title: Commission Directive 2008/61/EC of 17 June 2008 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 2000/29/EC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections (Codified version)

text:
               18.6.2008

               EN

               Official Journal of the European Union

               L 158/41

      COMMISSION DIRECTIVE 2008/61/EC
   of 17 June 2008
   establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 2000/29/EC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections
   (Codified version)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular Articles 3(8), 4(5), 5(5) and 13b(4) thereof,
   Whereas:

               (1)

               Commission Directive 95/44/EC of 26 July 1995 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 77/93/EEC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections (2) has been substantially amended (3). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               Under the provisions of Directive 2000/29/EC, harmful organisms listed in its Annexes I and II, whether singly or associated with the relevant plants or plant products listed in Annex II to that Directive, may not be introduced into and spread by movement within the Community or certain protected zones thereof.

               (3)

               Under Directive 2000/29/EC, plants, plant products and other objects listed in its Annex III may not be introduced into the Community or into certain protected zones thereof.

               (4)

               Plants, plant products and other objects listed in Annex IV to Directive 2000/29/EC may not be introduced into or moved within the Community or certain protected zones thereof unless the relevant special requirements indicated in that Annex are met.

               (5)

               Plants, plant products and other objects listed in Annex V, Part B to Directive 2000/29/EC coming from third countries may not be introduced into the Community unless they comply with the standards and requirements laid down in that Directive and are accompanied by an official phytosanitary certificate ensuring such compliance and are, moreover, inspected on an official basis for compliance with these provisions.

               (6)

               However, Articles 3(8), 4(5), 5(5) and 13b(4) of Directive 2000/29/EC provide for those rules not to apply to the introduction and movement of such harmful organisms, plants, plant products and other objects, for trial or scientific purposes and for work on varietal selections, under conditions which shall be determined at Community level.

               (7)

               Therefore, it is necessary to determine the conditions which must be satisfied in the case of such introductions or movements, in order to ensure that there is no risk of harmful organisms spreading.

               (8)

               The conditions laid down for material under Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (4) and under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (5), and other more specific Community provisions regarding endangered species of wild fauna and flora and genetically modified organisms, are not affected by this Directive.

               (9)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health.

               (10)

               This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex IV, Part B,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   1.   Member States shall ensure that for any activity for trial or scientific purposes and for work on varietal selections, hereinafter referred to as ‘the activities’, which would involve the use of harmful organisms, plants, plant products and other objects pursuant to Article 3(8), 4(5), 5(5) or 13b(4) of Directive 2000/29/EC, hereinafter referred to as ‘the material’, an application shall be submitted to the responsible official bodies prior to the introduction into, or movement within, any Member State or relevant protected zones thereof, of any such material.
   2.   The application referred to in paragraph 1, shall specify at least the following:

               (a)

               the name and address of the person responsible for the activities;

               (b)

               the scientific name or names of the material, including the harmful organism concerned, where appropriate;

               (c)

               the type of material;

               (d)

               the quantity of material;

               (e)

               the place of origin of the material, with appropriate documentary evidence for material to be introduced from a third country;

               (f)

               the duration, nature and objectives of the activities envisaged, including, at least, a resumé of the work and a specification for trial or scientific purposes or work on varietal selections;

               (g)

               the address and description of the specific site or sites for quarantine containment and, where appropriate, for testing;

               (h)

               the place of first storage or of first planting, as appropriate, after the material has been officially released, where appropriate;

               (i)

               the proposed method of destruction or treatment of material on completion of the approved activities, where appropriate;

               (j)

               the proposed point of entry into the Community for material to be introduced from a third country.

         Article 2
   1.   Member States, on receipt of the application referred to in Article 1, shall approve the activities concerned, if it is established that the general conditions laid down in Annex I are satisfied.
   Member States shall withdraw the said approval at any time if it is established that the conditions laid down in Annex I cease to be met.
   2.   Following the approval of the activities referred to in paragraph 1, Member States shall approve the introduction into or movement within the Member State or relevant protected zones of the material referred to in the application, provided that such material is accompanied in all cases by a letter of authority for such introduction or movement of harmful organisms, plants, plant products and other objects for trial or scientific purposes and for work on varietal selections, hereinafter referred to as a ‘letter of authority’, conforming to the model set out in Annex II and issued by the responsible official body of the Member State in which the activities are to be undertaken, and

               (a)

               in the case of material originating in the Community:

                           (i)

                           where the place of origin is in another Member State, the accompanying letter of authority shall be officially endorsed by the Member State of origin for movement of the material under quarantine containment conditions; and

                           (ii)

                           for those plants, plant products and other objects listed in Annex V, Part A to Directive 2000/29/EC, the material shall also be accompanied by a plant passport issued in accordance with Article 10 of Directive 2000/29/EC, on the basis of the examination carried out pursuant to Article 6 of that Directive for compliance with the provisions laid down therein, other than those relating to any harmful organism in respect of which the activities have been approved under the first subparagraph of paragraph 1 of this Article. The plant passport shall contain the following statement: ‘This material is moved under Directive 2008/61/EC’.
                           In cases where the address of the specific site or sites for quarantine containment is located in another Member State, the Member State responsible for issuing the plant passport shall issue a plant passport only on the basis of information regarding the approval referred to in the first subparagraph of paragraph 1 of this Article received officially from the Member State responsible for the approval of the activities, and on the assurance that quarantine containment conditions shall be applied during movement of the material; and

               (b)

               in the case of material introduced from a third country:

                           (i)

                           Member States shall ensure that the letter of authority is issued on the basis of appropriate documentary evidence as regards the place of origin of the material; and

                           (ii)

                           for plants, plant products and other objects listed in Annex V, Part B to Directive 2000/29/EC the material shall also be accompanied wherever possible by a phytosanitary certificate issued in the country of origin in accordance with Article 13(1) of Directive 2000/29/EC, on the basis of the examination carried out pursuant to Article 6 of that Directive for compliance with the provisions laid down therein, other than those relating to any harmful organism in respect of which the activities have been approved under the first subparagraph of paragraph 1 of this Article.
                           The certificate shall, under ‘Additional declaration’, contain the following indication: ‘This material is imported under Directive 2008/61/EC’. The relevant harmful organism or organisms shall also be specified, where appropriate.

