CELEX: 52001GC0618
Language: en
Date: 2007-01-17
Title: Draft Commission Decision of […] on additional guarantees in intra-Community trade of pigs relating to Aujeszky's disease and criteria to provide information on this disease (…/…/EC) (codified version)

EN

|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        C(2006)

                                                                      Draft

                                                               COMMISSION DECISION

                                                                      of […]

   on additional guarantees in intra-Community trade of pigs relating to Aujeszky's disease and criteria to provide information on this disease

                                                                     (…/…/EC)

                                                                (Codified version)

                                            ê 2001/618/EC (adapted)

                                                                      Draft

                                                               COMMISSION DECISION

                                                                      of […]

 on additional guarantees in intra-Community trade of pigs relating to Aujeszky's disease Ö and Õ criteria to provide information on this disease

                                                     (notified under document number C(…) …)
                                                            (Text with EEA relevance)

                                                                     (…/…/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade  in  bovine  animals  and
swine[1], and in particular Article 8, Article 9(2) and Article 10(2) thereof,

Whereas:

                                            ê 

   1) Commission Decision 2001/618/EC of 23 July 2001 on additional guarantees in intra-Community trade of pigs relating to  Aujeszky's  disease,
      criteria to provide information on this disease and repealing Decisions 93/24/EEC and 93/244/EEC[2] has been substantially amended  several
      times[3]. In the interests of clarity and rationality the said Decision should be codified.

                                            ê 2001/618/EC Recital 3

   2) The International Office of Epizootic Diseases (OIE) is the international organisation designated under the Agreement on the Application of
      Sanitary and Phytosanitary Measures in application of GATT 1994 which is responsible for the establishment of international  animal  health
      rules for trade in animals and animal products. These rules are published in the International Animal Health Code.

                                            ê 2001/618/EC Recital 4 (adapted)

   3) The chapter of the International Animal Health Code on Aujeszky's disease has been substantially amended.

                                            ê 2001/618/EC Recital 5

   4) It is appropriate to modify the additional guarantees required in intra-Community trade of pigs in relation to Aujeszky's disease in  order
      to ensure their consistency with the international rules on this disease and better control in the Community.

                                            ê 2001/618/EC Recital 6

   5) Criteria must be established on the information to be provided by the Member States on Aujeszky's disease, in accordance with Article 8  of
      Directive 64/432/EEC.

                                            ê 2001/618/EC Recital 8 (adapted)

   6) The measures provided for in this Decision are in accordance with the opinion of the Ö Standing Committee on  the  Food  Chain  and  Animal
      Health Õ,

                                            ê 2001/618/EC

HAS ADOPTED THIS DECISION:

                                                                    Article 1

The dispatching of pigs intended for breeding or production destined for the Member States or regions free of Aujeszky's disease listed in  Annex
I and coming from any other Member State or region not listed in that Annex is authorised subject to the following conditions:

                                            ê 2001/618/EC (adapted)

Ö (1) Õ     Aujeszky's disease must be compulsorily notifiable in the Member State of origin;

Ö (2) Õ     a plan for the control and eradication of Aujeszky's disease, fulfilling  the  criteria  laid  down  in  Article  9(1)  of  Directive
       64/432/EEC, must be in place in the Member State or regions of origin under  the  supervision  of  the  competent  authority.  Appropriate
       measures on pig transport and movements must be in place according to this plan for preventing a spread of disease between holdings  of  a
       different status;

Ö (3) Õ     with regard to the holding of origin of the pigs:

       Ö (a) Õ    no clinical, pathological or serological evidence of Aujeszky's disease has been recorded in the  previous  12  months  in  the
           holding in question Ö ; Õ

       Ö (b) Õ    no clinical, pathological or serological evidence of Aujeszky's disease has been recorded in the  previous  12  months  in  the
           holdings located in an area of 5 km surrounding the holding of origin of the pigs; however, this provision shall  not  apply  if,  in
           these latter holdings, disease monitoring and eradication measures have been regularly applied under the supervision of the competent
           authority and in accordance with the eradication plan referred to in point Ö (2) Õ, and these measures have effectively prevented any
           spread of disease to the holding in question Ö ; Õ

       Ö (c) Õ    vaccination against Aujeszky's disease has not been carried out for at least 12 months Ö ; Õ

