What changed between the draft committee report and the plenary report

Removed:In this regulation, the focus is on the marketing standard and not the production. Regarding the category, it is important that the final labeling on the market correspond to the real standards.

Added:Article 14 – paragraph 6: 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).

Removed:Article 20 – paragraph 2 – subparagraph 2 – point b – point i: (i) to the purpose of ensuring food and feed security, or ensuring high value of industrial processing; or

Added:Article 15 – paragraph 2 – subparagraph 2 – point a: (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

Removed:This amendments gives more flexibility for the certification.

Added:Article 15 – paragraph 2 – subparagraph 2 – point b: (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.

Removed:Flowering mixtures and mixtures for greening currently contain many species that are not listed. This is important because these species are used as part of nature conservation measures. These mixtures are currently used on a large scale.

Added:Article 17 – paragraph 3: 3. Any space of the official label or the operator’s label apart from the elements mentioned in paragraph 4, 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 ...). .

Removed:Article 22 – paragraph 1 – subparagraph 1 – point b: (b) it is naturally associated with a particular area (‘region of origin’) contributing to the conservation of genetic resources or the restoration of the natural environment;

Added:Article 17 – paragraph 4 – subparagraph 1 – point h: deleted

Removed:This definition of "source area" is the the same definition of "region of origin" in the in Article 3 of EU Directive 2010/60, which currently regulates the marketing of preservation mixtures. This amendments it to avoid misunderstandings.

Added:Article 17 – paragraph 4 – subparagraph 1 – point i: deleted

Added:Article 17 – paragraph 4 – subparagraph 1 – point n a (new): (na) the label for polyclonal material referred to in Article 9(4).

Added:Article 19 – paragraph 1 – introductory part: In the case where official controls carried out during the marketing of PRM show that it has not been produced or marketed within the Union in compliance with the respective requirements applicable to that PRM, the competent authorities shall ensure that the professional operator concerned takes the necessary corrective actions concerning the PRM, its premises and production methods, as appropriate. Those actions shall aim at achieving one or more of the following elements:

Added:Article 19 – paragraph 1 – point c: (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 marketed under a lower category, in accordance with the requirements applicable for that category;

Added:Article 19 – paragraph 1 – point d: (d) where applicable, the professional operator may be sanctioned by additional means to the withdrawal or modification of the authorisation referred to in Article 11.

Added:Article 20 – paragraph 2 a (new): 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).

Added:Article 21 – paragraph 1 – subparagraph 1: Mixtures of certified seed or mixtures of standard seed of various genera or species listed in 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 fulfil the requirements of this Article.

Added:Article 21 – paragraph 1 – subparagraph 2 – point b: (b) an operator’s label, in all other cases.

Added:Article 21 – paragraph 1 – subparagraph 3: 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.

Added:Article 22 – paragraph 1 – subparagraph 1 – introductory part: 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 Parts A, B and C of Annex I, and genera or species of other Parts of that Annex, or of genera or species not listed in that Annex, if such mixtures fulfil all of the following conditions:

Added:Article 22 – paragraph 1 – subparagraph 1 – point a: (a) they contribute to the conservation of genetic resources, or the restoration of the natural environment; and

Added:Article 22 – paragraph 1 – subparagraph 1 – point b: (b) they are naturally associated with a particular area (‘region of origin’) contributing to the conservation of genetic resources or the restoration of the natural environment;

Added:Article 22 – paragraph 1 – subparagraph 1 – point c: (c) they comply with the requirements of Annex V.

Added:Article 22 – paragraph 1 – subparagraph 1 – point c a (new): (ca) they do not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) or of a category 1 or 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… OJNGT Regulation].

Added:Article 22 – paragraph 1 – subparagraph 2: Such mixtures constitute ‘preservation mixtures’ and this shall be mentioned on their label.

Removed:The fodder plants are inherently breeded as heterogeneous material so it should be excluded.

Added:Article 26 – paragraph 1: 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.

Added:Article 26 – paragraph 3: 3. A professional operator who uses this derogation shall annually notify to the competent authority this activity.

Added:Article 27 – paragraph 1: 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. PRM of heterogeneous material shall be notified to and registered by the competent authority prior to its production and/or marketing, in accordance with the requirements set out in Annex VI.

Added:Article 27 – paragraph 2: 2. By way of derogation from Article 7, Article 8, Article 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.

Added:Article 27 – paragraph 3 – subparagraph 1 – point c: (c) improve the rules on maintenance of heterogenous PRM, where applicable, on the basis of the emergence of best practices.

Added:Article 27 – paragraph 4: 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 three months by the competent authority, the PRM of heterogeneous material may be marketed.

