COMMISSION IMPLEMENTING DIRECTIVE 2014/98/EU
of 15 October 2014
implementing Council Directive 2008/90/EC as regards specific requirements for the genus and species of fruit plants referred to in Annex I thereto, specific requirements to be met by suppliers and detailed rules concerning official inspections
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (1), and in particular Article 4 and Articles 6(4), 9(1) and 13(3) thereof,
Whereas:
(1)
Provisions for the certification and marketing of pre-basic, basic and certified material should take into account the different production cycles of the various genera and species covered by this Directive.
(2)
It is necessary that pre-basic material complies with very strict requirements concerning health and quality in order to ensure health and quality of the propagating material and fruit plants derived from pre-basic material.
(3)
In order to ensure the identification and quality of pre-basic material, it is appropriate to lay down rules concerning the establishment and verification of its trueness to the variety to which that material belongs. Moreover, identification and quality of pre-basic material should be ensured through rules concerning its propagation, which may include renewal and multiplication. In order to ensure the health of pre-basic material, it is important to lay down rules concerning the absence of pests, inspections, sampling and testing, as appropriate for the genus and species concerned. Furthermore, the quality of that material should be ensured through the adoption of rules concerning defects.
(4)
In order to ensure the identification and quality of rootstocks not belonging to a variety, those rootstocks should be true to the description of the species to which they belong.
(5)
It is necessary that plants from which material is intended to be taken for the production of basic material or certified material, other than fruit plants, are identified. Those plants are referred to as ‘mother plants’. Mother plants for the production of pre-basic material (pre-basic mother plants) should fulfil the same requirements as pre-basic material. Pre-basic mother plants and pre-basic material should be identified throughout the production process. The responsible official body should establish the trueness of the pre-basic mother plant to the description of its variety by the observation of the expression of the characteristics of the variety. Furthermore, the trueness to the description of the variety of the pre-basic mother plant and of the derived pre-basic material should be verified regularly.
(6)
In the case of material intended for certification, the trueness to the description of a variety should be established on the basis of an official description of that variety, which ensures that the variety is distinct, uniform and stable, the description accompanying an application for registration or for a plant variety right or an officially recognised description. In case of a variety with an officially recognised description, it is appropriate to require that the variety has been registered in a national register in order to ensure that that description is appropriate for the material under certification.
(7)
In the case of pre-basic and basic material, the establishment of trueness to the description of the variety should also be possible on the basis of a description accompanying the application for registration of a variety in a Member State and of a description accompanying the application for registration of a plant variety right, provided that a report is already available in the Union or in a third country indicating that the respective variety is distinct, uniform and stable. The purpose of granting that possibility is to accelerate the initial phases of the certification process, in cases where the registration of the variety is close to completion but still pending. However, and in order to ensure transparency and informed choices for the users of that material, its marketing should only be allowed once the variety registration has been concluded.
(8)
It is important that strict provisions apply concerning the protection of pre-basic material from all types of infections by pests. Therefore the suppliers should maintain pre-basic mother plants and pre-basic material in designated facilities, which are insect proof and ensure freedom from infection through aerial vectors and any other possible sources. For the same reason, pre-basic mother plants and pre-basic material should be grown or produced, isolated from the soil, in pots of soil-free or of sterilised growing media. However, and in order to address particular production needs, Member States should be permitted to apply for the authorisation to produce pre-basic mother plants and pre-basic material in the field provided that appropriate measures are taken to prevent infection by the relevant pests.
(9)
Council Directive 2000/29/EC (2) sets out the rules preventing the introduction into the Union of certain harmful organisms and their spread therein. This includes requirements for certain genera and species that complement the certification requirements in this Directive in respect of harmful organisms covered by Directive 2000/29/EC. Additional rules on other harmful organisms should be set out. Where a pest could cause unacceptable damage to the health or usefulness of pre-basic material of the genera or species concerned, its absence should be required. Those pests should be listed. Where a pest could cause such damage only when its presence exceeds certain levels, its presence should only be prohibited in quantities exceeding those levels. Those pests should be listed separately from those whose absence is required.
(10)
Candidate pre-basic mother plants constitute the starting point of the production and certification process of propagating material and fruit plants. For that reason, they should be subject to the most stringent phytosanitary requirements to ensure freedom from the relevant pests. In view of the biology and characteristics of the respective genera or species of the plants and the relevant pests concerned, visual inspections of the candidate pre-basic mother plants should be required for the presence of the pests listed in Annex I. In case of doubts regarding the presence of those pests, each candidate pre-basic mother plant should be sampled and tested in order to ensure accurate findings. Each candidate pre-basic mother plant should be tested for the pests listed in Annex II to ensure with certainty the absence of the relevant pests. Very similar requirements should apply to pre-basic mother plants produced by renewal due to their importance for the further production and certification process.
(11)
In view of the biology and characteristics of the respective genera or species of the plants and the relevant pests concerned, visual inspections of the pre-basic mother plants or pre-basic material should be required for the presence of the pests listed in Annexes I and II. In case of doubts regarding the presence of those pests, pre-basic mother plants and pre-basic material should be sampled and tested in order to ensure accurate findings.
(12)
In view of the biology and characteristics of the respective genera or species of the plants and the pests concerned, appropriate rules should be established concerning the frequencies of visual inspections, sampling and testing of basic mother plants, basic material, certified mother plants and certified material. Those rules should be based on the experience gathered by the responsible official bodies and the fruit plant producers during the application of national certification schemes. Those rules should take into account the needs of the users of a particular category.
