneous material








1.


PRM of heterogeneous material shall comply with the requirements 
equal to those set for the lowest category for the respective species including requirements set for the species listed in Annex IV
 for the analytical purity and germination requirements for seed and the quality requirements for other material of the lowest category for the respective species. [Am. 309]

The plants shall be treated or excluded as a source of PRM, in case of defects or positive test results or visual symptoms of pests in accordance with Regulation (EU) 2016/2031.












2.


By way of derogation from point D.1, professional operators may place on the market PRM of heterogeneous material which does not satisfy the conditions with respect to germination, provided that the operator indicates the germination rate of the PRM concerned on the label or directly on the package.




E.   Requirements for packaging and labelling of PRM of heterogeneous material








1.


PRM of heterogeneous material shall be contained in small packages and in maximum quantities as defined in point H. However, they may be contained in other packages or containers, only if these are closed in such a manner that they cannot be opened without leaving evidence of tampering on the package or container.












2.


The professional operators shall affix on packages or containers of PRM of heterogeneous material a label in at least one of the official languages of the Union.
That label shall:






(i)


be legible, printed or written on one side, newly issued and easily visible;










(ii)


include the information set out in point G of this Annex, except where that information is printed or written directly on the package or the container; and










(iii)


be yellow, with a green diagonal cross.
















3.


In the case of small, transparent packages, the label may be placed inside the package provided it is clearly legible.












4.


By way of derogation from points E.1 and E.2, PRM of heterogeneous material contained in closed and labelled packages and containers may be sold to final users in unmarked and unsealed packages up to the maximum quantities provided for in point H, if on request, the purchaser is informed in writing at the time of delivery, about the species, the denomination of the heterogeneous material and the reference number of the lot.




F.   Maintenance of heterogeneous material








1.


Where maintenance is possible, the professional operator who has notified the heterogeneous material to the competent authorities, shall preserve the main characteristics of the material at the time of its notification, by maintaining it as long as it remains on the market.












2.


That maintenance shall be undertaken in accordance with accepted practices adapted to the maintenance of such heterogeneous material. The professional operator responsible for the maintenance shall keep records of duration and content of maintenance.












3.


At all times, the competent authorities shall have access to all records kept by the professional operator responsible for the material, in order to check its maintenance. The professional operator shall keep those records for 5 years after the moment the heterogeneous material is not marketed anymore.




G.   Content of the label of the packages
PRM of heterogeneous material shall be marketed in packages bearing a label containing the following elements:






(1)


the denomination of the heterogeneous material, together with the phrase ‘heterogeneous material’;










(2)


the indication ‘EU rules and standards’;










(3)


the name and address of the professional operator responsible for affixing the label, or its registration code;










(4)


country of production;










(5)


lot reference number given by the professional operator responsible for affixing the labels;










(6)


month and year of closing, following the term: ‘closed’;










(7)


species, indicated at least under its botanical name, which may be given in abridged form and without the authors’ names;










(8)


declared net or gross weight, or declared number of PRM, except for small packages;










(9)


where weight is indicated and pelleting substances or other solid additives are used, the nature of the additive and also the approximate ratio between the weight of pure seeds and the total weight; and










(10)


the germination rate, if applicable.




H.   Maximum quantities of PRM of heterogeneous material in small packages






Species


Maximum net mass (kg)





Fodder plants




10 
[Am. 310 ]





Beet


10 




Cereals


30 




Oil and fiber plants


10 




Potato


30 




Vegetable:


 




Legumes


5 




Onions, chervil, asparagus, spinach beet or chard, red beet or beetroot, turnips, water melon, gourd, marrows, carrots, radishes, scorzonera or black salsify, spinach, corn-salad or lamb’s lettuce


0,5 




All other vegetable species


0,1 









Annex VII

CONTENTS OF THE NATIONAL AND UNION VARIETY REGISTERS AS REFERRED TO IN ARTICLE 46

The national variety registers and the Union variety register shall contain all of the following elements:






(a)


the name of the genus or species to which the variety belongs;










(b)


the denomination of the variety and, for varieties marketed before the entry into force of this Regulation, where applicable, other alternative denominations used for that variety;










(c)


the name and, where applicable, the reference number, of the applicant;










(d)


the date of the registration of the variety and, where applicable, of the renewal of the registration;










(e)


the date of the end of validity of registration;










(f)


a reference to the link of the file, where the official description of the variety, or, if applicable, the officially recognised description of the variety, can be found;










