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EUROPEAN
COMMISSION
Brussels, 5.7.2023
COM(2023) 414 final
ANNEXES 1 to 8
ANNEXES
to the proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of
the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC (Regulation on plant reproductive material) {SEC(2023) 414 final} - {SWD(2023) 410 final} - {SWD(2023) 414 final} - {SWD(2023) 415 final}
ANNEX I
GENERA AND SPECIES, AND THEIR RESPECTIVE USES, AS REFERRED TO IN ARTICLE 2
PART A
Genera and species to be used for the production of agricultural crops, other than vegetables
Agrostis canina L.
Agrostis capillaris L.
Agrostis gigantea Roth
Agrostis stolonifera L.
Alopecurus pratensis L.
Arachis hypogaea L.
Arrhenatherum elatius (L.) P. Beauv. ex J. Presl & C. Presl
Avena nuda L.
Avena sativa L. (includes A. byzantina K. Koch)
Avena strigosa Schreb.
Beta vulgaris L. partim
Biserrula pelecinus L.
Brassica juncea (L.) Czern.
Brassica napus L. var. napobrassica (L.) Rchb.
Brassica napus L. var. napus
Brassica nigra (L.) W.D.J. Koch
Brassica oleracea L. convar. acephala (DC.) Alef. var. medullosa Thell. + var. varidis L.
Brassica rapa L. var. silvestris (Lam.) Briggs
Bromus catharticus Vahl
Bromus sitchensis Trin.
Cannabis sativa L.
Carthamus tinctorius L.
Carum carvi L.
Cynodon dactylon (L.) Pers.
Dactylis glomerata L.
Festuca arundinacea Schreber
Festuca filiformis Pourr
Festuca ovina L.
Festuca pratensis Huds.
Festuca rubra L.
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Festuca trachyphylla (Hack.) Krajina
Galega orientalis Lam.
Glycine max (L.) Merr. partim
Gossypium spp.
Hedysarum coronarium L.
Helianthus annuus L.
Hordeum vulgare L.
Lathyrus cicera L.
Linum usitatissimum L.
Lolium multiflorum Lam.
Lolium perenne L.
Lolium x hybridum Hausskn
Lotus corniculatus L.
Lupinus albus L.
Lupinus angustifolius L.
Lupinus luteus L.
Medicago doliata Carmign.
Medicago italica (Mill.) Fiori
Medicago littoralis Rohde ex Loisel.
Medicago lupulina L.
Medicago murex Willd.
Medicago polymorpha L.
Medicago rugosa Desr.
Medicago sativa L.
Medicago sativa L. nothosubsp. varia (Martyn) Arcang.
Medicago scutellata (L.) Mill.
Medicago truncatula Gaertn.
Onobrychis viciifolia Scop.
Ornithopus compressus L.
Ornithopus sativus Brot.
Oryza sativa L.
Papaver somniferum L.
Phacelia tanacetifolia Benth.
Phalaris aquatica L.
Phalaris canariensis L.
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Phleum nodosum L.
Phleum pratense L.
Pisum sativum L. partim
Plantago lanceolata L.
Poa annua L.
Poa nemoralis L.
Poa palustris L.
Poa pratensis L.
Poa trivialis L.
Raphanus sativus L. var. oleiformis Pers.
Secale cereale L.
Sinapis alba L.
Sorghum bicolor (L.) Moench subsp. bicolor
Sorghum bicolor (L.) Moench subsp. bicolor x Sorghum bicolor (L.) Moench subsp.
drummondii (Steud.) de Wet ex Davidse
Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse
Trifolium alexandrinum L. Berseem
Trifolium fragiferum L.
Trifolium glanduliferum Boiss.
Trifolium hirtum All.
Trifolium hybridum L.
Trifolium incarnatum L.
Trifolium isthmocarpum Brot.
Trifolium michelianum Savi
Trifolium pratense L.
Trifolium repens L.
Trifolium resupinatum L.
Trifolium squarrosum L.
Trifolium subterraneum L.
Trifolium vesiculosum Savi
Trigonella foenum-graecum L.
Trisetum flavescens (L.) P. Beauv.
Triticum aestivum L. subsp. aestivum
Triticum aestivum L. subsp. spelta (L.) Thell.
Triticum turgidum L. subsp. durum (Desf.) van Slageren
Vicia benghalensis L.
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Vicia faba L. partim
Vicia pannonica Crantz
Vicia sativa L.
Vicia villosa Roth
xFestulolium Asch. & Graebn
xTriticosecale Wittm. ex A. Camus
Zea mays L. partim
PART B
Genera and species to be used for the production of vegetables
Allium cepa L.
Allium fistulosum L.
Allium porrum L.
Allium sativum L.
Allium schoenoprasum L.
Anthriscus cerefolium (L.) Hoffm.
Apium graveolens L.
Asparagus officinalis L.
Beta vulgaris L. partim
Brassica oleracea L. partim
Brassica rapa L. partim
Capsicum annuum L.
Cichorium endivia L.
Cichorium intybus L.
Citrullus lanatus (Thunb.) Matsum. et Nakai
Cucumis melo L.
Cucumis sativus L.
Cucurbita maxima Duchesne
Cucurbita pepo L.
Cynara cardunculus L.
Daucus carota L.
Foeniculum vulgare Mill.
Lactuca sativa L.
Petroselinum crispum (Mill.) Nyman ex A. W. Hill
Phaseolus coccineus L.
Phaseolus vulgaris L.
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Pisum sativum L. partim
Raphanus sativus L. partim
Rheum rhabarbarum L.
Scorzonera hispanica L.
Solanum lycopersicum L.
Solanum melongena L.
Spinacia oleracea L.
Valerianella locusta (L.) Laterr.
Vicia faba L. partim
Zea mays L. partim
Hybrids resulting from the crossing of species referred in this Part.
PART C
Genera and species to be used for the production of fruit plants
Castanea sativa Mill.
Citrus L.
Corylus avellana L.
Cydonia oblonga Mill.
Ficus carica L.
Fortunella Swingle
Fragaria L.
Juglans regia L.
Malus Mill.
Olea europaea L.
Pistacia vera L.
Poncirus Raf.
Prunus amygdalus Batsch
Prunus armeniaca L.
Prunus avium (L.) L.
Prunus cerasus L.
Prunus domestica L.
Prunus persica (L.) Batsch
Prunus salicina Lindley
Pyrus L.
Ribes L.
Rubus L.
Vaccinium L.
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PART D
Genera and species to be used for the production of vine
Vitis L.
PART E
Genera and species to be used for the production of potatoes
Solanum tuberosum L.
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ANNEX II
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC,
BASIC AND CERTIFIED SEEDS AND MATERIAL AS REFERRED TO IN
ARTICLE 7
PART A
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC,
BASIC AND CERTIFIED SEEDS OF AGRICULTURAL AND VEGETABLE SPECIES
1. General requirements for the production of pre-basic, basic and certified seeds
A. Sowing or planting:
(a) The variety of the seed sown, including where applicable mother plants, shall
be identified through an official label or a label issued by the professional
operator, and shall be recorded to ensure its traceability. The label, or the
records on the mother plant, shall be retained by the professional operator until
the issuance of the official label of the marketed seed.
(b) The previous cropping of the field shall be compatible with the production of
seed of the species, variety and category of the crop, and the field shall be
sufficiently free from such plants, which may have remained from previous
cropping (volunteers).