         In all cases Member States shall ensure that the material is held under quarantine containment conditions during the said introduction or movement, and is moved directly and immediately to the site or sites specified in the application.
   3.   The responsible official body shall monitor the approved activities and shall ensure that:

               (a)

               the quarantine containment conditions and other general conditions specified in accordance with Annex I are complied with throughout the duration of the activities, by examination of the premises and activities at appropriate times;

               (b)

               the following procedures are applied according to the type of approved activities:

                           (i)

                           for plants, plant products or other objects intended for release from quarantine:

                                       —

                                       the plants, plant products or other objects shall not be released without approval by the responsible official body, hereinafter referred to as ‘official release’. Prior to official release, the plants, plant products or other objects shall have been subject to quarantine measures, including testing, and must have been found free by such measures from any harmful organism, unless it is identified as one which is known to occur in the Community and is not listed in Directive 2000/29/EC,

                                       —

                                       the quarantine measures, including testing, shall be carried out by scientifically trained staff of that body or of any officially approved body, and shall be carried out in accordance with the provisions laid down in Annex III to this Directive for the plants, plant products and other objects specified,

                                       —

                                       any plants, plant products or other objects which have not been found free, by such measures, from harmful organisms as specified in the first indent, and any other plants, plant products or other objects with which they have been in contact or which may have become contaminated shall be destroyed or subjected to an appropriate treatment or quarantine measure aimed at eradicating the relevant harmful organisms; the provisions of (ii), second indent shall apply accordingly;

                           (ii)

                           for all other material (including harmful organisms), at the end of the duration of the approved activities, and for all material found to be contaminated during the activities:

                                       —

                                       the material (including the harmful organisms and any contaminated material) and any other plants, plant products or other objects with which it has been in contact or which may have become contaminated shall be destroyed, sterilised or otherwise treated in a manner to be specified by the responsible official body, and

                                       —

                                       the premises and facilities at which the activities in question have been undertaken shall be sterilised or otherwise cleaned, as necessary, in a manner to be specified by the responsible official body;

               (c)

               any contamination of the material by harmful organisms listed in Directive 2000/29/EC and any other harmful organism considered a risk to the Community by the responsible official body and detected during the activity shall be notified immediately to the responsible official body by the person responsible for the activities, along with notification of any event resulting in the escape of such organisms into the environment.

         4.   Member States shall ensure that for activities utilising plants, plant products and other objects listed in Annex III to Directive 2000/29/EC and not covered by Part A, Sections I, II and III of Annex III to this Directive, appropriate quarantine measures, including testing, shall be carried out. These quarantine measures shall be notified to the Commission and to the other Member States. The details of such quarantine measures shall be completed and inserted in Annex III to this Directive once the necessary technical information is available.
   Article 3
   1.   Before 1 September each year, Member States shall send to the Commission and to the other Member States a list, with quantities, of the introductions and movements of material approved under this Directive during the preceding period of one year ending on 30 June, and of any contamination by harmful organisms of such material, which has been confirmed under the quarantine measures, including testing, carried out under Annex III during the same period.
   2.   Member States shall cooperate administratively through the authorities established or designated pursuant to Article 1(4) of Directive 2000/29/EC, with regard to the provision of details of the quarantine containment conditions and measures imposed for activities approved under this Directive.
   Article 4
   Member States shall immediately communicate to the Commission all provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.
   Article 5
   Directive 95/44/EC, as amended by the Directive listed in Annex IV, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex IV, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex V.
   Article 6
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 7
   This Directive is addressed to the Member States.

      Done at Brussels, 17 June 2008.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission Directive 2007/41/EC (OJ L 169, 29.6.2007, p. 51).

      (2)  OJ L 184, 3.8.1995, p. 34. Directive as amended by Directive 97/46/EC (OJ L 204, 31.7.1997, p. 43).

      (3)  See Annex IV, Part A.

      (4)  OJ L 61, 3.3.1997, p. 1. Regulation as last amended by Commission Regulation (EC) No 318/2008 (OJ L 95, 8.4.2008, p. 3).

      (5)  OJ L 106, 17.4.2001, p. 1. Directive as last amended by Directive 2008/27/EC (OJ L 81, 20.3.2008, p. 45).

      ANNEX I

                  1.

                  For the purposes of Article 2(1) of this Directive the following general conditions shall apply:

                              —

                              the nature and objectives of the activities for which the material is to be introduced or moved shall have been examined by the responsible official body and found to comply with the concept of trial or scientific purposes and for work on varietal selections provided for under Directive 2000/29/EC,

                              —

                              the quarantine containment conditions of the premises and facilities at the site or sites at which the activities are to be undertaken shall have been inspected for compliance with the provisions laid down in point 2 and approved by the responsible official body,

                              —

                              the responsible official body shall limit the quantity of material to an amount that is adequate for the approved activities and in any case the amount shall not exceed quantities which have been determined having regard to available quarantine containment facilities,

                              —

                              the scientific and technical qualifications of the personnel by whom the activities are to be undertaken shall have been examined and approved by the responsible official body.

                  2.

                  For the purposes of point 1, the quarantine containment conditions of the premises and facilities at the site or sites at which the activities are to be undertaken shall be sufficient to ensure a safe handling of the material such that any harmful organisms of concern are contained and the risk of spreading such harmful organisms eliminated. For each activity specified in the application, the risk of spread of the harmful organisms held under quarantine containment conditions shall be determined by the responsible official body, having regard to the type of material and the activity envisaged, and to the biology of the harmful organisms, the means of their dispersal, the interaction with the environment and other relevant factors relating to the risk posed by the material concerned. As a result of the assessment of the risk, the responsible official body shall consider and lay down as appropriate:

                              (a)

                              the following quarantine measures concerning the premises, facilities and working procedures:

                                          —

                                          physical isolation from all other plant/harmful organism material, including consideration of control of vegetation in surrounding areas,

                                          —

                                          designation of a contact person responsible for the activities,

                                          —

                                          restricted access to the premises and facilities and to the surrounding area, as appropriate, to named personnel only,

                                          —

                                          appropriate identification of the premises and facilities indicating the type of activities and the personnel responsible,

                                          —

                                          maintenance of a register of the activities performed and a manual of operating procedures, including procedures in the event of escape of harmful organisms from containment,

                                          —

                                          appropriate security and alarm systems,

                                          —

                                          appropriate control measures to prevent the introduction into and the spread within the premises of harmful organisms,

                                          —

                                          controlled procedures for sampling and for transfer between premises and facilities, of the material,

                                          —

                                          controlled waste, soil and water disposal, as appropriate,

                                          —

                                          appropriate hygiene and disinfection procedures and facilities for personnel, structures and equipment,

                                          —

                                          appropriate measures and facilities for disposal of experimental material,

                                          —

                                          appropriate indexing (including testing) facilities and procedures; and

                              (b)

