Changes from plenary report to adopted text

Added(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.

RemovedArticle 1 – paragraph 1: This Regulation lays down rules for the production 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, identity and quality requirements, certification, labelling, packaging, imports, professional operators and the registration of varieties.

Added(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+.

RemovedArticle 1 – paragraph 2: 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 cultivation for purposes beyond the production and marketing of PRM, for the production of food, feed and other products.

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

RemovedArticle 2 – paragraph 1 – subparagraph 3: The requirements concerning production or imports of PRM shall apply only with a view to its marketing within the Union.

Added(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]

RemovedArticle 2 – paragraph 2 – point a: (a) to ensure quality, safety and diversity of choice for PRM, and its availability for professional operators, farmers and final users;

Added(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.

RemovedArticle 2 – paragraph 2 – point b: (b) to ensure fair conditions for the competition of the professional operators across the Union and the functioning of the internal market in PRM;

Added(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]

RemovedArticle 2 – paragraph 2 – point d: (d) to contribute to the dynamic conservation and sustainable use of plant genetic resources and agro-biodiversity;

Added(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.

RemovedArticle 2 – paragraph 2 – point e: (e) to contribute to sustainable agricultural production, adapted to current and future projected climatic and soil conditions;

Added(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.

RemovedArticle 2 – paragraph 2 – point f: (f) to contribute to food security and food sovereignty.

Added(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 .

RemovedArticle 2 – paragraph 3 – subparagraph 1: The Commission is empowered in accordance with Article 75 to adopt delegated acts, amending Annex I, in order to adapt 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.

Added(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 () (‘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).

RemovedArticle 2 – paragraph 3 – subparagraph 2 – introductory part: The delegated 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:

Added(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.

RemovedArticle 2 – paragraph 3 – subparagraph 2 – point c a (new): (ca) present an interest in terms of environmental sustainability.

Added(18a) Rules for the in vitro production of clones and their marketing should also be established. [Am. 7]

RemovedArticle 2 – paragraph 4 – point a: (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;

Added(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]

RemovedArticle 2 – paragraph 4 – point b: (b) forest reproductive material as defined in Article 3 of Regulation (EU) .../… of the European Parliament and of the Council47+ and propagating material of genera or species listed in Annex I to this Regulation which are exclusively used for forestry purposes; / 47 Regulation (EU) .../… of the European Parliament and of the Council …. (OJ…., p….)..

Added(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.

RemovedArticle 2 – paragraph 4 – point c: (c) PRM produced solely for export to third countries;

Added(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.

RemovedArticle 2 – paragraph 4 – point e: (e) PRM 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;

Added(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.

RemovedArticle 2 – paragraph 4 – point e a (new): (ea) PRM accessed, sold or transferred in any way in small quantities as defined in Annex VIIa, whether free of charge or not, for the purpose of dynamic conservation as set out in Article 29;

Added(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.

RemovedArticle 2 – paragraph 4 – point e b (new): (eb) PRM produced by farmers for their own use.

Added(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.

RemovedArticle 3 – paragraph 1 – point 2 – introductory part: (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:

Added(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.

RemovedArticle 3 – paragraph 1 – point 2 – point c: (c) maintenance or multiplication of varieties;

Added(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.

RemovedArticle 3 – paragraph 1 – point 3: (3) ‘marketing’ means the following commercial actions conducted by a professional operator: sale, holding, 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;

Added(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.

RemovedArticle 3 – paragraph 1 – point 5: (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;

Added(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.

RemovedArticle 3 – paragraph 1 – point 6: (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 occured, to which the selected clone belongs;

Added(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.

RemovedArticle 3 – paragraph 1 – point 7: (7) ‘polyclonal plant reproductive material’ means propagating material obtained from a selection of a group of at least seven genotypes with the prediction of genetic gains, made through quantitative genetic tools, from the same experimental set of a specific ancient variety, containing most of its intra-varietal diversity;

Added(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.

RemovedArticle 3 – paragraph 1 – point 8: deleted

Added(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.

RemovedArticle 3 – paragraph 1 – point 12: (12) ‘variety maintenance’ means the actions taken for controlling varietal purity and identity with the aim to ensure that the variety characteristics remain true to their description over subsequent cycles of reproduction;

Added(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 (). As a party to the Treaty the Union has committed to support those objectives. [Am. 9]

RemovedArticle 3 – paragraph 1 – point 14: (14) ‘pre-basic seed’ means seed that belongs to a generation preceeding 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 Parts A and D of Annex II;

Added(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.

RemovedArticle 3 – paragraph 1 – point 15: (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 Parts A and D of Annex II;

Added(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.

RemovedArticle 3 – paragraph 1 – point 16: (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 Parts A and D of Annex II;

Added(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]

RemovedArticle 3 – paragraph 1 – point 17: (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 Parts A and D of Annex III;

Added(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(). 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]

RemovedArticle 3 – paragraph 1 – point 18: (18) ‘pre-basic material’ means PRM, other than seeds, that belongs to a generation preceeding 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 Parts B, C and E of Annex II;