(c) The mother plants or seed shall be planted and/or sowed in a way, which
assures:
(i) sufficient distance from pollen sources of the same species and/or
different varieties, from any undesirable foreign pollination, so as to
avoid cross pollination with other crops, where applicable; and
(ii) an appropriate source and level of pollination to ensure the subsequent
reproduction, where applicable.
(d) The quality of soil, substrates, mother plants and the immediate environment
shall be inspected to avoid presence of pests or their vectors, in accordance
with Regulation (EU) 2016/2031.
(e) The machines and any equipment used shall be inspected, and weed or seed
from other species or varieties shall be removed.
(f) Where appropriate, the production of seeds shall take place separately from the
cultivation of seeds belonging to the same genera or species intended for the
production of food or feed, to ensure the fulfillment of the requirements
applicable only for the PRM concerned.
(g) Where applicable, in vitro propagation may also be used for the reproduction
of seeds.
B. Field cultivation:
(a) It shall be ensured that plants of other species, other varieties, appearing as
varietal impurity, obviously differing from the variety in one or more
characteristics from the variety description (‘off-type’), in the field, are absent.
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Where this is not possible due to the characteristics of the species concerned,
they shall be present up to the lowest possible level.
In the case of presence of off-types or other plant species or varieties during the
cultivation stage, or during seed processing, appropriate treatment and/or
elimination shall be applied to ensure varietal identity and purity of the seed,
and to avoid the presence of any undesirable species.
(b) The plants shall be treated or excluded as a source of PRM in case of positive
test results or visual symptoms of pests, in accordance with Regulation (EU)
2016/2031, or defects.
(c) PRM, including, where applicable, mother plants, shall be maintained in a way
to ensure the identity of the variety. That maintenance shall be based on the
official description or the officially recognised description of the variety.
(d) The mother plants shall be maintained in all phases of production, under
conditions to enable the production of seeds, and permit their identification
with the official description of their variety.
(e) All crops in the field shall be inspected officially or under official supervision
at their relevant growth stage(s), at the relevant frequency and with the relevant
methods, as appropriate, for the species concerned to verify the respective
requirements. The methods for inspections shall be in accordance with the
applicable international standards. If it is not possible to remove or separate
non-compliant plants during the growing phase, the entire field shall be
discarded for seed production, unless the undesirable seeds can be
mechanically separated at a later stage.
C. Harvesting and post-harvesting:
(a) The seed shall be harvested in bulk or as individual plants, as appropriate, to
ensure its identity and purity and a correct traceability.
(b) A sample of seed shall be taken from each sealed lot. The sample size and the
sampling intensity, equipment and method shall be appropriate for the species
concerned and in accordance with the applicable international standards.
(c) All seed samples shall be subjected to laboratory testing, to ensure the
fulfilment of the quality requirements for the respective species. Laboratory
testing shall be carried out in accordance with methods, equipment and
growing media appropriate for the species concerned, and in acordance with
the applicable international standards. Testing shall include, where appropriate,
retesting of germination rate after a certain period appropriate to the species
concerned.
(d) All the seed lots belonging to the pre-basic, basic category, or certified
category if it will be used for the production of further seed generations, and at
least 5% of the seed lots belonging to a certified category that will be no longer
multiplied, are subject to control plot-testing by the operator, under official
supervision, to verify the compliance with:
(i) their varietal identity;
(ii) the standards of the minimum varietal purity; and
(iii) the plant health requirements.
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Seed lots belonging to the pre-basic, basic, or certified category shall be subject
to risk-based official post-control testing to verify the compliance with the
previous requirements. The samples used for the official post-control tests shall
be taken officially.
Control plot-testing shall be carried out in accordance with the applicable
international standards.
Appropriate bio-molecular methods may be utilised.
2. Requirements for the marketing of seeds
The seed shall fulfil all of the following quality requirements, depending on the characteristics
of each genus or species and the category concerned:
(a) have a minimum germination to allow an appropriate number of plants per square
metre after sowing, and consequently to secure the yield and quality of the
production;
(b) have a maximum content of hard seed to allow an appropriate number of plant per
square metre;
(c) have a minimum purity to secure the highest level of varietal identity;
(d) have a maximum moisture content to ensure the preservation of the material during
processing, storage and making available on the market;
(e) have a maximum content of seeds of other genera or species to ensure the lowest
presence of undesirable plants in the lot;
(f) have a minimum vigour, defined dimension and specific grading to ensure the
appropriateness of the material and the sufficient homogeneity of the lot for sowing
or planting;
(g) have a maximum presence of earth or extraneous matter to prevent fraudulent
practices and technical impurities; and
(h) be free from specific defects and damages to ensure the quality and health of the
material.
PART B
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC,
BASIC AND CERTIFIED MATERIAL OF AGRICULTURAL AND VEGETABLE
SPECIES
1. Requirements for the production of pre-basic, basic and certified material
A. Sowing or planting:
(a) The identity of the material, including, where applicable, mother plants or seed
sown, shall be determined through an official label or a label issued by the
professional operator, and recorded by the professional operator to ensure its
traceability. The label of the material after the marketing of that material, or the
records on the mother plant, shall be kept by the professional operator.
(b) The material shall be planted in a way that:
(i) the pre-basic material is maintained in facilities that ensure freedom from
infection through aerial vectors and any other possible sources
throughout the production process;
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(ii) there is sufficient distance from other plants of the same genera or
species, determined on the basis of botanical characteristics and breeding
techniques of each species, 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
(iii) planting densities are adequate to allow plants to be observed
individually.
(c) 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.
B. Field cultivation:
(a) During all stages of cultivation, propagating and planting material shall be kept
separate from each other.
(b) PRM satisfying the requirements for a given category shall not be mixed with
material of other categories.
(c) Off-types and deformed or damaged plants shall be disposed of at all stages of
cultivation.
(d) Mother plants shall be treated or excluded as a source of PRM in case of
positive test results or visual symptoms of pests, in accordance with Regulation
(EU) 2016/2031 or defects.
(e) Mother plants shall be maintained in all phases of cultivation, under conditions
to enable the production of PRM, and to permit their identification and
verification of compliance with the official description or the officially
recognised description of their variety. In the case of mother 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 belong.
(f) Mother 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.
(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.
(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.
C. Harvesting and post-harvesting for species and genera belonging to Part E of Annex I
(seed potatoes):
(a) The material shall be harvested in bulk or as individual plants, as appropriate,
to ensure its identity, health and traceability.
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(b) A sample of tubers shall be taken from each sealed lot. The sample size and the
sampling intensity, equipment and method shall be appropriate for the species
concerned and in accordance with the applicable international standards.
(c) All tubers samples shall be subjected to laboratory testing, to ensure the
fulfilment of the quality and phytosanitary requirements for the respective
species. Laboratory testing shall be carried out in accordance with methods,
equipment and growing media appropriate for the species concerned, and in
accordance with the applicable international standards.
(d) All the lots belonging to the pre-basic or basic category, and at least 5% of the
lots belonging to a certified category, shall be subject to control plot-testing by
the operator, under official supervision of the competent authority, to verify the
compliance with:
(i) their varietal identity;
(ii) the standards of the minimum varietal purity;
(iii) their germination capacity;
(iv) the plant health requirements.
