WORKSHOP ON CERTIFICATION OF PLANT MATERIAL

Transcription

1 WORKSHOP ON CERTIFICATION OF PLANT MATERIAL Variety registration, identification and plant breeders rights Packing, labeling and marketing Nis, November 2014

2 EU LEGISLATION Directive 2008/90/EC Marketing of fruit plant propagating material and fruit plants for fruit production- Recast of Directive 92/34/EEC

3 EU LEGISLATION Implementing measures Directive 2014/96/EU COMMISSION IMPLEMENTING DIRECTIVE 2014/96/EU of 15 October 2014 on the requirements for the labelling, sealing and packaging of fruit plant propagating material and fruit plants intended for fruit production, falling within the scope of Council Directive 2008/90/EC Directive 2014/97/EU COMMISSION IMPLEMENTING DIRECTIVE 2014/97/EU of 15 October 2014 implementing Council Directive 2008/90/EC as regards the registration of suppliers and of varieties and the common list of varieties Directive 2014/98/EU 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

4 EU LEGISLATION Regulation EC 2100/94 on EU plant variety rights; Implementing measures Regulation EC 874/2009- implementing rules for the above Regulation on proceedings before the Community Plant Variety Office; Regulation EC 1238/95 - implementing rules for the above Regulation on fees payable to the Community Plant Variety Office Regulation EC 1768/95 - implementing rules on the agricultural exemption (Article 14 (3) of Regulation EC 2100/94

5 EU LEGISLATION eting_requirements/fruit_en.htm

6 EU LEGISLATION NATIONAL LEGISLATION Regulations are the most direct form of EU law - as soon as they are passed, they have binding legal force throughout every Member State, on a par with national laws National governments do not have to take action themselves to implement EU regulations

7 EU LEGISLATION NATIONAL LEGISLATION Directives are addressed to national authorities National authorities must then take action to make them part of national law

8 EU LEGISLATION NATIONAL LEGISLATION During Negotiations for accession to the European Union a candidate Member State could agree a transitional period for one or more provisions; A transitional period usually is up to three years

9 SCOPE: DIRECTIVE 2008/90/EC The Directive shall apply to the marketing of fruit plant propagating material and fruit plants intended for fruit production within the Community and to the genera and species listed in Annex I as well as to their hybrids This Directive shall also apply to rootstocks and other parts of plants of other genera or species than those listed in Annex I or their hybrids, if material of genera or species listed in Annex I or their hybrids is grafted or is to be grafted onto them This Directive shall apply without prejudice to the plant health rules laid down by Directive 2000/29/EC

10 DIRECTIVE 2008/90/EC SCOPE: This Directive shall not apply to propagating material or fruit plants shown to be intended for export to third countries, provided they are identified as such and kept sufficiently isolated

11 DIRECTIVE 2008/90/EC Categories: pre-basic material - propagating material basic material - propagating material certified material - propagating material and fruit plants CAC material (Conformitas Agraria Communitatis) - propagating material and fruit plants

12 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: The propagating material has to be officially certified as pre-basic material, basic material or certified material or if it meets the conditions to be qualified as CAC material; The fruit plants have to be officially certified as certified material or they meet the conditions to be qualified as CAC material

13 DIRECTIVE 2008/90/EC Exemption from marketing requirements: Member States may authorise suppliers on their own territory to place on the market appropriate quantities of propagating material and fruit plants intended: for trials or scientific purposes; for selection work; or to help preserve genetic diversity

14 DIRECTIVE 2008/90/EC Specific requirements for genus and species: the conditions with which CAC material must comply, propagation system applied, to the purity of the growing crop, plant health and to varietal aspects; the conditions with which pre-basic, basic and certified material must comply, relating to quality, plant health, the testing methods, the propagation system(s) and, except in the case of rootstocks where the material does not belong to a variety, to varietal aspects; the conditions with which rootstocks and other parts of plants of genera or species other than those listed in Annex I, or their hybrids, must comply if propagating material of the genus or species listed in Annex I or their hybrids is grafted onto them

