Changes from plenary report to adopted text

Added6. Where the competent authority assigns a new seed lot reference number, it shall either keep a record of the former seed lot reference number or ensure that this former number is included on the new labels.

Added7. Repackaging of mixtures of certified seed may only be carried out where the professional operator or the seed sampler has established that the ratio of the different components within a mixture will be maintained during the repackaging process.

AddedArticle 24 Control plot tests for pre-basic, basic and certified seeds

Added1. After the production of pre-basic, basic and certified seeds, the competent authorities shall carry out annual field tests, immediately after, or during, the season following the drawing of the samples, additionally to field inspection, in plots where the variety is compared to an officially validated sample of seed of the variety to ascertain that the characteristics of varieties have remained unchanged in the process of production and to verify the varietal identity and purity of individual seed lots.

AddedThose tests shall be used for assessing:

Addeda) whether the requirements for the next categories or generations are fulfilled. When, as a result of such tests of the immediately descending category or generation, it is established that the varietal identity or purity of the seeds has not been maintained, the competent authority shall not certify seed derived from the lot concerned;

Addedb) that such seed complies with the respective identity, quality and other certification requirements. When, as a result of such test, it is established that the requirements of Article 7 have not been fulfilled, the competent authority shall withdraw the lot concerned from the market or ensure that it complies with the applicable requirements.

Added2. The proportion of these control plot tests for pre-basic, basic and certified seed shall be determined on the basis of a risk analysis concerning possible non-compliance of the seeds with the respective requirements.

Added3. On the basis of the risk analysis referred to in paragraph 2, control plot tests shall be carried out through samples taken by the competent authority from the harvested seed.

Added4. The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation by setting out rules for the control plot tests of seeds per genera or species. Those rules shall adapt to the development of scientific and technical knowledge and international standards, and may be established per particular genera, species or categories. They may concern the following:

Added(a) criteria for the conduct of the risk analysis referred to in paragraph 2;

Added(b) the testing procedure;

Added(c) evaluation of results of the tests.

Added5. In the case of control of varietal identity and purity, the use of bio-molecular techniques may be used as a supplementary tool where the results of the control plot tests referred to in paragraph 1 are non conclusive

AddedArticle 25 Control plot tests for standard seeds

Added1. After the marketing of standard seeds, the competent authorities shall, if indicated by the risk analysis, carry out control plot tests to check whether the seeds comply with the respective varietal identity and varietal purity requirements, and with other requirements set out in Article 8 and in Annex III, as appropriate. [Am. 139]

Added2. The proportion of the control plot tests shall be determined on the basis of a risk analysis concerning possible non-compliance of the respective seeds with those requirements. Such a risk analysis shall be carried out by the competent authority on the basis of territorial characteristics, the existence of plant health risks in the region, and the track record of the professional operator. [Am. 140]

Added3. Based on the risk analysis of non-compliance with the respective rules, the control plot tests referred to in paragraph 1 shall be carried out annually, by using samples taken by the competent authority from homogeneous seed lots. Those tests shall assess identity and varietal purity of the seed concerned, and its germination rate and analytical purity.

Added4. In the case of control of varietal identity and purity, the use of bio-molecular techniques may be use as a supplementary tool where the results of the control plot tests referred to in paragraph 1 are non conclusive.

AddedSECTION 7 Derogations from the requirements of Articles 5 to 25

AddedArticle 26 PRM belonging to conservation varieties

Added1. 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. [Am. 141]

Added2. PRM referred to in paragraph 1 shall be accompanied by an operator’s label with the indication ‘Conservation variety’.