(g)


in the case of 
conservation
 varieties with

, an
 officially recognised description and, if appropriate, an indication of the region(s), where the variety has historically

traditionally
 been grown and
, in the case of newly-bred conservation varieties,
 to which 
local growing conditions
 it is naturally adapted (‘region(s) of origin’); [Am. 311]











(h)


the name of the person responsible for the maintenance of a variety;










(i)


the name of the Member States having established the relevant national variety register(s);










(j)


the reference under which the variety has been registered in the national variety register(s);










(k)


where applicable, the indication that the variety is an ‘organic variety suitable for organic production’;










(l)


where applicable, the indication that the variety contains, or consists of, a genetically modified organism;










(m)


where applicable, the indication that the variety is a component variety of another registered variety;










(n)


where applicable, the indication that PRM belonging to the variety is only produced and marketed in rootstocks;










(o)


where applicable, a reference to the link of the file, where the results of the examinations for value for sustainable cultivation and use, as referred to in Article 52, can be found;










(p)


where applicable, an indication of the reproduction method of the variety, including information on whether it is a hybrid or a synthetic variety,










(q)


where applicable, the indication that the variety contains, or consists of a category 1 NGT plant within the meaning of Article 3(7) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation) and the identification number(s) referred to in Article 9(1), point (e) of [NGT Proposal] assigned to the category 1 NGT plant(s) it has been derived from;










(r)


where applicable, the indication that the variety contains, or consists of a category 2 NGT plant within the meaning of Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation);










(s)


where applicable, indication that the variety is herbicide tolerant and indication of the applicable cultivation conditions;










(t)


where applicable, indication that the variety has certain characteristics, other than the one referred to in point (s),

that may lead to undesirable agronomic effects
 and indication of the applicable cultivation conditions.

; [Am. 312]













(ta)






where applicable, the respective intellectual property rights covering the variety, its components, characteristics and development process, including, where applicable and appropriate, the number of any relevant granted or pending patent(s) which the competent authority needs to provide and update; [Am. 313]













(tb)






where applicable, a description of which breeding techniques have been applied for the development of the variety. [Am. 314]












Annex VIIa










MAXIMUM QUANTITIES FOR DYNAMIC CONSERVATION








The quantity applies per natural or legal person, year and variety/accession/ecotype/plant genetic resource.








Species






Maximum net mass (kg)








Fodder plants






20








Beet






20








Cereals






200








Oil and fibre plants






20








Potato






1000








Vegetable:




 






Legumes






75








Onions, chervil, asparagus, spinach beet or chard, red beet or beetroot, turnips, water melon, gourd, marrows, carrots, radishes, scorzonera or black salsify, spinach, corn-salad or lamb's lettuce






1








All other vegetable seed






0,5








Vegetatively propagated vegetables






500 plants








Fruit and vine propagating material






150 stocks







[Am. 315]






Annex VIII

CORRELATION TABLES







Council Directive 66/401/EC


This Regulation




Article 1


Article 1




Article 1a


Article 2, Article 3




Article 2(1)A


Article 2, Article 3, Article 7




Article 2(1)B.1


Article 3, Article 7




Article 2(1)C


Article 3, Article 7




Article 2(1)D


-




Article 2(1)E


Article 3




Article 2(1)F


-




Article 2(1)G


-




Article 2(1), point (a)


Article 2




Article 2(1), point (b)


Article 7




Article 2(1), point (d)


Article 36




Article 2(2)


Article 83




Article 2(3)A


Article 10




Article 2(3)B


Article 10




Article 2(4)


Article 10




Article 3(1)


Article 20




Article 3(1), point (a)


-




Article 3(2)


-




Article 3(3)


Article 20




Article 3(4)


Article 7




Article 3a


Article 7, Article 35




Article 4


Article 34




Article 4a


Article 31, Article 32




Article 5


-




Article 5a


-




Article 6


Article 63




Article 7(1)


Article 7




Article 7(1a)


Article 10, Article 12




Article 7(1b)


Article 10, Article 12




Article 7(2)


Article 7




Article 8(1)


Article 14




Article 8(2)


-




Article 9(1)


Article 14




Article 9(2)


Article 23




Article 9(3)


-




Article 10.1a


Article 15




Article 10a


Article 15




Article 10b


Article 15




Article 10c


Article 15




Article 10d


Article 14




Article 11


Article 15




Article 11a


Article 17




Article 12


Article 12




Article 13


Article 21, Article 22




Article 13a


Article 38




Article 14


Article 36




Article 14a


Article 7, Article 15




Article 15(1)