(13)
The presence of certain pests, and in particular nematodes, in the soil may cause unacceptable damage to the health and usefulness of the plants concerned, in case those pests host viruses affecting the genera or species concerned. Therefore those pests should be listed and identified separately, and their presence in the respective soil should not be permitted, unless they are shown by testing to be free of the relevant viruses. Sampling and testing should show whether those pests or the relevant viruses are present. For the setting of the rules concerning sampling and testing, the different categories of propagating material and fruit plants should be taken into account. However, it is proportionate to permit, under certain conditions, that sampling and testing does not need to be carried out where host plants have not been grown in the field of production for a period of at least five years.
(14)
Where sampling and testing is carried out, it should take place in accordance with the protocols of the European and Mediterranean Plant Protection Organization (EPPO), or other protocols which are internationally recognised. This is necessary to ensure that the practice of sampling and testing carried out in the Union is up to date with the international scientific and technical developments. Where such protocols are not available, sampling and testing should take place in accordance with relevant protocols established at national level.
(15)
The quality and usefulness of pre-basic mother plants and pre-basic material may be affected by injuries, discoloration, scar tissues, desiccation and other defects. Therefore, it should be laid down that pre-basic mother plants and pre-basic material must be practically free from any such defects.
(16)
In order to guarantee the appropriate quality of the propagating material, rules should be laid down for its maintenance under appropriate conditions. Those conditions should depend on the category of the propagating material and fruit plants under certification. In view of recent developments it is important to also allow the maintenance method of cooling to ultra-low temperatures, known as cryopreservation. This is considered a useful alternative to in vitro culture because the properties of the propagating material will remain unchanged during storage at these temperatures.
(17)
Basic material constitutes the next stage of production process after pre-basic material. Therefore mother plants for the production of basic material (basic mother plants) should either be grown from pre-basic material or multiplied from other basic mother plants.
(18)
The requirements concerning basic material should be the same as the requirements for pre-basic material concerning identification, health and quality, because those requirements are equally important for the health and usefulness of basic material. However, basic material should be permitted to be produced in open fields to facilitate its effective propagation into the next generations and categories. Therefore, the requirements for the maintenance of basic material should allow maintenance in insect proof facilities or in fields isolated from potential sources of infection by aerial vectors, root contact, cross infection by machinery, grafting tools and any other possible sources.
(19)
Basic mother plants which are grown from pre-basic material should be permitted to be multiplied in a number of generations to attain the number of basic mother plants necessary for the production of basic and certified material. Different generations of basic mother plants should be kept separate from each other and identifiable throughout the production process.
(20)
Certified material and certified fruit plants may constitute the next stage of the production process after pre-basic material or basic material. Therefore mother plants for the production of certified material (certified mother plants) should be grown from either pre-basic material or basic material.
(21)
Minimum requirements should be adopted to ensure a harmonised procedure for the establishment and verification of the trueness to the description of the variety, concerning propagating material and fruit plants to be qualified as CAC material. Those requirements should be less stringent than the requirements for pre-basic, basic and certified material, since CAC material gives rise to lower expectations on the part of users concerning its health and quality, as simpler production procedures and stages are applied. However, suppliers should ensure the identification of material intended to be used for propagation. Moreover, it should be ensured that quality and health standards, appropriate as regards the cultivation of CAC material and the expectations of the users of that propagating material, apply. In view of the nature of the pests affecting certain Citrus L. species, Fortunella Swingleand Poncirus Raf., specific rules concerning visual inspection, sampling and testing are necessary in order to ensure that the respective propagating material or fruit plants are of adequate quality and health.
(22)
In order to allow the responsible official body to conduct official inspections and to verify if the propagating material and fruit plants comply with the quality and health standards for official certification set out in this Directive, the supplier should have in place a plan to identify and monitor critical points in the production process of propagating material and fruit plants for the relevant genera or species, and should keep records on that monitoring. The plan and records of field inspections, sampling and testing should be kept as long as the respective propagating material or fruit plants remain under the control of the supplier, and for a period of at least three years after that propagating material or those fruit plants are removed or marketed.That period is necessary to allow the detection of pests on woody plants where the symptoms may only become apparent several years after the infection has occurred.
(23)
Member States should ensure that propagating material and fruit plants are officially inspected during production and marketing in order to verify compliance with the requirements and conditions set out in this Directive. In order to ensure a harmonised procedure to carry out official inspections, rules should be laid down with respect to visual inspection and, where appropriate, sampling and testing.
(24)
In order to avoid any disruption of trade, Member States should be allowed to authorise, for a transitional period, the marketing in their own territory of propagating material and fruit plants produced from pre-basic, basic and certified mother plants or from CAC mother plants which already existed at the date of application of this Directive even if that material or those fruit plants do(es) not fulfil the new conditions.
(25)
Commission Directives 93/48/EEC (3) and 93/64/EEC (4) should be repealed.