15 DIRECTIVE 2008/90/EC Requirements to be met by suppliers: Registration Member States shall ensure that suppliers are officially registered in relation to the activities which they carry out under this Directive Exemption from registration Member States may have exemt from registration of suppliers marketing only to non-professional final consumers

16 IMPLEMENTING DIRECTIVE 2014/98/EC Specific requirements for suppliers Suppliers are responsible for: Quality of the production Level of harmful organisms Keeping records of their sales or purchases Suppliers marketing only to non-professional final consumers have to monitor the level of harmful organisms and keep records of their sales or purchases

17 IMPLEMENTING DIRECTIVE 2014/97/EU Register of suppliers Member States shall keep and update a register of suppliers The register of suppliers shall include: Name, address and contact details of the supplier; activities within the meaning of Article 2(9) of Directive 2008/90/EC that are exercised by the supplier in the Member State concerned, the address of the premises involved and the main genera or species concerned; and registration number or code

18 Register of suppliers: IMPLEMENTING DIRECTIVE 2014/97/EU Member States shall ensure that the responsible official body removes a natural or legal person from the register of suppliers, if it is established that that person no longer exercises any activity within the meaning of Article 2(9) of Directive 2008/90/EC Article 2(9) Supplier means any natural or legal person carrying out professionally at least one of the following activities with regard to propagating material or fruit plants: reproducing, producing, preserving and/or treating, importing and marketing;

19 IMPLEMENTING DIRECTIVE 2014/97/EU Notification obligation of suppliers: Member States shall ensure that supplier notifys the information about the name, address, contact details and activities No notification shall be required from suppliers accredited in accordance with Article 6(1) of Directive 92/34/EEC Member States shall ensure that suppliers notify any change in their situation Member States shall ensure that suppliers are informed of their registration and of any modifications thereto within a time period to be laid down by national legislation

20 DIRECTIVE 2008/90/EC Variety identification Propagating material and fruit plants are marketed with a reference to the variety to which they belong In the case of rootstocks, the material does not belong to a variety, reference shall be made to the species or interspecific hybrid concerned

21 DIRECTIVE 2008/90/EC Variety identification Reference to the varieties shall be: Legally protected by a plant variety right in accordance with provisions on the protection of new varieties; Officially registered; Commonly known

22 DIRECTIVE 2008/90/EC Variety identification A variety is considered to be commonly known if: (i) it has been officially registered in another Member State; (ii) it is the subject of an application for official registration in any Member State, or of an application for a plant variety right; or (iii) it has been already marketed before 30 September 2012 in the territory of the Member State concerned or of another Member State, provided that it has an officially recognised description

23 DIRECTIVE 2008/90/EC Variety identification As far as possible, each variety shall bear the same denomination in all the Member States, in accordance with implementing measures or, in their absence, in accordance with accepted international guidelines

24 DIRECTIVE 2008/90/EC Variety identification Varieties may be officially registered if they have been found to satisfy certain officially approved conditions and have an official description They may also be officially registered if their material has been already marketed before 30 September 2012 in the territory of the Member State concerned, provided that they have an officially recognised description

25 DIRECTIVE 2008/90/EC Variety identification A genetically modified variety may be officially registered only if the genetically modified organism of which it consists has been authorised pursuant to Directive 2001/18/EC or pursuant to Regulation 1829/2003/EC

26 DIRECTIVE 2008/90/EC Marketing requirements: Lot composition and identification While growing and during lifting or removal from the parent material, propagating material and fruit plants shall be kept in separate lots If propagating material and fruit plants of different origins are put together or mixed during packaging, storage, transport or at delivery, the supplier shall keep records including the following data: composition of the lot and origin of its individual components

27 DIRECTIVE 2008/90/EC Marketing requirements: Labelling Propagating material and fruit plants shall be marketed only in sufficiently homogeneous lots and: In case of CAC material, to be qualified as CAC and accompanied by supplier s document In case of pre-basic, basic or certified material, to be certified as such by the responsible official body and labeled and/or sealed by a label, prepared and affixed by the official body