Lots belonging to the pre-basic, basic, or certified category shall be subject to
risk-based official post-control testing to verify the compliance with the
previous requirements. The samples used for the official post-control tests shall
be taken officially.
Control plot-testing shall be carried out in accordance with the applicable
international standards.
Appropriate bio-molecular methods may be utilised.
2. Requirements for the marketing of pre-basic, basic and certified material
The material shall fulfil all of the following requirements, depending on the characteristics of
each genus or species and the category concerned:
(a) have minimum vigour or germination rate, defined dimension, and, where applicable,
specific grading, to ensure the appropriateness of the material and sufficient
homogeneity of the lot for planting;
(b) be practically free from specific defects.
PART C
REQUIREMENTS FOR THE PRODUCTION, REGISTRATION AND MARKETING
OF SELECTED CLONES, MULTICLONAL MIXTURES AND POLYCLONAL PRM
OF PRE-BASIC, BASIC AND CERTIFIED MATERIAL AS REFERRED TO IN
ARTICLE 9 (1)
1. Requirements for the production of pre-basic, basic and certified selected
clones, multiclonal mixtures and polyclonal PRM
A. Planting:
(a) The identity of the selected clone, multiclonal mixture or polyclonal PRM shall
be determined through an official label or a label issued by the profesional
11
operator and recorded by the professional operator to ensure its traceability.
The label of the material or the records, on the respective mother plants for the
production of each selected clone and the respective genotypes for the
production of the polyclonal PRM, shall be kept by the professional operator
after the marketing of that PRM.
(b) The material shall be planted in a way that:
(i) there is sufficient distance from other plants of the same genera or
species, determined on the basis of botanical characteristics for each
species 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;
(ii) planting densities are adequate to allow each plant to be observed
individually.
(c) 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.
B. Field cultivation:
(a) During all stages of cultivation, propagating and planting material shall be kept
separate from each other.
(b) Reproductive material satisfying the requirements of a given category shall not
be mixed with material of other categories.
(c) Off-types and deformed or damaged plants shall be disposed of at all stages of
cultivation in order to ensure varietal identity and purity, or, in the case of
rootstocks not belonging to a variety, trueness to the identity of the species, and
efficient production.
(d) The respective mother plants and the respective genotypes shall be excluded as
a source of PRM in case of defects.
(e) The respective mother plants and the respective genotypes shall be maintained
in all phases of cultivation, under conditions to enable the production of PRM,
and to permit their identification and verification of compliance with the
official description or the officially recognised description of their variety. In
the case of mother 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 belong.
(f) Mother 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.
(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.
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(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.
(i) In the case of multiclonal mixtures, the mixture of selected clones constituting
the multiclonal mixture shall be made before the final packaging of that PRM
and shall include identical proportions of all selected clones that constitute the
multiclonal mixture.
(j) In the case of polyclonal PRM, the mixture of genotypes constituting the
polyclonal PRM shall be made before the final packaging of that PRM and
shall include identical proportions of all genotypes that constitute the
polyclonal PRM.
2. Requirements for the registration of a selected clone, multiclonal mixture and
polyclonal PRM
(a) The applicant shall submit an application to the competent authority indicating:
(i) species and, as applicable, variety to which the selected clone,
multiclonal mixture or polyclonal PRM belongs, whereby the variety
shall be registered in a national variety register referred to in Article 44;
(ii) proposed denomination and synonyms;
(iii) where applicable, description of the composition of the multiclonal
mixture or polyclonal PRM;
(iv) the maintainer of the selected clone, multiclonal mixture or polyclonal
PRM;
(v) reference to the description of the main characteristics of the variety to
which the selected clone, multiclonal mixture or polyclonal PRM
belongs;
(vi) description of the main VSCU characteristics of the selected clone,
multiclonal mixture or polyclonal PRM;
(vii) the estimated genetic gain of the selected clone, multiclonal mixture or
polyclonal PRM in relation to the overall performance of the relevant
variety;
(viii) information on whether the selected clone, multiclonal mixture or
polyclonal PRM is already registered in a register of another Member
State.
(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:
(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;
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(ii) in the case of vine propagating material, the polyclonal PRM shall be
composed of 7 to 20 distinct genotypes;
(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.
The 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.
(c) The requirements for the marketing of pre-basic, basic and certified material as
set out in Part B point 2 shall apply accordingly.
PART D
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC,
BASIC AND CERTIFIED SEED OF FRUIT PLANTS, VINE AND SEED POTATOES
1. Requirements for the production of pre-basic, basic and certified seed of fruit
plants, vine and seed potatoes
A. Sowing or planting:
(a) The mother plants and, where appropriate, the pollinator plants shall be planted
in a way that:
(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
(ii) planting densities are adequate to allow plants to be observed
individually.
(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.
B. Field cultivation:
(a) During all stages of cultivation, propagating and planting material shall be kept
separate from each other.
(b) Reproductive material satisfying the requirements of a given category shall not
be mixed with material of other categories.
(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.
(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.
14
(e) Mother plants and pollinator plants shall be excluded as a source of seeds in
case of defects.
(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.
(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.
(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.
(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.
2. Requirements for the marketing of pre-basic, basic and certified seed of fruit
plants, vine and seed potatoes
The seed shall fulfil all of the following quality requirements, depending on the characteristics
of each genus or species and the category concerned:
(a) belong to the variety and, in the case of seeds not belonging to a variety, to the
species;
(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
(c) be practically free from specific defects and damages to ensure the quality of the
seeds.
PART E
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF PRE-BASIC,
BASIC AND CERTIFIED MATERIAL PRODUCED BY IN VITRO PROPAGATION
1. Requirements for the production of pre-basic, basic and certified material
produced by in vitro propagation
A. In vitro culture
(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.
(b) Material that has been sampled from in vivo material shall be sanitised.
B. In vitro production
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(a) The clone(s) that originate from the material referred to under point A.(a) shall
be produced by in vitro propagation.
(b) During all stages of cultivation, propagating and planting material shall be kept
separate from each other.
(c) Clone(s) satisfying the requirements of a given PRM category shall not be
mixed with clone(s) of other categories.
(d) The number of successive propagation cycles by in vitro propagation shall be
restricted, as appropriate, for the genera or species concerned.
(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.
(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.
(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.
(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.
2. Requirements for the marketing of pre-basic, basic and certified material
produced by in vitro propagation
The 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:
(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:
(i) observing the phenotypic characteristics of the in vivo material referred to
under point A.(a);
(ii) producing in vivo plants from the in vitro material referred to under point A.(a)
and observing the phenotypic characteristics of those plants;
(iii) producing in vivo plants from the clone(s) referred to under point B.(a) and
observing the phenotypic characteristics of those plants; and
(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);
(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;
16
(c) be practically free from specific defects and damages.
17
ANNEX III
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD
SEED AND MATERIAL AS REFERRED TO IN ARTICLE 8
PART A
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD
SEED OF AGRICULTURAL AND VEGETABLE SPECIES
1. General requirements for the production of standard seed
A. Sowing or planting:
(a) The variety of the seed sown, including where applicable, mother plants, shall
be determined to ensure its traceability. The label of the material, or the records
on the mother plant, shall be kept at least for 2 years.
(b) The previous cropping of the field shall not have been incompatible with the
production of seed of the species and variety of the crop, and the field shall be
sufficiently free from such plants, which may have remained from previous
cropping (volunteers).