(26)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Propagating Material and Plants of Fruit Genera and Species,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER 1
DEFINITIONS AND GENERAL PROVISIONS
Article 1
Definitions
For the purpose of this Directive, the following definitions shall apply:
(1)
‘mother plant’ means an identified plant intended for propagation;
(2)
‘candidate pre-basic mother plant’ means a mother plant which the supplier intends to have accepted as pre-basic mother plant;
(3)
‘pre-basic mother plant’ means a mother plant intendedfor the production of pre-basic material;
(4)
‘basic mother plant’ means a mother plant intendedfor the production of basic material;
(5)
‘certified mother plant’ means a mother plant intendedfor the production of certified material;
(6)
‘pest’ means any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products and listed in Annexes I, II and III;
(7)
‘visual inspection’ means the examination of plants or parts of plants using the unaided eye, lens, stereoscope or microscope;
(8)
‘test’ means examination, other than visual inspection;
(9)
‘fruiting plant’ means a plant propagated from a mother plant and grown for the production of fruit in order to permit the verification of the varietal identity of that mother plant;
(10)
‘category’ means pre-basic material, basic material, certified material or CAC material;
(11)
‘multiplication’ means vegetative production of mother plants in order to obtain a sufficient number of mother plants in the same category;
(12)
‘renewal of a mother plant’ means replacing a mother plant by a plant vegetatively produced from it;
(13)
‘micropropagation’ means the multiplication of plant material in order to produce a large number of plants, using in vitro culture of differentiated vegetative buds or differentiated vegetative meristems taken from a plant;
(14)
‘practically free from defects’ means that defects likely to impair the quality and usefulness of the propagating material or fruit plants, are present at a level equal to, or lower than, the level expected to result from good cultivating and handling practices, and that level is consistent with good cultivating and handling practices;
(15)
‘practically free from pests’ means that the extent to which pests are present on the propagating material or fruit plants is sufficiently low to ensure acceptable quality and usefulness of the propagating material;
(16)
‘laboratory’ means any facility used for the testing of propagating material and fruit plants;
(17)
‘cryopreservation’ means the maintenance of plant material by cooling to ultra-low temperatures, in order to retain the viability of the material.
Article 2
General provisions
1. Member States shall ensure that propagating material and fruit plants belonging to the genera and species listed in Annex I to Directive 2008/90/EC comply, during production and marketing, with Articles 3 to 27 of this Directive, as appropriate.
2. Member States shall ensure that, during production of propagating material and fruit plants belonging to the genera and species listed in Annex I to Directive 2008/90/EC, suppliers comply with the requirements set out in Articles 28 and 29.
3. Member States shall ensure that, during production and marketing, propagating material and fruit plants, belonging to the genera and species listed in Annex I to Directive 2008/90/EC, are officially inspected in accordance with Article 30.
4. Propagating material that fulfils the requirements of a certain category shall not be mixed with material of other categories.
CHAPTER 2
REQUIREMENTS FOR PROPAGATING MATERIAL AND, WHERE APPLICABLE, FRUIT PLANTS
SECTION 1
Requirements for pre-basic material
Article 3
Requirements for the certification of pre-basic material
1. Propagating material, other than mother plants and other than rootstocks not belonging to a variety, shall, on request, be officially certified as pre-basic material if it has been found to fulfil the following requirements:
(a)
it is directly propagated from a mother plant in accordance with Article 13 or Article 14;
(b)
it is true to the description of its variety and its trueness to the description of the variety is verified pursuant to Article 7;
(c)
it is maintained pursuant to Article 8;
(d)
it complies with the health requirements of Article 10;
(e)
where the Commission has granted a derogation pursuant to Article 8(4) to grow pre-basic mother plants and pre-basic material in the field under non-insect proof conditions, the soil complies with Article 11;
(f)
it complies with Article 12 concerning defects.
2. The mother plant referred to in paragraph (1)(a) shall either have been accepted in accordance with Article 5, or have been obtained by multiplication in accordance with Article 13 or micropropagation in accordance with Article 14.
3. Where a pre-basic mother plant or pre-basic material no longer fulfils the requirements of Articles 7 to 12, the supplier shall remove it from the vicinity of other pre-basic mother plants and pre-basic material. That removed mother plant or material may be used as basic, certified or CAC material provided that it fulfils the requirements set out in this Directive for the respective categories.
Instead of removing that mother plant or that material, the supplier may take appropriate measures in order to ensure that that mother plant or that material complies with those requirements again.
Article 4
Requirements for the certification of rootstocks not belonging to a variety as pre-basic material
1. A rootstock not belonging to a variety, shall, on request, be officially certified as pre-basic material if it has been found to fulfil the following requirements:
(a)
it is directly propagated, by vegetative or sexual propagation from a mother plant; in the case of sexual propagation pollinating trees (pollenisers) are directly produced by vegetative propagation from a mother plant;
(b)
it is true to the description of its species;
(c)
it is maintained pursuant to Article 8;
(d)
it complies with the health requirements of Article 10;
(e)
where the Commission has granted a derogation pursuant to Article 8(4) to grow pre-basic mother plants and pre-basic material in the field under non-insect proof conditions, the soil complies with Article 11;
(f)
it complies with Article 12 concerning defects.
2. The mother plant referred to in paragraph (1)(a) shall either have been accepted in accordance with Article 6, or have been obtained by multiplication in accordance with Article 13 or micropropagation in accordance with Article 14.
3. Where a rootstock which is a pre-basic mother plant or pre-basic material no longer fulfils the requirements of Articles 8 to 12, the supplier shall remove it from the vicinity of other pre-basic mother plants and pre-basic material. That removed rootstock may be used as basic, certified or CAC material provided that it fulfils the requirements set out in this Directive for the respective categories.
Instead of removing that rootstock, the supplier may take appropriate measures in order to ensure that that rootstock complies with those requirements again.
Article 5
Requirements for the acceptance of a pre-basic mother plant
1. The responsible official body shall accept a plant as a pre-basic mother plant if it complies with Articles 7 to 12, and if its trueness to the description of its variety is established in accordance with paragraphs 2, 3 and 4.
That acceptance shall take place on the basis of an official inspection and the testing results, records and procedures pursuant to Article 30.
2. The responsible official body shall establish the trueness of the pre-basic mother plant to the description of its variety by the observation of the expression of the characteristics of the variety. That observation shall be based on one of the following elements:
(a)
the official description for varieties registered in any of the national registers, and for varieties legally protected by a plant variety right;
(b)
the description accompanying the application for varieties which are the subject of an application for registration in any Member State, as referred to in Article 5(1)of Commission Implementing Directive 2014/97/EU (5);
(c)
the description accompanying the application for varieties which are the subject of an application for registration of a plant variety right;
(d)
the officially recognised description, if the variety subject to that description is registered in a national register.
