Changes from report parliamentary committee draft to plenary report

AddedArticle 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.

AddedArticle 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;

AddedThe 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.

AddedArticle 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.

AddedThe 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.

AddedArticle 52 – title: Value for sustainable and productive cultivation and use

AddedArticle 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.

AddedArticle 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:

AddedArticle 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;

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

AddedArticle 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;

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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

AddedArticle 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;

AddedArticle 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;

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedRegulation (EU) 2017/625

AddedArticle 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(Regulation (EU) 2017/625)

AddedThe 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.

AddedRegulation (EU) 2018/848

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

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

AddedArticle 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.’

AddedAnnex 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.

AddedAnnex 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);

AddedTo 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

AddedAnnex 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.)