Criteria for programmes to control rabies

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«ANNEX III

Criteria for programmes to control rabies

Programmes to control rabies shall contain at least:

(a) the criteria referred to in points 1 to 7 of Annex 1;

(b) detailed information regarding the region or regions in which the oral immunization of foxes is to take place and its natural limits. This region or these regions must cover at least 6 000 km2 or the total national area of a Member State and may include adjacent areas of a third country;

(c) detailed information regarding the vaccines to be used, the distribution system, the density and frequency of bait-laying;

(d) where appropriate, all details and the cost and purpose of schemes to conserve or preserve flora and fauna undertaken by voluntary organizations on the territory covered by these projects.»

  1. The Council, acting by a qualified majority on a proposal from the Commission, shall designate a specific institute to establish the criteria necessary for the standardization of the serological tests and shall decide on its responsibilities.
  2. Member States shall ensure that the costs of applying the serological test are borne by the importers.

 

Article 10a

 

As regards rabies and in accordance with the procedure laid down in Article 26, following presentation of the appropriate grounds, Articles 9 and 10 shall be amended to take account of the situation in Finland and Sweden in order to apply to them the same provisions as applicable to Member States in an equivalent situation.

 

Article 11

 

  1. The Member States shall ensure that, without prejudice to the decisions to be taken in implementation of Articles 21 and 23, only semen, ova and embryos meeting the conditions laid down in paragraphs 2, 3, 4 and 5 are the subject of trade.
  2. Semen of the ovine, caprine and equine species must, without prejudice to any criteria to be complied with for the entry of equids in stud books for certain specific breeds:

— have been collected, processed and stored with a view to artificial insemination in a centre approved from the health point of view in accordance with Annex D(I), or, in the case of ovine and caprine animals by way of derogation from the above, in a holding satisfying the requirements of Directive 91/68/EEC,

— have been collected from animals meeting the conditions laid down in Annex D(II),

— have been collected, processed, preserved, stored and transported in accordance with Annex D(III),

— have been accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined in accordance with the procedure referred to in Article 26.

  1. Ova and embryos of the ovine, caprine, equine and porcine species must:

— have been removed from donor females meeting the conditions laid down in Annex D(IV) by a collection team or have been produced by a production team approved by the competent authority of the Member State and satisfying the conditions to be established in Annex D(I) in accordance with the procedure referred to in Article 26,

— have been collected, processed and preserved in an appropriate laboratory, stored and transported in accordance with Annex D(III),

— be accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined in accordance with the procedure referred to in Article 26.

Semen used for the insemination of donor females must comply with the provisions of paragraph 2 in the case of sheep, goats and equids and with the provisions of Directive 90/429/EEC for swine.

Any additional guarantees may be determined in accordance with the procedure referred to in Article 26.

  1. The approved centres referred to in the first indent of paragraph 2 and the approved teams referred to in the first indent of paragraph 3 shall be registered by the competent authority of the Member State concerned, each centre and team being given a veterinary registration number.

Each Member State shall draw up and keep up to date a list of those approved centres and teams and their veterinary registration numbers and shall make it available to the other Member States and to the public.

Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedure referred to in Article 26.

  1. The animal health requirements and the specimen health certificates applicable to semen, ova and embryos of species not mentioned in paragraphs 2 and 3 shall be established in accordance with the procedure referred to in Article 26.

Pending the establishment of animal health requirements and specimen health certificates for trade in such semen, ova and embryos, national rules shall continue to apply.

 

Article 12

 

  1. The rules on checks established by Directive 90/425/EEC shall apply, in particular as regards the organization of and follow-up to the checks to be carried out, to the animals, semen, ova and embryos covered by this Directive which are accompanied by a health certificate. Other animals must come form holdings subject to the principles of that Directive as regards checks on origin and destination.
  2. Article 10 of Directive 90/425/EEC shall apply to animals, semen, ova and embryos covered by this Directive.
  3. For the purpose of trade, Article 12 of Directive 90/425/EEC shall extend to dealers who keep, on a permanent or occasional basis, animals referred to in Articles 7, 9 and 10.
  4. The communication of the place of destination as provided for in Article 4(2) of Directive 90/425/EEC shall, in respect of animals, semen, ova or embryos accompanied by a health certificate in accordance with this Directive, take place using the Animo system.
  5. Without prejudice to the specific provisions of this Directive, the competent authority shall, where it is suspected that this Directive has not been complied with or there is doubt as to the health of the animals or the quality of the semen, ova and embryos referred to in Article 1, carry out any checks it deems appropriate.
  6. Member States shall take the appropriate administrative or penal measures to penalize any infringement of this Directive, in particular where it is found that the certificates or documents drawn up do not correspond to the actual state of the animals referred to in Article 1, that the identification of the animals or the marking of the semen, ova and embryos in question does not comply with this Directive or that the animals or products in question have not undergone the checks provided for in this Directive.

