21999A0318(01)
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
Dates:
of document: 17/12/1998
of effect: 17/12/1998; Entry into force See Art 18 And OJ L
71/99 P. 64
of signature: 17/12/1998; Ottawa
end of validity: 99/99/9999
Authentic language: English ; French
Author:
European Community ; Canada
Subject matter: External relations ; Commercial policy ; Health and
safety
Directory code: 03503000 ; 03800000 ; 11404000
EUROVOC descriptor: animal product ; meat ; prevention of disease ;
public health ; Canada ; EC agreement
Legal basis:
192E113................... Adoption
192E228-P2F1.............. Adoption
Instruments cited:
294A1223(01)..............
294A1223(05)..............
Amended by:
Corrected by.. 299A0318(01)R(01). (FR)
Adopted by.... 399D0201.......... DP18/3/99
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
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 may:
(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.
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.
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
>REFERENCE TO A GRAPHIC>
For the Government of Canada
>REFERENCE TO A GRAPHIC>
ANNEX I
>TABLE POSITION>
ANNEX II
RESPONSIBLE AUTHORITIES
A. Responsible authorities of Canada
The following departments are responsible for the application of
sanitary measures in respect of domestically produced, exported and
imported animals and animal products and for issuing health
certificates attesting to agreed standards unless otherwise noted:
the Canadian Food Inspection Agency (CFIA), or the Department of
Health, as appropriate.
B. Responsible authorities of the Community
Control is shared between the national services in the individual
Member States and the European Communities. In this respect the
following applies:
- In terms of exports to Canada, the Member States are responsible
for control of the production circumstances and requirements,
including statutory inspections and issuing health certification
attesting to the agreed standards and requirements.
- The European Commission is responsible for overall coordination,
inspection/audits of inspection systems and the necessary
legislative action to ensure uniform application of standards and
requirements within the Single European Market.
ANNEX III
DISEASES FOR WHICH REGIONALISATION DECISIONS CAN BE TAKEN
>TABLE POSITION>
Aquaculture diseases
The list of aquaculture diseases is to be discussed further by the
Parties on the basis of the International Aquatic Animal Health code
of the OIE.
ANNEX IV
REGIONALISATION AND ZONING
Further to Article 5(3), the Parties agree that the following forms
the basis for regionalisation decisions for the diseases listed in
Annex III. Each Party agrees to recognise regionalisation decisions
taken in accordance with this Annex.
Animal diseases
Regionalisation - Adjacent countries or parts of countries which
have the same animal health status and similar disease controls can
be treated as a region. The region must be clearly delineated by
natural, artificial or legal boundaries which must be effective. The
region must have a common control policy for the specific disease.
There must be a uniform effective system of epidemiological
surveillance throughout the region and an official sanitary
agreement between the countries involved.
In assessing risk from a given proposed importation of animals or
animal products, three sets of factors may be considered:
3. destination risk factors.
Source risk factors
The primary determinant of the risk of importing diseases is the
status of the country of origin in respect of the disease in
question. However, declarations of disease freedom must be backed up
by effective surveillance programmes.
The overriding consideration in this context, therefore, is the
quality of the veterinary infrastructure. No other factors can be
assessed without full confidence in the veterinary administration.
In particular, their ability to detect and control an outbreak of
disease and to provide meaningful certification is crucial.
The ability to detect the presence of disease depends on the
surveillance carried out. This surveillance can be active, passive,
or both.
Active surveillance implies definitive action intended to identify
the presence of disease, such as systematic clinical inspections,
ante and post mortem examination, serology on farm or in abattoir,
referral of pathological material for laboratory diagnosis, sentinel
animals.
Passive surveillance means that the disease must be compulsorily
notifiable and that there must be a sufficiently high level of
supervision of the animals in order to ensure that the disease will
be observed quickly and reported as a suspect. There must also be a
mechanism for investigation and confirmation, and farmers and
veterinarians must have a high level of awareness of the disease and
its symptoms.
Epidemio-surveillance may be augmented by voluntary and compulsory
herd/flock health programmes, particularly those which ensure a
regular veterinary presence on the farm.
Other factors to be considered include:
- disease history,
- vaccination history,
- controls on movements into the zone, out of the zone and within
the zone,
- animal identification and recording,
- presence of disease in adjacent areas,
- physical barriers between zones of differing status,
- meteorological conditions,
- use of buffer zones (with or without vaccination),
- presence of vectors and/or reservoirs,
- active control and eradication programmes (where appropriate),
- ante and post mortem inspection system.
On the basis of these factors, a zone may be defined.
The authority with the responsibility for implementing the zoning
policy is in the best position to define and maintain the zone. When
there is a high level of confidence in that authority, the decisions
it makes can be the basis for trade.