(c) The mother plants or seed shall be planted and /or sowed in a way that there is:
(i) sufficient distance from pollen sources of the same species and/or the
different varieties, in accordance with isolation rules determined on the
basis of botanical characteristics for each species and breeding
techniques, to ensure protection from any undesirable foreign pollination
and to avoid cross pollination with other crops, where applicable; and
(ii) an appropriate source and level of pollination to ensure the subsequent
reproduction, where applicable.
(d) The quality of soil, substrates, mother plants and the immediate environment
shall be inspected to avoid presence of pests or their vectors, in accordance
with Regulation (EU) 2016/2031.
(e) Appropriate attention shall be paid to the machines and any equipment used to
ensure absence of weed or other species, which are difficult to distinguish in
laboratory tests.
(f) Where appropriate, the production of seeds shall take place separately from the
cultivation of seeds belonging to the same genera or species intended for the
production of food or feed, to ensure health of the material concerned.
(g) Where applicable, in vitro propagation may also be used for the reproduction
of seeds.
B. Field production:
(a) It shall be ensured that off-types, in the field, are absent. Where this is not
possible due to the characteristics of the species concerned, they shall be
present up to the lowest possible level.
In the case of presence of off-types or other plant species, or varieties, during
the cultivation stage, or during seed processing, appropriate treatment and/or
elimination shall be applied to ensure varietal identity and purity of the seed,
and to avoid the presence of any undesirable species.
18
(b) The plants shall be treated or excluded as a source of PRM in case of positive
test results or visual symptoms of pests, in accordance with Regulation (EU)
2016/2031 or defects.
(c) PRM, including, where applicable, mother plants, shall be maintained in a way
to ensure the identity of the variety. That maintenance shall be based on the
official description or the officially recognised description of the variety.
(d) The mother plants shall be maintained in all phases of production, under
conditions to enable the production of seeds, and permitting their identification
and verification of compliance with the official description of their variety.
(e) All crops in the field shall be inspected at their relevant growth stage(s), at the
relevant frequency and with the relevant methods, as appropriate, for the
species concerned to verify the respective requirements. The methods for
inspections shall be such to ensure the reliability of the observations. If it is not
possible to remove or separate non-compliant plants during the growing phase,
the entire field shall be discarded for seed production, unless the undesirable
seeds can be mechanically separated at a later stage.
C. Harvesting and post-harvesting:
(a) The seed shall be harvested in bulk or as individual plants, as appropriate, to
ensure its identity, purity and traceability.
(b) A sample of seed shall be taken from each lot and tested in a laboratory to
ensure the fulfilment of the quality requirements for the respective species,
including germination. Testing shall include, where appropriate, retesting of
germination rate after a certain period appropriate to the species concerned.
(c) Seed lots shall be subject to risk-based official post-control-testing to verify the
compliance with:
(i) their varietal identity;
(ii) the standards of the minimum varietal purity;
(iii) their germination capacity; and
(iv) the plant health requirements.
The samples used for the official post-control tests shall be taken officially.
Appropriate bio-molecular methods may be utilised.
2. Requirements for marketing of standard seed
The seed shall fulfil all of the following quality requirements, depending on the characteristics
of each genus or species:
(a) have at least a minimum germination, to allow an appropriate number of plants per
square metre after sowing, and consequently to secure the yield and quality of the
production;
(b) have at most a maximum content of hard seed, to allow an appropriate number of
plants per square metre;
(c) have at least a minimum purity, to secure the highest level of varietal identity;
(d) have at most a maximum moisture content, to ensure the preservation of the material
during processing, storage and making available on the market;
19
(e) have at most a maximum content of seeds of other genera or species, to ensure the
lowest presence of undesirable plants in the lot;
(f) have sufficient vigour, defined dimension and specific grading, to ensure
appropriateness of the material and sufficient homogeneity of the lot for sowing or
planting;
(g) have a maximum presence of earth or extraneous matter, to prevent fraudulent
practices and technical impurities; and
(h) be free from specific defects and damage to ensure the quality and health of the
material.
PART B
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD
MATERIAL OF AGRICULTURAL AND VEGETABLE SPECIES
With the exception of point (b)(i) thereof, Part B of Annex II shall apply accordingly for the
production and marketing of standard material.
PART C
REQUIREMENTS FOR THE REGISTRATION, PRODUCTION AND MARKETING
OF SELECTED CLONES, MULTICLONAL MIXTURES AND POLYCLONAL PRM
OF STANDARD MATERIAL AS REFERRED TO IN ARTICLE 9 (1)
Vine rootstocks may not be marketed as standard material.
Part C of Annex II shall apply accordingly for the registration, production and marketing of
selected clones, multiclonal mixtures and polyclonal PRM of standard material.
PART D
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD
SEED OF FRUIT PLANTS, VINE AND SEED POTATOES
Part D of Annex II shall apply accordingly for the production and marketing of standard seed
of fruit plants, vine and seed potatoes.
PART E
REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF STANDARD
MATERIAL PRODUCED BY IN VITRO PROPAGATION
Part E of Annex II shall apply accordingly for the production and marketing of standard
material produced by in vitro propagation.
20
ANNEX IV
GENERA AND SPECIES WHICH MAY ONLY BE PRODUCED AND MARKETED
AS PRE-BASIC, BASIC OR CERTIFIED SEED OR MATERIAL, IN ACCORDANCE
WITH ARTICLE 20(1)
PART A
GENERA AND SPECIES TO BE USED FOR THE PRODUCTION OF
AGRICULTURAL CROPS, OTHER THAN VEGETABLES WHICH MAY ONLY BE
PRODUCED AND MARKETED AS PRE-BASIC, BASIC OR CERTIFIED SEED
Agrostis canina L.
Agrostis capillaris L.
Agrostis gigantea Roth.
Agrostis stolonifera L.
Alopecurus pratensis L.
Arachis hypogaea L.
Arrhenatherum elatius (L.) P. Beauv. ex J. Presl & C. Presl.
Avena nuda L.
Avena sativa L.(including A. byzantina K. Koch.)
Avena strigosa Schreb.
Beta vulgaris L.
Brassica juncea (L.) Czern.
Brassica napus L. var. napobrassica (L.) Rchb.
Brassica napus L. var. napus
Brassica nigra (L.) W.D.J. Koch
Brassica oleracea L. convar. acephala (DC.) Alef. var. medullosa Thell. + var. varidis L.
Brassica rapa L.
Bromus catharticus Vahl
Bromus sitchensis Trin.
Cannabis sativa L.
Carthamus tinctorius L.
Carum carvi L.
Cynodon dactylon (L.) Pers.
Dactylis glomerata L.
Festuca arundinacea Schreb.
Festuca filiformis Pourr.
Festuca ovina L.
21
Festuca pratensis Huds.
Festuca rubra L.
Festuca trachyphylla (Hack.) Krajina
xFestulolium Asch. et Graebn.
Galega orientalis Lam.
Glycine max (L.) Merrill
Gossypium L.
Hedysarum coronarium L.
Helianthus annuus L.
Hordeum vulgare L.
Linum usitatissimum L.
Lolium × boucheanum Kunth
Lolium multiflorum Lam.
Lolium perenne L.
Lotus corniculatus L.
Lupinus albus L.
Lupinus angustifolius L.
Lupinus luteus L.
Medicago lupulina L.