 

Article 13

 

  1. Trade in animals of species susceptible to the diseases listed in Annex A or to the diseases listed in Annex B, where the Member State of destination applies the guarantee provided for in Articles 14 and 15, and trade in semen, ova or embryos of such animals consigned to and from bodies, institutes or centres approved in accordance with Annex C shall be subject to production of a transport document corresponding to the specimen in Annex E. This document, which must be completed by the veterinarian responsible for the body, institute or centre of origin, must specify that the animals, semen, ova or embryos come from a body, institute or centre approved in accordance with Annex C and must accompany them during transport.
  2. (a) To be approved, bodies, institutes or centres shall, as regards notifiable diseases, submit to the competent authority of the Member State all relevant supporting documents relating to the requirements contained in Annex C.

(b) After receiving the file relating to the request for approval or for renewal of approval, the competent authority shall examine it in the light of the information it contains and, where appropriate, of the results of the tests conducted on the spot.

(c) The competent authority shall withdraw approval in accordance with point 3 of Annex C.

(d) All approved bodies, institutes and centres shall be registered and issued with an approval number by the competent authority.

Each Member State shall draw up and keep up to date a list of approved bodies, institutes and centres and their approval numbers and shall make it available to the other Member States and to the public.

Detailed rules for the uniform application of this point may be adopted in accordance with the procedure referred to in Article 26.

(e) Sweden shall have a period of two years from the date of entry into force of the Accession Treaty to implement the measures laid down regarding bodies, institutes and centres.

 

Article 14

 

  1. Where a Member State draws up or has drawn up, either directly or through the breeders, a voluntary or compulsory control or monitoring programme for one of the diseases referred to in Annex B, it may present the programme to the Commission outlining in particular:

— the distribution of the disease in its territory,

— whether the disease is notifiable,

— reasons for undertaking the programme, taking account of its cost-effectiveness and the significance of the disease,

— the geographical area in which the programme is to be implemented,

— the status categories to be applied to establishments, the requirements for each species when being introduced into a holding and the test procedures to be used,

— the programme monitoring procedures, including the extent of the breeders’ involvement in implementing the control or monitoring programme,

— the action to be taken if, for any reason, a holding loses its status,

— the measures to be taken if the results of the tests carried out under the programme are positive,

— the non-discriminatory nature of trade in the territory of the Member State concerned with respect to intra-Community trade.

  1. The Commission shall examine the programmes presented by the Member States. Programmes may be approved under the procedure provided for in Article 26 in compliance with the criteria laid down in paragraph 1. Under the same procedure, the additional guarantees, general or limited, which may be required in trade, shall be defined at the same time or at the latest three months after presentation of the programmes. Such guarantees must not exceed those which the Member State implements nationally.
  2. Programmes submitted by Member States may be amended or supplemented under the procedure laid down in Article 26. Under the same procedure, amendments may be made to the guarantees referred to in paragraph 2.

 

Article 15

 

  1. Where a Member State considers that its territory or part of its territory is free from one of the diseases listed in Annex B to which the animals covered by this Directive are susceptible, it shall present to the Commission appropriate supporting documentation, setting out in particular:

— the nature of the disease and the history of its occurrence in its territory,

— the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation,

— the period during which this disease was notifiable to the competent authorities,

— the period over which the surveillance was carried out,

— where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition,

— the arrangements for verifying the absence of the disease.

  1. The Commission shall examine the documentation provided for in paragraph 1 and submit to the Standing Veterinary Committee a decision approving or rejecting the plan submitted by the Member State. If the plan is accepted, the additional guarantees, general or specific, which may be required in trade shall be defined under the procedure laid down in Article 26. They must not exceed those which the Member State implements nationally.

Pending a decision, the Member State concerned may maintain in its trade dealings the relevant requirements needed in order to maintain its status.

  1. The Member State concerned shall notify the Commission of any change in the particulars specified in paragraph 1. The guarantees defined as laid down in paragraph 2 may, in the light of such notification, be amended or withdrawn under the procedure laid down in Article 26.

 

Chapter III. PROVISIONS APPLICABLE TO IMPORTS INTO THE COMMUNITY

 

Article 16

 

The conditions applicable to imports of animals, semen, ova and embryos covered by this Directive must be at least equivalent to those laid down in Chapter II.