Article 35, Article 39




Article 15(2)


Article 35




Article 15(3)


Article 35, Article 39




Article 16


Article 39




Article 17


Article 33




Article 18


Article 2




Article 19(1)


Article 24




Article 19(2)


Article 40




Article 20


Article 24




Article 21


Article 76




Article 21a


Article 7




Article 22


-




Article 22a


Article 7, Article 26, Article 22




Article 23


Article 83




Article 23a


-




Article 24


-




Annex I


Article 7




Annex II


Article 7




Annex III


Article 7, Article 13




Annex IV


Article 17




Annex V


Article 35













Council Directive 66/402/EC


This Regulation




Article 1


Article 1




Article 1a


Article 2




Article 2(1)A


Article 2




Article 2(1)B


Article 3, Article 7




Article 2(1)C


Article 3, Article 7




Article 2(1)Ca


Article 3, Article 7




Article 2(1)C


Article 3, Article 7




Article 2(1)D


Article 3, Article 7




Article 2(1)E


Article 3, Article 7




Article 2(1)F


Article 3, Article 7




Article 2(1)H


Article 3, Article 10




Article 2(1), point (a)


Article 2




Article 2(1), point (b)


Article 7




Article 2(1), point (c)


Article 7




Article 2(1), point (e)


-




Article 2(2)


-




Article 2(3)


Article 10




Article 2(4)


Article 10




Article 3


Article 20, Article 7




Article 3a


Article 7, Article 35




Article 4


Article 34




Article 4a


Article 31, Article 32




Article 5


-




Article 5a


-




Article 6


Article 63




Article 7(1)


Article 7




Article 7.1a


Article 10, Article 12




Article 7.1b


Article 10, Article 12




Article 7(2)


Article 7




Article 8(1)


Article 14




Article 8(2)


-




Article 9(1)


Article 14




Article 9(2)


Article 23




Article 9(3)


-




Article 10(1), point (a)


Article 15




Article 10(1), point (b)


-




Article 10(2)


Article 14




Article 10(3)


-




Article 10a


Article 14




Article 11


Article 15




Article 11a


Article 15




Article 12


Article 17




Article 13


Article 21




Article 13a


Article 38




Article 14


Article 36




Article 14a


Article 7, Article 15




Article 15(1)


Article 35, Article 39




Article 15(2)


Article 35




Article 15(3)


Article 35, Article 39




Article 16


Article 39




Article 17


Article 33




Article 18


Article 2




Article 19(1)


Article 24




Article 19(2)


Article 40




Article 20


Article 24




Article 21


Article 76




Article 21a


Article 7




Article 21b


Article 7




Article 22


-




Article 22a


Article 7




Article 23


Article 83




Article 23a


-




Article 24


-




Annex I


Article 7




Annex II


Article 7




Annex III


Article 7




Annex IV


Article 17




Annex V


Article 35













Council Directive 68/193/EEC


This Regulation




Article 1


Article 1




Article 2


Article 3




Article 2(1)A


-




Article 2(1)B


-




Article 2(1)C


-




Article 2(1)D


Article 7




Article 2(1)E


Article 7




Article 2(1)F


Article 7




Article 2(1)G


Article 8




Article 2(1)H


-




Article 2(1)I


Article 3, point (3)




Article 2.2


-




Article 3(1)


Article 7, Article 8




Article 3(2)


—




Article 3(3)


Article 2




Article 3(4)


Article 7(3), 7(4), Annex II, Part E, Annex III, Part E




Article 3(5)


Article 7(4), Article 8(5)




Article 4


Article 36




Article 5


Article 44




Article 5a


Article 47(1)




Article 5b.1


Article 48




Article 5b.2


Article 50




Article 5b.3


Article 49




Article 5ba.1


-




Article 5ba.2


-




Article 5ba.3


Article 47(1)




Article 5c


Article 47(4)




Article 5d


Article 47(1)




Article 5e


Article 71(1)




Article 5f


Article 47(1), Annex VII




Article 5g


Article 72




Article 7


Article 14




Article 8(1)


Article 13




Article 8(2)


Article 28




Article 9


Article 14




Article 10


Article 15




Article 10a


Article 17




Article 11(1)


Article 80




Article 11(2)


Article 40




Article 12


-




Article 12a


-




Article 13


Article 7(2)