                              further quarantine measures according to the specific biology and epidemiology of the type of material involved and the activities approved:

                                          —

                                          maintenance in facilities with separate chamber ‘double door’ access to personnel,

                                          —

                                          maintenance under negative air pressure,

                                          —

                                          maintenance in escape-proof containers with appropriate mesh size and other barriers e.g. water barrier for mites, closed soil containers for nematodes, electric insect traps,

                                          —

                                          maintenance in isolation from other harmful organisms and material, e.g. viruliferous plant food material, host material,

                                          —

                                          maintenance of material for breeding in breeding cages with manipulation devices,

                                          —

                                          no interbreeding of the harmful organisms with indigenous strains or species,

                                          —

                                          avoidance of continuous culture of the harmful organisms,

                                          —

                                          maintenance under conditions that strictly control the multiplication of the harmful organism, e.g. under an environmental regime such that diapause does not occur,

                                          —

                                          maintenance in such a way that no spread by propagules can occur, e.g. air streams should be avoided,

                                          —

                                          procedures to check the purity of cultures of the harmful organisms for freedom from parasites and other harmful organisms,

                                          —

                                          appropriate control programmes for the material to eliminate possible vectors,

                                          —

                                          for in vitro activities, handling of the material under sterile conditions: equipping the laboratory for the performance of aseptic procedures,

                                          —

                                          maintenance of harmful organisms spread by vectors under conditions such that there is no spread via the vector e.g. controlled mesh size, containment of soil,

                                          —

                                          seasonal isolation to ensure the activities are done during periods of low plant health risk.

      ANNEX II
      Model Letter of Authority for the introduction and/or movement of harmful organisms, plants, plant products and other objects for trial or scientific purposes and for work on varietal selections

      ANNEX III
      QUARANTINE MEASURES INCLUDING TESTING ON PLANTS, PLANT PRODUCTS AND OTHER OBJECTS INTENDED FOR RELEASE FROM QUARANTINE
      PART A
      For certain plants, plant products and other objects listed in Annex III to Directive 2000/29/EC
      Section I:   Plants of Citrus L., Fortunella Swingle, Poncirus Raf. and their hybrids, other than fruit and seeds

                  1.

                  The plant material, as appropriate, shall be subjected to appropriate therapy procedures as laid down in FAO/IPGRI Technical Guidelines.

                  2.

                  The plant material, following the therapy procedures carried out pursuant to point 1, shall be subjected to indexing procedures in its entirety. All plant material including indexing plants, shall be held at the approved facilities under the quarantine containment conditions laid down in Annex I. Plant material intended for approval for official release shall be held under conditions conducive to a normal cycle of vegetative growth and be subjected to visual inspection for signs and symptoms of harmful organisms including all relevant harmful organisms listed in Directive 2000/29/EC, on arrival and subsequently, at appropriate times, during the period of the indexing procedures.

                  3.

                  For the purposes of point 2, the plant material shall be indexed for harmful organisms (tested for and identified) according to the following procedures:

                              3.1.

                              The testing shall use appropriate laboratory methods and, where appropriate, indicator plants, including Citrus sinensis (L.) Osbeck, C. aurantiifolia Christm. Swing, C. medica L., C. reticulata Blanco and Sesamum L., in order to detect at least the following harmful organisms:

                                          (a)

                                          Citrus greening bacterium

                                          (b)

                                          Citrus variegated chlorosis

                                          (c)

                                          Citrus mosaic virus

                                          (d)

                                          Citrus tristeza virus (all isolates)

                                          (e)

                                          Citrus vein enation woody gall

                                          (f)

                                          Leprosis

                                          (g)

                                          Naturally spreading psorosis

                                          (h)

                                             Phoma tracheiphila (Petri) Kanchaveli & Gikashvili

                                          (i)

                                          Satsuma dwarf virus

                                          (j)

                                             Spiroplasma citri Saglio et al.

                                          (k)

                                          Tatter leaf virus

                                          (l)

                                          Witches' broom (MLO)

                                          (m)

                                             Xanthomonas campestris (all strains pathogenic to Citrus).

                              3.2.

                              For diseases such as Blight and Blight-like for which there are no short-term indexing procedures the plant material must be subjected upon arrival to shoot-tip grafting onto seedling stock grown under sterile culture as set out in FAO/IPGRI Technical Guidelines, and the resulting plants subjected to therapy procedures according to point 1.

                  4.

                  The plant material subjected to the visual inspections referred to in point 2 and on which signs and symptoms of harmful organisms have been observed shall be subjected to an investigation including testing where necessary, to determine, as far as possible, the identity of the harmful organisms causing the signs and symptoms.

            Section II:   Plants of Cydonia Mill., Malus Mill., Prunus L. and Pyrus L. and their hybrids and Fragaria L., intended for planting, other than seeds

                  1.

                  The plant material, as appropriate, shall be subjected to appropriate therapy procedures as laid down in FAO/IPGRI Technical Guidelines.

                  2.

                  The plant material, following the therapy procedures carried out pursuant to point 1, shall be subjected to indexing procedures in its entirety. All plant material including indexing plants, shall be held at the approved facilities under the quarantine containment conditions laid down in Annex I. Plant material intended for approval for official release shall be held under conditions conducive to a normal cycle of vegetative growth and be subjected to visual inspection for signs and symptoms of harmful organisms including all relevant harmful organisms listed in Directive 2000/29/EC, on arrival and subsequently, at appropriate times, during the period of the indexing procedures.

                  3.

                  For the purposes of point 2 the plant material shall be indexed for harmful organisms (tested for and identified) according to the following procedures:

                              3.1.

                              In the case of Fragaria L., irrespective of the country of origin of the plant material, the testing shall use appropriate laboratory methods and, where appropriate, indicator plants, including Fragaria vesca, F. virginiana and Chenopodium spp. for the detection of at least the following harmful organisms:

                                          (a)

                                          Arabis mosaic virus

                                          (b)

                                          Raspberry ringspot virus

                                          (c)

                                          Strawberry crinkle virus

                                          (d)

                                          Strawberry latent ‘C’ virus

                                          (e)

                                          Strawberry latent ringspot virus

                                          (f)

                                          Strawberry mild yellow edge virus

                                          (g)

                                          Strawberry vein banding virus

                                          (h)

                                          Strawberry witches' broom mycoplasm

                                          (i)

                                          Tomato black ring virus

                                          (j)

                                          Tomato ringspot virus

                                          (k)

                                             Colletotrichum acutatum Simmonds

                                          (l)

                                             Phytophthora fragariae Hickman var. fragariae Wilcox & Duncan

                                          (m)

                                             Xanthomonas fragariae Kennedy & King.