Medicago sativa L.
Medicago × varia T. Martyn
Onobrychis viciifolia Scop.
Oryza sativa L.
Papaver somniferum L.
Phacelia tanacetifolia Benth.
Phalaris aquatica L.
Phalaris canariensis L.
Phleum nodosum L.
Phleum pratense L.
Pisum sativum L.
Poa annua L.
Poa nemoralis L.
Poa palustris L.
Poa pratensis L.
Poa trivialis L.
22
Raphanus sativus L.
Secale cereale L.
Sinapis alba L.
Solanum tuberosum L.
Sorghum bicolor (L.) Moench
Sorghum bicolor (L.) Moench × Sorghum sudanense (Piper) Stapf.
Sorghum sudanense (Piper) Stapf.
Trifolium alexandrinum L.
Trifolium hybridum L.
Trifolium incarnatum L.
Trifolium pratense L.
Trifolium repens L.
Trifolium resupinatum L.
Trigonella foenum-graecum L.
Trisetum flavescens (L.) P. Beauv.
xTriticosecale Wittm. ex A. Camus.
Triticum aestivum L.
Triticum durum Desf.
Triticum spelta L.
Vicia faba L.
Vicia pannonica Crantz .
Vicia sativa L.
Vicia villosa Roth.
Zea mays L.
PART B
GENERA AND SPECIES WHICH MAY ONLY BE PRODUCED AND MARKETED
AS PRE-BASIC, BASIC OR CERTIFIED MATERIAL
Solanum tuberosum L.
23
ANNEX V
PRODUCTION AND MARKETING REQUIREMENTS FOR PRESERVATION
MIXTURES AS REFERRED TO IN ARTICLE 22
1. Source area
Competent authorities may designate specific source areas for the preservation
mixtures, with which such mixtures are naturally associated. For that purpose, they
shall take into account information from plant genetic resource authorities or
organisations recognised for this purpose by the Member States.
Where the source area is located in more than one Member State, it shall be
identified by a common agreement of all Member States concerned.
2. Species
The species and, where relevant, subspecies, used in preservation mixtures shall be:
(a) typical for the habitat type of the source area;
(b) of importance for the preservation of the natural environment in the context of
conservation of genetic resources, as components of the mixture;
(c) adequate for the purpose of recreating the habitat type of the source area.
The preservation mixture shall not contain the species Avena fatua, Avena sterilis
and Cuscuta spp.
The maximum content of Rumex spp., other than Rumex acetosella and Rumex
maritimus, shall not exceed 0,05 % by weight.
3. Authorisation of professional operators
Professional operators shall be authorised prior to the production of preservation
mixtures.
The professional operator shall submit an application for the authorisation referred to
in Article 22(1), including all of the following elements:
(a) name and address of the professional operator;
(b) harvesting method: whether the mixture is directly harvested or multiplied;
(c) components as species and, where relevant, subspecies and varieties of the
preservation mixture; which are typical for the habitat type of the source area
site and which are, as components of the mixture, of importance for the
preservation of the natural environment in the context of the conservation of
genetic resources;
(d) quantity of the mixture to which the authorisation is to apply;
(e) source area of the mixture;
(f) collection site, and in the case of a multiplied preservation mixture, in addition,
the multiplication site;
(g) habitat type of the source area of the mixture; and
(h) year of collection.
The application shall be accompanied by the information necessary to verify
compliance with requirements set out in point 4 in the case of directly harvested
preservation mixtures, or point 5 in the case of multiplied preservation mixtures.
24
Competent authorities may issue an authorisation which shall include the
authorisation date and the scope of the authorisation, according to the operator
application and the compliance of the requirements, and the restriction to marketing
in the source area.
Professional operators before the beginning of each production season shall notify
the quantity of seed of preservation mixtures, for which the authorisation is intended,
together with size and location of the intended collection site or sites and the date or
dates of collection.
4. Production of directly harvested preservation mixtures
Directly harvested preservation mixtures shall comply the following requirements:
(a) a seed mixture that has been collected at the source area (‘directly harvested
preservation mixture’) shall be collected at a site which has not been sown in
the 40 years previous to the date of the authorisation;
(b) the percentage of the components of the directly harvested preservation
mixture that are species and, where relevant, subspecies, shall be adequate for
the purpose of recreating the habitat type of the source area;
(c) the maximum content of species and, where relevant, subspecies which do not
comply with point (b) shall not exceed 1 % by weight;
(d) the competent authorities may carry out visual inspections on the collection site
during the period of growth at intervals appropriate, and during the collection
activities, to ensure that the mixture complies with the requirements provided
for this preservation mixtures; they shall document the results thereof.
(e) tests shall be carried out officially, or under the official supervision of the
competent authority, to check that the preservation mixture complies with the
requirements provided; such tests shall be carried out in accordance with
current international methods, or, where such methods do not exist, in
accordance with any appropriate methods;
(f) samples shall be drawn from homogenous lots, and shall be sufficient to carry
out the test referred to in point (e).
5. Production of multiplied preservation mixtures
Preservation mixtures seeds may be also multiplied by an authorized operator in
accordance with the following process:
(a) seed of individual species is taken at the source area, or is a directly harvested
preservation mixtures purchased to other operator;
(b) the seed referred to in point (a) is multiplied outside the source area as single
species. Multiplication may take place for five generations;
(c) the seeds of those species are then mixed to create a mixture which is
composed of those genera, species and, where relevant, subspecies which are
typical for the habitat type of the source area;
(d) this mixture may also include seed from species listed in Part A of Annex I that
has been produced conventionally, if it complies with point (c);
(e) the collected seed from which the preservation mixture is multiplied shall have
been collected in its source area at a collection site which has not been sown in
25
the 40 years previous to the date of the authorization by the operator, referred
to in point 3.
(f) the seed of the multiplied preservation mixture shall be of species and, where
relevant, subspecies which are typical for the habitat type of the source area
and which are, as components of the mixture, of importance for the
preservation of the natural environment in the context of conservation of
genetic resources;
(g) the germination rate of the components referred to in point (f) shall be
sufficient for the purpose of recreating the habitat type of the source area;
(h) the maximum content of species and, where relevant, subspecies which do not
comply with point (g) shall not exceed 1 % by weight;
(i) components of a multiplied preservation mixture which are seeds of species
listed in Part A of Annex I shall, before mixing, comply at least with the
requirements for standard seed for the concerned species;
(j) tests shall be carried out officially or under official supervision of the Member
State to check that the preservation mixture complies with the requirements
provided. Such tests shall be carried out in accordance with current
international methods, or, where such methods do not exist, in accordance with
any appropriate methods;
(k) samples shall be drawn from homogenous lots, and shall be sufficient to carry
out the test referred to in point (j).
26
ANNEX VI
REQUIREMENTS FOR PRODUCTION AND MARKETING OF PRM OF
HETEROGENEOUS MATERIAL AS REFERRED TO IN ARTICLE 27(2)
A. Notification of heterogeneous material
PRM 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:
a) the contact details of the applicant;
b) the species and denomination of the heterogeneous material;
c) the description of the heterogeneous material as referred in point B
d) a declaration by the applicant concerning the truth of the elements in points (a), (b)
and (c).
e) a representative sample
The 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.
