Changes from plenary report to adopted text

AddedAnnex VI

AddedREQUIREMENTS FOR PRODUCTION AND MARKETING OF PRM OF HETEROGENEOUS MATERIAL AS REFERRED TO IN ARTICLE 27(2)

AddedA. Notification of heterogeneous material

AddedPRM of heterogeneous material as referred to in Article 27(2) may be marketed following a notification of the heterogeneous material by the professional operator to the competent authorities, made my means of a dossier containing:

Added(a) the contact details of the applicant;

Added(b) the species and denomination of the heterogeneous material;

Added(c) the description of the heterogeneous material as referred in point B;

Added(d) a declaration by the applicant concerning the truth of the elements in points (a), (b) and (c);

Added(e) a representative sample.

AddedThe 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. [Am. 307]

AddedB. Description of the heterogeneous material

Added1. The description of heterogeneous material shall include all of the following elements:

Added(a) a description of its characteristics, including:

Added(i) the phenotypic characterisation of the key characters which are common to the material, together with the description of the heterogeneity of the material, by characterising the phenotypic diversity observable between individual reproductive units;

Added(ii) documentation of its relevant characteristics, including agronomic aspects such as yield, yield stability, suitability for low input systems, performance, resistance to abiotic stress, disease resistance, quality parameters, taste or colour;

Added(iii) any available results from tests concerning the characteristics referred to in point (ii);

Added(b) a description of the type of technique used for the breeding or production method of the heterogeneous material;

Added(c) a description of the parental material used to breed or produce the heterogeneous material and own production control programme used by the operator concerned with a reference to the practices as referred to in point B.2.(a) and, if applicable, in point B.2.(c);

Added(d) a description of the on-farm management and selection practices with a reference to point B.2.(b) and, if applicable, of the parental material with a reference to point B.2.(c);

Added(e) a reference to the country of breeding or production, with information on the year of production and description of the pedo-climatic conditions.

Added2. The heterogeneous material may be generated by originate from one of the following techniques: [Am. 308]

Added(a) crossing of several different types of parental material, using crossing protocols to produce diverse heterogeneous material by bulking of the progeny, repeatedly re-sowing and exposing the stock to natural and/or human selection, provided that this material shows a high level of genetic diversity;

Added(b) on-farm-management practices, including selection, establishing or maintaining material, which is characterized by a high level of genetic diversity;

Added(c) any other technique used for breeding or production of heterogeneous material, taking into account particular features of propagation.

AddedC. Requirements concerning the identity of PRM lots of heterogeneous material

AddedPRM of heterogeneous material shall be identifiable on the basis of all of the following elements:

Added(a) the initial material and the production scheme used in the crossing for creation of the heterogeneous material, as provided for in point B.2.(a) or, if applicable, in point B.2.(c), or the history of the material and the on-farm management practices, including whether the selection has occurred naturally and/or through human intervention, in the cases of points B.2.(b) and point B.2.(c);

Added(b) the country of breeding or production; and

Added(c) characterisation of the common key characters and of the phenotypic heterogeneity of the material.

AddedD. Requirements concerning the sanitary quality, analytical purity and germination of PRM of heterogeneous material

Added1. PRM of heterogeneous material shall comply with the requirements equal to those set for the lowest category for the respective species including requirements set for the species listed in Annex IV for the analytical purity and germination requirements for seed and the quality requirements for other material of the lowest category for the respective species. [Am. 309]

AddedThe plants shall be treated or excluded as a source of PRM, in case of defects or positive test results or visual symptoms of pests in accordance with Regulation (EU) 2016/2031.

Added2. By way of derogation from point D.1, professional operators may place on the market PRM of heterogeneous material which does not satisfy the conditions with respect to germination, provided that the operator indicates the germination rate of the PRM concerned on the label or directly on the package.

AddedE. Requirements for packaging and labelling of PRM of heterogeneous material

Added1. PRM of heterogeneous material shall be contained in small packages and in maximum quantities as defined in point H. However, they may be contained in other packages or containers, only if these are closed in such a manner that they cannot be opened without leaving evidence of tampering on the package or container.

Added2. The professional operators shall affix on packages or containers of PRM of heterogeneous material a label in at least one of the official languages of the Union.

AddedThat label shall:

Added(i) be legible, printed or written on one side, newly issued and easily visible;

Added(ii) include the information set out in point G of this Annex, except where that information is printed or written directly on the package or the container; and

Added(iii) be yellow, with a green diagonal cross.

Added3. In the case of small, transparent packages, the label may be placed inside the package provided it is clearly legible.

Added4. By way of derogation from points E.1 and E.2, PRM of heterogeneous material contained in closed and labelled packages and containers may be sold to final users in unmarked and unsealed packages up to the maximum quantities provided for in point H, if on request, the purchaser is informed in writing at the time of delivery, about the species, the denomination of the heterogeneous material and the reference number of the lot.

AddedF. Maintenance of heterogeneous material

Added1. Where maintenance is possible, the professional operator who has notified the heterogeneous material to the competent authorities, shall preserve the main characteristics of the material at the time of its notification, by maintaining it as long as it remains on the market.

Added2. That maintenance shall be undertaken in accordance with accepted practices adapted to the maintenance of such heterogeneous material. The professional operator responsible for the maintenance shall keep records of duration and content of maintenance.

Added3. At all times, the competent authorities shall have access to all records kept by the professional operator responsible for the material, in order to check its maintenance. The professional operator shall keep those records for 5 years after the moment the heterogeneous material is not marketed anymore.

AddedG. Content of the label of the packages

AddedPRM of heterogeneous material shall be marketed in packages bearing a label containing the following elements:

Added(1) the denomination of the heterogeneous material, together with the phrase ‘heterogeneous material’;

Added(2) the indication ‘EU rules and standards’;

Added(3) the name and address of the professional operator responsible for affixing the label, or its registration code;

Added(4) country of production;

Added(5) lot reference number given by the professional operator responsible for affixing the labels;

Added(6) month and year of closing, following the term: ‘closed’;

Added(7) species, indicated at least under its botanical name, which may be given in abridged form and without the authors’ names;

Added(8) declared net or gross weight, or declared number of PRM, except for small packages;

Added(9) where weight is indicated and pelleting substances or other solid additives are used, the nature of the additive and also the approximate ratio between the weight of pure seeds and the total weight; and

Added(10) the germination rate, if applicable.

AddedH. Maximum quantities of PRM of heterogeneous material in small packages

AddedAnnex VII