With respect to cats, dogs and ferrets, import conditions must be at least equivalent to those provided for in points (a) to (d) of Article 10(1) and point (a) of Article 12 of Regulation (EU) No 576/2013.

In addition to the conditions referred to in the second subparagraph, dogs, cats and ferrets shall, during transport to the place of destination, be accompanied by a health certificate, which is completed and signed by an official veterinarian who shall attest that a clinical examination was carried out within 48 hours prior to the time of dispatch of the animals by a veterinarian authorised by the competent authority who has verified that at the time of the clinical examination, the animals were fit to be transported for the intended journey.

 

Article 17

 

  1. For the purposes of uniform application of Article 16, the provisions of the following paragraphs shall apply.
  2. Only animals and semen, ova and embryos referred to in Article 11 which satisfy the following requirements may be imported into the Community:

(a) they must come from a third country on a list to be drawn up in accordance with paragraph 3(a);

(b) they must be accompanied by the health certificate corresponding to a specimen to be drawn up in accordance with the procedure referred to in Article 26, signed by the competent authority of the exporting country and certifying that,

(i) the animals

— meet the additional conditions or offer the equivalent guarantees referred to in paragraph 4, and

— come from approved centres, bodies, institutes offering guarantees at least equivalent to those in Annex C;

(ii) semen, ova and embryos come from approved collection and storage centres or collection and production teams offering guarantees at least equivalent to those to be established in Annex D(I) in accordance with the procedure referred to in Article 26.

Pending the establishment of lists of third countries, approved establishments listed in point (b), animal health requirements and specimen health certificates as referred to in paragraphs (a) and (b), national rules shall continue to apply provided they are not more favourable than those laid down in Chapter II.

  1. The following shall be established:

(a) in accordance with the procedure referred to in Article 26, a list of third countries or parts of third countries able to provide Member States and the Commission with guarantees equivalent to those provided for in Chapter II in relation to animals, semen, ova and embryos;

(b) in accordance with this point, a list of approved centres or teams as referred to in the first indent of paragraph 2 of Article 11 and the first indent of paragraph 3 of that article situated in one of the third countries appearing on the list referred to in point (a) of this paragraph and for which the competent authority is able to give the guarantees provided for in Article 11(2) and (3).

The list of approved centres and teams referred to in the first subparagraph and their veterinary registration numbers shall be communicated to the Commission.

The approval of centres or teams must be immediately suspended or withdrawn by the competent authority of the third country where it no longer complies with the conditions referred to in Article 11(2) and (3) and the Commission must be immediately informed thereof.

The Commission shall provide the Member States with any new and updated lists that it receives from the competent authority of the third country in accordance with the second and third subparagraphs and shall make them available to the public for information purposes.

Detailed rules for the uniform application of this point may be adopted in accordance with the procedure referred to in Article 26;

(c) in accordance with the procedure referred to in Article 26, the specific animal health requirements, in particular for the protection of the Community from certain exotic diseases, or guarantees equivalent to those provided for in this Directive.

The specific requirements and equivalent guarantees established for third countries may not be more favourable than those provided for in Chapter II.

  1. The list provided for in paragraph 3 may include only third countrys or parts of third countries:

(a) from which imports are not prohibited:

— as a result of the existence of one of the diseases referred to in Annex A or of any other disease exotic to the Community,

— pursuant to Articles 6, 7 and 14 of Directive 72/462/EEC and Article 17 of Directive 91/495/EEC and of Directive 71/118/EEC <*> or, in the case of the other animals covered by this Directive, under a decision taken in accordance with the procedure laid down in Article 26 account being taken of their state of health;

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<*> Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (OJ No L 55, 8.3.1971, p. 23). Last amended by Directive 90/654/EEC (OJ No L 353, 17.12.1990, p. 48).

 

(b) which, in view of their legislation and the organization of their veterinary services and inspection services, the powers of such services and the supervision to which they are subject, have been recognized, in accordance with Article 3(2) of Directive 72/462/EEC, as capable of guaranteeing the implementation of their legislation in force;

(c) the veterinary services of which are able to guarantee that health requirements at least equivalent to those laid down in Chapter II are being complied with.

  1. Experts from the Commission and the Member States shall carry out on-the-spot inspections to verify whether the guarantees given by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the Community.

The experts from the Member States responsible for these inspections shall be appointed by the Commission acting on a proposal from the Member States.

These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection.

  1. Pending the organization of the inspections referred to in paragraph 5, national rules applicable to inspection in third countries shall continue to apply, subject to notification, through the Standing Veterinary Committee, of any failure to comply with the guarantees offered in accordance with paragraph 3, found during these inspections.