Added:Article 27 – paragraph 5 – subparagraph 3 – point d: (d) the breeding or production location of the PRM of heterogeneous material;

Added:Article 27 – paragraph 5 – subparagraph 4: The competent authorities shall have access to the information referred to in this paragraph, in the context of post-marketing controls.

Added:Article 27 – paragraph 7 – subparagraph 1: 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.

Added:Article 27 – paragraph 7 – subparagraph 2: The competent authorities shall keep, update and publish that register, make it accessible online and notify immediately its content and updates to the Commission.

Added:Article 28 – paragraph 1 – subparagraph 2: A professional operator who uses this derogation shall annually notify this activity to the competent authority.

Added:Article 28 – paragraph 2: deleted / (deleted)

Added:Article 29 – title: PRM marketed to, by, between and within organisations and networks dedicated to dynamic conservation

Added:Article 29 – paragraph 1 – subparagraph 1: By way of derogation from Articles 5 to 25, PRM may be marketed to, by, between and within organisations and networks including farmers, dedicated to dynamic conservation whereby any of the activities are carried out for non-profit purposes.

Added:Article 29 – paragraph 1 – subparagraph 2: It may also be marketed from those conservation organisations and networks or their members to persons who carry out dynamic conservation of that PRM as final consumers or for farming purposes.

Added:Article 29 – paragraph 1 – subparagraph 3 – point a: (a) be listed in a register kept by those conservation organisations and networks with 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;

Added:Article 29 – paragraph 1 – subparagraph 3 – point b: (b) be conserved by those 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

Added:Article 29 – paragraph 1 – subparagraph 3 – point c: (c) be practically free from quality pests and any defects likely to impair its quality as a reproductive material.

Added:Article 29 – paragraph 2: 2. The conservation organisations and networks shall notify the competent authority of the use of the derogation referred to in paragraph 1 and the species concerned.

Removed:This amendments allows for more flexibility in the application of this article.

Added:Article 30 – paragraph 1 – point 2: (2) is derived from the respective farmer’s own crops;

Added:Article 30 – paragraph 1 – point 3: (3) 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

Added:Article 30 – paragraph 1 – point 4: (4) the PRM is used for dynamic management and conservation of the farmer’s own PRM for the purpose of contributing to agro-diversity.

Added:Article 30 – paragraph 2 – introductory part: 2. Such PRM shall fulfil all of the following requirements:

Added:Article 30 a (new): 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.

Added:Article 31: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Added:Article 32 – paragraph 1 – subparagraph 1 – introductory part: 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:

Added:Article 32 – paragraph 1 – subparagraph 2: Such authorisation may be granted 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 limited quantities per species as specified by the competent authority in correlation with the volume of production at Member State level.

Added:Article 32 – paragraph 1 – subparagraph 2 a (new): This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC.

Added:Article 32 – paragraph 2 – introductory part: 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 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:

Added:Article 32 – paragraph 3 – point a: deleted

Added:Article 32 – paragraph 3 – point e: deleted

Added:Article 32 – paragraph 3 – point f: deleted

Removed:The process of equivalence for derogatory regimes (PRM belonging to conservation varieties; of heterogeneous material; marketed to final users; marketed to and between gene banks, organizations and networks; and exchanged between farmers) should be allowed.

Added:Article 35 – paragraph 5 a (new): 5a. This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC.

Added:Article 36 – paragraph 1 – subparagraph 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.

Added:Article 36 – paragraph 2 – point b: (b) a justification on the necessity and proportionality of such requirements in light of possible additional costs of production and marketing.

Added:Article 37 – paragraph 1 – subparagraph 1 a (new): 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.

Added:Article 37 – paragraph 2: 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.

Added:Article 38 – paragraph 1 – subparagraph 1: By way of derogation from Articles 2, 5, 6, 7, 8, 9, 20, 26, 27 and 47 to 53, the Commission 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 registered 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.

Added:Article 38 – paragraph 1 – subparagraph 2: 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, 9, 20, 26, 27 and 47 to 53 of this Regulation.

Added:Article 38 – paragraph 2 – subparagraph 1 – introductory part: The delegated acts referred to in paragraph 1 shall specify one or more of the following elements:

Added:Article 38 – paragraph 2 – subparagraph 2: Those delegated acts shall adapt to the evolution of techniques for production of the PRM concerned, and shall be based on any comparative trials carried out by the Member States.

Added:Article 38 – paragraph 3: 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 to 9, 20, 26, 27 and 47 to 53.