28 DIRECTIVE 2008/90/EC Marketing requirements: Labelling In the case of retail supply of propagating material or fruit plants to a non-professional final consumer, information on the label may be confined to appropriate product information In the case of propagating material or a fruit plant of a variety which has been genetically modified, any label and document, official or otherwise, which is affixed to or accompanies the material shall clearly indicate that the variety has been genetically modified and shall identify the genetically modified organisms

29 Marketing requirements: IMPLEMENTING DIRECTIVE 2014/96/EU Labelling Propagating material or fruit plants forming part of the same lot may be marketed with a single label where such material or such plants are part of the same package, bundle or container Member States may provide that fruit plants, which are one or more years old, are to be labelled individually. In this case, labelling may be carried out in the field before or during uprooting or later. Where labelling is carried out later, plants of the same lot shall be uprooted together and be kept separate from other lots in labelled containers until those plants are labelled

30 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: Information on the label, issued by the official body: a) The indication EU rules and standards ; b) Member State of labelling or the respective code; c) Responsible official body or the respective code; d) Name of supplier or its registration number/code issued by the responsible official body; e) Reference number of package or bundle, individual serial number, week number or batch number; (f) Botanical name; (g) Category, and for basic material also the generation number; (h) Denomination of the variety

31 Marketing requirements: IMPLEMENTING DIRECTIVE 2014/96/EU Information on the label, issued by the official body: Denomination of the variety and, where appropriate, the clone. In the case of rootstocks not belonging to a variety, the name of the species or the interspecific hybrid concerned. For grafted fruit plants such information shall be given for the rootstock and the top-graft For varieties for which an application for official registration or for a plant variety right is pending, such information shall indicate: proposed denomination and application pending ;

32 Marketing requirements: IMPLEMENTING DIRECTIVE 2014/96/EU (2) Information on the label, issued by official body: i) The indication variety with an officially recognised description, where appropriate; (j) Quantity; (k) Country of production and the respective code, where different from the Member State of labelling; (l) Year of issue; (m) In case the original label is replaced by another label: the year of issue of the original label

33 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: Label: The label shall be indelibly printed in one of the official languages of the Union, easily visible and legible If a coloured label is used in respect of any category of plants or parts of plants, the colour of the label shall be: (a) White with a diagonal violet stripe for pre-basic-material; (b) White for basic material; (c) Blue for certified material

34 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: Affixing of the label: The label shall be affixed to the plants or parts of plants to be marketed as propagating material or fruit plants. Where such plants or parts of plants are to be marketed in a package, bundle or container, the label shall be affixed to that package, bundle or container

35 Marketing requirements: IMPLEMENTING DIRECTIVE 2014/96/EU Accompanying document for pre-basic, basic or certified material Member States may provide that an accompanying document maybe made by the responsible official body, or by the supplier concerned under the supervision of this body, for lots of different varieties or types of pre-basic, basic or certified material to be marketed together to complement the label

36 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: Accompanying document for pre-basic, basic or certified material The accompanying document shall fulfil the following requirements: (a) Include the information set out in the label; (b) Be written in one of the official languages of the Union; (c) Be delivered at least in duplicate (supplier and recipient); (d) Accompany the material from the place of the supplier to the place of the recipient; (e) Include the name and address of the recipient; (f) Include the date of issue of the document; (g) Include, where appropriate, additional information relevant to the lots concerned

37 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: Sealing and packaging requirements for pre-basic, basic or certified material Where pre-basic, basic or certified material is marketed in lots of two or more plants or parts of plants, those lots have to be sufficiently homogeneous. Plants or parts of plants making up such lots are in a sealed package or container, or are part of a sealed bundle Sealing means: in the case of a package or container, closing in such a way that it cannot be opened without damaging the closure, in the case of a bundle, tying up in such a way that the plants or parts of plants forming part of the bundle cannot be separated without damaging the tie or ties. The package, the container or bundle shall be labelled in such a way that the removal of the label renders it invalid