 

Article 18

 

  1. Member States shall ensure that the animals, semen, ova and embryos covered by this Directive are imported into the Community only if they:

— are accompanied by a certificate to be drawn up by the official veterinarian.

The specimen certificate shall, depending on the species, be drawn up under the procedure laid down in Article 26,

— have satisfied the checks required by Directives 90/675/EEC and 91/496/EEC <*>,

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<*> Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directive 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ No L 268, 24.9.1991, p. 56).

 

— have undergone, prior to shipment to Community territory, a check by an official veterinarian to ensure that the transport conditions specified in Directive 91/628/EEC <*> have been complied with, in particular as regards watering and feeding,

———————————

<*> Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC (OJ No L 340, 11.12.1991, p. 17).

 

— have, in the case of the animals referred to in Articles 5 to 10, been quarantined before being placed on the market, in accordance with detailed rules to be established under the procedure laid down in Article 26.

  1. Pending the establishment of specific rules for this Article, the national rules applicable to imports from third countries for which such requirements have not been adopted at Community level shall continue to apply, provided they are not more favourable than those laid down in Chapter II.

 

Article 19

 

The following shall be decided under the procedure laid down in Article 26:

(a) specific animal health requirements, for imports into the Community, and the nature and content of accompanying documents for animals intended for zoos, circuses, amusement parks or experimental laboratories, according to the species;

(b) additional guarantees to those provided for in respect of the various animal species covered by this Directive, to protect the Community species concerned.

 

Article 20

 

The rules laid down in Directive 97/78/EC shall apply in particular to the organisation of, and follow-up to the checks to be carried out by the Member States and the safeguard measures to be applied in accordance with the procedure referred to in Article 22 of that Directive.

Pending implementation of the decisions provided for in Article 8, point B and Article 30 of Directive 91/496/EEC, the relevant national rules for applying Article 8(1) and (2) of the said Directive shall continue to apply, without prejudice to compliance with the principles and rules referred to in paragraph 1 of this Article.

 

Chapter IV. COMMON FINAL PROVISIONS

 

Article 21

 

Any specimens of certificates applicable to trade and the animal health conditions to be met in order for it to be possible to trade in animals, semen, ova and embryos other than those covered by Article 5 to 11 shall, where the need arise, be determined under the procedure laid down in Article 26.

 

Article 22

 

The Annexes to this Directive shall, where the need arises, be amended under the procedure laid down in Article 26.

Annex B shall be re-examined before the date of entry into force of the Accession Treaty in order, in particular, to amend the list of diseases to include those to which ruminants and suidae are susceptible and those which are transmissible by ovine semen, ova and embryos.

 

Article 23

 

Under the procedure laid down in Article 26, special requirements may be laid down, if appropriate, by way of derogation from Chapter II, for the movement of circus and fairground animals and for trade in animals, semen, ova and embryos intended for zoos.

 

Article 24

 

  1. The Member States shall be authorized to subject the entry into their territory of the animals (including cage birds), semen, ova and embryos referred to in this Directive which have passed through the territory of a third country to production of a health certificate certifying compliance with the requirements of this Directive.
  2. Member States which have recourse to the possibility laid down in paragraph 1 shall inform the Commission and the other Member States within the Standing Veterinary Committee.

 

Article 25

 

The following shall be added to Annex A to Directive 90/425/EEC:

«Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(1) to Directive 90/425/EEC (OJ No L 268, 14.9.1992, p. 54).»

 

Article 26

 

  1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council <*>.

———————————

<*> OJ L 31, 1.2.2002, p. 1.

 

  1. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC <*> shall be set at three months.

———————————

<*> OJ L 184, 17.7.1999, p. 23.

 

  1. The Committee shall adopt its Rules of Procedure.

 

Article 27

 

Member States which implement an alternative control system providing guarantees equivalent to those laid down in this Directive as regards movements within their terrritory of the animals, semen, ova and embryos which it covers, may grant one another derogations from Article 6(A)(1)(f), Article 8(b) and Article 11(1)(d) on a reciprocal basis.

 

Article 28

 

Under the procedure laid down in Article 26, transitional measures may be adopted for a period of three years to facilitate the transition to the new arrangements established by this Directive.

 

Article 29

 

  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1994. They shall forthwith inform the Commission thereof.

When these measures are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

  1. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
  2. The setting of the deadline for transposition into national law at 1 January 1994 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 89/662/EEC and 90/425/EEC.

 

Article 30

This Directive is addressed to the Member States.

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