Article 14


Article 33




Article 14a


Article 38




Article 15(1)


Article 2




Article 15(2)


Article 39




Article 16


Article 38




Article 16a


Article 7(4), Article 8(5)




Article 16b


Article 7(4), Article 8(5)




Article 17


Article 76




Article 17a


Article 7(3), (4), Article 8(4), (5)




Article 18


-




Article 18a


-




Article 18b


-




Article 19


-




Article 20


Article 83




Annex I


Article 7(4), Article 8(5)




Annex II


Article 7(4), Article 8(5)




Annex III


Article 14(6)




Annex IV


Article 17













Council Directive 2002/53/EC


This Regulation




Article 1(1)


Article 1




Article 1(2)


Article 44(3), Article 45




Article 1(3)


Article 2(4)




Article 2


-




Article 3(1)


Article 44(1)




Article 3(2)


Article 44(4)




Article 3(3)


Article 44(2)




Article 4(1)


Article 47(1)




Article 4(2)


Article 44(4)




Artile 5(1)


Article 47(1), Article 48,




Article 5(2)


Article 50




Article 5(3)


Article 49




Article 5(4)


Article 52




Article 6


Article 44(2)




Article 7(1)


Article 59




Article 7(2)


-




Article 7(3)


Article 63




Article 7(4)


Article 47(1)




Article 7(5)


-




Article 8


-




Article 9(1)


Article 44, Article 46, Annex VII




Article 9(2), (3)


Article 47(1), point (b), Article 54




Article 9(4)


Article 47(1), point (a), Annex VII




Article 9(5)


Article 46, Annex VII




Article 10


Article 44(3), Article 45, Article 46(1), Annex VII




Article 11


Article 72




Article 12(1)


Article 69(1)




Article 12(2)


Article 69(2)




Article 13


-




Article 14


Article 71




Article 15


Article 71




Article 16(1)


Article 44(2)




Article 16(2)


Article 47(1), points (f) and (g)




Article 17


Article 45




Article 18


Article 37




Article 19


-




Article 20(1)


Article 47(4)




Article 20(2), (3)


Article 26




Article 21


-




Article 22


Article 39




Article 23


Article 76




Article 24


-




Article 25


-




Article 26


-




Article 27


Article 83




Article 28


Article 83













Council Directive 2002/54/EC


This Regulation




Article 1


Article 1




Article 1(2)


Article 2(4)




Article 2


Article 3, Article 7(4)




Article 3(2)


Article 6




Article 3(2)


Article 80




Article 4


Article 6, Article 7(4)




Article 5


Article 34, Article 35




Article 6


Article 2(4)




Article 7


Article 36




Article 8


Article 63




Article 9(1)


Article 24, Article 25




Article 9(2)


Article 13(5)




Article 10(1)


Article 13, Article 14




Article 10(2)


Article 28




Article 11


Article 14




Article 12


Article 15, 17(4)




Article 13


Article 14




Article 14(1)


Article 28




Article 14(2)


Article 17(4)




Article 15


Article 13, Article 14, Article 23




Article 16


Article 18




Article 17


Article 15, Article 17(3)




Article 18


Article 15, Article 17




Article 19


Article 38




Article 20


-




Article 21(1)


Article 7(1), (3), Article 15, Annex II




Article 21(2)


Article 15, Article 17(4)




Article 21(3)


Article 39




Article 22(1)


Article 6, Article 7(4)




Article 22(2)


Article 35




Article 23(1)


Article 39




Article 23(2)


-




Article 24


Article 33




Article 25(1)


Article 80




Article 25(2)


Article 39




Article 26


-




Article 27


Article 7(3)




Article 28


Article 76




Article 29


-




Article 30


Article 7(4)




Article 30A


-




Article 31


-




Article 32


-




Article 33


-




Article 34


Article 83




Article 35


Article 83




Annex I


Article 17(4)




Annex II


Article 13(5)




Annex III


Article 17(4)




Annex IV


Article 17(4), point (m), Article 35




Annex V


-




Annex VI


-













Council Directive 2002/55/EC


This Regulation




Article 1


Article 1




Article 2


Article 2(1), Article 3, Article 7(4), Article 8(5)




Article 3(1)


Article 5




Article 3(2)


Article 44




Article 3(3)


Article 45




Article 3(4)


Article 44(2)




Article 4(1)


Article 47(1), point (a)




Article 4(2)


Article 47(1), point (c)




Article 4(3)


-




Article 4(4)