                              3.2.

                              In the case of Malus Mill.:

                                          (i)

                                          where the plant material originates from a country which is not known to be free of any of the following harmful organisms:

                                                      (a)

                                                      Apple proliferation mycoplasm; or

                                                      (b)

                                                      Cherry rasp leaf virus (American),

                                                the testing shall use appropriate laboratory methods and, where appropriate, indicator plants for the detection of the relevant harmful organisms, and

                                          (ii)

                                          irrespective of the country of origin of the plant material, the testing shall use appropriate laboratory methods and, where appropriate, indicator plants for the detection of at least the following harmful organisms:

                                                      (a)

                                                      Tobacco ringspot virus

                                                      (b)

                                                      Tomato ringspot virus

                                                      (c)

                                                         Erwinia amylovora (Burr.) Winsl. et al.

                              3.3.

                              In the case of Prunus L., as appropriate for each Prunus species:

                                          (i)

                                          where the plant material originates from a country which is not known to be free of any of the following harmful organisms:

                                                      (a)

                                                      Apricot chlorotic leafroll mycoplasm;

                                                      (b)

                                                      Cherry rasp leaf virus (American); or

                                                      (c)

                                                         Pseudomonas syringae pv. persicae (Prunier et al.) Young et al.,

                                                the testing shall use appropriate laboratory methods and, where appropriate, indicator plants for the detection of the relevant harmful organisms; and

                                          (ii)

                                          irrespective of the country of origin of the plant material, the testing shall use appropriate laboratory methods and, where appropriate, indicator plants for the detection of at least the following harmful organisms:

                                                      (a)

                                                      Little cherry pathogen (non-European isolates)

                                                      (b)

                                                      Peach mosaic virus (American)

                                                      (c)

                                                      Peach phony rickettsia

                                                      (d)

                                                      Peach rosette mosaic virus

                                                      (e)

                                                      Peach rosette mycoplasm

                                                      (f)

                                                      Peach X-disease mycoplasm

                                                      (g)

                                                      Peach yellows mycoplasm

                                                      (h)

                                                      Plum line pattern virus (American)

                                                      (i)

                                                      Plum pox virus

                                                      (j)

                                                      Tomato ringspot virus

                                                      (k)

                                                         Xanthomonas campestris pv. pruni (Smith) Dye.

                              3.4.

                              In the case of Cydonia Mill. and Pyrus L. irrespective of the country of origin of the plant material, testing by appropriate laboratory methods, and, where appropriate, indicator plants, for detection of at least the following harmful organisms:

                                          (a)

                                             Erwinia amylovora (Burr.) Winsl. et al.

                                          (b)

                                          Pear decline mycoplasm.

                  4.

                  The plant material subjected to the visual inspections referred to in point 2 and on which signs and symptoms of harmful organisms have been observed shall be subject to an investigation including testing where necessary, to determine, as far as possible, the identity of the harmful organisms causing the signs and symptoms.

            Section III:   Plants of Vitis L., other than fruits

                  1.

                  The plant material shall be subjected, as appropriate, to appropriate therapy procedures, as laid down in FAO/IPGRI Technical Guidelines.

                  2.

                  The plant material, following the therapy procedures carried out pursuant to point 1, shall be subjected to indexing procedures in its entirety. All plant material including indexing plants, shall be held at the approved facilities under the quarantine containment conditions laid down in Annex I. Plant material intended for approval for official release shall be held under conditions conducive to a normal cycle of vegetative growth and shall be subjected to visual inspection for signs and symptoms of harmful organisms including those of Daktulosphaira vitifoliae (Fitch) and of all other relevant harmful organisms listed in Directive 2000/29/EC, on arrival and subsequently, at appropriate times, during the period of the indexing procedures.

                  3.

                  For the purposes of point 2 the plant material shall be indexed for harmful organisms (tested for and identified) according to the following procedures:

                              3.1.

                              Where the plant material originates in a country which is not known to be free of the following harmful organisms:

                                          (i)

                                             Ajinashika disease

                                          The testing shall use an appropriate laboratory method. In the event of a negative result, the plant material shall be indexed on the vine variety Koshu and kept under observation during at least two cycles of vegetation.

                                          (ii)

                                             Grapevine stunt virus

                                          The testing shall use appropriate indicator plants, including the vine variety Campbell Early, and observation shall take place during one year.

                                          (iii)

                                             Summer mottle

                                          The testing shall use appropriate indicator plants, including the vine varieties Sideritis, Cabernet-Franc and Mission.

                              3.2.

                              Irrespective of the country of origin of the plant material, the testing shall use appropriate laboratory methods and, where appropriate, indicator plants for the detection of at least the following harmful organisms:

                                          (a)

                                          Blueberry leaf mottle virus

                                          (b)

                                          Grapevine Flavescence dorée MLO and other grapevine yellows

                                          (c)

                                          Peach rosette mosaic virus

                                          (d)

                                          Tobacco ringspot virus

                                          (e)

                                          Tomato ringspot virus (strain ‘yellow vein’ and other strains)

                                          (f)

                                             Xylella fastidiosa (Well & Raju)

                                          (g)

                                             Xylophilus ampelinus (Panagopoulos) Willems et al.

                  4.

                  The plant material subjected to the visual inspections referred to in point 2 and on which signs and symptoms of harmful organisms have been observed shall be subjected to an investigation including testing where necessary, to determine, as far as possible, the identity of the harmful organisms causing the signs and symptoms.

            Section IV:   Plants of stolon- or tuber-forming species of Solanum L. or their hybrids, intended for planting

                  1.

                  The plant material, as appropriate, shall be subjected to the therapy procedures as laid down in FAO/IPGRI Technical Guidelines.

                  2.

                  Each unit of the plant material, following the therapy procedures carried out pursuant to point 1, shall be subjected to indexing procedures. All plant material, including indexing plants, shall be held at the approved facilities under the quarantine containment conditions laid down in Annex I. Plant material intended for approval for official release shall be held under conditions conducive to a normal cycle of vegetative growth and be subjected to visual inspection for signs and symptoms of harmful organisms including all relevant harmful organisms listed in Directive 2000/29/EC and potato yellow vein disease, on arrival and subsequently, at regular intervals until senescence, during the period of the indexing procedures.

                  3.

