EN Official Journal of the European Communities L 71/3

AGREEMENT

between the European Community and the Government of Canada on sanitary measures to protect public and animal health in respect of trade in live animals and animal products

THE EUROPEAN COMMUNITY (the ‘Community’)

and

THE GOVERNMENT OF CANADA (‘Canada’)

hereinafter referred to collectively as the ‘Parties’:

ACKNOWLEDGING that their systems of sanitary measures are intended to provide comparable health assurances;

REAFFIRMING their commitment to their rights and obligations under the Marrakesh Agreement establishing the World Trade Organisation (the ‘WTO Agreement’), and its Annexes, in particular the Agreement on the application of sanitary and phytosanitary measures (the ‘SPS Agreement’);

DESIRING to facilitate trade in live animals and animal products between the Community and Canada while safeguarding animal and public health in relation to the wholesomeness of food products;

RESOLVING to take the fullest account: of the risk of spread of animal infection and disease and the measures put in place to control and eradicate such infections and diseases, and in particular to avoid disruptions to trade,

HAVE AGREED AS FOLLOWS:

Article 1

Objective

The objective of this Agreement is to facilitate trade in live animals and animal products between the Community and Canada by establishing a mechanism for the recognition of equivalence of sanitary measures maintained by the two Parties consistent with the protection of public and animal health, and to improve communication and cooperation on sanitary measures.

Article 2

Definitions

For the purposes of this Agreement:

(a) live animals and animal products means the live animals and animal products, including fish and fishery products, listed in Annex I;

(b) sanitary measures means sanitary measures as defined in paragraph 1 of Annex A to the SPS Agreement;

(c) appropriate level of sanitary protection means the appropriate level of sanitary protection as defined in paragraph 5 of Annex A of the SPS Agreement;

(d) region means both ‘zone’ and ‘region’ as defined in the Animal Health Code of the Office International des Epizooties (OIE), and for aquaculture as defined in the International Aquatic Animal Health Code of the OIE;

(e) responsible authorities means: (i) for Canada, the authorities described in Part A of Annex II; and (ii) for the Community, the authorities described in Part B of Annex II.

Article 3

Scope

1. This Agreement applies in respect of trade between the Community and Canada in live animals and animal products.

2. Subject to paragraph 3, the provisions of this Agreement shall apply initially to sanitary measures of the Parties that apply to trade in live animals and animal products.

3. Unless otherwise specified under the provisions set out in the Annexes to this Agreement, and without prejudice to Article 11, the scope of this Agreement shall exclude sanitary measures related to food additives (all food additives and colours), sanitary stamps, processing aids, flavours, irradiation (ionisation), contaminants (including microbiological standards), transport, chemicals originating from the migration of substances from packaging materials, labelling of foodstuffs, nutritional labelling, animal feedingstuffs, medicated feeds and premixes.

4. The parties may agree to apply the principles of this Agreement to address veterinary issues other than sanitary measures applicable to trade in live animals and animal products.

5. The Parties may agree to modify this Agreement in the future to extend the scope to other sanitary or phytosanitary measures affecting trade between the Parties.

Article 4

Relation to the WTO Agreement

Nothing in this Agreement shall modify the rights Or obligations of the Parties under the WTO Agreement and in particular the SPS Agreement.

Article 5

Recognition of regional conditions

1. The Parties recognise the concept of regionalisation, which they agree to apply in respect of the diseases listed in Annex III.

2. Where one of the Parties considers that it has a special status with respect to a specific disease, it may request recognition of that status. The importing Party may also request additional guarantees in respect of imports of live animals and animal products appropriate to the agreed status. The guarantees for specific diseases shall be specified in Annex V.

3. Without prejudice to paragraph 2, the importing Party shall recognise regionalisation decisions taken in accordance with criteria as defined in Annex IV as the basis for trade from a party whose territory is affected by one or more of the diseases listed in Annex III.

Article 6

Recognition of equivalence

1. The importing Party shall recognise a sanitary measure of the exporting Party as equivalent if the exporting Party objectively demonstrates that its measure achieves the importing Party's appropriate level of protection.

2. Once determined, equivalence shall be applied in relation to individual or groups of sanitary measures for live animals or animal product sectors, or parts of sectors, in relation to legislation, inspection and control systems, parts of systems, or in relation to specific legislation, inspections and/or hygiene requirements.