       Ö (d) Õ    the pigs have been subjected on at least two occasions at Ö an interval Õ of at least four months to a serological  survey  for
           the presence of ADV-gE or ADV-gB or ADV-gD antibody or to the whole Aujeszky's disease virus. This survey must have shown the absence
           of Aujeszky's disease and that vaccinated pigs have been free from gE antibodies Ö ; Õ

       Ö (e) Õ    no pigs have been introduced from holdings of a lower animal health status as regards Aujeszky's disease  in  the  previous  12
           months, unless they have been tested for Aujeszky's disease with negative results;

Ö (4) Õ     the pigs to be moved:

       Ö (a) Õ    have not been vaccinated Ö ; Õ

       Ö (b) Õ    have been kept isolated in accommodation approved by the competent authority, during the 30 days prior to movement, and in such
           a way that any risk of spreading Aujeszky's disease to these pigs is prevented Ö ; Õ

       Ö (c) Õ    must have lived in the holding of origin or in a holding of an equivalent status since birth, and have remained in the  holding
           of origin for at least:

           (i)   30 days, in the case of pigs intended for production;

           (ii)  90 days, in the case of pigs intended for breeding Ö ; Õ

       Ö (d) Õ    have been subjected with negative results to at least two serological tests for  ADV-gB  or  ADV-gD  or  the  whole  Aujeszky's
           disease virus, at a distance of at least 30 days between each test. However,  in  case  of  pigs  less  than  four  months  old,  the
           serological test for ADV-gE may also be used. Sampling for the last test must be performed within 15  days  prior  to  shipment.  The
           number of pigs tested in the isolation unit must be sufficient to detect:

                                            ê 2001/618/EC

           (i)   2% seroprevalence with 95% confidence in the isolation unit in case of pigs intended for production;

           (ii)  0.1% seroprevalence with 95% confidence in the isolation unit in case of pigs intended for breeding.

            However, the first of the two tests shall not be necessary if:

                                            ê 2001/618/EC (adapted)

           (i)   in the framework of the plan referred to in point Ö (2) Õ , a serological survey has been carried out in the holding of  origin
                between 45 and Ö 170 Õ days prior to shipment, demonstrating the absence of Aujeszky's disease  antibodies  and  that  vaccinated
                pigs have been free from gE antibodies;

                                            ê 2001/618/EC

           (ii)  the pigs to be moved have lived in the holding of origin since birth;

           (iii) no pigs have moved on to the holding of origin while the pigs to be moved have been kept in isolation.

                                                                    Article 2

The dispatching of pigs intended for slaughter destined for the Member States or regions free of Aujeszky's disease listed in Annex I and  coming
from any other Member State or region not listed in that Annex, is authorised subject to the following conditions:

                                            ê 2001/618/EC (adapted)

Ö (1) Õ     Aujeszky's disease must be compulsorily notifiable in the Member State of origin;

Ö (2) Õ     a plan for the control and eradication of Aujeszky's disease is in place in the Member State  or  regions  of  origin  of  the  pigs,
       fulfilling the criteria laid down in Article 1 Ö (2) Õ;

Ö (3) Õ     all the pigs in question must be transported directly to the slaughterhouse of destination and either:

       Ö (a) Õ    they come from a holding which fulfils the conditions laid down in Article 1 Ö (3); Õ or

       Ö (b) Õ    they have been vaccinated against Aujeszky's disease at least 15 days prior to their shipment and come from a holding of origin
           where:

           (i)   in the framework of the plan referred to in point Ö (2) Õ , Aujeszky's disease monitoring and eradication  measures  have  been
                regularly applied under the supervision of the competent authority for the previous 12 months;

           (ii)  they had remained for at least 30 days before dispatch and where no clinical or pathological evidence of this disease has  been
                detected at the moment of completion of the health certificate referred to in Article 7Ö ; Õ or

       Ö (c) Õ    they have not been vaccinated and they proceed from a holding where:

           (i)   in the framework of the plan referred to in point Ö (2) Õ , Aujeszky's disease monitoring and eradication  measures  have  been
                regularly applied under the supervision of the competent authority in the previous 12 months and  no  clinical,  pathological  or
                serological evidence of Aujeszky's disease has been recorded in the previous six months;

           (ii)  vaccination against Aujeszky's disease and introduction of vaccinated pigs have been  forbidden  by  the  competent  authority,
                since the holding is in the process of reaching the highest status as regards  Aujeszky's  disease  in  accordance  to  the  plan
                referred to in point Ö (2) Õ ;

                                            ê 2001/618/EC

           (iii) they have lived for at least 90 days before dispatch.