                  The indexing procedures referred to in point 2 shall follow the technical provisions set out in point 5, in order to detect at least the following harmful organisms:

                              —

                                 Bacteria

                                          (a)

                                             Clavibacter michiganensis (Smith) Davis et al. ssp. sepedonicus (Spieckermann et Kotthoff) Davis et al.;

                                          (b)

                                             Ralstonia solanacearum (Smith) Yabuuchi et al.

                              —

                                 Viruses and virus-like organisms

                                          (a)

                                          Andean potato latent virus,

                                          (b)

                                          Potato black ringspot virus,

                                          (c)

                                          Potato spindle tuber viroid,

                                          (d)

                                          Potato yellowing alfamovirus,

                                          (e)

                                          Potato virus T,

                                          (f)

                                          Andean potato mottle virus,

                                          (g)

                                          Common potato viruses A, M, S, V, X and Y (including Yo, Yn and Yc) and potato leaf roll virus.

                        However, in the case of true seed of potato, the indexing procedures shall be carried out in order to detect at least the viruses and virus-like organisms listed above at (a) to (e).

                  4.

                  The plant material subjected to the visual inspections referred to in point 2 and on which signs and symptoms of harmful organisms have been observed shall be subjected to an investigation including testing where necessary, to determine, as far as possible, the identity of the harmful organisms causing the signs and symptoms.

                  5.

                  The technical provisions referred to in point 3 shall be as follows:

                              —

                                 Bacteria

                                          1.

                                          For tubers, test the heel end of each tuber. The standard sample size shall be 200 tubers. However, the procedure can be applied for samples with less than 200 tubers.

                                          2.

                                          For young plants and cuttings, including micro-plants, test the lower sections of the stem and, where appropriate, the roots, for each unit of the plant material.

                                          3.

                                          For testing of progeny tubers, or of stem bases for non-tuber forming species, one normal cycle of vegetative growth after the testing referred to in points 1 and 2, is recommended.

                                          4.

                                          For the material referred to in point 1, the testing method for Clavibacter michiganensis (Smith) Davis et al. ssp. sepedonicus (Spieckermann et Kotthoff) Davis et al. shall be the Community method set out in Annex I to Council Directive 93/85/EEC (1). For the material referred to in point 2, this testing method could be applied.

                                          5.

                                          For the material referred to in point 1, the testing method for Ralstonia solanacearum (Smith) Yabuuchi et al. shall be the test scheme set out in Annex II to Council Directive 98/57/EC (2). For the material referred to in point 2, this testing method could be applied.

                              —

                                 Viruses and virus-like organisms, other than potato spindle tuber viroid

                                          1.

                                          The minimum testing for vegetative material (tubers, young plants and cuttings, including micro-plants) shall include a serological test done at or near flowering for each of the specified list of harmful organisms other than potato spindle tuber viroid, and followed by a biological test of material testing negative in the serological test. For Potato leaf roll virus, two serological tests shall be done.

                                          2.

                                          The minimum testing for true seed shall be a serological test or a biological test if no serological test is available. Retesting of a proportion of negative samples and testing of borderline results by another method is highly recommended.

                                          3.

                                          The serological and biological testing referred to in points 1 and 2 shall be done on glasshouse grown plants, sampled from at least two positions on every stem, including a young fully expanded leaflet at the top of each stem and an older leaflet from a midway position; each stem shall be sampled because of possible non-systemic infection. In the case of the serological testing, no bulking of leaflets from separate plants shall be done, unless the bulking rate has been validated for the method of use; leaflets from each stem may however be bulked to make up the sample from each plant. In the case of the biological testing, the maximum bulking is up to five plants with inoculation of a minimum of duplicate indicator plants.

                                          4.

                                          The appropriate indicator plants to be used for the biological testing referred to in points 1 and 2 shall be those listed by the European and Mediterranean Plant Protection Organization (EPPO), or other officially approved indicator plants, which have been shown to detect the viruses.

                                          5.

                                          Only material which has been directly tested shall be released from quarantine. Where eye indexing has been done, only the progeny of the tested eye may be released. The tuber should not be released because of possible problems with non-systemic infection.

                              —

                                 Potato spindle tuber viroid

                                          1.

                                          For all material, glasshouse grown plants shall be tested, as soon as they are well established but prior to flowering and pollen production. Testing on tuber sprouts/in vitro plants/small seedlings shall only be regarded as a preliminary test.

                                          2.

                                          Samples shall be taken from a fully expanded leaflet at the top of each stem of the plant.

                                          3.

                                          All material for testing shall be grown at temperatures not less than 18 °C (preferably at temperatures higher than 20 °C) and with at least a 16-hour photo-period.

                                          4.

                                          Testing shall be by radioactive or non-radioactive labelled cDNA or RNA-probes, return-PAGE (with silver staining) or RT-PCR.

                                          5.

                                          The maximum bulking rate for probes and return-PAGE is 5. Use of this or higher bulking rates must be validated.

            PART B
      For plants, plant products and other objects listed in Annexes II and IV to Directive 2000/29/EC

                  1.

                  The official quarantine measures shall include appropriate inspection or testing for the relevant harmful organisms listed in Annexes I and II to Directive 2000/29/EC and shall be carried out in respect of the special requirements laid down in Annex IV to Directive 2000/29/EC for specific harmful organisms, as appropriate. In respect of such special requirements the methods used for the quarantine measures shall be those laid down in Annex IV to Directive 2000/29/EC or other equivalent officially approved measures.

                  2.

                  The plants, plant products and other objects must be found free, according to the provisions of point 1, from the relevant harmful organisms specified in Annexes I, II and IV to Directive 2000/29/EC for those plants, plant products and other objects.

         (1)  OJ L 259, 18.10.1993, p. 1. Directive as amended by Commission Directive 2006/56/EC (OJ L 182, 4.7.2006, p. 1).

         (2)  OJ L 235, 21.8.1998, p. 1. Directive as amended by Commission Directive 2006/63/EC (OJ L 206, 27.7.2006, p. 36).