Article 7

Criteria for recognition of equivalence

1. In determining whether a sanitary measure maintained by an exporting Party achieves the importing Party's appropriate level of sanitary protection, the Parties shall follow the process set out below:

(i) identification of the sanitary measures for which recognition of equivalence is sought;

(ii) explanation by the importing Party of the objective of its sanitary measures, including an assessment, as appropriate to the circumstances, of any risks that the sanitary measures are intended to address, and identification by the importing Party of its appropriate level of sanitary protection;

(iii) provision of information by the exporting Party supporting its view that its sanitary measures achieve the importing Party's appropriate level of sanitary protection;

(iv) assessment by the importing Party of whether the exporting Party's sanitary measures achieve the importing Party's appropriate level of sanitary protection; this step may include an evaluation of: (a) the risks identified by the importing Party and evidence provided by the exporting Party that its sanitary measures effectively address those risks; (b) the legislation authority, standards, practices and procedures including those of laboratories, as well as the programmes in place to ensure that the domestic requirements of the exporting Party and the importing Party's requirements are met; (c) the documented structure of the relevant responsible authorities, their command chain, their authority, their operational procedures and the resources available to them; and (d) the performance of the relevant responsible authorities in relation to the control programme and assurances. The importing Party may carry out audit and verification procedures, in accordance with Article 10, to assist this assessment.

2. Where equivalence has not been recognised, the conditions for trade shall be those required by the importing Party, as set out in Annex V, to meet its appropriate level of protection. The exporting Party may agree to meet the importing Party's conditions, without prejudice to the result of the process set out in paragraph 1.

3. In carrying out the process described in paragraph 1, and setting the conditions referred to in paragraph 2, the Parties shall take account of experience and information already acquired.

Article 8

Status of the recognition of equivalence of the Parties' sanitary measures

1. Annex V lists those sectors, or parts of sectors, for which at the date of entry into force of this Agreement the Parties' respective sanitary measures are recognised as equivalent for trade purposes.

2. Annex V also lists those sectors, or parts of sectors, for which, at the date of entry into force of this Agreement, the Parties apply different sanitary measures and have not concluded the process described in paragraph 1 of Article 7. The Parties shall carry out the actions set out in Annex V based on the process described in paragraph 1 of Article 7, with the objective of recognising equivalence by the dates indicated in Annex V.

3. With respect to sanitary measures recognised as equivalent for trade purposes at the date of entry into force of this Agreement, the Parties, within their competences, shall initiate the necessary legislative and administrative actions within three months to implement these recognitions.

Article 9

Health certificate

When required, each consignment of live animals or animal products presented for import, and for which equivalence has been recognised, will be accompanied by an official health certificate, the model attestation of which is prescribed in Annex VII. The Parties may jointly determine principles or guidelines for certification. Any such principles or guidelines shall be set out in Annex VII.

Article 10

Audit and verification

1. To maintain confidence in the effective implementation of the provisions of this Agreement, each Party has the right to carry out audit and verification procedures of all or part of the exporting Party's authorities' total control programme as specified in Annex VI.

2. Each Party has the right to carry out frontier checks on consignments on importation, in accordance with Article 11, the results of which may contribute to the audit and verification process.

3. The Community shall carry out the audit and verification procedures provided for in paragraph 1 and the frontier checks provided for in paragraph 2.

4. For Canada, its responsible authorities carry out the audit and verification procedures and frontier checks provided for in paragraphs 1 and 2.

5. Upon the mutual consent of the Parties, either Party

(a) share the results and conclusions of its audit procedures and frontier checks with countries that are not Parties to this Agreement, or

(b) use the results and conclusions of the audit procedures and frontier checks of countries that are not Parties to this Agreement.

Article 11

Frontier (import) checks and inspection fees

1. The frequency and nature of frontier checks shall be based on the risk to public and animal health associated with the importation of a live animal or animal product.

2. The frequency rate of frontier checks on imported live animals and animal products shall be as set out in Annex VIII.

3. In the event that frontier checks reveal non-conformity with the relevant import requirements, the action taken by the importing Party shall be based on an assessment of the risk involved.

4. Wherever possible, the importer of a non-conforming consignment, or his representative, shall be notified of the reason for non-conformity, and shall be given access to the consignment and the opportunity to contribute relevant information to assist the importing Party in taking a final decision.

5. A Party may collect fees for the costs incurred in conducting frontier checks. Provisions concerning these fees may be added to Annex VII.

