Changes from plenary report to adopted text

Added(vii) the estimated genetic gain of the selected clone, multiclonal mixture or polyclonal PRM in relation to the overall performance of the relevant variety;

Added(viii) information on whether the selected clone, multiclonal mixture or polyclonal PRM is already registered in a register of another Member State.

Added(b) The selected clone, multiclonal mixture or polyclonal PRM shall fulfil the following requirements as appropriate for the type of material concerned in order to be registered:

Added(i) the polyclonal PRM shall be selected in a single field trial containing a representative sample of the overall genetic diversity of the variety according to an experimental design based on internationally accepted methods. In the case of polyclonal PRM of vine that design shall be based on methods prescribed by the International organisation of vine and wine;

Added(ii) in the case of vine propagating material, the polyclonal PRM shall be composed of 7 to 20 distinct genotypes;

Added(iii) the trueness of the selected clone, each selected clone of the multiclonal mixture, each genotype of the polyclonal PRM to the identity of the variety shall be ensured through the observation of the phenotypic characteristics and, where appropriate, through molecular analysis pursuant to internationally accepted standards.

AddedThe competent authority shall decide on the registration only after it concludes that the points (i) - (iii) as applicable for the type of material are fulfilled.

Added(c) The requirements for the marketing of pre-basic, basic and certified material as set out in Part B point 2 shall apply accordingly. [Am. 276]

AddedPART D

AddedREQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED SEED OF FRUIT PLANTS, VINE AND SEED POTATOES [Am. 277]

Added1. Requirements for the production of pre-basic, basic and certified seed of fruit plants, vine and seed potatoes [Am. 278]

AddedA. Sowing or planting:

Added(a) The mother plants and, where appropriate, the pollinator plants shall be planted in a way that:

Added(i) there is sufficient distance from other plants of the same genera or species, determined by the botanical characteristics and breeding techniques and as appropriate for the category of the material, to ensure protection from any undesirable foreign pollination and to avoid cross pollination with other crops; and

Added(ii) planting densities are adequate to allow plants to be observed individually.

Added(b) Where appropriate, the cultivation of material shall take place separately from the cultivation of material belonging to the same genera or species intended for food or feed purposes.

AddedB. Field cultivation:

Added(a) During all stages of cultivation, propagating and planting material shall be kept separate from each other.

Added(b) Reproductive material satisfying the requirements of a given category shall not be mixed with material of other categories.

Added(c) The flowering mother plant shall be subject to self-pollination or cross-pollination with pollen from the surrounding pollinator plants, as appropriate for the genera or species concerned.

Added(d) Off-types and deformed or damaged plants shall be disposed of at all stages of cultivation in order to ensure trueness to the identity of the variety, or for plants not belonging to a variety, to ensure the trueness to the identity of the species to which they belong, their sufficient purity and efficient production.

Added(e) Mother plants and pollinator plants shall be excluded as a source of seeds in case of defects.

Added(f) Mother plants shall be maintained in all phases of cultivation, under conditions to enable the production of seeds. Mother plants and pollinator plants shall be maintained in all phases of cultivation, under conditions permitting their identification and verification of compliance with the official description or the officially recognised description of their variety. In the case of mother plants and pollinator plants not belonging to a variety, that verification of compliance with the official description or the officially recognised description shall concern the species to which those mother plants and pollinator plants belong.

Added(g) Mother plants and pollinator plants shall be inspected at their relevant growth stage(s), at the relevant frequency and with the relevant methods as appropriate for the genera or species concerned.

Added(h) The sample to be drawn from a lot shall have the appropriate minimum size for determining the fulfilment of the quality requirements for the respective genera or species. The intensity, equipment and method of sampling shall be appropriate for the genera or species concerned and in accordance with the applicable international standards.

Added(i) Testing shall be carried out in accordance with the methods, equipment and growing media appropriate for the genera or species concerned, and in accordance with the applicable international standards, to ensure that the quality requirements have been fulfilled.

Added2. Requirements for the marketing of pre-basic, basic and certified seed of fruit plants, vine and seed potatoes

AddedThe seed shall fulfil all of the following quality requirements, depending on the characteristics of each genus or species and the category concerned:

Added(a) belong to the variety and, in the case of seeds not belonging to a variety, to the species;

Added(b) have minimum vigour, defined dimension, and, where applicable, specific grading, to ensure the appropriateness of the material and sufficient homogeneity of the lot for planting; and

Added(c) be practically free from specific defects and damages to ensure the quality of the seeds.

AddedPART E

AddedREQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC, BASIC AND CERTIFIED MATERIAL PRODUCED BY IN VITRO PROPAGATION

Added1. Requirements for the production of pre-basic, basic and certified material produced by in vitro propagation

AddedA. In vitro culture

Added(a) The identity of the in vitro or in vivo material, as applicable, shall be determined through a label and recorded to ensure its traceability. The label of the material shall be kept.

Added(b) Material that has been sampled from in vivo material shall be sanitised.

AddedB. In vitro production

Added(a) The clone(s) that originate from the material referred to under point A.(a) shall be produced by in vitro propagation.

Added(b) During all stages of cultivation, propagating and planting material shall be kept separate from each other.

Added(c) Clone(s) satisfying the requirements of a given PRM category shall not be mixed with clone(s) of other categories.

Added(d) The number of successive propagation cycles by in vitro propagation shall be restricted, as appropriate, for the genera or species concerned.

Added(e) Clone(s) shall be maintained in all phases of production, under conditions to enable the production of PRM, and permitting their identification and verification of compliance with the official description or the officially recognised description of their variety. In the case of clone(s) not belonging to a variety, that verification of compliance with the official description or the officially recognised description shall concern the species to which those clone(s) belong.

Added(f) Clone(s) shall be inspected at their relevant growth stage(s), at the relevant frequency and with the relevant methods as appropriate for the genera or species concerned.

Added(g) The sample to be drawn from a lot shall have the appropriate minimum size for determining the fulfilment of the quality requirements for the respective genera or species. The intensity, equipment and method of sampling shall be appropriate for the genera or species concerned and in accordance with the applicable international standards.

Added(h) Testing shall be carried out in accordance with the methods, equipment and growing media appropriate for the genera or species concerned, and in accordance with the applicable international standards, to ensure that the quality requirements have been fulfilled.

Added2. Requirements for the marketing of pre-basic, basic and certified material produced by in vitro propagation

AddedThe in vitro or in vivo material shall fulfil all of the following requirements, depending on the characteristics of each genus or species and the category concerned:

Added(a) belong to the variety and, in the case of material not belonging to a variety, belong to the species indicated on the label by:

Added(i) observing the phenotypic characteristics of the in vivo material referred to under point A.(a);

Added(ii) producing in vivo plants from the in vitro material referred to under point A.(a) and observing the phenotypic characteristics of those plants;

Added(iii) producing in vivo plants from the clone(s) referred to under point B.(a) and observing the phenotypic characteristics of those plants; and

Added(iv) where appropriate, molecular analysis of the in vitro material referred to under point A.(a) and/or the clone(s) referred to under point B.(a);

Added(b) have minimum vigour, defined dimension, and, where applicable, specific grading, to ensure the appropriateness of the material and sufficient homogeneity of the lot for planting;

Added(c) be practically free from specific defects and damages.

AddedAnnex III

AddedREQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD SEED AND MATERIAL AS REFERRED TO IN ARTICLE 8

AddedPART A

AddedREQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD SEED OF AGRICULTURAL AND VEGETABLE SPECIES

Added1. General requirements for the production of standard seed