3. Where point (b) or point (c) of paragraph 2 applies, the pre-basic mother plant shall only be accepted if a report, produced by any responsible official body in the Union or in a third country, is available proving that the respective variety is distinct, uniform and stable. However, pending the registration of the variety, the mother plant concerned and the material produced from it may only be used for the production of basic or certified material and shall not be marketed as pre-basic, basic or certified material.
4. Where the establishment of the trueness to the description of the variety is only possible on the basis of the characteristics of a fruiting plant, the observation of the expression of the characteristics of the variety shall be carried out on the fruits of a fruiting plant propagated from the pre-basic mother plant. Those fruiting plants shall be kept separate from the pre-basic mother plants and pre-basic material.
Fruiting plants shall be visually inspected in the most appropriate periods of the year taking into account climatic and growing conditions of plants of the genera or species concerned.
Article 6
Requirements for the acceptance of a rootstock not belonging to a variety
The responsible official body shall accept a rootstock not belonging to a variety as a pre-basic mother plant if it is true to the description of its species and if it complies with Articles 8 to 12.
That acceptance shall take place on the basis of an official inspection and the testing results, records and procedures used by the supplier pursuant to Article 30.
Article 7
Verification of trueness to the description of the variety
The responsible official body and, where appropriate, the supplier shall regularly verify the trueness of pre-basic mother plants and of pre-basic material to the description of their variety, in accordance with Article 5(2) and (3), as appropriate for the variety concerned and the propagation method used.
In addition to the regular verification of pre-basic mother plants and pre-basic material, the responsible official body and, where appropriate, the supplier shall, after each renewal, verify the pre-basic mother plants resulting from it.
Article 8
Requirements concerning the maintenance of pre-basic mother plants and pre-basic material
1. The suppliers shall maintain pre-basic mother plants and pre-basic material in facilities, which are designated for the genera or species concerned, and which are insect proof and ensure freedom from infection through aerial vectors and any other possible sources throughout the production process.
Candidate pre-basic mother plants shall be kept under insect proof conditions, and physically isolated from pre-basic mother plants in the facilities referred to in the first subparagraph, until all tests concerning compliance with Article 9(1) and (2) have been concluded.
2. Pre-basic mother plants and pre-basic material shall be maintained in a manner that ensures that they are individually identified throughout the production process.
3. Pre-basic mother plants and pre-basic material shall be grown or produced, isolated from the soil, in pots of soil-free or of sterilised growing media. They shall be identified by labels ensuring their traceability.
4. By way of derogation from paragraphs 1, 2 and 3 a Member State may be granted authorisation to produce pre-basic mother plants and pre-basic material in the field under non-insect proof conditions for specific genera or species. Such material shall be identified by labels to ensure its traceability. That authorisation shall be granted provided that the Member State concerned ensures that appropriate measures are taken to prevent infection of the plants by aerial vectors, root contact, cross infection by machinery, grafting tools and any other possible sources.
5. Pre-basic mother plants and pre-basic material may be maintained by cryopreservation.
6. Pre-basic mother plants may only be used for a period calculated on the basis of the stability of the variety or the environmental conditions under which they are grown and any other determinants having an impact on the stability of the variety.
Article 9
Health requirements for candidate pre-basic mother plants and for pre-basic mother plants produced by renewal
1. A candidate pre-basic mother plant shall be free from the pests listed in Annex I, as regards the genus or species concerned.
The candidate pre-basic mother plant concerned shall, by visual inspection in the facilities and fields be found free from the pests listed in Annex I, as regards the genus or species concerned.
That visual inspection shall be carried out by the responsible official body and, where appropriate, the supplier.
In case of doubts concerning the presence of those pests, the responsible official body and, where appropriate, the supplier shall carry out sampling and testing of the candidate pre-basic mother plant concerned.
2. A candidate pre-basic mother plant shall be free from the pests listed in Annex II, as regards the genus or species concerned.
The candidate pre-basic mother plant concerned shall, by visual inspection in the facilities and fields, and by sampling and testing, be found free from the pests listed in Annex II, as regards the genus or species concerned.
That visual inspection, sampling and testing shall be carried out by the responsible official body and, where appropriate, the supplier.
That sampling and testing shall take place in the most appropriate period of the year taking into account the climatic conditions and the growing conditions of the plant, and the biology of the pests relevant for that plant. Sampling and testing shall also take place at any time of the year in case of doubts concerning the presence of those pests.
3. As regards the sampling and testing, as provided for in paragraphs 1 and 2, Member States shall apply protocols of the European and Mediterranean Plant Protection Organization (EPPO), or other protocols which are internationally recognised. Where such protocols do not exist, the responsible official body shall apply the relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
The responsible official body and, where appropriate, the supplier shall submit the samples to laboratories officially accepted by the responsible official body.
The testing method for viruses, viroids, virus-like diseases and phytoplasmas applied to candidate pre-basic mother plants shall be biological indexing on indicator plants. Other test methods may be applied in case the Member State considers, on the basis of peer reviewed scientific evidence, that they produce results as reliable as biological indexing on indicator plants.
4. By way of derogation from paragraph 2, where a candidate pre-basic mother plant is a seedling, visual inspection, sampling and testing shall only be required in respect of viruses, viroids or virus-like diseases transmitted by pollen and listed in Annex II, as regards the genus or species concerned, provided that an official inspection has confirmed that the seedling concerned was grown from a seed produced by a plant free from symptoms caused by those viruses, viroids and virus-like diseasesand that that seedling has been maintained in accordance with Article 8(1) and (3).