The zones so defined may be assigned a risk category.
Possible categories are:
- low/negligible risk,
- medium risk,
- high risk,
- unknown risk.
Calculation of estimates of risk for e.g. live animals may assist in
this categorisation. Import conditions may then be defined for each
category, disease and commodity, individually or in groups.
Low/negligible risk implies that importation may take place based on
a simple guarantee of origin.
Medium risk implies that some combination of certification and/or
guarantees may be required before or after importation.
High risk implies that importation will only take place under
conditions which significantly reduce the risk, e.g. by additional
guarantees, testing or treatment.
Unknown risk implies that imports will only take place if the
commodity itself is of very low risk, e.g. hides, wool, or under the
conditions for 'high risk` if the commodity factors warrant.
Commodity risk factors
These include:
- is the disease transmissible by the commodity?
- could the agent be present in the commodity if derived from a
healthy and/or clinically affected animal?
- can the predisposing factor be reduced, e.g. by vaccination?
- what is the likelihood that the commodity has been exposed to
infection?
- has the commodity been obtained in such a way as to reduce the
risk, e.g. deboning?
- has the commodity been subjected to a treatment which inactivates
the agent?
Appropriate tests and quarantine will reduce the risk.
Destination risk factor
- presence of susceptible animals;
- presence of vectors;
- possible vector-free period;
- preventive measures such as waste food feeding and animal waste
rendering rules;
- intended use of product e.g. petfood, human consumption only.
These factors are inherent in or are under the control of the
importing country, and some may therefore be modified to facilitate
trade. These may, for example, include restricted entry conditions
e.g. animals to be confined to a certain vector-free region until
the incubation period has passed, or canalisation systems. However,
destination risk factors will also be taken into account by the
infected country with respect to the risk presented by movements
from the infected part to the free part of its territory.
Aquaculture diseases
Pending the development of any specific provisions to be included in
this Annex, the basis for regionalisation decisions for aquaculture
diseases will be the International Aquatic Health Code of the OIE.
ANNEX V
>TABLE POSITION>
>TABLE POSITION>
11. Meat must not be treated with tenderisers, or come from animals
treated with hormonal growth promoters.
12. For trade from Canada to Sweden and Finland, Canada will certify
in accordance with Council Decision 95/409/EC (fresh: veal, beef and
pigmeat), Council Decision 95/410/EC (live poultry for slaughter),
Council Decision 95/411/EC (fresh poultrymeat), Commission Decision
95/160/EC (breeding poultry and day-old chicks), and Commission
Decision 95/161/EC (laying hens).
No attestation is required for consignments of fresh meat as defined
in Directive 72/462/EEC intended for an establishment for the
purposes of pasteurisation, sterilisation or for treatment having an
equivalent effect.
13. Wood shall not be used for pens for sick and suspect animals.
Pens for sick and suspect animals shall be sited and constructed to
preclude contact with animals intended for slaughter for export to
the EC and effluent from such pens shall not flow into adjoining
pens or passageways.
II. EC EXPORTS TO CANADA
1. Ensure separation of waste water and other effluents necessary to
prevent backflow contamination.
2. Room temperatures not to exceed:
>TABLE POSITION>
Product temperatures for refrigerated meat products not to exceed 4
°C.
3. Continuous assessment of health status of employees. Details on
systems in place in Member States to be provided.
4. Compliance with Canada rules on post-mortem inspection for
poultry.
Footnote B
Fisheries products for human consumption
I. CANADIAN EXPORTS TO THE EC:
1. For identification purposes, products should bear the Canadian
registration number of the production facility, in accordance with
Chapter VII of the Appendix to Directive 91/493/EEC.
2. Processing plants must have automatic temperature recorders in
frozen fish storage areas and non-hand operated wash-basins in
processing areas.
4. Aquaculture products must meet the maximum residue levels as
prescribed by Council Regulation (EC) No 3277/90.
II. EC EXPORTS TO CANADA
2. Products must meet the microbiological guidelines as defined by
the Canadian bacteriological guidelines for fish and fish products.
3. Products must meet the Canadian guidelines for chemical
contaminants and toxins in fish and fish products.
4. Smoked fish packed in hermetically sealed containers must be
frozen or contain a salt level not less than 9 % (water phase
method).
5. Aquaculture products must meet the Canadian guidelines for
therapeutant use.
Footnote C
Live bivalve molluscs for human consumption
I. CANADIAN EXPORTS TO THE EC:
2. Product must be destined for direct human consumption and not for
wet storage, relaying or depuration in EC.