      ANNEX IV
      PART A
      Repealed Directive with its amendment
      (referred to in Article 5)

                  Commission Directive 95/44/EC

                  (OJ L 184, 3.8.1995, p. 34)

                  Commission Directive 97/46/EC

                  (OJ L 204, 31.7.1997, p. 43)

            PART B
      List of time-limits for transposition into national law
      (referred to in Article 5)

                  Directive

                  Time-limit for transposition

                  95/44/EC

                  1 February 1996

                  97/46/EC

                  1 January 1998

      ANNEX V
      Correlation table

                  Directive 95/44/EC

                  This Directive

                  Article 1(1)

                  Article 1(1)

                  Article 1(2), introductory sentence

                  Article 1(2), introductory sentence

                  Article 1(2), first indent

                  Article 1(2)(a)

                  Article 1(2), second indent

                  Article 1(2)(b)

                  Article 1(2), third indent

                  Article 1(2)(c)

                  Article 1(2), fourth indent

                  Article 1(2)(d)

                  Article 1(2), fifth indent

                  Article 1(2)(e)

                  Article 1(2), sixth indent

                  Article 1(2)(f)

                  Article 1(2), seventh indent

                  Article 1(2)(g)

                  Article 1(2), eighth indent

                  Article 1(2)(h)

                  Article 1(2), ninth indent

                  Article 1(2)(i)

                  Article 1(2), tenth indent

                  Article 1(2)(j)

                  Articles 2 and 3

                  Articles 2 and 3

                  Article 4(1)

                  —

                  Article 4(2)

                  Article 4

                  —

                  Article 5

                  Article 5

                  Article 6

                  Article 6

                  Article 7

                  Annexes I, II and III

                  Annexes I, II and III

                  —

                  Annex IV

                  —

                  Annex V


Avis juridique important

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31980L0219

Council Directive 80/219/EEC of 22 January 1980 amending Directive 64/432/EEC as regards tuberulosis and brucellosis

Official Journal L 047 , 21/02/1980 P. 0025 - 0032 Finnish special edition: Chapter 3 Volume 11 P. 0226  Greek special edition: Chapter 03 Volume 27 P. 0259  Swedish special edition: Chapter 3 Volume 11 P. 0226  Spanish special edition: Chapter 03 Volume 17 P. 0136  Portuguese special edition Chapter 03 Volume 17 P. 0136