Added3. A professional operator who uses this derogation shall annually notify to the competent authority this activity, with regard to the species and quantities concerned. [Am. 142]

AddedArticle 27 PRM of heterogeneous material

Added1. 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. The PRM of heterogeneous material shall be notified to and register registered by the competent authority prior to its production and/or marketing, in accordance with the requirements set out in Annex VI. [Am. 143]

Added2. By way of derogation from Articles 7(1), (3) and Article 7, Article 8, Article 8(1), (3)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. [Am. 144]

Added3. The Commission is empowered to adopt a delegated act in accordance with Article 75, amending Annex VI. Those amendments may concern all, or particular genera or species only, and shall:

Added(a) improve the provision of information in notifications, description and identification of heterogeneous PRM, on the basis of experience gained by the application of the respective rules;

Added(b) improve the rules concerning packaging and labelling of heterogeneous PRM, on the basis of the experience gained from the checks carried out by the competent authorities;

Added(c) improve the rules on maitenance maintenance of heterogenous PRM, where applicable, on the basis of the emergence of best practices. [Am. 145]

AddedThose amendments shall be adopted 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 or certain genera or species only.

Added4. 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 a time determined three months by the competent authority, the PRM of heterogeneous material may be marketed. [Am. 146]

Added5. The professional operator shall ensure the traceability of the PRM of heterogeneous material by keeping information allowing to identify the professional operators which have supplied them with the initial material used for the production (parental material) of heterogeneous material.

AddedThe professional operator shall keep that information for 5 years.

AddedThe professional operator producing PRM of heterogeneous material intended for marketing shall also record and keep the following information:

Added(a) the name of the species and denomination used for each notified heterogeneous material;

Added(b) the type of technique used for the production of heterogeneous material as referred to in paragraph 1;

Added(c) the characterisation of the notified heterogeneous material;

Added(d) the breeding or production location of the PRM of heterogeneous material and production location; [Am. 147]

Added(e) the surface area for the production of PRM of heterogeneous material and quantity produced.

AddedThe competent authorities shall have access to the information referred to in this paragraph, in the context of post-marketing controls. [Am. 148]

Added6. Article 54 shall apply accordingly for the suitability of the denomination of heterogeneous material.

Added7. 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. [Am. 149]

AddedThe competent authorities shall keep, update and publish that register, make it accessible online and notify immediately its content and updates to the Commission. [Am. 150]

AddedArticle 28 PRM marketed to final users

Added1. By way of derogation from Articles 5 - 12, 14, 15 and 20, PRM may be marketed to final users, if it complies with all of the following requirements:

Added(a) to bear an operator’s label with the denomination of the PRM and the indication ‘Plant reproductive material for final users – not officially certified’ or, in the case of seeds, ‘Seeds for final users – not officially certified’;

Added(b) in case not belonging to a variety registered in a national variety register referred to in Article 44, to have a description made publicly available, on the basis of a private documentation, in a commercial catalogue kept by the professional operator. This private documentation shall be made available by the professional operator upon request to the competent authority;

Added(c) to be practically free from quality pests and any defects likely to impair its quality as reproductive material, and shall have satisfactory vigour and dimensions in respect of its usefulness as PRM, and, in the case of seeds, shall have satisfactory germination capacity; and

Added(d) to be marketed as individual plants, or, in the case of seeds and tubers, in small packages.

AddedA professional operator who uses this derogation shall annually notify this activity to the competent authority, with regard to the species and quantities concerned. [Am. 151]

Added2. The Commission shall, by means of implementing acts, adopt rules concerning the size, form, sealing and handling requirements concerning the small packages referred to in paragraph 1 point (d).

AddedThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2). [Am. 152]

AddedArticle 29 PRM marketed to, by, and between gene banks, and within organisations and networks dedicated to dynamic conservation [Am. 153]

Added1. By way of derogation from Articles 5 to 25, PRM may be marketed to, or by, between, gene banks, and within organisations and networks with a statutory objective, or an objective official notified to the competent authority, to conserve plant genetic resources, including farmers, dedicated to dynamic conservation, whereby any of the activities are carried out for non-profit purposes. [Am. 154]

AddedIt can may also be marketed as well from those gene banks, conservation organisations and networks or their members to persons who carry out dynamic conservation of that PRM as final consumers, for non-profit or for farming purposes. [Am. 155]

AddedIn the cases provided for in the first and the second subparagraphs, PRM shall fulfil the following requirements:

Added(a) be listed in a register kept by those gene banks, conservation organisations and networks with an appropriate 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; [Am. 156]

Added(b) be conserved by those gene banks, 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 [Am. 157]