Added:Article 39 – paragraph 1 – subparagraph 2: However, such import shall not be authorised, nor shall such equivalence be recognised under paragraph 2, for the PRM referred to in Articles 22 to 29, except where it originates in neighbouring countries.

Added:Article 40 – paragraph 1 – subparagraph 3 – point g: (g) the name of the final user, farmer or professional operator importing the PRM.

Added:Article 40 – paragraph 2 – point g: (g) the name of the final user, farmer or professional operator importing the PRM.

Added:Article 41 – paragraph 1 – introductory part: Professional operators, which produce PRM with the aim of commercial exploitation, shall:

Added:Article 41 – paragraph 1 – point e: (e) keep records of the monitoring of the critical points referred to in point (d) and provide them for examination when requested by the competent authorities;

Added:Article 41 – paragraph 1 a (new): The requirements laid down in paragraph 1, points (d) and (e), shall not apply to micro-enterprises.

Added:Article 41 – paragraph 1 b (new): The activities referred to in Articles 28, 29 and 30 shall not be subject to the provisions of this Article.

Added:Article 42 – paragraph 3 a (new): 3a. The activities referred to in Articles 28, 29 and 30 shall not be subject to the provisions of this Article.

Removed:Turf grasses shall be exempted from VSCU testing. The purpose of turf grasses is not the production of food or renewable raw materials.

Added:Article 46 – paragraph 2: 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.

Removed:Article 47 – paragraph 1 – subparagraph 1 a (new): As regards points (f) and (g) of the first subparagraph, the Commission may decide, by means of implementing acts, that the provisions adopted by Member States have to be repealed or amended, if it concludes that those provisions are not sufficiently based on the latest scientific and technical knowledge or proportionate to the objective of pursued. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

Added:Article 47 – paragraph 1 – subparagraph 1 – point a – point i: (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

Removed:The Commission and not the member state should be empowered to decide on this topic that must be regulated uniformly in the Union.

Added:Article 47 – paragraph 1 – subparagraph 1 – point f: (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 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;

Removed:Article 47 – paragraph 3: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Added:Article 47 – paragraph 1 – subparagraph 1 – point g: (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 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.

Removed:This regulation should be focused on the marketing standard. The production standards will be indirect modified by the new marketing standard.

Added:Article 47 – paragraph 2 – subparagraph 1 – introductory part: 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:

Added:Article 47 – paragraph 3 – subparagraph 1 – introductory part: 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 paragraph 1, points (f) and (g), concerning:

Added:Article 47 – paragraph 3 – subparagraph 1 – point i: (a) measures in the field, including crop rotation;

Added:Article 47 – paragraph 3 – subparagraph 1 – point ii: (b) monitoring measures;

Added:Article 47 – paragraph 3 – subparagraph 1 – point iii: (c) the mode of notification of the conditions referred to in point (a) to the Commission and the other Member States;

Added:Article 47 – paragraph 3 – subparagraph 1 – point iv: (d) rules for reporting from professional operators to the competent authorities concerning the application of the conditions referred to in point (a);

Added:Article 47 – paragraph 3 – subparagraph 1 – point v: (e) the indication of the conditions referred to in point (a) in the national variety registers.

Added:Article 47 – paragraph 4: 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.

Added:Article 53 – paragraph 1 – point b: (b) it has an indication of its initial region of origin, when known, or the local conditions under which it has been newly bred;

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

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

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

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

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

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

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

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

Added: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: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: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: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: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.

Removed:Annex I – Part A – subheading 1 a (new): Cicer arietinum Lens culinaris Medik., 1787 Fagopyrum esculentu / Camelina sativa / Triticum monococcum

Added: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;

Removed:Annex VII – paragraph 1 – point g: (g) in the case of conservation varieties with officially recognised description and, if appropriate, an indication of the region(s), where the variety has historically been grown and to which it is naturally adapted (‘region(s) of origin’);

Added: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;

Removed:To clarify the type of variety referred to in article 46.

Added: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;

Removed:In accordance with the previous amendments.

Added:Regulation (EU) 2018/848

Removed:Annex VII – paragraph 1 – point t a (new): (ta) disclosure of which breeding techniques have been applied for the development of the variety (e.g. cell fusion, genetic engineering, chemical or iradiation mutation breeding, microspore culture);

Added:Article 81, Article 3, Article 13 and second paragraph of point 1.8.4. of Part I of Annex II: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Removed:Annex VII – paragraph 1 – point t b (new): (tb) disclosure of whether the variety is covered by existing patents.

Added:Article 83 – paragraph 3 – point b: (b) Article 52 shall apply, provided that the respective examination requirements, methodologies and standards for assessing the characteristics listed in Article 52(1), second subparagraph, points (a) to (gb), exist. It shall be binding in its entirety and directly applicable in all Member States.