3. Labelling on each bag or container must be marked with the
species of shellfish (common and scientific names), the official
registration number identifying the processing plant (dispatch
center) and the packing date.
II. EC EXPORTS TO CANADA:
2. Product must be destined for direct human consumption and not for
wet storage, relaying or depuration in Canada.
3. Labelling on each bag or container must include the common name
of the shellfish, date and area of harvest, name, address and
registration number of the dispatch center.
4. Products must meet the microbiological guidelines as defined by
the Canadian Bacteriological Guidelines for Fish and Fish Products.
5. Products must meet the Canadian Guidelines for Chemical
Contaminants and Toxins in Fish and Fish Products.
Footnote D
Live bovine animals and bovine semen - IBR
Canada will certify in accordance with Article 3 of Commission
Decision 93/42/EEC or Article 2 of Commission Decision 95/109/EC as
appropriate for exports to Member States or regions of Members
States which have been granted special conditions for
intra-Community trade.
Footnote E
Live porcine animals and porcine semen - Aujeszky's disease
Canada will certify in accordance with Article 5 of Commission
Decision 93/24/EEC or Article 4 of Commission Decision 93/244/EEC as
appropriate for exports to Member States or regions of Member States
which have been granted special conditions for intra-Community
trade.
ANNEX VI
GUIDELINES ON PROCEDURES FOR CONDUCTING AN AUDIT
1. General principles
1.1. Audits should be made in cooperation between the auditing party
(the 'auditor`) and the audited party, (the 'auditee`) in accordance
with the provisions set out in this Annex.
1.2. Audits should be designed to check the effectiveness of the
controlling authority rather than to reject individual animals,
groups of animals, consignments of food or establishments. The
process can include study of the relevant regulations, method of
implementation, assessment of the end result, including assessments
conducted, as considered necessary, at establishments or facilities,
level of compliance and subsequent corrective actions. Where an
audit reveals a serious risk to animal or human health, the auditee
shall take immediate corrective action.
1.3. The frequency of audits should be based on performance. A low
level of performance should result in an increased frequency of
audit; unsatisfactory performance must be corrected by the auditee
to the auditor's satisfaction.
2. Principles relating to the auditor
Those responsible for conducting the audit should prepare a plan,
preferably in accordance with recognised international standards,
that covers the following points:
2.2. the date and place of the audit, along with a timetable up to
and including the issue of the final report;
2.4. the identity of the auditors including, if a team approach is
used, the leader. Specialised professional skills may be required to
carry out audits of specialised systems and programmes;
2.5. a schedule of meetings with officials and visits to
establishments or facilities, as appropriate. The identity of
establishments or facilities to be visited should be stated in
advance, although additional or alternate facilities may be visited
during the audit if it is considered necessary;
2.6. subject to provisions on freedom of information, respect of
commercial confidentiality shall be observed by the auditor.
Conflicts of interest must be avoided;
3. Principles relating to the auditee
The following principles apply to actions taken by the auditee, in
order to facilitate audit.
3.1. The auditee must cooperate fully with the auditor and should
nominate personnel responsible for this task. Cooperation may
include, for example:
- access to all relevant regulations and standards,
- access to compliance programmes and appropriate records and
documents,
- access to audit and inspection reports,
- documentation concerning corrective actions and sanctions,
- facilitating entry to establishments or facilities.
4. Procedures
4.1. Opening meeting
An opening meeting should be held between representatives of both
parties. At this meeting the auditor will be responsible for
reviewing the audit plan and confirming that adequate resources,
documentation, and any other necessary facilities are available for
conducting the audit.
4.2. Document review
The document review may consist of a review of the documents and
records referred to in paragraph 3.1, the structures and powers of
the auditee, and any relevant changes to food inspection and
certification systems since the adoption of this Agreement or since
the previous audit, with emphasis on the implementation of elements
of the system of inspection and certification for animals or
products of interest. This may include an examination of relevant
inspection and certification records and documents.
4.3. On-site verification
4.3.1. The decision to include this step should be based upon an
assessment of risk, taking into account factors such as the animals
or products concerned, the history of conformity with requirements
by the industry sector or exporting country, the volume of product
produced and imported or exported, changes in infrastructure and the
nature of the inspection and certification systems.
5. Working documents
Working documents may include checklists of elements to evaluate,
such as the following:
- legislation,
- structure and operations of inspection and certification services,
- establishment details and working procedures (including any HACCP
documentation),
- health statistics, sampling plans and results,
- compliance action and procedures,
- reporting and complaint procedures, and
- training programmes.
6. Closing meeting
A closing meeting shall be held between representatives of both
Parties. At this meeting the auditor will present the findings of
the audit. The information should be presented in a clear, concise
manner so that the conclusions of the audit are clearly understood.
