Changes between two versions
What changed between the plenary report and the adopted text
From · plenary report· 22 Mar 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)
To · adopted text· 24 Apr 2024
Production and marketing of plant reproductive material
These two texts have too little in common to compare paragraph by paragraph: they are different documents rather than versions of one (for example one group’s motion and the joint text that was adopted).
+1,753 added · −415 removed · 6 changed paragraphs, packaging included.
Part 21 of 38: Paragraphs 1140–1199
Added: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]
Added:(a) all varieties registered pursuant to the procedure set out in Articles 55 - 68;
Added:(b) the conservation varieties referred to in Article 26 and registered pursuant to Article 53.
Added: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.
Added: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.
Added:4. This Article, and Articles 45 to 74, may not apply to varieties which are bred solely as components of hybrid varieties.
Added:Article 45 Establishment of a Union variety register
Added:1. The Commission shall establish, publish, in an electronic format, and keep updated a single register of varieties (‘the Union variety register’).
Added: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]
Added:The Union variety register may be accessible by an electronic portal containing other registers of plant variety rights, forest reproductive material or other plants.
Added:Article 46 Contents of the national and Union variety registers
Added: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).
Added: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.
Added: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]
Added:SECTION 2 REQUIREMENTS FOR REGISTRATION OF VARIETIES
Added:Article 47 Requirements for registration in national variety registers
Added:1. Varieties shall be registered in a national variety register in accordance with Articles 55 to 68, only if:
Added:(a) they have:
Added:(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]
Added:(ii) an officially recognised description pursuant to Article 53, if they are conservation varieties;
Added:(b) they bear a denomination deemed suitable pursuant to Article 54;
Added:(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;
Added:(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;
Added:(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;
Added:(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]
Added:(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]
Added:A variety may not be registered with both an official description and an officially recognised description.
Added: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]
Added:(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
Added:(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;
Added:Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).
Added:They shall adapt the respective requirements to the development, where applicable, of international standards, and the new scientific and technical knowledge.
Added: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.
Added: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]
Added:(i)(a) measures in the field, including crop rotation; [Am. 213]
Added:(ii)(b) monitoring measures; [Am. 214]
Added:(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]
Added:(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]
Added:(v)(e) the indication of the conditions referred to in point (i)(a) in the national variety registers. [Am. 217]
Added:Those conditions shall be based on the latest scientific and technical knowledge.
Added: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]
Added:Article 48 Distinctness
Added: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]
Added: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:
Added:(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]
Added:(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
Added:(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.
Added: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.
Added:Article 49 Uniformity
Added: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.
Added:Article 50 Stability
Added: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.
Added:Article 51 Granted plant variety rights
Added: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).
Added:Article 52 Value for sustainable cultivation and use
Added: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.
Added:The characteristics referred to in the first subparagraph are the following, as appropriate for the species, regions, agro-ecological conditions and uses concerned:
Added:(a) yield, including yield stability and yield under low-input conditions;
Added:(b) tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses, insects and other pests;
Added:(c) tolerance/resistance to abiotic stresses, including adaptation to climate change conditions;