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Changes between two versions

What changed between the plenary report and the adopted text

From · plenary report· 22 Mar 2024

A-9-2024-0149

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

TA-9-2024-0341

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 9 of 38: Paragraphs 481–540

Removed:Article 53 – paragraph 1 – subparagraph 1 a (new): The registration under this Article shall be free of charge for the applicant.

Added:Article 7 Requirements for the production and marketing of pre-basic, basic and certified seed and material

Removed:Article 53 – paragraph 2 – subparagraph 2: 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.

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

Removed:Article 53 – paragraph 4 – subparagraph 2: deleted

Added:(a) the pre-basic, basic or certified seed is practically free from quality pests;

Removed:Article 53 a (new): 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 Organisa…

Added:(b) it is produced and marketed:

Removed:Article 54 – paragraph 1 – point c – paragraph 1 – point i: (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;

Added:(i) following official certification by the competent authorities, or certification by the professional operator under official supervision;

Removed:Article 54 – paragraph 1 – point c – paragraph 2: deleted

Added:(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]

Removed:Article 56 – paragraph 1 – point d: (d) a provisional designation;

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

Removed:Article 56 – paragraph 1 – point d a (new): (da) a variety denomination proposed by the applicant which may accompany the application;

Added:(a) the pre-basic, basic or certified material is practically free from quality pests;

Removed:Article 56 – paragraph 1 – point j: (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;

Added:(b) it is produced and marketed:

Removed:Article 56 – paragraph 1 – point k: deleted

Added:(i) following official certification by the competent authorities, or certification by the professional operator under official supervision;

Removed:Article 56 – paragraph 1 – point o: (o) 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;

Added:(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]

Removed:Article 56 – paragraph 1 – point o a (new): (oa) the breeding techniques used for the development of the variety;

Added: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]

Removed:Article 56 – paragraph 1 – point o b (new): (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.

Added:(a) sowing and planting, and production in the field, of pre-basic, basic and certified seed;

Removed:Article 61 – paragraph 1 – introductory part: 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, is if:

Added:(b) harvesting and post-harvesting of pre-basic, basic and certified seed;

Removed:Article 61 – paragraph 1 – point a: deleted

Added:(c) marketing of seeds;

Removed:Article 61 – paragraph 1 – point c a (new): (ca) the examination does not replace the risk assessment required to apply for marketing authorisation under Directive 2001/18/EC on genetically modified organisms or under Regulation (EU) .../... on plants obtained by certain new genomic techniques.

Added:(d) sowing and planting, and production in the field, of pre-basic, basic and certified material;

Removed:Article 63 – paragraph 3: 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.

Added:(e) harvesting and post-harvesting of pre-basic, basic and certified material;

Removed:Article 67 – paragraph 2 – point a: (a) it establishes that the respective requirements set out in Article 47(1) and Article 48 are not fulfilled; or

Added:(f) marketing of pre-basic, basic and certified material;

Removed:Article 68 – paragraph 1: 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 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 of Directive 2008/90/EC, without applying the registration procedure set out by those Articles.

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

Removed:Article 68 – paragraph 2: 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… [the date of 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.

Added:(h) production of pre-basic, basic and certified material produced by in vitro propagation;

Removed:Article 69 – paragraph 1 – subparagraph 2: 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.

Added:(i) marketing of pre-basic, basic and certified material produced by in vitro propagation.

Removed:Article 70 – paragraph 4: 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 Council Regulation (EC) No 2100/94, and provided that the variety is off the list for a minimum of two years.

Added: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]

Removed:Article 75 – paragraph 2 – subparagraph 1: The 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 five years from ... [the date of entry into force of this Regulation].

Added:(a) specific uses of the genera, species or the types of the PRM concerned;

Removed:Article 75 – paragraph 3: 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 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.

Added:(b) production methods of PRM, including sexual and asexual reproduction and in vitro propagation;

Removed:Article 75 – paragraph 6: 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.

Added:(c) conditions for sowing or planting;

Removed:Article 77 – paragraph 1 – point a: (a) quantities of certified and standard PRM per year and species with a specification of the quantities used for organic varieties suitable for organic production;

Added:(d) field cultivation;

Removed:Article 77 – paragraph 1 – point d: (d) number of professional operators using the derogations for marketing to final users in accordance with Article 28, the species concerned;

Added:(e) harvesting and post-harvesting;

Removed:Article 77 – paragraph 1 – point e: (e) number of 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;

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

Removed:Article 77 – paragraph 1 – point f: deleted

Added:(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;

Removed:Article 77 – paragraph 1 – point g: deleted

Added:(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;