5. Paragraphs 1 and 3 shall also apply to a pre-basic mother plant produced by renewal.
A pre-basic mother plant produced by renewal shall be free from the viruses and viroids listed in Annex II, as regards the genus or species concerned.
That pre-basic mother plant shall, by visual inspection in the facilities, fields and lots, and by sampling and testing, be found free from those viruses and viroids.
That visual inspection, sampling and testing shall be carried out by the responsible official body and, where appropriate, the supplier.
Article 10
Health requirements for pre-basic mother plants and for pre-basic material
1. A pre-basic mother plant or pre-basic material shall be free from the pests listed in Part A of Annex I and Annex II, as regards the genus or species concerned.
The pre-basic mother plant or the pre-basic material concerned shall, by visual inspection in the facilities, fields and lots, be found free from the pests listed in Part A of Annex I and Annex II, as regards the genus or species concerned. That visual inspection shall be carried out by the responsible official body and, where appropriate, the supplier.
The percentage of pre-basic mother plants or pre-basic material, which is infested by the pests listed in Part B of Annex I, shall not exceed the tolerance levels as set out therein. The pre-basic mother plants or the pre-basic material concerned shall, by visual inspection in the facilities, fields and lots, be found to comply with those levels. That visual inspection shall be carried out by the responsible official body and, where appropriate, the supplier.
In case of doubts concerning the presence of those pests, the responsible official body and, where appropriate, the supplier shall carry out sampling and testing of the pre-basic mother plant or pre-basic material concerned.
2. The responsible official body and, where appropriate, the supplier shall carry out visual inspection, sampling and testing of a pre-basic mother plant or pre-basic material, as set out in Annex IV as regards the genus or species concerned.
3. As regards sampling and testing, as provided for in paragraph 1, Member States shall apply protocols of EPPO, or other protocols which are internationally recognised. Where such protocols do not exist, the responsible official body shall apply the relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
The responsible official body and, where appropriate, the supplier shall submit the samples to laboratories officially accepted by the responsible official body.
4. Paragraph 1 shall not apply to pre-basic mother plants and pre-basic material during cryopreservation.
Article 11
Soil requirements
1. Pre-basic mother plants and pre-basic material may only be grown in soil that is free from any pests which are listed in Annex III, for the genus or species concerned, and which host viruses affecting that genus or species. Freedom from such pests shall be established by sampling and testing.
That sampling shall be carried out by the responsible official body and, where appropriate, the supplier.
That sampling and testing shall be carried out before the pre-basic mother plants or the pre-basic material concerned is planted, and it shall be repeated during growth where there is suspicion concerning the presence of the pests referred to in subparagraph 1.
That sampling and testing shall be carried out taking into account the climatic conditions and the biology of the pests listed in Annex III, and where those pests are relevant for the pre-basic mother plants or the pre-basic material concerned.
2. Sampling and testing shall not be carried out where plants which are hosts for the pests listed in Annex III, for the genus or species concerned, have not been grown in the soil of production for a period of at least five years and where there is no doubt concerning the absence of the relevant pests in that soil.
Sampling and testing shall not be carried out when the responsible official body concludes on the basis of an official inspection that the soil is free from any pests which are listed in Annex III, for the genus or species concerned, and which host viruses affecting that genus or species.
3. In the case of sampling and testing as referred to in paragraph 1, Member States shall apply protocols of the EPPO, or other protocols which are internationally recognised. Where such protocols do not exist, Member States shall apply the relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
Article 12
Requirements concerning defects likely to impair quality
Pre-basic mother plants and pre-basic material shall be found practically free from defects on the basis of visual inspection. That visual inspection shall be carried out by the responsible official body and, where appropriate, the supplier. Injuries, discoloration, scar tissues or desiccation shall be considered as defects, if they affect the quality and usefulness as propagating material.
Article 13
Requirements concerning multiplication, renewal and propagation of pre-basic mother plants
1. The supplier may multiply or renew a pre-basic mother plant accepted in accordance with Article 5(1).
2. The supplier may propagate a pre-basic mother plant to produce pre-basic material.
3. Multiplication, renewal and propagation of pre-basic mother plants shall take place in accordance with the protocols referred to in paragraph 4.
4. Member States shall apply protocols concerning multiplication, renewal and propagation of pre-basic mother plants. Member States shall apply protocols of EPPO, or other protocols which are internationally recognised. Where such protocols do not exist, Member States shall apply relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
The protocols referred to in subparagraph 1 of this paragraph shall have been tested on the relevant genera or species for a period of time considered appropriate for those genera or species. That period of time shall be considered appropriate when it allows phenotype validation of the plants as regards the trueness to the description of the variety based on the observation of the fruit production or of the vegetative development of rootstocks.
5. The supplier may only renew the pre-basic mother plant before the end of the period referred to in Article 8(6).
Article 14
Requirements concerning multiplication, renewal and propagation by micropropagation of pre-basic mother plants
1. In the case of multiplication, renewal and propagation by micropropagation of pre-basic mother plants, for the production of other pre-basic mother plants or pre-basic material, it shall take place in accordance with the protocols set out in paragraph 2.
2. Member States shall apply protocols concerning micropropagation of pre-basic mother plants and pre-basic material which are protocols of EPPO, or other protocols which are internationally recognised. Where such protocols do not exist, Member States shall apply relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
Member States shall only apply protocols which have been tested on the relevant genus or species for a period of time considered sufficient to allow phenotype validation of the plants as regards the trueness to the description of the variety based on the observation of the fruit production or of the vegetative development of rootstocks.