                                                                    Article 3

Pigs intended for breeding destined for the Member States  or  regions  listed  in  Annex  II,  where  approved  Aujeszky's  disease  eradication
programmes are in place, must either:

                                            ê 2001/618/EC (adapted)

Ö (1) Õ     come from Member States or regions listed in Annex I; or

Ö (2) Õ     come from:

       Ö (a) Õ    Member States or regions listed in Annex II Ö ; Õ and

       Ö (b) Õ    a holding which fulfils the requirements of Article 1 Ö (3) Õ ; or

Ö (3) Õ     fulfil the following conditions:

       Ö (a) Õ    Aujeszky's disease must be compulsorily notifiable in the Member State of origin Ö ; Õ

       Ö (b) Õ    a plan for the control and eradication of Aujeszky's disease is in place in the  Member  States  or  region  of  origin,  which
           fulfils the criteria laid down in Article 1 Ö (2); Õ

       Ö (c) Õ    no clinical, pathological or serological evidence of Aujeszky's disease has been recorded in the  previous  12  months  in  the
           holding of origin of the pigs in question Ö ; Õ

       Ö (d) Õ    the pigs must have been isolated in accommodation approved by the competent authority for the  30  days  immediately  prior  to
           movement and kept isolated in such a way that any risk of spreading of Aujeszky's disease is prevented Ö ; Õ

       Ö (e) Õ    the pigs must have been subjected, with negative results, to a serological test for the presence of gE antibodies. Sampling for
           the last test must be performed within 15 days prior to shipment. The  number  of  pigs  tested  must  be  sufficient  to  detect  2%
           seroprevalence with 95% confidence in these pigs Ö ; Õ

       Ö (f) Õ    the pigs must have lived in the holding of origin or in a holding of an equivalent status since birth, and have remained in the
           holding of origin for at least 90 days.

                                            ê 2001/618/EC

                                                                    Article 4

Pigs intended for production destined for the Member States or regions  listed  in  Annex  II,  where  approved  Aujeszky's  disease  eradication
programmes are in place, must either:

                                            ê 2001/618/EC (adapted)

Ö (1) Õ     come from Member States or regions listed in Annex I; or

Ö (2) Õ     come from:

       Ö (a) Õ    Member States or regions listed in Annex II Ö ; Õ and

       Ö (b) Õ    a holding which fulfils the requirements of Article 1 Ö (3) Õ ; or

Ö (3) Õ     fulfil the following conditions:

       Ö (a) Õ    Aujeszky's disease must be compulsorily notifiable in the Member State of origin Ö ; Õ

       Ö (b) Õ    a plan for the control and eradication of Aujeszky's disease is in place in the  Member  States  or  region  of  origin,  which
           fulfils the criteria laid down in Article 1 Ö point (2); Õ

       Ö (c) Õ    no clinical, pathological or serological evidence of Aujeszky's disease has been recorded in the  previous  12  months  in  the
           holding of origin of the pigs in question Ö ; Õ

       Ö (d) Õ    a serological survey for Aujeszky's disease, demonstrating its absence  and  that  vaccinated  pigs  have  been  free  from  gE
           antibodies, has been carried out in the holding of origin and between 45 and 170 days prior to shipment Ö ; Õ

       Ö (e) Õ    the pigs must either have lived in the holding of origin since birth or have remained in such holdings for  at  least  30  days
           after introduction from a holding of an equivalent status, where a serological survey equivalent to the one referred  to  in  Ö point
           (d) Õ has been carried out.

                                            ê 2001/618/EC (adapted)

                                                                    Article 5

The serological tests carried out to monitor or detect Aujeszky's disease in pigs in accordance with this Decision must meet the  standards  laid
down in Annex III.