B. Description of the heterogeneous material
1. The description of heterogeneous material shall include all of the following elements:
(a) a description of its characteristics, including:
(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;
(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;
(iii) any available results from tests concerning the characteristics referred to
in point (ii);
(b) a description of the type of technique used for the breeding or production
method of the heterogeneous material;
(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);
(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);
27
(e) a reference to the country of breeding or production, with information on the
year of production and description of the pedo-climatic conditions.
2. The heterogeneous material may be generated by one of the following techniques:
(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;
(b) on-farm-management practices, including selection, establishing or
maintaining material, which is characterized by a high level of genetic
diversity;
(c) any other technique used for breeding or production of heterogeneous material,
taking into account particular features of propagation.
C. Requirements concerning the identity of PRM lots of heterogeneous material
PRM of heterogeneous material shall be identifiable on the basis of all of the following
elements:
(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);
(b) the country of breeding or production; and
(c) characterisation of the common key characters and of the phenotypic heterogeneity
of the material.
D. Requirements concerning the sanitary quality, analytical purity and
germination of PRM of heterogeneous material
1. PRM of heterogeneous material shall comply with the requirements for the analytical
purity and germination requirements for seed and the quality requirements for other
material of the lowest category for the respective species.
The 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.
2. 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.
E. Requirements for packaging and labelling of PRM of heterogeneous material
1. 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.
2. 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.
That label shall:
28
(i) be legible, printed or written on one side, newly issued and easily visible;
(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
(iii) be yellow, with a green diagonal cross.
3. In the case of small, transparent packages, the label may be placed inside the package
provided it is clearly legible.
4. 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.
F. Maintenance of heterogeneous material
1. 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.
2. 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.
3. 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.
G. Content of the label of the packages
PRM of heterogeneous material shall be marketed in packages bearing a label containing the
following elements:
(1) the denomination of the heterogeneous material, together with the phrase
‘heterogeneous material’;
(2) the indication ‘EU rules and standards’;
(3) the name and address of the professional operator responsible for affixing the label,
or its registration code;
(4) country of production;
(5) lot reference number given by the professional operator responsible for affixing the
labels;
(6) month and year of closing, following the term: ‘closed’;
(7) species, indicated at least under its botanical name, which may be given in abridged
form and without the authors’ names;
(8) declared net or gross weight, or declared number of PRM, except for small packages;
29
(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
(10) the germination rate, if applicable.
H. Maximum quantities of PRM of heterogeneous material in small packages
|
Species
|
Maximum net mass (kg)
|
|
Fodder plants
|
10
|
|
Beet
|
10
|
|
Cereals
|
30
|
|
Oil and fiber plants
|
10
|
|
Potato
|
30
|
|
Vegetable:
|
|
|
Legumes
|
5
|
|
Onions, chervil, asparagus, spinach beet or chard, red beet or
beetroot, turnips, water melon, gourd, marrows, carrots, radishes,
scorzonera or black salsify, spinach, corn-salad or lamb’s lettuce
|
0,5
|
|
All other vegetable species
|
0,1
|
30
ANNEX VII
CONTENTS OF THE NATIONAL AND UNION VARIETY REGISTERS AS
REFERRED TO IN ARTICLE 46
The national variety registers and the Union variety register shall contain all of the following
elements:
(a) the name of the genus or species to which the variety belongs;
(b) the denomination of the variety and, for varieties marketed before the entry into force
of this Regulation, where applicable, other alternative denominations used for that
variety;
(c) the name and, where applicable, the reference number, of the applicant;
(d) the date of the registration of the variety and, where applicable, of the renewal of the
registration;
(e) the date of the end of validity of registration;
(f) a reference to the link of the file, where the official description of the variety, or, if
applicable, the officially recognised description of the variety, can be found;
(g) in the case of varieties with officially recognised description and, if appropriate, an
indication of the region(s), where the variety has historically been grown and to
which it is naturally adapted (‘region(s) of origin’);
(h) the name of the person responsible for the maintenance of a variety;
(i) the name of the Member States having established the relevant national variety
register(s);
(j) the reference under which the variety has been registered in the national variety
register(s);
(k) where applicable, the indication that the variety is an ‘organic variety suitable for
organic production’;
(l) where applicable, the indication that the variety contains, or consists of, a genetically
modified organism;
(m) where applicable, the indication that the variety is a component variety of another
registered variety;
(n) where applicable, the indication that PRM belonging to the variety is only produced
and marketed in rootstocks;
(o) where applicable, a reference to the link of the file, where the results of the
examinations for value for sustainable cultivation and use, as referred to in Article
52, can be found;
(p) where applicable, an indication of the reproduction method of the variety, including
information on whether it is a hybrid or a synthetic variety,
(q) where applicable, the indication that the variety contains, or consists of a category 1
NGT plant within the meaning of Article 3(7) of Regulation (EU) .../... (Office of
Publications, please insert reference to NGT Regulation) and the identification
number(s) referred to in Article 9(1), point (e) of [NGT Proposal] assigned to the
category 1 NGT plant(s) it has been derived from;
31
(r) where applicable, the indication that the variety contains, or consists of a category 2
NGT plant within the meaning of Article 3(8) of Regulation (EU) .../... (Office of
Publications, please insert reference to NGT Regulation);
(s) where applicable, indication that the variety is herbicide tolerant and indication of the
applicable cultivation conditions;
(t) where applicable, indication that the variety has certain characteristics, other than the
one referred to in point (s), and indication of the applicable cultivation conditions.