Article 12

Notification and consultation

1. The Parties shall notify each other, in writing, of:

(a) significant changes in health status, such as the presence and evolution of diseases in Annex III, within 24 hours of confirmation of the change;

(b) findings of epidemiological importance with respect to diseases which are not in Annex III or which are new diseases, without delay; and

(c) any additional measures beyond the basic requirements of their respective sanitary measures taken to control or eradicate animal disease or protect public health, and any changes in preventative policies, including vaccination policies.

2. In cases of serious and immediate concern with respect to public or animal health, oral notification shall be made immediately, and written confirmation should follow within 24 hours.

3. Written and oral notifications shall be made to the contact points set out in Annex X.

4. Where a Party has serious concerns regarding a risk to public or animal health, consultations regarding the situation shall, on request, take place as soon as possible, and in any case within 14 days of the request. Each Party shall endeavour in such situations to provide all the information necessary to avoid a disruption in trade, and to reach a mutually acceptable solution.

Article 13

Safeguard clause

A Party may, on serious public or animal health grounds, take provisional measures necessary for the protection of public or animal health. These measures shall be notified to the other Party within 24 hours of the decision to implement them and, on request, consultations regarding the situation shall be held within 14 days of the notification. The Parties shall take due account of any information provided through such consultations.

Article 14

Information exchange

1. The parties shall exchange information relevant to the implementation of this Agreement on a uniform and systematic basis, to provide assurance, engender mutual confidence and demonstrate the efficacy of the programmes controlled. Where appropriate, this may include exchanges of officials.

2. The information exchange on changes in their respective sanitary measures, and other relevant information, shall include:

(a) the opportunity to consider proposals for the introduction of new measures or changes in existing measures, which may affect this Agreement, in advance of their finalisation. Where either Party considers it necessary, proposals may be dealt with in accordance with Article 16(4);

(b) briefing on current developments affecting trade in live animals and animal products;

(c) information on the results of the audit and verification procedures provided for in Article 10.

3. The contact points for this exchange of information are set out in Annex X.

4. The Parties shall provide for the submission of scientific papers or data to the relevant scientific fora to substantiate any views or claims made in respect of a matter arising under this Agreement. Such information shall be evaluated by the relevant scientific fora in a timely manner, and the results of that examination shall be made available to both Parties.

Article 15

Outstanding issues

The principles of this Agreement shall be applied to address outstanding issues affecting trade between the Parties in live animals and animal products as listed in Annex IX. Modifications shall be made to this Annex and, as appropriate, the other Annexes, to take account of progress made and new issues identified.

Article 16

Joint Management Committee

1. A Joint Management Committee (hereinafter referred to as ‘the Committee’), consisting of representatives of the Parties is hereby established. The Committee shall consider any matters relating to the Agreement, and shall examine all matters which may arise in relation to its implementation. The Committee shall meet within one year of the entry into force of this Agreement, and at least annually thereafter. The Committee may also address issues out of session by correspondence.

2. The Committee shall, at least once a year, review the Annexes to this Agreement, notably in the light of progress made under the consultations provided for under this Agreement. Following its review, the Committee shall issue a report of its proceedings including any recommendations of the Committee.

3. In the light of the provisions set out in paragraph 2, the Parties may agree to modify the Annexes consistent with the Agreement. Modifications shall be agreed by an exchange of notes.

4. The Parties agree to establish technical working groups consisting of expert-level representatives of the Parties, which shall identify and address technical and scientific issues arising from this Agreement.

When additional expertise is required, ad hoc groups, notably scientific groups, may be constituted by the Parties. Membership of such ad hoc groups need not be restricted to representatives of the Parties.

Article 17

Territorial application

This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty, and on the other hand, to the territory of Canada.

Article 18

Final provisions

1. This Agreement and its Annexes shall enter into force upon an exchange of notes indicating that the Parties have completed all legal requirements necessary for that purpose.

2. Each Party shall implement the commitments and obligations arising from this Agreement and its Annexes in accordance with its internal procedures.

3. Either Party may terminate this Agreement by giving at least six months' notice in writing. The Agreement shall terminate on the expiry of the period of notice.

In witness whereof, the undersigned being duly authorised, have signed this Agreement. Done in two copies, this seventeenth day of December 1998, in each of the English and French languages, each version being equally authentic. For the European Community For the Government of Canada