                                                                    Article 6

Without prejudice to Article 10(3) of Directive 64/432/EEC, information Ö on Õ the occurrence of Aujeszky's disease,  including  details  of  the
monitoring and eradication programmes in operation in the Member States listed in Annex II and in the other Member States or regions  not  listed
in that Annex where monitoring and eradication programmes are in place, must be provided at least annually by each  Member  State  in  accordance
with the uniform criteria laid down in Annex IV.

                                                                    Article 7

1.    Without prejudice to the provisions laid down in Community legislation concerning health certificates, before the completion,  for  animals
       of the porcine species destined for Member States or regions listed in Annex I or II, of section C of the health certificate  required  by
       Directive 64/432/EC, the official veterinarian shall ascertain:

       (a)  the status of the holding and of the Member State or region of origin of the pigs in question as regards Aujeszky's disease;

       (b)  in case the pigs are not originating from a Member State or a region free of the disease, the status of the holding and of the Member
           State or regions of destination for the pigs in question as regards Aujeszky's disease;

       (c)  the compliance of the pigs in question with the conditions laid down in this Decision.

2.    For animals of the porcine species destined for Member States or regions listed in Annex I or II, the certification under  paragraph  4  of
       Section C of the health certificate referred to in paragraph 1 shall be completed and supplemented as follows:

       (a)  in the first indent, after the word «disease:» the word «Aujeszky» must be added;

       (b)  in the second indent, reference shall be made to this Decision. In the same line, the number of the Article of this  Decision,  which
           is relevant for the pigs in question, shall be quoted between brackets.

                                                                    Article 8

Member States must ensure that when pigs destined for Member States or regions listed in Annex I or II are transported, they shall  not  come  in
contact with pigs of different or unknown status, as regards Aujeszky's disease, during transport or transit.

                                            ê 

                                                                    Article 9

Decision 2001/618/EC is repealed.

References to the repealed Decision shall be construed as references to this Decision and shall be read in accordance with the correlation  table
in Annex VI.

                                            ê 2001/618/EC Art. 11

                                                                    Article 10

This Decision is addressed to the Member States.

Done at Brussels, […]

      For the Commission
      […]
      Member of the Commission

                                            ê 2005/768/EC

                                                                     ANNEX I

                         Member States or regions thereof free of Aujeszky's disease and where vaccination is prohibited

|ISO code          |Member State                |Regions                                                                                         |
|AT                |Austria                     |Whole territory.                                                                                |
|CY                |Cyprus                      |Whole territory.                                                                                |
|CZ                |Czech Republic              |All regions.                                                                                    |
|DE                |Germany                     |All regions.                                                                                    |
|DK                |Denmark                     |All regions.                                                                                    |
|FI                |Finland                     |All regions.                                                                                    |
|FR                |France                      |The Departments of Ain, Aisne, Allier, Alpes-de-Haute-Provence, Alpes-Maritimes, Ardèche,       |
|                  |                            |Ardennes, Ariège, Aube, Aude, Aveyron, Bas-Rhin, Bouches-du-Rhône, Calvados, Cantal, Charente,  |
|                  |                            |Charente-Maritime, Cher, Corrèze, Côte-d'Or, Creuse, Deux-Sèvres, Dordogne, Doubs, Drôme,       |
|                  |                            |Essonne, Eure, Eure-et-Loir, Gard, Gers, Gironde, Hautes-Alpes, Hauts-de-Seine, Haute-Garonne,  |
|                  |                            |Haute-Loire, Haute-Marne, Hautes-Pyrénées, Haut-Rhin, Haute-Saône, Haute-Savoie, Haute-Vienne,  |
|                  |                            |Hérault, Indre, Indre-et-Loire, Isère, Jura, Landes, Loire, Loire-Atlantique, Loir-et-Cher,     |
|                  |                            |Loiret, Lot, Lot-et-Garonne, Lozère, Maine-et-Loire, Manche, Marne, Mayenne, Meurthe-et-        |
|                  |                            |Moselle, Meuse, Moselle, Nièvre, Oise, Orne, Paris, Pas-de-Calais, Pyrénées-Atlantiques,        |
|                  |                            |Pyrénées-Orientales, Puy-de-Dôme, Réunion, Rhône, Sarthe, Saône-et-Loire, Savoie,               |
|                  |                            |Seine-et-Marne, Seine-Maritime, Seine-Saint-Denis, Somme, Tarn, Tarn-et-Garonne, Territoire de  |
|                  |                            |Belfort, Val-de-Marne, Val-d'Oise, Var, Vaucluse, Vendée, Vienne, Vosges, Yonne, Yvelines       |
|LU                |Luxembourg                  |All regions.                                                                                    |
|SE                |Sweden                      |All regions.                                                                                    |
|UK                |United Kingdom              |All regions in England, Scotland and Wales.                                                     |