32
ANNEX VIII
CORRELATION TABLES
Council Directive 66/401/EC This Regulation
Article 1 Article 1
Article 1a Article 2, Article 3
Article 2(1)A Article 2, Article 3, Article 7
Article 2(1)B.1 Article 3, Article 7
Article 2(1)C Article 3, Article 7
Article 2(1)D -
Article 2(1)E Article 3
Article 2(1)F -
Article 2(1)G -
Article 2(1), point (a) Article 2
Article 2(1), point (b) Article 7
Article 2(1), point (d) Article 36
Article 2(2) Article 83
Article 2(3)A Article 10
Article 2(3)B Article 10
Article 2(4) Article 10
Article 3(1) Article 20
Article 3(1), point (a) -
Article 3(2) -
Article 3(3) Article 20
Article 3(4) Article 7
Article 3a Article 7, Article 35
Article 4 Article 34
Article 4a Article 31, Article 32
EN 34 EN
Article 5 -
Article 5a -
Article 6 Article 63
Article 7(1) Article 7
Article 7(1a) Article 10, Article 12
Article 7(1b) Article 10, Article 12
Article 7(2) Article 7
Article 8(1) Article 14
Article 8(2) -
Article 9(1) Article 14
Article 9(2) Article 23
Article 9(3) -
Article 10.1a Article 15
Article 10a Article 15
Article 10b Article 15
Article 10c Article 15
Article 10d Article 14
Article 11 Article 15
Article 11a Article 17
Article 12 Article 12
Article 13 Article 21, Article 22
Article 13a Article 38
Article 14 Article 36
Article 14a Article 7, Article 15
Article 15(1) Article 35, Article 39
Article 15(2) Article 35
Article 15(3) Article 35, Article 39
EN 35 EN
Article 16 Article 39
Article 17 Article 33
Article 18 Article 2
Article 19(1) Article 24
Article 19(2) Article 40
Article 20 Article 24
Article 21 Article 76
Article 21a Article 7
Article 22 -
Article 22a Article 7, Article 26, Article 22
Article 23 Article 83
Article 23a -
Article 24 -
Annex I Article 7
Annex II Article 7
Annex III Article 7, Article 13
Annex IV Article 17
Annex V Article 35
Council Directive 66/402/EC This Regulation
Article 1 Article 1
Article 1a Article 2
Article 2(1)A Article 2
Article 2(1)B Article 3, Article 7
Article 2(1)C Article 3, Article 7
Article 2(1)Ca Article 3, Article 7
Article 2(1)C Article 3, Article 7
35
EN 37 EN
Article 10(1), point (a) Article 15
Article 10(1), point (b) -
Article 10(2) Article 14
Article 10(3) -
Article 10a Article 14
Article 11 Article 15
Article 11a Article 15
Article 12 Article 17
Article 13 Article 21
Article 13a Article 38
Article 14 Article 36
Article 14a Article 7, Article 15
Article 15(1) Article 35, Article 39
Article 15(2) Article 35
Article 15(3) Article 35, Article 39
Article 16 Article 39
Article 17 Article 33
Article 18 Article 2
Article 19(1) Article 24
Article 19(2) Article 40
Article 20 Article 24
Article 21 Article 76
Article 21a Article 7
Article 21b Article 7
Article 22 -
Article 22a Article 7
Article 23 Article 83
EN 38 EN
Article 23a -
Article 24 -
Annex I Article 7
Annex II Article 7
Annex III Article 7
Annex IV Article 17
Annex V Article 35
Council Directive 68/193/EEC This Regulation
Article 1 Article 1
Article 2 Article 3
Article 2(1)A -
Article 2(1)B -
Article 2(1)C -
Article 2(1)D Article 7
Article 2(1)E Article 7
Article 2(1)F Article 7
Article 2(1)G Article 8
Article 2(1)H -
Article 2(1)I Article 3, point (3)
Article 2.2 -
Article 3(1) Article 7, Article 8
Article 3(2) -
Article 3(3) Article 2
Article 3(4) Article 7(3), 7(4), Annex II, Part E, Annex III,
Part E
EN 39 EN
Article 3(5) Article 7(4), Article 8(5)
Article 4 Article 36
Article 5 Article 44
Article 5a Article 47(1)
Article 5b.1 Article 48
Article 5b.2 Article 50
Article 5b.3 Article 49
Article 5ba.1 -
Article 5ba.2 -
Article 5ba.3 Article 47(1)
Article 5c Article 47(4)
Article 5d Article 47(1)
Article 5e Article 71(1)
Article 5f Article 47(1), Annex VII
Article 5g Article 72
Article 7 Article 14
Article 8(1) Article 13
Article 8(2) Article 28
Article 9 Article 14
Article 10 Article 15
Article 10a Article 17
Article 11(1) Article 80
Article 11(2) Article 40
Article 12 -
Article 12a -
Article 13 Article 7(2)
Article 14 Article 33
EN 40 EN
Article 14a Article 38
Article 15(1) Article 2
Article 15(2) Article 39
Article 16 Article 38
Article 16a Article 7(4), Article 8(5)
Article 16b Article 7(4), Article 8(5)
Article 17 Article 76
Article 17a Article 7(3), (4), Article 8(4), (5)
Article 18 -
Article 18a -
Article 18b -
Article 19 -
Article 20 Article 83
Annex I Article 7(4), Article 8(5)
Annex II Article 7(4), Article 8(5)
Annex III Article 14(6)
Annex IV Article 17
Council Directive 2002/53/EC This Regulation
Article 1(1) Article 1
Article 1(2) Article 44(3), Article 45
Article 1(3) Article 2(4)
Article 2 -
Article 3(1) Article 44(1)
Article 3(2) Article 44(4)
Article 3(3) Article 44(2)
EN 41 EN
Article 4(1) Article 47(1)
Article 4(2) Article 44(4)
Artile 5(1) Article 47(1), Article 48,
Article 5(2) Article 50
Article 5(3) Article 49
Article 5(4) Article 52
Article 6 Article 44(2)
Article 7(1) Article 59
Article 7(2) -
Article 7(3) Article 63
Article 7(4) Article 47(1)
Article 7(5) -
Article 8 -
Article 9(1) Article 44, Article 46, Annex VII
Article 9(2), (3) Article 47(1), point (b), Article 54
Article 9(4) Article 47(1), point (a), Annex VII
Article 9(5) Article 46, Annex VII
Article 10 Article 44(3), Article 45, Article 46(1), Annex
VII
Article 11 Article 72
Article 12(1) Article 69(1)
Article 12(2) Article 69(2)
Article 13 -
Article 14 Article 71
Article 15 Article 71
Article 16(1) Article 44(2)
Article 16(2) Article 47(1), points (f) and (g)
EN 42 EN
Article 17 Article 45
Article 18 Article 37
Article 19 -
Article 20(1) Article 47(4)
Article 20(2), (3) Article 26
Article 21 -
Article 22 Article 39
Article 23 Article 76
Article 24 -
Article 25 -
Article 26 -
Article 27 Article 83
Article 28 Article 83
Council Directive 2002/54/EC This Regulation
Article 1 Article 1
Article 1(2) Article 2(4)
Article 2 Article 3, Article 7(4)
Article 3(2) Article 6
Article 3(2) Article 80
Article 4 Article 6, Article 7(4)
Article 5 Article 34, Article 35
Article 6 Article 2(4)
Article 7 Article 36
Article 8 Article 63
Article 9(1) Article 24, Article 25
Article 9(2) Article 13(5)
EN 43 EN
Article 10(1) Article 13, Article 14
Article 10(2) Article 28
Article 11 Article 14
Article 12 Article 15, 17(4)
Article 13 Article 14
Article 14(1) Article 28
Article 14(2) Article 17(4)
Article 15 Article 13, Article 14, Article 23
Article 16 Article 18
Article 17 Article 15, Article 17(3)
Article 18 Article 15, Article 17
Article 19 Article 38
Article 20 -
Article 21(1) Article 7(1), (3), Article 15, Annex II
Article 21(2) Article 15, Article 17(4)
Article 21(3) Article 39
Article 22(1) Article 6, Article 7(4)
Article 22(2) Article 35
Article 23(1) Article 39
Article 23(2) -
Article 24 Article 33
Article 25(1) Article 80
Article 25(2) Article 39