38 Marketing requirements: Supplier's document for CAC material IMPLEMENTING DIRECTIVE 2014/96/EU Member States shall ensure that CAC material is marketed with a document prepared by the supplier ( the supplier's document ) Member States shall ensure that the supplier's document does not resemble a label, issued by official body or an accompanying document, so as to avoid any possible confusion between the supplier's document and those two documents

39 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: (1) Supplier's document for CAC material The supplier's document shall contain at least the following information: a) The indication EU rules and standards ; b) Member State where the supplier's document has been prepared, or the respective code; c) Responsible official body or the respective code; d) Name of supplier or its registration number/code issued by the responsible official body; e) Individual serial number, week number or batch number; f) Botanical name; g) CAC material; h) Denomination

40 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: Supplier's document for CAC material Denomination of the variety and, where appropriate, the clone. In the case of rootstocks not belonging to a variety, the name of the species or the interspecific hybrid concerned. For grafted fruit plants such information shall be given for the rootstock and the top-graft. For varieties for which an application for official registration or for a plant variety right is pending, such information shall indicate: proposed denomination and application pending ;

41 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: (2) Supplier's document for CAC material i) Quantity; j) Country of production and the respective code, where different from the Member State where the supplier's document has been prepared; k) Date of issue of the document

42 IMPLEMENTING DIRECTIVE 2014/96/EU Marketing requirements: Supplier's document for CAC material The supplier's document shall be indelibly printed in one of the official languages of the Union and easily visible and legible

43 Pre-basic material certificate issued by the Netherlands For Malus (apple), shows: number of pieces, variety, Virus-free status and category (Pre-basic) plus a declaration, supplier s registration no. and certificate number. 43

44 Basic material certificate issued by the Netherlands For Malus (apple) rootstock, shows: number of pieces, variety,virus-free status and category (Basic) plus a declaration, supplier s registration no. and certificate number. 44

45 Basic material certificate issued by the UK For Malus (apple) mother trees, shows: number of trees, variety and rootstock and grade name (Super-Elite) which is category Basic, plus a declaration, and certificate number. 45

46 Basic material certificate issued by the UK For Fragaria (strawberry), shows: number of mother plants in field, field name, variety, grade name (Super-Elite) which is category (Basic), plus a declaration, supplier s registration no. and certificate number 46

47 Certification labels from France for Malus (apple) Basic (propagation) material label above, showing variety and rootstock variety, VF, category and supplier Below: Certified material label, showing same 47

48 Plant passport from France, combined with EU Marketing Directive certification label, for Malus (apple) Certification information Passport information 48

49 Certification label combined with plant passport from The Netherlands, for Prunus budwood Certification information (above), plant passport details left 49

50 Extra information for EU Marketing requirements: EC Quality, Category =CAC, Name of variety of Scion and rootstock Plant passport as a label (from Italy) Combining plant passport with supplier s document 50

51 Supplier s document for CAC issued by a UK producer For Malus (apple) rootstock M9, shows: number plants variety, supplier s registration number 51

52 Exemptions from marketing requirements: Local circulation DIRECTIVE 2008/90/EC Member States may exempt: From the application of labeling requirements, small producers all of whose production and sales of propagating material and fruit plants is intended for final use by persons on the local market who are not professionally involved in plant production (local circulation); From the checks and official inspections the local circulation of propagating materials and fruit plants produced by such exempt persons

53 IMPLEMENTING DIRECTIVE 2014/98/EU Variety registration: Requirements for the official registration of the variety are set up in IMPLEMENTING DIRECTIVE 2014/98/EU of 15 October 2014 Member States shall keep, update and publish a register of varieties; That register should include varieties registered under Council Directive 92/34/EEC in addition to those registered under Directive 2008/90/EC; That register should indicate whether varieties have an official description or an officially recognised description.