SECTION 2
Requirements for basic material
Article 15
Requirements for the certification of basic material
1. Propagating material, other than basic mother plants and other than rootstocks not belonging to a variety, shall, on request, be officially certified as basic material if it fulfils the requirements of paragraphs 2, 3 and 4.
2. The propagating material shall be propagated from a basic mother plant.
A basic mother plant shall fulfil one of the following requirements:
(a)
be grown from pre-basic material; or
(b)
be produced by multiplication from a basic mother plant in accordance with Article 19.
3. The propagating material shall fulfil the requirements set out in Article 7, Article 8(6) and Article 12.
4. The propagating material shall fulfil the additional requirements concerning:
(a)
health, as set out in Article 16;
(b)
soil, as set out in Article 17;
(c)
maintenance of basic mother plants and basic material as set out in Article 18; and
(d)
specific conditions for propagation, as set out in Article 19.
5. A rootstock not belonging to a variety, shall, on request, be officially certified as basic material if it is true to the description of its species, it fulfils the requirements set out in Article 8(2) and (6), and the additional requirements of Articles 12, 16, 17, 18 and 19.
6. For the purpose of this Section, any reference in the provisions referred to in paragraphs 3 and 5 to pre-basic mother plants shall be construed as reference to basic mother plants, and any reference to pre-basic material shall be construed as reference to basic material.
7. Where a basic mother plant or basic material no longer fulfils the requirements of Article 7, Article 8(2) and (6) and Articles 12, 16 and 17 the supplier shall remove it from the vicinity of other basic mother plants and basic material. That removed mother plant or material may be used as certified or CAC material provided that it fulfils the requirements set out in this Directive for the respective categories.
Instead of removing that mother plant or that material, the supplier may take appropriate measures in order to ensure that that mother plant or that material complies with those requirements again.
8. Where a rootstock not belonging to a variety is a basic mother plant or basic material that no longer fulfils the requirements of Article 8(2) and (6) and Articles 12, 16 and 17, the supplier shall remove it from the vicinity of other basic mother plants and basic material. That removed rootstock may be used as certified or CAC material provided that it fulfils the requirements set out in this Directive concerning the respective categories.
Instead of removing that rootstock, the supplier may take appropriate measures in order to ensure that that rootstock complies with those requirements again.
Article 16
Health requirements
1. A basic mother plant or basic material shall be free from the pests listed in Part A of Annex I and Annex II, as regards the genus or species concerned.
The basic mother plant or the basic material concerned shall, by visual inspection in the facilities, fields and lots, be found free from the pests listed in Part A of Annex I and Annex II, as regards the genus or species concerned. That visual inspection shall be carried out by the responsible official body and, where appropriate, the supplier.
The percentage of basic mother plants or basic material, which is infested by the pests listed in Part B of Annex I, shall not exceed the tolerance levels as set out therein. The basic mother plants or the basic material concerned shall, by visual inspection in the facilities, fields and lots, be found to comply with those levels. That visual inspection shall be carried out by the responsible official body and, where appropriate, the supplier.
In case of doubts concerning the presence of those pests, the responsible official body and, where appropriate, the supplier shall carry out sampling and testing of the basic mother plant or basic material concerned.
2. The responsible official body and, where appropriate, the supplier shall carry out visual inspection, sampling and testing of a basic mother plant or basic material, as set out in Annex IV as regards the genus or species concerned.
3. As regards sampling and testing, as provided for in paragraph 1, Member States shall apply protocols of EPPO, or other protocols which are internationally recognised. Where such protocols do not exist, the responsible official body shall apply the relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
The responsible official body and, where appropriate, the supplier shall submit the samples to laboratories officially accepted by the responsible official body.
4. Paragraph 1 shall not apply to basic mother plants and basic material during cryopreservation.
Article 17
Soil requirements
1. Basic mother plants and basic material may only be grown in soil that is free from any pests which are listed in Annex III, for the genus or species concerned, and which host viruses affecting that genus or species. Freedom of such pests hosting viruses shall be established by sampling and testing.
That sampling shall be carried out by the responsible official body and, where appropriate, the supplier.
That sampling and testing shall be carried out before the basic mother plants or the basic material concerned is planted and it shall be repeated during growth where there is suspicion concerning the presence of the pests referred to in subparagraph 1.
That sampling and testing shall be carried out taking into account the climatic conditions and the biology of the pests listed in Annex III, and where those pests are relevant for the basic mother plants or the basic material concerned.
2. Sampling and testing shall not be carried out where plants which are hosts for the pests listed in Annex III, for the genus or species concerned, have not been grown in the soil of production for a period of at least five years and where there is no doubt concerning the absence of the relevant pests in that soil.
Sampling and testing shall not be carried out when the responsible official body concludes on the basis of an official inspection that the soil is free from any pests which are listed in Annex III, for the genus or species concerned, and which host viruses affecting that genus or species.
3. In the case of sampling and testing as referred to in paragraph 1, Member States shall apply protocols of EPPO, or other protocols which are internationally recognised. Where such protocols do not exist, Member States shall apply the relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
Article 18
Requirements concerning the maintenance of basic mother plants and basic material
1. Basic mother plants and basic material shall be maintained in fields isolated from potential sources of infection by aerial vectors, root contact, cross infection by machinery, grafting tools and any other possible sources.
2. The isolation distance of the fields referred to in paragraph 1 shall depend on regional circumstances, the type of propagating material, the presence of pests in the area concerned and the relevant risks involved as set out by the responsible official body based on official inspection.
