Changes from plenary report to adopted text

RemovedArticle 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(g) the label for PRM marketed to final users referred to in Article 28(1), point (a);

RemovedArticle 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(h) the label for the PRM marketed by certain gene banks, organisations and networks referred to in Article 29; [Am. 118]

RemovedThe 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(i) the label for breeder’s material referred to in Article 31(2); [Am. 119]

RemovedArticle 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(j) the label for PRM of not yet registered varieties referred to in Article 32(5);

RemovedThe 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(k) the label for PRM authorised in cases of temporary difficulties in the supply referred to in Article 33(2); and

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

Added(l) the label for seeds with a provisional authorisation for marketing referred to in Article 34(3);

RemovedArticle 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(m) the label for seeds which are not finally certified referred to in Article 35(3);

RemovedArticle 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(n) the label for PRM imported from third countries referred to in Article 40(1) and (2);

RemovedArticle 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(na) the label for polyclonal material referred to in Article 9(4). [Am. 120]

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

AddedThat implementing act shall be adopted in accordance with the examination procedure referred to in Article 76(2).

RemovedArticle 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;

Added5. The competent authority may authorise the professional operator to indicate information other than the content referred to in paragraph 4, and other than advertising material, placed at the periphery of the official label, in an area of a size not larger than 20 % of the total area of the official label, bearing the title ‘Non official information’. Such information shall be in letters not larger than those used for the content of the official label as referred to in paragraph 4.

RemovedArticle 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 18 Reference to lots

RemovedArticle 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.

AddedThe official label and the operator’s label shall be issued for each lot.

RemovedArticle 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.

AddedIf a lot of the same variety is split into two or more lots, a new official label or operator’s label shall be issued for each lot.

RemovedArticle 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.

AddedIf several lots of the same variety are merged into a new lot, a new official label or operator’s label shall be issued for that new lot.

RemovedArticle 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 19 Non-compliance of PRM with production and marketing requirements

RemovedArticle 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.

AddedIn the case where official controls carried out during the marketing of PRM show that pre-basic, basic, certified seeds or material, or standard seeds or material, have it has not been produced or marketed within the Union in compliance with the respective requirements referred to in Articles 7 or 8, or in the case where the varietal identity and purity of the PRM were not confirmed in the control plot testing in accordance with Article 24 applicable to that PRM, the competent authorities shall ensure that the professional operator concerned takes the necessary corrective actions concerning the PRM concerned and, its premises and production methods, as appropriate. Those actions shall aim at achieving one or more of the following elements: [Am. 121]

RemovedArticle 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(a) the PRM concerned complies with the respective requirements;

RemovedArticle 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(b) the PRM concerned is withdrawn from the market or is used as material other than PRM;

RemovedArticle 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(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 produced or marketed under a lower category, in accordance with the requirements applicable for that category; [Am. 122]

RemovedArticle 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(d) where applicable, the professional operator is may be sanctioned by additional means to the withdrawal or modification of the authorisation referred to in Article 11. [Am. 123]

RemovedArticle 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 20 PRM to be only produced and marketed as pre-basic, basic or certified seeds or material

RemovedArticle 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.

Added1. PRM belonging to the genera or species as listed in Annex IV may only be produced and marketed as pre-basic, basic or certified seeds or material.

RemovedArticle 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.

Added2. The Commission is empowered to adopt a delegated act in accordance with Article 75 in order to amend Annex IV.

RemovedRegulation (EU) 2017/625

AddedThe delegated act referred to in the first subparagraph shall add a genus or a species to Annex IV, if both the following conditions are fulfilled:

RemovedArticle 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(a) there is a need for higher guarantees for the quality of seeds belonging to that genus or species; and.

Removed(Regulation (EU) 2017/625)

Added(b) the costs of the certification activities, necessary to produce and market the respective seed as pre-basic, basic and certified seed are proportionate:

RemovedThe 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(i) to the purpose of ensuring food and feed security, or ensuring high value of industrial processing; and

RemovedRegulation (EU) 2018/848

Added(ii) to the economic benefits deriving from the highest standards concerning identity and quality of the seed, resulting from the compliance with the requirements for pre-basic, basic and certified seed compared to those for standard seed.

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

AddedThat proportionality shall be based on an overall assessment of the following elements in combination: the importance of the respective genus or species for the Union food and feed security; the volume of its production in the Union; its demand by the professional operators and operators of the food/feed industry; the costs of the production of pre-basic, basic and certified seed compared to the cost of production of other seed of the same genus or species; and the economic benefits derived from the production and marketing of pre-basic, basic and certified seed compared to other seed of the same genus or species.