54 IMPLEMENTING DIRECTIVE 2014/97/EU Variety register: The variety register shall include the following information: * denomination of the variety and synonyms; * species the variety belongs to; * the indication official description or officially recognised description ; * date of registration, or of renewal of registration; * end of validity of registration Member States shall keep a file for each variety they register That file shall contain a description of the variety and a summary of all the facts relevant to the registration of the variety

55 IMPLEMENTING DIRECTIVE 2014/97/EU Registration of varieties: A variety is registered as a variety with an official description if it fulfils the following requirements: (a) it is distinct, uniform and stable; (b) a sample of the variety is available; and (c) as regards genetically modified varieties, the genetically modified organism of which the variety consists is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003

56 IMPLEMENTING DIRECTIVE 2014/97/EU Application for registration of a variety: (1) For registration of a variety as a variety with an official description, Member States shall require a written application The application shall be accompanied by the following: the information required by the technical questionnaires set out at the time of application: (i) In the Protocols for distinctness, uniformity and stability tests of the Administrative Council of the Community Plant Variety Office (CPVO); or, where no such protocols have been published;

57 IMPLEMENTING DIRECTIVE 2014/97/EU Application for registration of a variety: (2) For registration of a variety as a variety with an official description, Member States shall require a written application The application shall be accompanied by the following: the information required by the technical questionnaires set out at the time of application: (ii)in the Test guidelines for the conduct of tests for distinctness, uniformity and stability of the International Union for the Protection of new Varieties of Plants (UPOV); or where no such guidelines have been published; (iii) in national provisions;

58 IMPLEMENTING DIRECTIVE 2014/97/EU Application for registration of a variety: (3) For registration of a variety as a variety with an official description, Member States shall require a written application The application shall be accompanied by the following: information on whether the variety is officially registered in another Member State, or is the subject of an application for such a registration in another Member State; a proposed denomination; in the case of a genetically modified variety, evidence that the genetically modified organism of which the variety consists is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003

59 IMPLEMENTING DIRECTIVE 2014/97/EU Application for registration of a variety: For registration of a variety as a variety with an official description, Member States shall require a written application The applicant may submit any of the following with its application: an official description established; any other relevant information

60 Examination of applications: IMPLEMENTING DIRECTIVE 2014/97/EU Member States shall ensure that, where a responsible official body receives an application for registration of a variety as a variety with an official description, an examination of that variety is performed in accordance with the follows: Growing trials shall be carried out to establish an official description of the variety

61 Examination of applications: IMPLEMENTING DIRECTIVE 2014/97/EU Where the applicant submits an official description of the variety and the responsible official body considers that this information fulfils the requirements, no growing trials shall, however, be carried out Where growing trials are to be carried out, the responsible official body shall request a sample of the material of the variety

62 IMPLEMENTING DIRECTIVE 2014/97/EU The growing trials: The growing trials shall be performed in accordance with the following provisions as regards trial design, growing conditions and characteristics of the variety to be covered as a minimum: CPVO protocols, for species for which there are protocols; UPOV guidelines, for species for which there are guidelines ; National provisions If the responsible official body concludes that the variety concerned fulfils the requirements it shall establish an official description and include that variety in the variety register

63 IMPLEMENTING DIRECTIVE 2014/97/EU Period of validity of variety registration The maximum period of validity of the registration of a variety shall be 30 years In the case of genetically modified varieties, the validity of the registration shall be limited to the period for which the genetically modified organism of which the variety consists is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003

64 Renewal of variety registration : IMPLEMENTING DIRECTIVE 2014/97/EU The registration of a variety may be renewed for further maximum periods of 30 years, provided that material of that variety is still available Renewal of a genetically modified variety shallbe subject to the condition of the Directive 2001/18/EC or Regulation (EC) No 1829/2003 The renewal period shall be limited to the period of authorisation of the genetically modified organism concerned

65 IMPLEMENTING DIRECTIVE 2014/97/EU Removal of a variety from the variety register: A variety is removed from the variety register if: the conditions for registration are no longer fulfilled; at the time of the application for registration or during examination, false or fraudulent particulars had been supplied concerning the facts on the basis of which the variety was registered