Added:Annex I – Part A – row 107 a (new): Cicer arietinum / Camelina sativa / Fagopyrum esculentu / Lens culinaris / Triticum monococcum / Chenopodium quinoa / Vicia ervilia / Vicia narbonensis / Tritordeum / Lathyrus sativus / Eragrostis tef / Ceratonia siliqua

Added:Annex I – Part B – row 29 a (new): Salvia hispanica.

Added:Annex II – Part B – title: REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED MATERIAL OF AGRICULTURAL AND VEGETABLE SPECIES, FRUIT PLANTS

Added:Annex II – Part C – title: REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF SELECTED CLONES OF PRE-BASIC, BASIC AND CERTIFIED MATERIAL AS REFERRED TO IN ARTICLE 9 (1)

Added:Annex II – Part C – paragraph 1 – introductory part: Requirements for the production of pre-basic, basic and certified selected clones

Added:Annex II – Part C – paragraph 1 – point A – point a: (a) The identity of the selected clone shall be determined through an official label or a label issued by the profesional 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 shall be kept by the professional operator after the marketing of that PRM.

Added:Annex II – Part C – paragraph 1 – point A – point b – point i: deleted

Added:Annex II – Part C – paragraph 1 – point B – point d: (d) The respective mother plants shall be excluded as a source of PRM in case of defects.

Added:Annex II – Part C – paragraph 1 – point B – point e: (e) 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. 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.

Added:Annex II – Part C – paragraph 1 – point B – point i: deleted

Added:Annex II – Part C – paragraph 1 – point B – point j: deleted

Added:Annex II – Part C – paragraph 2: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Added:Annex II – Part D – title: REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED SEED OF FRUIT PLANTS, VINE AND POTATOES

Added:Annex II – Part D – paragraph 1 – introductory part: Requirements for the production of pre-basic, basic and certified seed of fruit plants, vine and potatoes

Added:Annex III – Part A – paragraph 1 – point B – point d: (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.

Added:Annex III – Part B – title: REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD MATERIAL OF AGRICULTURAL AND VEGETABLE SPECIES, FRUIT PLANTS AND VINE

Added:Annex III – Part B – paragraph 1: Part A of Annex 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.

Added:Annex III – Part B – paragraph 1 a (new): Vine rootstocks may not be marketed as standard material.

Added:Annex III – Part C – title: REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF POLYCLONAL PRM AS REFERRED TO IN ARTICLE 9 (1)

Added:Annex III – Part C – paragraph 1: 1. Planting / Part C, point 1 of Annex II shall apply accordingly to the planting of polyclonal PRM.

Added:Annex III – Part C – paragraph 2: 2. 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.

Added:Annex III – Part C – paragraph 2 a (new): 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.

Added:Annex III – Part D – title: REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD SEED OF FRUIT PLANTS, VINE AND POTATOES

Added:Annex III – Part D – paragraph 1: Part D of Annex II shall apply accordingly for the production and marketing of standard seed of fruit plants, vine and potatoes.

Added:Annex V – subheading 1: 1. Region of origin

Added:Annex V – subheading 1 – paragraph 1: Competent authorities may designate specific 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.

Added:Annex V – subheading 1 – paragraph 2: Where the region of origin is located in more than one Member State, it shall be identified by a common agreement of all Member States concerned.

Added:Annex V – subheading 2 – paragraph 1 – point a: (a) typical for the habitat type of the region of origin;

Added:Annex V – subheading 2 – paragraph 1 – point c: (c) adequate for the purpose of recreating the habitat type of the region of origin.

Added:Annex V – subheading 2 – paragraph 3: 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.

Added:Annex V – subheading 3 – paragraph 2 – point c: (c) components as species and, where relevant, subspecies of the preservation mixture; which are typical for the habitat type of the 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;

Added:Annex V – subheading 3 – paragraph 2 – point d: deleted

Added:Annex V – subheading 3 – paragraph 2 – point e: (e) region of origin of the mixture;

Added:Annex V – subheading 3 – paragraph 2 – point g: (g) habitat type of the region of origin of the mixture; and

Added:Annex V – subheading 3 – paragraph 3: The application shall be accompanied by the information necessary to verify compliance with requirements set out in paragraph 4 in the case of directly harvested preservation mixtures, or paragraph 5 in the case of multiplied preservation mixtures.

Added:Annex V – subheading 3 – paragraph 5: Professional operators at the end of each calendar or fiscal year, as appropriate, shall notify the quantity of authorised preservation mixtures to the competent authority.