The Parties may discuss specific actions to be taken as the result
of the findings.
7. Audit report
The auditor shall provide the auditee with a draft report of the
audit generally within 60 days of the conclusion of the audit. To
the extent possible, the report shall be presented in a standardised
format to be agreed upon by the Parties in order to make the
approach to audit more uniform, transparent and efficient. The
report will assess the adequacy of the auditee's enforcement and
control programme and identify any deficiencies noted during the
conduct of the audit. Thereafter, the auditee may within 60 days
comment on the draft report and shall describe any specific
corrective actions that will be taken, preferably with target dates
for completion. Any comments made by the auditee shall be included
in the final report.
ANNEX VII
CERTIFICATION
Official health certificates will cover consignments of live animals
and/or animal products being traded between the Parties.
Health attestations:
(a) Equivalence agreed
Model health attestation to be used ('yes 1` for animal and/or
public health).
'The live animals or animal products herein described comply with
the relevant European Community/Canadian standards and requirements
which have been recognised as equivalent to the Canadian/European
Community standards and requirements as prescribed in the
Canadian/EC Veterinary Agreement. Specifically in accordance with
(insert: exporting country's legislation)`.
(b) Until certificates on the basis of equivalence have been
adopted, existing certification shall continue to be used as set out
in Annex V.
Language:
Exports from Canada: the official health certificate will be issued
either in English or French or both as well as in one of the
languages of the Member State in which the border inspection post is
situated and where the consignment is presented.
Exports from the EC: the official health certificate will be issued
in the language of the Member State of origin as well as either in
English or French or both.
ANNEX VIII
FRONTIER CHECKS
Frequencies of frontier checks on consignments of live animals and
animal products
The Parties may modify any frequency rate, within their
responsibilities, as appropriate, taking into account the nature of
any checks applied by the exporting Party prior to export, the
importing Party's past experience with products imported from the
exporting Party, any progress made toward the recognition of
equivalence, or as a result of other actions or consultations
provided for in this Agreement.
>TABLE POSITION>
For the purposes of this Agreement, 'consignment` means a quantity
of products of the same type, covered by the same health certificate
or document, conveyed by the same means of transport, consigned by a
single consignee and originating from the same exporting Party or
part of such Party.
ANNEX IX
OUTSTANDING ISSUES
1. The Parties agree that the following areas are to be explored as
part of a work programme:
- contaminants (including microbiological standards),
- food additives,
- animal feeding stuffs,
- medicated feeds and premixes,
- labelling of foodstuffs,
- nutritional labelling,
- flavours,
- processing aids,
- chemicals originating from the migration of substances from
packaging materials,
- irradiation,
- sanitary stamps,
- zootechnical standards.
2. Canada has submitted a document outlining a proposed model for a
risk based import inspection model. There is agreement between the
Parties to explore the possibility of implementing this approach.
of live animals through the territory of the Parties.
ANNEX X
CONTACT POINTS FOR THE ADMINISTRATION OF THIS AGREEMENT
A Party may unilaterally amend its section of this Annex. Such
amendments shall be notified to the other Party without delay, and
shall come into force on the date specified in the notification, but
shall not come into force prior to the date of the notification.
Pursuant to Article 14(3), the following are the contact points for
each of the Parties.
For Canada
The initial contact point is:
Agriculture Counsellor
Agriculture Section
Canadian Mission to the European Union
Avenue de Tervuren/Tervurenlaan 2
B-1040 Brussels;
Telephone: (32) 2 741-0610 (Agriculture Counsellor)
(32) 2 741-0698 (Agricultural Affairs Assistant)
(32) 2 741-0611 (Switchboard)
Fax: (32) 2 741-0629
Other important contacts are:
For matters related to live animals, agri-food, fish, and seafood
products:
Executive Director
Animal Products Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Nepean, Ontario
K1A 0Y9
Telephone: (613) 225-2342
Fax: (613) 228-6631
For matters specifically related to fish health and diseases:
Director
Aquaculture and Oceans Science Branch
Department of Fisheries and Oceans
200 Kent Street
Ottawa, Ontario
K1A 0E6
Telephone: (613) 990-0275
Fax: (613) 954-0807
For matters related to human health:
Director General
Food Directorate
Health Protection Branch
Health Canada
Health Protection Building, Tunney's Pasture
Ottawa, Ontario
K1A 0L2
For the Community
The initial contact point is:
The Director
DG VI.B.II Quality and Health
Commission of the European Communities
Rue de la Loi/Wetstraat 86 (Room 8/53)
Brussels;
Telephone: (32) 2 295 6838
Fax: (32) 2 296 4286