Article 26




Article 5(1)


Article 48




Article 5(2)


Article 50




Article 5(3)


Article 49




Article 6


Article 44(2)




Article 7(1), (2)


Article 59




Article 7(3)


Article 63




Article 7(4)


Article 47(1), point (c)




Article 8


Article 56




Article 9(1)


Article 44, Article 72




Article 9(2)


Article 47(1), point (b), Article 54




Article 10


Article 44(3), Annex VII




Article 11


Article 72




Article 12(1)


Article 69




Article 12(2)


Article 70




Article 13


-




Article 14


Article 71




Article 15


Article 71




Article 16(1)


Article 44(2)




Article 16(2)


Article 47(1), points (f) and (g)




Article 17


Article 45




Article 18


Article 37




Article 19


Article 44(2)




Article 20


Article 20




Article 21


Article 2(4), 6, Article 7(4)




Article 22


Article 34, Article 35




Article 23(1)


Article 2(4)




Article 23(2)


-




Article 24


Article 36




Article 25


Article 7(4), Article 8(5), Article 24, Article 25




Article 26


Article 13




Article 27


Article 14




Article 28


Article 15, Article 16, Article 17(4)




Article 29


Article 14, Article 28




Article 30


Article 14, Article 28




Article 31


Article 17(3)




Article 32


Article 17(4)




Article 33


Article 38




Article 34


-




Article 35


Article 7(4)




Article 36(1)


Article 6, Article 7




Article 36(2)


Article 15, Article 17




Article 36(3)


Article 39




Article 37


Article 39




Article 38


Article 33




Article 39(1)


Article 80




Article 39(2)


Article 39




Article 40


Article 24, Article 25




Article 41


Article 8(5)




Article 42


Article 19




Article 43


-




Article 44(1)


-




Article 44(2)


Article 26




Article 45


Article 2(2), Article 7(3), Article 8(4)




Article 46


Article 76




Article 47


-




Article 48


Article 26




Article 49


-




Article 50


-




Article 51


-




Article 52


Article 83




Article 53


Article 83




Annex I


Article 7(4), Article 8(5)




Annex II


Article 7(4), Article 8(5)




Annex III


Article 7(4), Article 8(5)




Annex IV


Article 17(4)




Annex V


Article 17(4), point (m)




Annex VI


-




Annex VII


-













Council Directive 2002/56/EC


This Regulation




Article 1, first paragraph


Article 1




Article 1, second paragraph


Article 2(4)




Article 2


Article 3




Article 3(1)


Article 20




Article 3(2)


-




Article 3(3)


Article 7(3)




Article 3(4)


Article 7(3)




Article 4


Article 7(4)




Article 5


Article 36




Article 6(1)


Article 2(4)




Article 6(2)


-




Article 6(3)


-




Article 7


Article 7(4)




Article 8


-




Article 9


Article 7(4)




Article 10


Article 7(4)




Article 11(1)


Article 13




Article 11(2)


Article 28




Article 12


Article 14




Article 13


Article 15, Article 17




Article 14


-




Article 15


Article 15




Article 16


-




Article 17


-




Article 18


Article 7(3), Article 17




Article 19


Article 38




Article 20


-




Article 21


Article 39




Article 22


Article 33




Article 23(1)


Article 80




Article 23(2)


Article 39




Article 24


Article 7(2)




Article 25


Article 76




Article 26


-




Article 27


Article 26




Article 28


-




Article 29


-




Article 30


Article 83




Article 31


Article 83




Annex I


Article7(3)




Annex II


Article 7(3)




Annex III


Article 17




Annex IV


-




Annex V


-













Council Directive 2002/57/EC


This Regulation




Article 1


Article 1, Article 2




Article 2(1), point (a)


Article 2, Article 3




Article 2(1), point (b)


Article 2




Article 2(1), point (d)


Article 2, Article 7




Article 2(1.e)


Article 2, Article 7




Article 2(1.f)


Article 2, Article 7




Article 2.1.g


Article 2, Article 7




Article 2.1.h


Article 2, Article 7




Article 2.1.j


-




Article 2.1.k


Article 3




Article 2(2)


Article 2




Article 2(3)


Article 7




Article 2(3a)


Article 7




Article 2(4)


-




Article 2(5)


Article 10, Article 12




Article 2(6)


Article 10, Article 12




Article 3(1)


Article 20




Article 3(2)


-




Article 3(3)


-




Article 3(4)