Article 19
Conditions for multiplication
1. The basic mother plants which are grown from pre-basic material within the meaning of Article 15(2)(a) may be multiplied in a number of generations to obtain the necessary number of basic mother plants. The basic mother plants shall be multiplied in accordance with Article 13 or shall be multiplied by micropropagation in accordance with Article 14. The maximum permitted number of generations, and the maximum permitted life span of basic mother plants, shall be as set out in Annex V for the relevant genera or species.
2. Where multiple generations of basic mother plants are permitted, each generation, other than the first one, may derive from any previous generation.
3. Propagating material of different generations shall be kept separately.
SECTION 3
Requirements for certified material
Article 20
Requirements for certification of certified material
1. Propagating material, other than mother plants, and fruit plants shall, on request, be officially certified as certified material if they fulfil the requirements set out in paragraphs 2, 3 and 4.
2. The propagating material, and fruit plants, shall be propagated from a certified mother plant.
A certified mother plant shall fulfil one of the following requirements:
(a)
be grown from pre-basic material;
(b)
be grown from basic material.
3. The propagating material, and fruit plants, shall fulfil the requirements set out in Article 7, Article 8(6) and Articles 12, 21 and 22.
4. The propagating material, and fruit plants, shall fulfil the health requirements set out in Article 21.
The propagating material and fruit plants shall be propagated from a certified mother plant which fulfils the soil requirements of Article 22.
5. A rootstock not belonging to a variety, shall, on request, be officially certified as certified material if it is true to the description of its species, it fulfils the requirements set out in Article 8(6) and the additional requirements of Articles 12, 21 and 22.
6. For the purpose of this Section, any reference in the provisions referred to in paragraphs 3 and 5 to pre-basic mother plants shall be construed as reference to certified mother plants, and any reference to pre-basic material shall be construed as reference to certified material.
7. Where a certified mother plant or certified material no longer fulfils the requirements of Article 7, Article 8(6) and Articles 12, 21 and 22, the supplier shall remove it from the vicinity of other certified mother plants and certified material. That removed mother plant or material may be used as CAC material provided that if fulfils the requirements set out in Section 4.
Instead of removing that mother plant or that material, the supplier may take appropriate measures in order to ensure that that mother plant or that material complies with those requirements again.
8. Where a rootstock not belonging to a variety is a certified mother plant or certified material that no longer fulfils the requirements of Article 8(6) and Articles 12, 21 and 22, the supplier shall remove it from the vicinity of other certified mother plants and certified material. That removed mother plant or material may be used as CAC material provided that if fulfils the requirements set out in Section 4.
Instead of removing that rootstock, the supplier may take appropriate measures in order to ensure that that rootstock complies with those requirements again.
Article 21
Health requirements
1. A certified mother plant or certified material shall be free from the pests listed in Part A of Annex I and Annex II, as regards the genus or species concerned.
The certified mother plant or the certified material concerned shall, by visual inspection in the facilities, fields and lots, be found free from the pests listed in Part A of Annex I and Annex II, as regards the genus or species concerned. That visual inspection shall be carried out by the responsible official body and, where appropriate, the supplier.
The percentage of certified mother plants or certified material, which is infested by the pests listed in Part B of Annex I, shall not exceed the tolerance levels as set out therein. The certified mother plants or the certified material concerned shall, by visual inspection in the facilities, fields and lots, be found to comply with those levels. That visual inspection shall be carried out by the responsible official body and, where appropriate, the supplier.
In case of doubts concerning the presence of those pests, the responsible official body and, where appropriate, the supplier shall carry out sampling and testing of the certified mother plant or certified material concerned.
2. The responsible official body and, where appropriate, the supplier shall carry out visual inspection, sampling and testing of a certified mother plant or certified material, as set out in Annex IV as regards the genus or species concerned.
3. As regards sampling and testing, as provided for in paragraph 1, Member States shall apply protocols of EPPO, or other protocols which are internationally recognised. Where such protocols do not exist, the responsible official body shall apply the relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
The responsible official body and, where appropriate, the supplier shall submit the samples to laboratories officially accepted by the responsible official body.
4. Paragraph 1 shall not apply to certified mother plants and certified material during cryopreservation.
Article 22
Soil requirements
1. Certified mother plants may only be grown in soil that is free from any pests which are listed in Annex III, for the genus or species concerned, and which host viruses affecting that genus or species. Freedom of such pests hosting viruses shall be established by sampling and testing.
That sampling shall be carried out by the responsible official body and, where appropriate, the supplier.
That sampling and testing shall be carried out before the certified mother plant concerned is planted, and it shall be repeated during growth where there is suspicion concerning the presence of the pests referred to in subparagraph 1.
That sampling and testing shall be carried out taking into account the climatic conditions and the biology of the pests listed in Annex III, and where those pests are relevant for the certified mother plants or the certified material concerned.
2. Sampling and testing shall not be carried out where plants which are hosts for the pests listed in Annex III, for the genus or species concerned, have not been grown in the soil of production for a period of at least five years and where there is no doubt concerning the absence of the relevant pests in that soil.
Sampling and testing shall not be carried out when the responsible official body concludes on the basis of an official inspection that the soil is free from any pests which are listed in Annex III, for the genus or species concerned, and which host viruses affecting that genus or species.
Sampling and testing shall not be carried out in the case of certified fruit plants.
3. In the case of sampling and testing as referred to in paragraph 1, Member States shall apply protocols of EPPO, or other protocols which are internationally recognised. Where such protocols do not exist, Member States shall apply the relevant protocols established at national level. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission.
SECTION 4
Requirements for CAC material
Article 23
Conditions for CAC material, other than rootstocks not belonging to a variety
1. CAC material, other than rootstocks not belonging to a variety, may only be marketed if it has been found to fulfil the following requirements:
(a)
it is propagated from an identified source of material recorded by the supplier;
(b)
it is true to the description of the variety, in accordance with Article 25;
(c)
it complies with the health requirements of Article 26;
(d)
it complies with Article 27 concerning defects.