Article 26 -
Article 27 Article 7(3)
Article 28 Article 76
Article 29 -
EN 44 EN
Article 30 Article 7(4)
Article 30A -
Article 31 -
Article 32 -
Article 33 -
Article 34 Article 83
Article 35 Article 83
Annex I Article 17(4)
Annex II Article 13(5)
Annex III Article 17(4)
Annex IV Article 17(4), point (m), Article 35
Annex V -
Annex VI -
Council Directive 2002/55/EC This Regulation
Article 1 Article 1
Article 2 Article 2(1), Article 3, Article 7(4), Article 8(5)
Article 3(1) Article 5
Article 3(2) Article 44
Article 3(3) Article 45
Article 3(4) Article 44(2)
Article 4(1) Article 47(1), point (a)
Article 4(2) Article 47(1), point (c)
Article 4(3) -
Article 4(4) Article 26
Article 5(1) Article 48
Article 5(2) Article 50
44
EN 46 EN
Article 26 Article 13
Article 27 Article 14
Article 28 Article 15, Article 16, Article 17(4)
Article 29 Article 14, Article 28
Article 30 Article 14, Article 28
Article 31 Article 17(3)
Article 32 Article 17(4)
Article 33 Article 38
Article 34 -
Article 35 Article 7(4)
Article 36(1) Article 6, Article 7
Article 36(2) Article 15, Article 17
Article 36(3) Article 39
Article 37 Article 39
Article 38 Article 33
Article 39(1) Article 80
Article 39(2) Article 39
Article 40 Article 24, Article 25
Article 41 Article 8(5)
Article 42 Article 19
Article 43 -
Article 44(1) -
Article 44(2) Article 26
Article 45 Article 2(2), Article 7(3), Article 8(4)
Article 46 Article 76
Article 47 -
Article 48 Article 26
EN 47 EN
Article 49 -
Article 50 -
Article 51 -
Article 52 Article 83
Article 53 Article 83
Annex I Article 7(4), Article 8(5)
Annex II Article 7(4), Article 8(5)
Annex III Article 7(4), Article 8(5)
Annex IV Article 17(4)
Annex V Article 17(4), point (m)
Annex VI -
Annex VII -
Council Directive 2002/56/EC This Regulation
Article 1, first paragraph Article 1
Article 1, second paragraph Article 2(4)
Article 2 Article 3
Article 3(1) Article 20
Article 3(2) -
Article 3(3) Article 7(3)
Article 3(4) Article 7(3)
Article 4 Article 7(4)
Article 5 Article 36
Article 6(1) Article 2(4)
Article 6(2) -
Article 6(3) -
EN 48 EN
Article 7 Article 7(4)
Article 8 -
Article 9 Article 7(4)
Article 10 Article 7(4)
Article 11(1) Article 13
Article 11(2) Article 28
Article 12 Article 14
Article 13 Article 15, Article 17
Article 14 -
Article 15 Article 15
Article 16 -
Article 17 -
Article 18 Article 7(3), Article 17
Article 19 Article 38
Article 20 -
Article 21 Article 39
Article 22 Article 33
Article 23(1) Article 80
Article 23(2) Article 39
Article 24 Article 7(2)
Article 25 Article 76
Article 26 -
Article 27 Article 26
Article 28 -
Article 29 -
Article 30 Article 83
Article 31 Article 83
EN 49 EN
Annex I Article7(3)
Annex II Article 7(3)
Annex III Article 17
Annex IV -
Annex V -
Council Directive 2002/57/EC This Regulation
Article 1 Article 1, Article 2
Article 2(1), point (a) Article 2, Article 3
Article 2(1), point (b) Article 2
Article 2(1), point (d) Article 2, Article 7
Article 2(1.e) Article 2, Article 7
Article 2(1.f) Article 2, Article 7
Article 2.1.g Article 2, Article 7
Article 2.1.h Article 2, Article 7
Article 2.1.j -
Article 2.1.k Article 3
Article 2(2) Article 2
Article 2(3) Article 7
Article 2(3a) Article 7
Article 2(4) -
Article 2(5) Article 10, Article 12
Article 2(6) Article 10, Article 12
Article 3(1) Article 20
Article 3(2) -
EN 50 EN
Article 3(3) -
Article 3(4) Article 7
Article 4 Article 7, Article 35
Article 5 Article 34
Article 6 Article 31, Article 32
Article 7 -
Article 8 Article 63
Article 9(1) Article 7
Article 9(1a) Article 10, Article 12
Article 9(1b) Article 10, Article 12
Article 9(2) Article 7
Article 10(1) Article 14
Article 10(2) -
Article 11(1) Article 14
Article 11(2) Article 23
Article 11(3) -
Article 12(1.a) Article 15
Article 12(1.b) -
Article 12(2) -
Article 12(3) -
Article 13 Article 15
Article 14 Article 17
Article 15 Article 17
Article 16 Article 38
Article 17 Article 36
Article 18 Article 7, Article 15
Article 19(1) Article 35, Article 39
EN 51 EN
Article 19(2) Article 35
Article 19a -
Article 20 Article 39
Article 21 Article 33
Article 22(1) Article 24
Article 22(2) Article 40
Article 23 Article 24
Article 24 Article 7
Article 25 Article 76
Article 26 -
Article 27 Article 7
Article 28
Article 29
Article 30
Article 31 Article 82
Article 32 Article 83
Article 33 Article 83
Annex I Article 7
Annex II Article 7
Annex III Article 7
Annex IV Article 17
Annex V Article 35
Annex VI Article 82
Annex VII Article 82
Council Directive 2008/72/EC This Regulation
EN 52 EN
Article 1 Article 1
Article 1(2) Article 2(1)
Article 1(3) Article 2(3)
Article 2 Article 2(4)
Article 3 Article 3
Article 4 Article 7(4), Article 8(5)
Article 5(1), (2) Article 41, Article 42
Article 5(3) -
Article 6(1) Article 10
Article 6(2) to (4) -
Article 7 -
Article 8(1) Article 10
Article 8(2) Article 2(4)
Article 8(3) Article 44
Article 9(1), (2) Article 5
Article 9(3) Article 45
Article 10(1) Article 13
Article 10(2) Article 22
Article 11(1) Article 13
Article 11(2) Article 28
Article 12 Article 2(4)
Article 13 Article 33
Article 14(1) -
Article 14(2) Article 5
Article 15 -
Article 16(1) Article 39
Article 16(2) -
EN 53 EN
Article 17 Article 7(1), (2), Article 8(1), (2)
Article 18 Article 7(3), Article 8(3)
Article 19(1) Article 19
Article 19(2) Article 38
Article 20 Article 28
Article 21 Article 76
Article 22 Article 7(3), Article 8(3)
Article 23(1) -
Article 23(2) Article 80
Article 24 Article 83
Article 25 -
Article 26 Article 83
Article 27 Article 83
Annex I Annex II and Annex III
Annex II Annex I
Annex III -
Council Directive 2008/90/EC This Regulation
Article 1(1) Article 1, Article 2
Article 1(2) Article 2(1)
Article 1(3) Article 4
Article 1(4) 2(4)
Article 2 Article 3
53
Article 3(1) Article 6
Article 3(2) -
Article 3(3) -
Article 3(4) Article 2(4), Article 29
Article 4 Article 7(4), Article 8(5)
Article 5 Article 41
Article 6(1) Article 7, Article 8
Article 6(2) Article 4
Article 6(3) Article 42
Article 6(4) -
Article 7(1) Article 5
Article 7(2) Article 47(1)
Article 7(3) Article 47(1), Article 54
Article 7(4) Article 47(1)
Article 7(5) Article 47(2)
Article 7(6) Article 47(2)
Article 8(1) Article 13
Article 8(2) Article 13, Article 18
Article 9(1) Article 13, Article 15, Article 16, Article 17
Article 9(2) Article 28
Article 9(3) Article 15, Article 17
Article 10 Article 2(4), Article 29, Article 30
Article 11 Article 33
Article 12(1) Article 39
Article 12(2) -
Article 13 Article 80
Article 14 Article 24, Article 25
EN 55 EN
Article 15 Article 80
Article 16 Article 19
Article 17 -
Article 18 Article 2(3)
Article 19 Article 76
Article 20 -
Article 21 -
Article 22 -
Article 23 Article 23
Article 24 Article 83
Annex I Annex I
Annex I