                                                               ___________________

                                                                     ANNEX II

                        Member States or regions thereof where approved Aujeszky's disease control programmes are in place

|ISO code              |Member State                |Regions                                                                                     |
|BE                    |Belgium                     |Whole territory.                                                                            |
|FR                    |France                      |The departments of Côtes-d’Armor, Finistère, Ille-et-Vilaine, Morbihan and Nord.            |
|IT                    |Italy                       |The Province of Bolzano.                                                                    |
|NL                    |Netherlands                 |Whole territory.                                                                            |

                                                               ___________________

                                            ê 2001/618/EC

                                                                    ANNEX III

   Standards for Aujeszky's disease serological tests — Protocol for the enzyme linked immunosorbent assay (ELISA) for detecting antibodies to
           Aujeszky's disease virus (whole virus), to glycoprotein B (ADV-gB), to glycoprotein D (ADV-gD) or to glycoprotein E (ADV-gE)

1.    The institutes listed in paragraph 2(d) shall evaluate Elisa ADV-gE tests and kits against the criteria in paragraph  2(a),  (b)  and  (c).
       The competent authority in each Member State shall ensure that only Elisa ADV-gE kits that meet these standards shall be  registered.  The
       examinations listed in 2(a) and (b) must be carried out prior to approval of the  test  and  the  examination  in  2(c),  at  least,  must
       thereafter be carried out on each batch.

2.    Standardisation, sensitivity and specificity of the test.

       (a)  The sensitivity of the test must be of such a level that the following Community reference sera are scored positive:

              – Community reference serum ADV 1 at 1:8 dilution,

              – Community reference serum ADV-gE A,

              – Community reference serum ADV-gE B,

              – Community reference serum ADV-gE C,

              – Community reference serum ADV-gE D,

              – Community reference serum ADV-gE E,

              – Community reference serum ADV-gE F.

       (b)  The specificity of the test must be of such a level that the following Community reference sera are scored negative:

              – Community reference serum ADV-gE G,

              – Community reference serum ADV-gE H,

              – Community reference serum ADV-gE J,

              – Community reference serum ADV-gE K,

              – Community reference serum ADV-gE L,

              – Community reference serum ADV-gE M,

              – Community reference serum ADV-gE N,

              – Community reference serum ADV-gE O,

              – Community reference serum ADV-gE P,

              – Community reference serum ADV-gE Q.

                                            ê 2001/618/EC (adapted)

       (c)  For batch control, Community reference serum ADV 1 must be scored positive at 1:8 dilution and one of the  Community  reference  sera
           from ADV-gE G to ADV-gE Q, as listed in point (b), must be scored negative.

                                            ê 2001/618/EC

            For batch control of ADV-gB and ADV-gD kits, Community reference serum ADV 1 must be scored positive  at  the  dilution  of  1:2  and
           Community reference serum Q referred to in (b) should be scored negative.

       (d)  The institutes listed below will, in addition, be responsible for checking the quality of the ELISA method in each Member State,  and
           in particular for producing and standardising national reference sera according to the Community reference sera:

              – Belgium — Centre de Recherches vétérinaires et agrochimiques, 1180 Bruxelles,

              – Denmark — Statens veterinære Institut for Virusforskning, Lindholm, 4771 Kalvehave,

              – Germany — Bundesforschungsanstalt für Viruskrankheiten der Tiere, 16868 Wusterhausen,

              – Greece — Veterinary Institute of Infectious and Parasitic Diseases, 15310 Ag. Paraskevi,

              – Spain — Laboratorio Central de Veterinaria de Algete, Madrid,

              – France — École nationale vétérinaire, Alfort, 94704 Maisons-Alfort,

              – Ireland — Veterinary Research Laboratory, Abbotstown, Castleknock, Dublin 15,

              – Italy — Istituto Zooprofilattico Sperimentale della Lombardia a dell'Emilia-Romagna, Brescia,