66 IMPLEMENTING DIRECTIVE 2014/97/EU Notifications : Each Member State shall notify to the other Member States and the Commission the information required to access the variety register of the Member State; Each Member State shall notify the Commission of the inclusion of a variety in its variety register, and any other amendment to its variety register

67 IMPLEMENTING DIRECTIVE 2014/97/EU Common list : The Commission shall establish, regularly update and publish in an electronic format a common list of the varieties included in the variety registers of the Member States

68 DIRECTIVE 2008/90/EC Free movement clause Propagating material and fruit plants which comply with the requirements and conditions of this Directive shall be subject to no marketing restrictions as regards supplier, plant health, growing medium and inspection arrangements, other than those laid down in this Directive As regards the propagating material and fruit plants of the genera and species referred to in Annex I, Member States shall refrain from imposing more stringent conditions or marketing restrictions other than those laid down in this Directive

69 IMPLEMENTING DIRECTIVE 2014/98/EU IMPLEMENTING DIRECTIVE 2014/97/EU IMPLEMENTING DIRECTIVE 2014/96/EU Transposition: Member States shall adopt and publish, by 31 December 2016 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive; They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive; They shall apply those provisions from 1 January 2017

70 Regulation EC 2100/94 Community plant variety rights A system of Community plant variety rights is hereby established as the sole and exclusive form of Community industrial property rights for plant varieties

71 Regulation EC 2100/94 Uniform effect of Community plant variety rights Community plant variety rights shall have uniform effect within the territory of the Community and may not be granted, transferred or terminated in respect of the abovementioned territory otherwise than on a uniform basis

72 Regulation EC 2100/94 National property rights for plant varieties This Regulation shall be without prejudice to the right of the Member States to grant national property rights for plant varieties

73 Regulation EC 2100/94 Object of Community plant variety rights Varieties of all botanical genera and species, including, inter alia, hybrids between genera or species, may form the object of Community plant variety rights

74 Regulation EC 2100/94 Protectable varieties Community plant variety rights shall be granted for varieties that are: (a) distinct; (b) uniform; (c) stable; and (d) new. Moreover, the variety must be designated by a denomination

75 Regulation EC 2100/94 Rights of the holder of a Community plant variety right and prohibited acts A Community plant variety right shall have the effect that the holder or holders of the Community plant variety right, hereinafter referred to as the holder, shall be entitled to effect the acts set out below:

76 Regulation EC 2100/94 Rights of the holder of a Community plant variety right and prohibited acts The following acts in respect of variety constituents, or harvested material of the protected variety, both referred to hereinafter as material, shall require the authorization of the holder: (a) production or reproduction (multiplication); (b) conditioning for the purpose of propagation; (c) offering for sale; (d) selling or other marketing; (e) exporting from the Community; (f) importing to the Community; (g) stocking for any of the purposes mentioned in (a) to (f)

77 Regulation EC 2100/94 Rights of the holder of a Community plant variety right and prohibited acts The holder may make his authorization subject to conditions and limitations This provisions shall apply in respect of harvested material only if this was obtained through the unauthorized use of variety constituents of the protected variety, and unless the holder has had reasonable opportunity

78 Regulation EC 2100/94 Limitation of the effects of Community plant variety rights (a) acts done privately and for non-commercial purposes; (b) acts done for experimental purposes; (c) acts done for the purpose of breeding, or discoverin and developing other varieties;

79 Regulation EC 2100/94 Duration of Community plant variety rights The term of the Community plant variety right shall run until the end of the 25th calendar year or, in the case of varieties of vine and tree species, until the end of the 30th calendar year, following the year of grant

80 Regulation EC 2100/94

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82 THANK YOU FOR YOUR ATTENTION

83 Bistra Pavlovska Executive Director EAVTFISC 125 Blvd Tzarigradsko shosse, Block Sofia Tel.: Fax: bistra.pavlovska@iasas.government.bg