Changes from plenary report to adopted text

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

AddedThe delegated act referred to in the first subparagraph shall remove a genus or a species from Annex IV, if one of the conditions set out in the second subparagraph, point (b), points (i) and (ii), is no longer fulfilled.

RemovedArticle 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.’

Added2a. 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).

RemovedAnnex 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.

AddedThe 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).

RemovedAnnex 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);

AddedThe 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 The Commission may decide, by means of implementing acts, that the authorisation is to be repealed, if it considers that it is no longer justified in view of the conditions referred to in paragraph 2, second subparagraph, points (a) and (b).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). [Am. 124]

RemovedTo 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

AddedSECTION 6 SPECIFIC REQUIREMENTS FOR MIXTURES OF SEEDS, RE-PACKAGING OF SEEDS AND CONTROL PLOT TESTS FOR SEEDS

RemovedAnnex 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.)

AddedArticle 21 Mixtures of seeds

Added1. Mixtures of certified seed or mixtures of standard seed of various genera or species listed in Part 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 fullfill fulfil the requirements of this Article. [Am. 125]

AddedThe seeds included in those mixtures shall be accompanied by:

Added(a) an official label, where the mixture consists only of certified seeds; or

Added(b) an operator’s label, in the case where the mixture consists only of standard seed, or of certified and standard seed all other cases. [Am. 126]

AddedFor 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. [Am. 127]

Added2. Μixtures of seeds referred to in paragraph 1 may only be produced by professional operators, which are authorised for that purpose by the competent authority. In order to receive an authorisation for the production of such mixtures, professional operators shall fulfil the following requirements:

Added(a) having installed suitable mixing equipment and appropriate procedures ensuring that the finished mixture is uniform and the stated ratio between the component varieties in each container can be achieved;

Added(b) having a person in charge who has direct responsibility for the mixing and packaging operation; and

Added(c) maintaining a register of seed mixtures and their intended use.

Added3. The mixing and packaging operation of the seeds referred to in paragraph 1, point (a), shall be carried out under the supervision of the competent authority.

AddedThe mixing operation shall be carried in a manner to ensure that there is no risk of presence of seeds not intended for inclusion and that the resulting mixture is as homogeneous as possible.

AddedThe weight of the seed in a single container, which consists of a mixture of both small-seeded species and species of which the seed is larger than the size of wheat, shall not exceed 40 kg.

Added4. The Commission may, by means of implementing acts, specify, on the basis of technical and scientific developments and the experience gained from the application of this Article, rules concerning:

Added(a) the mixing equipment and procedure;

Added(b) maximum lot sizes for particular species and varieties.

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

AddedArticle 22 Preservation mixtures

Added1. 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 Part Parts A, B and C of Annex I, as well as of different varieties of those genera or species, together with seeds of and genera or species of other Parts of that Annex, or of genera or species not listed in that Annex, if such a mixture fulfils mixtures fulfil all of the following conditions: [Am. 128]

Added(a) it contributes they contribute to the conservation of genetic resources, or the restoration of the natural environment; and [Am. 129]

Added(b) it is they are naturally associated with a particular area (‘source area region of origin’) contributing to the conservation of genetic resources or the restoration of the natural environment; [Am. 130]

Added(c) it complies they comply with the requirements of Annex V;. [Am. 131]

Added(ca) they do not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) …/… [NGT Regulation] or of a category 1 or 2 NGT plant as defined in Article 3(8) of that Regulation. [Am. 132]

AddedSuch mixture constitutes a mixtures constitute ‘preservation mixture mixtures’ and this shall be mentioned on its their label. [Am. 133]

Added2. The Commission is empowered to adopt a delegated act, in accordance with Article 75, amending Annex V concerning the following elements:

Added(a) authorisation requirements for mixtures of seeds collected directly from a natural place belonging to a defined source area region of origin, for the conservation and restoration of the natural environment (directly harvested preservation mixtures); [Am. 134]

Added(b) authorisation requirements for crop-grown preservation mixtures;

Added(c) use and content of certain species;

Added(d) requirements on sealing and packaging;

Added(e) requirements for the authorisation of the professional operators.

AddedThose amendments delegated acts shall be based on the experience gathered by the implementation of this Article, and any technical and scientific developments and the improvement of the quality and identification of preservation mixtures. They may concern particular genera or species only. [Am. 135]

Added3. Professional operators shall report to the respective competent authorities, for each production season, the amount of preservation mixtures produced and marketed by them.

AddedThe Member States shall report on request to the Commission and to the other Member States the amount of preservation mixtures produced and marketed in their territory and, where applicable, the names of competent authorities responsible for plant genetic resources or of organisations recognised for this purpose.

AddedArticle 23 Re-packaging and re-labelling of seed PRM lots [Am. 136]

Added1. Seed PRM lots of pre-basic, basic and certified seed shall be repackaged and relabeled in accordance with this Article, Articles 14 and 15, where this is necessary for splitting or merging of lots. [Am. 137]

Added2. The re-packaging and re-labelling of a seed PRM lot shall be conducted by: [Am. 138]

Added(a) the professional operator under the official supervision of the competent authority; or

Added(b) a seed sampler, who is authorised and supervised for that purpose by, and reports to, the competent authority.

AddedIn the case of point (b), the professional operator shall be notified in advance by the competent authority so as to organise its co-operation with the seed sampler.

Added3. The professional operator and the seed sampler carrying out re-packaging and re-labelling of seed lots, shall take all steps to ensure that during the operation of re-packaging, the identity and varietal purity of the seed lot is maintained, no contamination occurs, and the resulting seed lot is as homogeneous as possible.

Added4. The professional operators and the seed sampler shall keep records, when re-packaging and re-labelling seed lots, for 3 years after the respective re-labelling and re-packaging. The information contained in the records shall include:

Added(a) the reference number of the original seed lot;

Added(b) the reference number of the repackaged or relabeled seed lot;

Added(c) the weight of the original seed lot;

Added(d) the weight of the re-packaged or relabeled seed lot;

Added(e) the date of final disposal of the lot.

AddedThose records shall be kept in a form allowing to identify and verify the authenticity of the original seed lot, which is subject to re-packaging and re-labelling. They shall be made available to the competent authority on request.

Added5. The original seals and labels shall be removed from the seed lot. The professional operators or the seed sampler shall also keep the label, which was replaced, of each component seed lot.

AddedThe new labels shall either state the original seed lot reference number or a new seed lot reference number assigned by the competent authority.