Changes from plenary report to adopted text

Added(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.

RemovedArticle 3 – paragraph 1 – point 19: (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 Parts B, C and E of Annex II;

Added(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]

RemovedArticle 3 – paragraph 1 – point 20: (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 Parts B, C and E of Annex II;

Added(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 [NGT Regulation]. [Am. 13]

RemovedArticle 3 – paragraph 1 – point 21: (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 Parts B, C and E of Annex III;

Added(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.

RemovedArticle 3 – paragraph 1 – point 28: (28) ‘final user’ means any person acquiring, transferring and using PRM for purposes which are outside that person’s primary professional activities;

Added(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.

RemovedArticle 3 – paragraph 1 – point 29 – point a: (a) either a traditionally grown landrace or a newly bred variety (modern landrace) derived from on-farm selection or bred for adaptation to local conditions in the context of the sustainable use of plant genetic resources for food and agriculture;

Added(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(), 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.

RemovedArticle 3 – paragraph 1 – point 29 – point a a (new): (aa) not an F1 hybrid variety;

Added(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]

RemovedArticle 3 – paragraph 1 – point 29 – point b: (b) characterised by a satisfactory level of genetic and phenotypical diversity between individual reproductive units;

Added(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.

RemovedArticle 3 – paragraph 1 – point 29 – point b a (new): (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;

Added(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.

RemovedArticle 3 – paragraph 1 – point 30 – point c: (c) their presence has an unacceptable impact on the quality of the PRM, and an unacceptable economic impact as regards the use of that PRM in the Union;

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

RemovedArticle 3 – paragraph 1 – point 31: (31) ‘practically free from quality pests’ means a situation where the presence of quality pests on the respective PRM is so low that those pests do not affect excessively the quality of that PRM;

Added(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.

RemovedArticle 3 – paragraph 1 – point 32: (32) ‘seed potatoes’ means tubers of Solanum tuberosum L., used for the reproduction of potatoes;

Added(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.

RemovedArticle 3 – paragraph 1 – point 35 a (new): (35a) ‘dynamic conservation’ means the preservation of genetic diversity within and between cultivated plant species, and includes both the in situ conservation, whether on farm or in garden, the ex situ conservation outside of their natural habitat, and the 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;

Added(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]

RemovedArticle 3 – paragraph 1 – point 35 b (new): (35b) ‘NGT plant’ means plants obtained by certain new genomic techniques as defined in Article 3, point 2 of Regulation (EU) .../... [OJ, please insert reference to Regulation on plants obtained by certain new genomic techniques and their food and feed] of the European Parliament and of the Council];

Added(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]

RemovedArticle 3 – paragraph 1 – point 35 c (new): (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;

Added(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.

RemovedArticle 3 – paragraph 1 – point 35 d (new): (35d) ‘small packages’ means packages containing seed or material up to a maximum of: / (a) 30 kg for cereals, seed potatoes; / (b) 10 kg for fodder plants, beet, oil and fibre plants; / (c) 5 kg for legumes; / (d) 500 g for onions, chervil, asparagus, spinach beet or chard, red beet or beetrood, turnips, water melon, gourd, marrows, carrots, radishes, scorzonera or black salsify, spinach, cornsalad or lamb's lettuce; / (e) 100 g for all other species of vegetables; / (f) in the case of fruit and vine cuttings, 100 individuals with at least five useable eyes.

Added(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.

RemovedArticle 5 – paragraph 1 – point e: (e) as PRM exchanged between farmers in accordance with Article 30;

Added(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.

RemovedArticle 5 – paragraph 1 – point f: deleted

Added(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.

RemovedArticle 6 – paragraph 2 – point d: (d) as PRM exchanged between farmers in accordance with Article 30;

Added(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.

RemovedArticle 6 – paragraph 2 – point e: deleted

Added(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.

RemovedArticle 7 – paragraph 1 – point b – point ii: (ii) in accordance with the requirements set out in 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).

Added(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.

RemovedArticle 7 – paragraph 2 – point b – point ii: (ii) in accordance with the requirements set out in 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).

Added(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]

RemovedArticle 7 – paragraph 3 – introductory part: 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 shall only concern the requirements for the following:

Added(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.

RemovedArticle 7 – paragraph 3 – point g: (g) production and marketing of pre-basic, basic and certified material of selected clones;

Added(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.

RemovedArticle 7 – paragraph 4 – subparagraph 1 – introductory part: The Commission may adopt implementing acts specifying the production and marketing requirements referred to in 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

Added(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.

RemovedArticle 7 – paragraph 4 – subparagraph 1 – point f: (f) germination rates, purity and content of other PRM, moisture, presence of earth or extraneous matter;

Added(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.

RemovedArticle 7 – paragraph 4 – subparagraph 2: 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 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.

Added(62) Regulation (EU) 2017/625 of the European Parliament and of the Council 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.

RemovedArticle 8 – paragraph 1 – point b – point ii: (ii) in accordance with the requirements set out in 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.

Added(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.

RemovedArticle 8 – paragraph 2 – point b – point ii: (ii) in accordance with the requirements set out in 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.

Added(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]

RemovedArticle 8 – paragraph 3: deleted

Added(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.

RemovedArticle 8 – paragraph 4 – point g: (g) requirements for production and marketing of polyclonal PRM of standard material;