Article 7




Article 4


Article 7, Article 35




Article 5


Article 34




Article 6


Article 31, Article 32




Article 7


-




Article 8


Article 63




Article 9(1)


Article 7




Article 9(1a)


Article 10, Article 12




Article 9(1b)


Article 10, Article 12




Article 9(2)


Article 7




Article 10(1)


Article 14




Article 10(2)


-




Article 11(1)


Article 14




Article 11(2)


Article 23




Article 11(3)


-




Article 12(1.a)


Article 15




Article 12(1.b)


-




Article 12(2)


-




Article 12(3)


-




Article 13


Article 15




Article 14


Article 17




Article 15


Article 17




Article 16


Article 38




Article 17


Article 36




Article 18


Article 7, Article 15




Article 19(1)


Article 35, Article 39




Article 19(2)


Article 35




Article 19a


-




Article 20


Article 39




Article 21


Article 33




Article 22(1)


Article 24




Article 22(2)


Article 40




Article 23


Article 24




Article 24


Article 7




Article 25


Article 76




Article 26


-




Article 27


Article 7




Article 28


 




Article 29


 




Article 30


 




Article 31


Article 82




Article 32


Article 83




Article 33


Article 83




Annex I


Article 7




Annex II


Article 7




Annex III


Article 7




Annex IV


Article 17




Annex V


Article 35




Annex VI


Article 82




Annex VII


Article 82













Council Directive 2008/72/EC


This Regulation




Article 1


Article 1




Article 1(2)


Article 2(1)




Article 1(3)


Article 2(3)




Article 2


Article 2(4)




Article 3


Article 3




Article 4


Article 7(4), Article 8(5)




Article 5(1), (2)


Article 41, Article 42




Article 5(3)


-




Article 6(1)


Article 10




Article 6(2) to (4)


-




Article 7


-




Article 8(1)


Article 10




Article 8(2)


Article 2(4)




Article 8(3)


Article 44




Article 9(1), (2)


Article 5




Article 9(3)


Article 45




Article 10(1)


Article 13




Article 10(2)


Article 22




Article 11(1)


Article 13




Article 11(2)


Article 28




Article 12


Article 2(4)




Article 13


Article 33




Article 14(1)


-




Article 14(2)


Article 5




Article 15


-




Article 16(1)


Article 39




Article 16(2)


-




Article 17


Article 7(1), (2), Article 8(1), (2)




Article 18


Article 7(3), Article 8(3)




Article 19(1)


Article 19




Article 19(2)


Article 38




Article 20


Article 28




Article 21


Article 76




Article 22


Article 7(3), Article 8(3)




Article 23(1)


-




Article 23(2)


Article 80




Article 24


Article 83




Article 25


-




Article 26


Article 83




Article 27


Article 83




Annex I


Annex II and Annex III




Annex II


Annex I




Annex III


-













Council Directive 2008/90/EC


This Regulation




Article 1(1)


Article 1, Article 2




Article 1(2)


Article 2(1)




Article 1(3)


Article 4




Article 1(4)


2(4)




Article 2


Article 3




Article 3(1)


Article 6




Article 3(2)


-




Article 3(3)


-




Article 3(4)


Article 2(4), Article 29




Article 4


Article 7(4), Article 8(5)




Article 5


Article 41




Article 6(1)


Article 7, Article 8




Article 6(2)


Article 4




Article 6(3)


Article 42




Article 6(4)


-




Article 7(1)


Article 5




Article 7(2)


Article 47(1)




Article 7(3)


Article 47(1), Article 54




Article 7(4)


Article 47(1)




Article 7(5)


Article 47(2)




Article 7(6)


Article 47(2)




Article 8(1)


Article 13




Article 8(2)


Article 13, Article 18




Article 9(1)


Article 13, Article 15, Article 16, Article 17




Article 9(2)


Article 28




Article 9(3)


Article 15, Article 17




Article 10


Article 2(4), Article 29, Article 30




Article 11


Article 33




Article 12(1)


Article 39




Article 12(2)


-




Article 13


Article 80




Article 14


Article 24, Article 25




Article 15


Article 80




Article 16


Article 19




Article 17


-




Article 18


Article 2(3)




Article 19


Article 76




Article 20


-




Article 21


-




Article 22


-




Article 23


Article 23




Article 24


Article 83




Annex I


Annex I




Annex II


-







ELI: http://data.europa.eu/eli/C/2025/3767/oj
ISSN 1977-091X (electronic edition)