COUNCIL DIRECTIVE  of 22 January 1980  amending Directive 64/432/EEC as regards tuberculosis and brucellosis  (80/219/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas bovine tuberculosis has virtually disappeared from certain regions of the Community ; whereas it is necessary to reduce the cost of routine testing for tuberculosis in those regions;  Whereas, in order to reduce the time taken to restore officially tuberculosis-free status to herds in which tuberculosis has been found, the necessary methods of control must be adopted;  Whereas under Article 104 (3) of the Act of Accession, Denmark, Ireland and the United Kingdom were authorized to retain, until 31 December 1977, their national provisions for declaring a herd of cattle officially free of tuberculosis or free of brucellosis ; whereas these authorizations were extended on three occasions (4) (5) (6) in the case of tuberculosis and, in the case of Ireland and the United Kingdom, on two occasions (4) (5) as regards brucellosis-free status within the meaning of Article 2 of Directive 64/432/EEC (7), as last amended by Directive 77/98/EEC (8);  Whereas these derogations were instituted and extended because of the time required to provide solutions to basic technical problems;  Whereas, for the same reasons, these derogations apart from that affecting traditional trade in live animals between Ireland and the United Kingdom should be extended for a further period of one year;  Whereas, in order to facilitate trade in certain bovine animals and until such time as the Community accelerated disease-eradication programme is completed, it is necessary to amend and to prolong certain derogations relating to brucellosis which were provided for in Article 7 (1) (C) of Directive 64/432/EEC,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 64/432/EEC is hereby amended as follows:    1. The following paragraph shall be added to Article 3:  "14. By way of derogation from Annex A (I) (b), a decision may be taken in accordance with the procedure laid down in Article 12 that in a Member State or part of a Member State composed of several adjacent regions where at least 99 79 % of the bovine herds have been declared officially tuberculosis-free within the meaning of Article 2 (d) for at least 10 years, and where every year for at least six years bovine tuberculosis has not been found to be present in more than one herd per 10 000 herds in that Member State or part thereof, it being understood that all cattle which have reacted positively to a tuberculin test, and all cattle slaughtered within the territory of that Member State, must have been submitted to a post mortem examination by an official veterinarian and if necessary a bacteriological examination, the inspections for determining whether the status is to be retained may be carried out in a manner and in parts of the Member State to be decided in accordance with the same procedure.  (1)OJ No C 268, 23.10.1979, p. 2. (2)OJ No C 34, 11.2.1980, p. 109. (3)Opinion delivered on 21 November 1979 (not yet published in the Official Journal) (4)OJ No L 15, 19.1.1978, p. 32. (5)OJ No L 29, 3.2.1979, p. 27. (6)OJ No L 158, 26.6.1979, p. 17. (7)OJ No 121, 29.7.1964, p. 1977/64. (8)OJ No L 26, 31.1.1977, p. 81.   If one of the conditions provided for in the first subparagraph ceases to be fulfilled, the Commission, after assessing the circumstances of the recrudecence of tuberculosis, and if its assessment gives grounds for so doing, shall adopt a decision in accordance with the same procedure to rescind the derogation decision taken in respect of that Member State or part of that Member State composed of several adjacent regions."       2. In Annex A (I):      (i) under (b):        - in the second sentence, the words "or in a region of a Member State" shall be added after the words "Member State",               - the following sentence shall be added:  "If the percentage infected bovine herds does not exceed 0 71 % during two successive supervisory periods separated by an interval of three years, the interval between subsequent tuberculin tests may be increased to four years and/or the age at which animals have to undergo these tests may be increased to 24 months."                          (ii) the following subparagraph shall be added:  "If in an officially tuberculosis-free herd, an animal is deemed to have reacted positively to a routine tuberculin test, or a clinical case of tuberculosis has been diagnosed at routine post mortem examination of an animal from an officially tuberculosis-free herd, the officially tuberculosis-free status of the herd must be suspended until such time as all the remaining animals over six weeks of age have reacted negatively to at least two official intradermal tuberculin tests in accordance with Annex B, the first one carried out at least two months after elimination of the animal from the herd and the second one at least 42 days after the first."                  3. Annex B shall be replaced by the Annex to this Directive.       4. In Article 7 (1):      (a) under C:        - in the second sentence, the words "if over 30 days old" shall be inserted between the words "animals" and "must",               - in the second subparagraph the date "31 December 1979" shall be replaced by "31 December 1981";                          (b) the following point shall be added:  "E. Bovine animals which have not undergone the sero-agglutination test prescribed in C and D above, provided that they satisfy the following conditions:        (i) in the case of bovine animals intended for meat production:          - they are less than 42 days of age, or have been castrated before the age of four months,                   - they are moved under supervision, if necessary via a weaning unit, to an approved fattening holding and do not leave that holding except to go for slaughter;                                  (ii) in the case of bovine animals for slaughter, they are moved under official supervision directly to the slaughterhouse.  These provisions shall apply until 31 December 1981."                                 5. In Annex A (II) (A), the following paragraph shall be added:  "7. The tests provided for in paragraphs 1 to 6 shall not be required for male animals castrated before the age of four months."          Article 2 For the purpose of testing tuberculins known as "synthetic" tuberculins, a Member State which, at the date of adoption of this Directive, makes use of a standard tuberculin conforming with the international standard for old tuberculin may, by way of derogation from Annex B (1) to Directive 64/432/EEC, continue to apply this method until more advanced international standards are introduced.   Article 3 The Council, acting on a proposal from the Commission, and before 1 January 1984, shall designate the Community laboratories and the manner of their operation in accordance with Annex B (27) to Directive 64/432/EEC.  Under the procedure laid down in Article 12 of Directive 64/432/EEC the Standing Veterinary Committee shall designate the tuberculins to be tested and the examinations to be carried out, and may amend the list of laboratories where these examinations must be carried out.    Article 4 This Directive shall apply:    - from 1 January 1980 as regards Article 1 (4),       - by 31 December 1980 at the latest as regards the other provisions.          Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.  They shall forthwith inform the Commission thereof.  2. Until the date on which they are able to comply with this Directive, and until 31 December 1980 at the latest:    - Denmark, Ireland and the United Kingdom are hereby authorized to retain the methods applied in their territory whereby a herd of cattle becomes considered to be officially tuberculosis-free within the meaning of Article 2 of Directive 64/432/EEC,       - Ireland and the United Kingdom are hereby authorized to retain the methods applied in their territory whereby a herd of cattle becomes considered to be brucellosis-free within the meaning of Article 2 of Directive 64/432/EEC subject to the application of the provisions of that Directive relating to the presence of animals vaccinated against brucellosis.         The provisions relating to the tests laid down for animals traded within the Community shall continue to apply.   Article 6 This Directive is addressed to the Member States.     Done at Brussels, 22 January 1980.  For the Council  The President  G. MARCORA     ANNEX  "ANNEX B Standards for the manufacture and use of bovine and avian tuberculins    1. Officially supervised tuberculin tests must be carried out with PPD or HCSM tuberculins.       2. Manufacturers' working standards for the control of bovine PPD and HCSM tuberculins must be calibrated in Community tuberculin units (CTU) following biological assay against the appropriate EEC standard tuberculin.       3. Manufacturers' working standards for the control of avian tuberculins must be calibrated in international units following biological assay against the EEC standard for PPD of avian tuberculin.       4. The EEC standard for PPD of bovine tuberculin is that supplied by the Centraal Diergeneeskundig Instituut, Afdeling Rotterdam, the Netherlands.       5. The EEC standard for bovine HCSM tuberculin is that supplied by the Institut Pasteur, Paris, France.       6. The EEC standard for avian tuberculin is that supplied by the Central Veterinary Laboratory, Weybridge, Surrey, England.       7. Bovine tuberculins must be prepared with one of the mycobacterium bovis strains indicated below:      (a) AN5;           (b) Vallee.                  8. Avian tuberculins must be prepared with one of the mycobacterium avium strains indicated below:      (a) D4ER;           (b) TB56.                  9. The pH of tuberculins must be between 6 75 and 7 75.       10. Antimicrobial preservatives or other substances that may be added to a tuberculin shall have been shown, to the satisfaction of the State institute responsible for the official testing of the tuberculin, not to impair the safety and effectiveness of the product.  The following are the maximum permitted concentrations for phenol and glycerol:      (a) phenol : 0 75 % M/v;           (b) glycerol : 10 % v/v.                  11. Provided the tuberculins are stored at a temperature between 2 and 8 ºC, protected from light, they may be used up to the end of the following periods subsequent to the last satisfactory potency test:      (a) liquid PPD tuberculins : two years,  lyophilized PPD tuberculins : eight years;           (b) HCSM tuberculins diluted : two years.                   12. The State institutes listed below shall be responsible for the official testing of tuberculins in their respective countries: >PIC FILE= "T0013194">        13. Official testing must be carried out on each batch of bottled tuberculins ready for use.       14. Tuberculins shall be tested by biological and chemical methods.       