Added:Annex V – subheading 4 – paragraph 1 – point a: (a) a seed mixture that has been collected at the 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;

Added:Annex V – subheading 5 – paragraph 1 – point a: (a) seed of individual species is taken at the region of origin, or is a directly harvested preservation mixtures purchased to other operator;

Added:Annex V – subheading 5 – paragraph 1 – point b: deleted

Added:Annex V – subheading 5 – paragraph 1 – point d: deleted

Added:Annex V – subheading 5 – paragraph 1 – point h: (h) the maximum content of species and, where relevant, subspecies which do not comply with point (f) shall not exceed 1 % by weight;

Added:Annex VI – point A – paragraph 2: 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.

Added:Annex VI – point B – point 2 – introductory part: 2. The heterogeneous material may originate from one of the following techniques:

Added:Annex VI – point D – point 1 – paragraph 1: PRM of heterogeneous material shall comply with requirements equal to those set for the lowest category for the respective species including requierments set for the species listed in Annex IV for the analytical purity and germination requirements for seed and the quality requirements for other material.

Added:Annex VII – paragraph 1 – point g: (g) in the case of conservation, an officially recognised description and, if appropriate, an indication of the region(s), where the variety has traditionally been grown and, in the case of newly-bred conservation varieties, to which local growing conditions it is adapted;

Added:Annex VII – paragraph 1 – point t: (t) where applicable, indication that the variety has certain characteristics that may lead to undesirable agronomic effects and indication of the applicable cultivation conditions;

Added:Annex VII – paragraph 1 – point t a (new): (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;

Added:Annex VII – paragraph 1 – point t b (new): (tb) where applicable, a description of which breeding techniques have been applied for the development of the variety.

Added:In order to be registered as a variety, the distinctness, uniformity and stability of the PRM must be verified. In its proposal, the Commission proposes including a complementary technical test of the value for sustainable cultivation and use (VSCU), which should confirm that a variety offers a ‘clear improvement’ compared to other varieties that are already registered. Your rapporteur believes that the value of a variety depends, first and foremost, on the conditions in which it develops and has been bred: a variety cannot be considered to be sustainable in itself as everything depends on the agricultural production system using it. That is why VSCU should be tested in different production methods, notably where synthetic pesticides are not used, as in organic farming. Moreover, VSCU testing should not result in varieties being excluded if that reduces crop biodiversity. VSCU testing should also be optional for fruits and vegetables because of the costs involved for small and medium-sized seed producers.

Added:Finally, your rapporteur believes that the legislative proposal on PRM requires an amendment of Directive 98/44/EC on the legal protection of biotechnological inventions in order to maintain free access to genetic resources. To avoid destabilising the system of plant variety rights, which ensures fair remuneration for breeders without curbing access to innovation, PRM obtained from new genomic techniques (NGT) should not be patentable. Patents should only be extended to include the organic material derived therefrom. Finally, the scope of compulsory licensing should be widened in the case of a proven environmental or economic benefit.

Added:AMENDMENTS

Added:The Committee on the Environment, Public Health and Food Safety calls on the Committee on Agriculture and Rural Development, as the committee responsible, to take into account the following amendments:

Added:Recital 5: (5) In order to achieve this transition to sustainable food systems, the Union legislation should therefore take account of the need to ensure the adaptability and diversity of PRM to the changing agricultural, horticultural and environmental conditions, to face the challenges of climate change, to protect and restore biodiversity and to meet increasing farmers’ and consumers’ expectations related to quality, resilience and sustainability of PRM.

Added:Recital 36 a (new): (36 a) The Regulation should strive for the 'One Health Approach’ as an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems. It recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent;

Added:Recital 38 a (new): (38 a) Heterogeneous material should not consist of a GMO or a category 1 or category 2 NGT plant as defined in Regulation (EU).../...

Added:Recital 49: (49) In order to contribute to the sustainability of agricultural production and food systems while recognising that sustainability cannot be reduced to a single trait or variety but can only apply to a cultivated system as a whole, and in order to 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 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 storage, processing and distribution; and quality or nutritional characteristics (‘value for sustainable cultivation and use’). 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.

Added:Recital 64: deleted

Added:Article 1 – paragraph 1: This Regulation lays down rules for the production of plant reproductive material (‘PRM’) with a view to its marketing as PRM in the Union, 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:Article 2 – paragraph 1 – subparagraph 3: The requirements concerning production of PRM shall apply only to production with a view to its marketing as PRM in the EU.