              – Luxembourg — Laboratoire de Médecine Vétérinaire de l'État, 1020 Luxembourg,

              – The Netherlands — Instituut voor Veehouderij en Diergezondheid (ID-DLO), 8200 AB Lelystad,

              – Austria — Bundesanstalt für veterinärmedizinische Untersuchungen in Mödling, 2340 Mödling,

              – Portugal — Laboratório Nacional de Investigação Veterinária, 1500 Lisboa,

              – Finland — Eläinlääkintä- ja elintarviketutkimuslaitos, 00581 Helsinki,

              – Sweden — Statens veterinärmedicinska anstalt, 75189 Uppsala,

              – United Kingdom — Veterinary Laboratory Agency, New Haw, Weybridge, Surrey KT15 3NB.

                                                               ___________________

                                                                     ANNEX IV

                                                                      [pic]

                                                               ___________________

                                            é

                                                                     ANNEX V

                                                 Repealed Decision with its successive amendments

|Commission Decision 2001/618/EC                                     |                                                                    |
|(OJ L 215, 9.8.2001, p. 48)                                         |                                                                    |
|Commission Decision 2001/746/EC                                      |                                                              |
|(OJ L 278, 23.10.2001, p. 41)                                        |                                                              |
|Commission Decision 2001/905/EC                                      |                                                              |
|(OJ L 335, 19.12.2001, p. 22)                                        |                                                              |
|Commission Decision 2002/270/EC                                      |                                                              |
|(OJ L 93, 10.4.2002, p. 7)                                           |                                                              |
|Commission Decision 2003/130/EC                                      |                                                              |
|(OJ L 52, 27.2.2003, p. 9)                                           |                                                              |
|Commission Decision 2003/575/EC                                      |                                                              |
|(OJ L 196, 2.8.2003, p. 41)                                          |                                                              |
|Commission Decision 2004/320/EC                                      |only Article 2                                                |
|(OJ L 102, 7.4.2004, p.75)                                           |                                                              |
|Commission Decision 2005/768/EC                                      |                                                              |
|(OJ L 290, 4.11.2005, p.27)                                          |                                                              |

                                                                     ________

                                                                     ANNEX VI

                                                                Correlation Table

|Decision 2001/618/EC                                                |This Decision                                                       |
|Article 1(a) and (b)                                                |Article 1 points 1 and 2                                            |
|Article 1(c) first to fifth indent                                  |Article 1 point 3 (a) to (e)                                        |
|Article 1(d) first to fourth indent                                 |Article 1 point 4 (a) to (d)                                        |
|Article 2(a) and (b)                                                |Article 2 points 1 and 2                                            |
|Article 2(c) first to third indent                                  |Article 2 point 3 (a) to (c)                                        |
|Article 3(a)                                                        |Article 3 point 1                                                   |
|Article 3(b) first and second indent                                |Article 3 point 2 (a) and (b)                                       |
|Article 3(c) first to sixth indent                                  |Article 3 point 3 (a) to (f)                                        |
|Article 4(a)                                                        |Article 4 point 1                                                   |
|Article 4(b) first and second indent                                |Article 4 point 2 (a) and (b)                                       |
|Article 4(c) first to fifth indent                                  |Article 4 point 3 (a) to (e)                                        |
|Articles 5 to 8                                                     |Articles 5 to 8                                                     |
|Article 9                                                           |_                                                                   |
|Article 10                                                          |_                                                                   |
|_                                                                   |Article 9                                                           |
|Article 11                                                          |Article 10                                                          |
|Annexes I – IV                                                      |Annexes I – IV                                                      |
|_                                                                   |Annex V                                                             |
|_                                                                   |Annex VI                                                            |

                                                                    __________

                                                             -----------------------
[1]   OJ P 121, 29.7.1964, p. 1977/64. Ö Directive as last amended by Commission Regulation (EC) No 1226/2002 (OJ L 179, 9.7.2002, p. 13).Õ
[2]   OJ L 215, 9.8.2001, p. 48. Decision as last amended by Decision 2005/768/EC (OJ L 290, 4.11.2005, p. 27).
[3]   See Annex V.