2. The actions to comply with paragraph 1 shall be carried out by the supplier.
3. In case CAC material no longer complies with paragraph 1, the supplier shall carry out one of the following actions:
(a)
remove that material, from the vicinity of other CAC material; or
(b)
take appropriate measures to ensure that that material complies with those requirements again.
Article 24
Conditions for CAC material in the case of rootstocks not belonging to a variety
1. In the case of rootstocks not belonging to a variety, CAC material shall comply with the following requirements:
(a)
it is true to the description of its species;
(b)
it complies with the health requirements of Article 26;
(c)
it complies with Article 27 concerning defects.
2. The actions to comply with the requirements of paragraph 1 shall be carried out by the supplier.
3. In case CAC material no longer complies with the requirements of paragraph 1, the supplier shall carry out one of the following actions:
(a)
remove that material, from the vicinity of other CAC material; or
(b)
take appropriate measures to ensure that that material complies with those requirements again.
Article 25
Trueness to the description of the variety
1. The trueness of CAC material to the description of its variety shall be established by the observation of the expression of the characteristics of the variety. That observation shall be based on one of the following elements:
(a)
the official description for registered varieties, as referred to in Implementing Directive 2014/97/EU and for varieties legally protected by a plant variety right; or
(b)
the description accompanying the application for varieties which are the subject of an application for registration in any Member State, as referred to in Implementing Directive 2014/97/EU;
(c)
the description accompanying the application for a plant variety right;
(d)
the officially recognised description of a variety as referred to in Article 7(2)(c)(iii) of Directive 2008/90/EC.
2. The trueness of the CAC material to the description of its variety, shall be regularly verified through the observation of the expression of the characteristics of the variety in the CAC material concerned.
Article 26
Health requirements
1. CAC material shall be practically free from the pests listed in Annex I and Annex II, as regards the genus or species concerned.
The CAC material concerned shall, by visual inspection carried out by the supplier in the facilities, fields and lots, be found practically free from the pests listed Annex I and Annex II, as regards the genus or species concerned.
In case of doubts concerning the presence of those pests, the supplier shall carry out sampling and testing of the CAC material concerned.
2. The supplier shall carry out visual inspection, sampling and testing of CAC material, as set out in Annex IV as regards the genus or species concerned.
3. Paragraph 1 shall not apply to CAC material during cryopreservation.
4. In addition to the requirements of paragraphs 1 and 2, CAC material that belongs to the species Citrus L., Fortunella Swingle, and Poncirus Raf.shall comply with all of the following requirements:
(a)
it shall be produced from an identified source of material, and that source of material shall be found free, on the basis of sampling and testing, from the pests as listed for those species, in Annex II;
(b)
since the beginning of the last cycle of vegetation it shall be found practically free, on the basis of visual inspection, sampling and testing, from the pests as listed in Annex II, as regards species concerned.
Article 27
Requirements concerning defects
CAC material shall be found practically free from defects, on the basis of visual inspection. Injuries, discoloration, scar tissues or desiccation shall be considered as defects, if they affect the quality and usefulness as propagating material.
CHAPTER 3
SPECIFIC REQUIREMENTS FOR SUPPLIERS ENGAGED IN THE PRODUCTION OR REPRODUCTION OF PROPAGATING MATERIAL AND FRUIT PLANTS
Article 28
Plan to identify and monitor critical points in the production process
During the production of propagating material and fruit plants, Member States shall ensure that suppliers have in place, as appropriate for the relevant genera or species, a plan to identify and monitor critical points in the production process. That plan shall at least concern the following elements:
(a)
location and number of plants;
(b)
timing of their cultivation;
(c)
propagation operations;
(d)
packaging, storage and transportation operations.
Article 29
Keeping information on the monitoring available for examination
1. Member States shall ensure that the suppliers keep records with information on the monitoring of the critical points as referred to in Article 6(1) of Directive 2008/90/EC and, when requested, make them available for examination.
2. Those records shall remain available for a period of at least three years since the production of the material concerned.
3. Member States shall ensure that suppliers keep records of field inspections, sampling and testing as long as the respective propagating material and fruit plants are under their control, and for a period of at least three years after that propagating material and those fruit plants have been removed or marketed.
CHAPTER 4
OFFICIAL INSPECTIONS
Article 30
General requirements concerning official inspections
1. Official inspections shall consist of visual inspections, and, where appropriate, of sampling and testing.
2. During the official inspections, the responsible official body shall pay particular attention to:
(a)
the suitability and actual use of methods by the supplier for checking each of the critical points in the production process;
(b)
the overall competence of the supplier's staff to carry out the activities set out in Article 6(1) of Directive 2008/90/EC.
3. Member States shall ensure that the responsible official bodies produce and keep records of the results and dates of all field inspections, sampling and testing carried out by them.
CHAPTER 5
FINAL PROVISIONS
Article 31
Transposition
1. Member States shall adopt and publish, by at the latest 31 December 2016, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 January 2017.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 32
Transitional measures
Member States may until 31 December 2022 allow the marketing in their own territory of propagating material and fruit plants produced from pre-basic, basic and certified mother plants or CAC material which existed before 1 January 2017,and have been officially certified or meet the conditions to be qualified as CAC material before 31 December 2022. When marketed, such propagating material and fruit plants shall be identified by a reference to this Article on the label and a document.
Article 33
Repeal
Directive 93/48/EEC and Directive 93/64/EEC are repealed.
Article 34
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 35
Addressees
This Directive is addressed to the Member States.
Done at Brussels, 15 October 2014.