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

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

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

Added:Article 2 – paragraph 2 – point e: (e) to contribute to sustainable and productive food systems, adapted to diverse climatic and soil conditions, for current and future projected climatic conditions;

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

Added:Article 2 – paragraph 4 – point e: (e) PRM sold or transferred in any other way, whether free of charge or not, for official testing, breeding, inspections, exhibitions or scientific purposes, including for on-farm research and for activities carried out in the framework of the dynamic conservation of genetic resources;

Added:Article 2 – paragraph 4 – point e a (new): (e a) PRM produced by farmers for their own use;

Added:Article 3 – paragraph 1 – point 29 – point a: (a) traditionally grown or locally newly bred or developed under specific local conditions, and adapted to those conditions or the utilisation in a marginal environment or production system; and

Added:Article 3 – paragraph 1 – point 29 – point a a (new): (aa) not an F1 hybrid; and

Added:Article 3 – paragraph 1 – point 29 – point b: (b) in the case of seeds, can be characterised by a certain level of genetic and phenotypical diversity between individual reproductive units

Added:Article 3 – paragraph 1 – point 35 a (new): (35 a) Plant breeding means activities and practices involved in developing new plant varieties and their selection prior to application for registration;

Added:Article 3 – paragraph 1 – point 35 b (new): (35 b) ‘dynamic conservation of plant genetic resources’ means activities carried out by gene banks, community seed banks and other organisations and networks, as well as their members and individual seed savers, implying transfers of PRM in both formal and informal ways, whether or not for consideration and seeking to contribute to the long-term conservation and enrichment of plant genetic diversity.

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

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

Added:Article 22 – paragraph 1 – subparagraph 1 – point c a (new): (c a) it is not covered by an intellectual property right limiting its use for conservation purposes.

Added:Article 22 – paragraph 1 – subparagraph 1 – point c b (new): (cb) it does not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) or of a category 1 or 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation ...).

Added:Article 26 – paragraph 1: 1. By way of derogation from Article 20, PRM of all genera or species listed in Annex I 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.

Added:Article 26 – paragraph 2 a (new): 2 a. A variety of conservation, its parts and/or its genetic components may not be covered by an intellectual property right limiting its use for conservation, research, breeding and/or training, including on-farm participatory research and breeding.

Added:Article 27 – paragraph 3 – subparagraph 2: Those amendments shall be developed in consultation with respective multi actor stakeholders involved in heterogeneous material 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 species.

Added:Article 27 – paragraph 4: 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 three months, the PRM of heterogeneous material may be marketed.

Added:Article 27 – paragraph 7 – subparagraph 1: Heterogeneous material as notified pursuant to paragraph 1, shall be registered by the competent authorities in a dedicated register (‘heterogeneous material register’). Registration shall be free of charge.

Added:Article 29 – title: PRM marketed by, to, within and between organisations and networks dedicated to the dynamic conservation and sustainable use of plant genetic resources

Added:Article 29 – paragraph 1 – subparagraph 1: By way of derogation from Articles 5 to 25, PRM may be marketed by, to, within, or between organisations and networks, including farmers, dedicated to the dynamic conservation and sustainable use of plant genetic resources whereby any of the activities are carried out for non-profit purposes.

Added:Article 29 – paragraph 1 – subparagraph 2: It can be marketed as well from those conservation organisations and networks or their members to persons who carry out dynamic conservation of that PRM as final consumers, or for professional farming purposes.

Added:Article 29 – paragraph 1 – subparagraph 3 – introductory part: In the cases provided for in the first and the second subparagraphs, conservation organisations and networks shall not fulfil the obligations under Article 41 to 43, and PRM shall be listed in a register kept by those conservation organisations and networks with a basic description of that PRM.

Added:Article 29 – paragraph 1 – subparagraph 3 – point a: deleted

Added:Article 29 – paragraph 1 – subparagraph 3 – point b: deleted

Added:Article 29 – paragraph 1 – subparagraph 3 – point c: deleted

Added:Article 29 – paragraph 2: deleted

Added:Article 30 – title: PRM exchanged between farmers

Added:Article 30 – paragraph 1 – introductory part: 1. By way of derogation from Articles 5 - 25, farmers may exchange PRM in kind or for monetary compensation covering direct costs incurred, if such PRM fulfils all of the following conditions:

Added:Article 30 – paragraph 1 – point 3: (3) are not subject to a service contract for multiplication conducted by the respective farmer with a professional operator performing PRM production; and

Added:Article 30 – paragraph 1 – point 4: (4) the PRM is used for dynamic management of farmer’s own PRM for the purpose of contributing to agro-diversity.