15. Tuberculins must be sterile. Tests for sterility shall be carried out according to the specifications of the European Pharmacopeia.       16. A test for the absence of toxic or irritant properties shall be carried out according to the specifications of the European Pharmacopeia.       17. Tuberculins must be chemically analyzed to determine the concentration of glycerol and/or phenol and also the concentration of any other preservative which may have been added.       18. A test of non-sensitization to tuberculin must be carried out according to the specifications of the European Pharmacopeia.       19. The potency of tuberculins must be assessed by biological methods. These methods must be used for HCSM and PPD tuberculins ; they are based on the comparison with standard tuberculins of the tuberculins to be tested.       20. The protein content of PPD tuberculin must be estimated by the Kjeldahl method. The nitrogen is converted into tuberculo-protein content by multiplying by a factor of 6 725.       21. The EEC standard for bovine HCSM has a potency of 65 000 Community tuberculin units (CTU) per ml and is dispensed in ampoules containing 5 ml of tuberculin.       22. The EEC standard for bovine PPD has a potency of 50 000 Community tuberculin units (CTU) per mg of PPD and is dispensed lyophilized in ampoules containing 1 78 mg of PPD, i.e. 0 700002 mg PPD has a potency equal to one Community tuberculin unit.       23. The EEC standard for avian PPD has a potency of 50 000 international units (i.u.) per mg of the dried material of the purified protein derivative and is dispensed in the lyophilized in ampoules containing 10 mg of PPD plus 26 73 mg of salts, i.e. 0 70000726 mg of the standard has a potency equal to one international unit.       24. Tuberculins submitted by manufacturers for testing by the State institutes listed in paragraph 12 must have been tested for potency by biological assay against the appropriate standards as listed in paragraphs 2 and 3.        25.      (a) Potency testing on guinea pigs  Albino guinea-pigs weighing between 400 and 600 g must be used. These guinea-pigs must be in good health at the time of injection of the tuberculin. Not less than eight guinea-pigs shall be used for each assay. The assay should be made not less than one month after sensitization.    (aa)  For the assay of bovine tuberculins, guinea-pigs shall be sensitized by one of the following methods:        1. the injection of heat-killed Mycobacterium bovis strain AN5 in oil adjuvant,               2. the injection of living Mycobacterium bovis strain AN5 in physiological saline,               3. the injection of BCG vaccine.                          (bb) For the assay of avian tuberculins guinea-pigs shall be sensitized by injection of 2 mg of heat-killed avian-type tubercular bacilli suspended in 0 75 ml of sterile liquid paraffin or by the injection of live avian-type tubercular bacilli in physiological saline. The avian-type strain D4 must be used for this purpose.           (cc) Each tuberculin under test shall be assayed against the appropriate standard tuberculin by an intradermal assay using groups of guinea-pigs suitably sensitized.  The hair shall be clipped from both sides of each guinea-pig. The assay shall be carried out by comparing the reactions induced by a series of intracutaneous injections of doses of not more than 0 72 ml of dilutions of the standard tuberculin in isotonic buffered saline solution containing Tween 80, 0 70005 %, with a corresponding series of injections of the tuberculin under test. Dilutions shall be arranged in geometric series, and injected into guinea-pigs according to a randomized Latin square design (four sites on each side of an eight-point assay is used). The diameters of the reactions at each site should be measured and recorded after 24 to 28 hours.  For each sample of tuberculin under test, an estimate of relative potency against the appropriate standard and its fiducial limits shall be made by statistical methods, using the diameters of the reactions and the logarithms of the doses as metameters. The bovine tuberculin under test is of acceptable potency if its estimated potency guarantees per bovine dose 2 000 Community tuberculin units (± 25 %) in cattle. The potency of each tuberculin under test shall be expressed as appropriate in Community tuberculin units or international units per ml.   (b) Potency testing on cattle  Periodic potency testing of bovine tuberculins may be carried out on naturally or artificially infected tuberculous cattle. These potency tests, on groups of tuberculous cattle, shall be carried out by intradermal four or six-point assay of the tuberculin under test against the appropriate standard and the potency of the tuberculin shall be estimated by statistical methods as in the guinea-pig assay.                 26. The following requirements shall apply to the labelling of tuberculin containers and packages:  The label on the containers and the label on the package shall state:      - the name of the preparation,           - for liquid preparations, the total volume in the container,           - the number of Community or international units per ml or per mg,           - the manufacturer's name,           - the batch number,           - the nature and quantity of the reconstituting liquid for the freeze-dried preparation.             The label on the container or the label on the package shall state:      - the expiry date,           - the conditions of storage,            - the name and, if possible, the proportions of any added substance,           - the strain of bacillus from which the tuberculin has been made.                  27. Community laboratories designated in accordance with Article 3 will be made responsible for the additional examination of routine issue field tuberculins used in the Member States to ensure that the potency of each of these tuberculins is adequate in relation to the appropriate Community standard tuberculin. These examinations must be carried out, in tuberculous bovines, in suitably sensitized guinea-pigs and by appropriate chemical tests.       28. The following shall be recognized as official intradermal tuberculin tests:      (a) The single intradermal test - this test requires a single injection of bovine tuberculin.           (b) The intradermal comparative test - this test requires one injection of bovine tuberculin and one injection of avian tuberculin given simultaneously.                  29. The dose of tuberculin injected shall be:      1. not less than 2 000 CTU of bovine tuberculin;           2. not less than 2 000 IU of avian tuberculin.  The volume of each injection dose shall not exceed 0 72 ml.       30. Tuberculin tests shall be carried out by injecting tuberculin(s) into the skin of the neck. The injection sites shall be situated at the border of the anterior and middle thirds of the neck. When both avian and bovine tuberculins are injected in the same animal, the site for injection of avian tuberculins shall be about 10 cm from the crest of the neck and the site for the injection of bovine tuberculin about 12 75 cm lower on a line roughly parallel with the line of the shoulder or on different sides of the neck ; in young animals in which there is not room to separate the sites sufficiently on one side of the neck, one injection shall be made on each side of the neck at identical sites in the centre of the middle third of the neck.       31. The technique of tuberculin testing and interpretation of reactions shall be as follows:      (a) Technique:  Injection sites shall be clipped and cleansed. A fold of skin within each clipped area shall be taken between the forefinger and thumb and measured with calipers and recorded. A short sterile needle, bevel edge outwards, with graduated syringe charged with tuberculin attached shall be inserted obliquely into the deeper layers of the skin. The dose of tuberculin shall then be injected. A correct injection shall be confirmed by palpating a small pealike swelling at each site of injection. The skin-fold thickness of each injection site shall be remeasured 72 hours after injection and recorded.           (b) Interpretation of reactions:  The interpretation of reactions shall be based on clinical observations and the recorded increases(s) in skin-fold thickness at the sites of injection 72 hours after injection of tuberculin(s).    (ba)  Negative reaction : If only limited swelling is observed, with an increase of not more than 2 mm in the thickness of the fold of skin without clinical signs such as diffuse or extensive oedema, exudation, necrosis, pain or inflammation of the lymphatic ducts in that region or of the lymph nodes. (bb)  Inconclusive reaction : If no clinical signs such as mentioned in (ba) are observed and if the increase in skin-fold thickness is more than 2 mm and less than 4 mm. (bc)  Positive reaction : If clinical signs such as mentioned in (ba) are observed or there is an increase of 4 mm or more in the thickness of the fold of skin at the injection site.                   32. The interpretation of official intradermal tuberculin tests shall be as follows:      (a) single intradermal test: >PIC FILE= "T0013195">   Animals inconclusive to the single intradermal test shall be subjected to another test after a minimum of 42 days.  Animals which are not negative to this second test shall be deemed to be positive to the test.  Animals positive to the single intradermal test may be subjected to an intradermal comparative test;           (b) intradermal comparative test for the establishment and maintenance of officially tuberculosisfree herd status: >PIC FILE= "T0013196">   Animals inconclusive to the intradermal comparative test shall be subjected to another test after a minimum of 42 days. Animals which are not negative to this second test shall be deemed to be positive to the test;           (c) officially tuberculosis-free herd status may be suspended until such time as the status of the following animals is resolved:        1. animals which have been deemed to be inconclusive to the single intradermal tuberculin test;               2. animals which have been deemed to be positive to the single intradermal tuberculin test but are awaiting retest with an intradermal comparative test;               3. animals which have been deemed to be inconclusive to the intradermal comparative test.                                 33. Animals destined for intra-Community trade must be subjected to a single intradermal test within 30 days prior to movement. Any animal which shows an increase in skin-fold thickness greater than 2 mm or the presence of clinical signs must not be entered into intra-Community trade.  Animals from herds referred to in 32 (c) shall not be permitted to enter intra-Community trade until such time as the health status of the animals referred to therein has been clarified."