Added:Article 30 – paragraph 2 – introductory part: 2. Such PRM shall fulfil all of the following requirements:

Added:Article 30 – paragraph 2 – point a: (a) not to belong to a to variety for which plant variety rights have been granted in accordance with Regulation (EU) 2100/94 and where the right is still in force;

Added:Article 30 – paragraph 2 – point b: (b) to be limited to small quantities defined by the competent authorities sufficient to meet the own needs of a farmer for specific species per year, without using commercial intermediaries or public offer of marketing; and

Added:Article 30 – paragraph 2 – point c: (c) to be practically free from quality pests and any defects likely to impact their quality as PRM.

Added:Article 30 – paragraph 3: deleted

Added:Article 32 – paragraph 1 – subparagraph 2 a (new): This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Added:Article 33 – paragraph 4 a (new): 4a. This exceptional authorisation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Added:Article 35 – paragraph 1 – point c: (c) the requirements set out in paragraphs 2 to 5a are fulfilled.

Added:Article 35 – paragraph 5 a (new): 5 a. This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Added:Article 37 – paragraph 1 – subparagraph 1: Where there are reasonable grounds to suspect that the production or marketing of PRM could 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.

Added:Article 37 – paragraph 1 – subparagraph 1 a (new): By means of derogation from the first subparagraph, in 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.

Added:Article 41 – paragraph 1 a (new): The activities referred to in Articles 28, 29 and 30 shall not be subject to the provisions of this article.

Added:Article 42 – paragraph 3 a (new): 3a. The activities referred to in Articles 28, 29 and 30 shall not be subject to the provisions of this article.

Added:Article 47 – paragraph 1 – subparagraph 1 – point c a (new): (ca) where the varieties are tolerant to herbicides, they are subject to cultivation and monitoring conditions for the production of PRM and for any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for registration, to avoid the development of herbicide resistance in weeds due to their use;

Added:The ENVI committee doesn't have any competence over the point f) despite the fact that it is about GMO crops. the text is copied and ´´the monitoring conditions´´, as also normally imposed on cultivated GMO crop to respective properties of which pests can develop resistance, is added, as it is also considered relevant.

Added:Article 47 – paragraph 1 – subparagraph 1 – point c b (new): (cb) where the varieties have particular characteristics other than the ones referred to in point (ca) that may lead to undesirable agronomic effects, they are subject to cultivation and monitoring conditions for the production of PRM and any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for their registration, to avoid those particular undesirable agronomic effects, such as the development of resistance of pests to the respective varieties or undesirable effects on pollinators or on wild growing plants of the same genus as the respective variety.

Added:The ENVI committee doesn't have any competence over the point g) despite the fact that it is about GMO crops. the text is copied and ´´the monitoring conditions´´, as also normally imposed on cultivated GMO crop to respective properties of which pests can develop resistance, is added, as it is also considered relevant. also ´´wild growing plants´´ is added, as e.g. the cultivated maize MON810 in the EU has a wild relative present, teosinte, and also their co-occurrence is being monitored.

Added:Article 52 – title: Value for sustainable and productive cultivation and use

Added:Article 52 – paragraph 1 – subparagraph 1: For the purposes of Article 47(1), point (c), the value of a variety for sustainable and productive 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, are superior and offer a clear improvement, in at least one of the existing agricultural production systems, for the sustainable and productive cultivation and the uses which can be made of the crops, other plants or the products derived therefrom.

Added:Article 52 – paragraph 1 – subparagraph 2 – introductory part: The characteristics referred to in the first subparagraph shall be tested in different agricultural production systems, inter alia conventional, organic, agro-ecological, regenerative, conservation, integrated management using minimal fertilisers and irrigation. The characteristics may encompass the following as appropriate for the species, regions, agro-ecological conditions and uses concerned:

Added:Article 52 – paragraph 1 – subparagraph 2 – point f: (f) characteristics that strengthen sustainability and productivity across the whole agrifood value chain, including harvest, storage, distribution and processing or other relevant characteristics;

Added:Article 52 – paragraph 1 – subparagraph 2 – point g a (new): (g a) preservation of traditional and cultural heritage.

Added:Article 52 – paragraph 1 – subparagraph 2 – point g b (new): (g b) would strengthen the economic, ecological and social sustainability of a regional area, impacting positively on the conservation and preservation of the traditional landscape;

Added:Article 52 – paragraph 1 – subparagraph 2 – point g c (new): (g c) enhancement of the sustainability of the agricultural production systems in an ecosystem-based approach that takes into account all interactions with the environment concerned.

Added:Article 52 – paragraph 2 a (new): 2 a. The examination of the value for sustainable and productive cultivation and use shall remain voluntary for species listed in Parts B and C of Annex I.

Added:Article 52 – paragraph 2 b (new): 2 b. The examination of the value for sustainable and productive cultivation and use must not lead to the exclusion of varieties that would reduce the diversity of the species cultivated.

Added:Article 52 – paragraph 4 – subparagraph 1: In order to obtain information about the resilience of the PRM, the examination of the value for sustainable and productive cultivation and use may also be conducted under low-input conditions and with only the absolutely necessary for the completion of the testing treatments with pesticides and other external inputs, or under organic conditions in accordance with Regulation (EU) 2018/848, and in particular Article 5, points (d), (e), (f) and (g), and Article 12 and Part I of Annex II.

Added:Article 52 – paragraph 4 – subparagraph 2: 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 by professional operators involved in organic farming or by organic farmers under in-conversion or low-input conditions and with only the absolutely necessary treatments with pesticides and other external inputs for the completion of the examination. Where applicable, Member States must report annually to the Commission on the reasons implying those treatments as well as on the commitments taken to enable this transition in the future.

Added:Article 52 – paragraph 4 a (new): 4 a. Competent authorities shall consider to include testing of conventional seed under low input conditions, organic in-conversion, or organic conditions.

Added: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. It shall inform the applicant of its decision, stating, where applicable, the grounds for refusal.

Added: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, in a commercial catalogue of a professional operator, or in documentation that is publicly available or has been submitted to the competent authority by a natural or legal person involved in the dynamic conservation or sustainable use of plant genetic resources and crop biodiversity; or

Added: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:Article 56 – paragraph 1 – point l a (new): (la) the existence of intellectual property rights other than granted plant variety right on the variety as a whole or its components;

Added: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: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:Article 77 a (new): Article 77a / Commission report / No later than the entry into force of this Regulation, the Commission shall submit a report to the European Parliament and to the European Council assessing the adequacy of the provisions introduced by this Regulation and the resources available to the competent authorities to implement them. In its assessment, the Commission shall pay particular attention to the VSCU technical test as the derogation provided for in Article 61 of this Regulation should be used with great care in order to ensure the credibility of VSCU testing. Where appropriate, the Commission shall put forward proposals, including budgetary proposals, to balance the needs and resources of the competent authorities.

Added:Regulation (EU) 2017/625

Added:Article 80 – paragraph 1 – point 1, Article 1, para 2, points (ka) and (kb) (new): ‘(ka) the cultivation of varieties tolerant to herbicides; / (kb) cultivation of varieties with particular characteristics that may lead to undesirable agronomic effects’. / (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Added:The gives competent authorities the competence to control implementation of cultivation conditions prescribed for herbicide tolerant varieties and other varieties with particular characteristics that may lead to undesirable agronomic effects, as per Article 47. If authorities have no competence to control the cultivation of such varieties, the entire benefit and efficiency of this measure on herbicide tolerant varieties and of varieties with particular characteristics that may lead to undesirable agronomic effects, should these be defined at a later date, would be lost.

Added:Regulation (EU) 2018/848

Added:Article 81, Article 3, 13 and Annex II: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Added:Article 81 a (new): Article 81a / Amendment of Directive 98/44/EC / Directive 98/44/EC is amended as follows:

Added:Article 81 b (new): (1) In Article 4, the following paragraphs 4 and 5 are inserted: / ‘4. By way of derogation from paragraphs 1, 2 and 3, NGT plants, plant material and parts thereof, and the genetic information they contain, shall not be patentable. / 5. By way of derogation from paragraphs 1, 2 and 3, plants, plant material and parts thereof, and the genetic information they contain, which have been obtained using techniques excluded from the scope of Directive 2001/18/EC as listed in Annex 1B thereto, shall not be patentable.’

Added:Annex VI – Part B – point 2 – point c a (new): (c a) Heterogeneous material must not be derived from parental material covered by patents nor be protected by patents.

Added:Annex VII – paragraph 1 – point t a (new): (ta) whether there are any intellectual property rights covering the variety as a whole or its genetic components or the genetic information contained therein, including, where applicable, the number of any relevant patent(s);

Added:To provide transparency to users, the information provided on a variety in the EU and national registers should include information on intellectual property rights, especially patents that may have been granted on parts of the registered variety, such as genetic sequences or traits. This is crucial information for all follow-on users, whether farmers, breeders, seed conservation

Added:Annex VII – paragraph 1 – point t b (new): (tb) disclose which breeding techniques have been applied for the development of the plant (e.g., cell fusion, genetic engineering, chemical or irradiation mutation breeding, microspore culture, etc.)