AGREEMENT ON THE
APPLICATION OF
SANITARY AND PHYTOSANITARY
MEASURES
Members,
Reaffirming that no Member should be prevented from adopting or enforcing measures
necessary
to protect human, animal or plant life
or health, subject to the requirement that these measures are not
applied in a manner which would
constitute a means of arbitrary or unjustifiable discrimination between
Members where the same conditions
prevail or a disguised restriction on international trade;
Desiring to improve the human health, animal health and phytosanitary situation in
all Members;
Noting that sanitary and phytosanitary measures are often applied on the basis of
bilateral
agreements or protocols;
Desiring the establishment of a multilateral framework of rules and disciplines to guide
the
development, adoption and enforcement
of sanitary and phytosanitary measures in order to minimize
their negative effects on trade;
Recognizing the important contribution that international standards, guidelines and
recommendations can make in this
regard;
Desiring to further the use of harmonized sanitary and phytosanitary measures
between Members,
on the basis of international
standards, guidelines and recommendations developed by the relevant
international organizations, including
the Codex Alimentarius Commission, the International Office
of Epizootics, and the relevant
international and regional organizations operating within the framework
of the International Plant Protection
Convention, without requiring Members to change their appropriate
level of protection of human, animal or
plant life or health;
Recognizing that developing country Members may encounter special difficulties in
complying
with the sanitary or phytosanitary
measures of importing Members, and as a consequence in access
to markets, and also in the formulation
and application of sanitary or phytosanitary measures in their
own territories, and desiring to assist
them in their endeavours in this regard;
Desiring therefore to elaborate rules for the application of the provisions of GATT
1994 which
relate to the use of sanitary or
phytosanitary measures, in particular the provisions of Article XX(b)1;
Hereby agree as follows:
Article 1
General Provisions
1. This Agreement applies to all
sanitary and phytosanitary measures which may, directly or
indirectly, affect international trade.
Such measures shall be developed and applied in accordance with
the provisions of this Agreement.
1In
this Agreement, reference to Article XX(b) includes also the chapeau of that
Article.
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2. For the purposes of this Agreement,
the definitions provided in Annex A shall apply.
3. The annexes are an integral part of
this Agreement.
4. Nothing in this Agreement shall
affect the rights of Members under the Agreement on Technical
Barriers to Trade with respect to
measures not within the scope of this Agreement.
Article 2
Basic Rights and
Obligations
1. Members have the right to take
sanitary and phytosanitary measures necessary for the protection
of human, animal or plant life or
health, provided that such measures are not inconsistent with the
provisions of this Agreement.
2. Members shall ensure that any
sanitary or phytosanitary measure is applied only to the extent
necessary to protect human, animal or
plant life or health, is based on scientific principles and is not
maintained without sufficient
scientific evidence, except as provided for in paragraph 7 of Article 5.
3. Members shall ensure that their
sanitary and phytosanitary measures do not arbitrarily or
unjustifiably discriminate between
Members where identical or similar conditions prevail, including
between their own territory and that of
other Members. Sanitary and phytosanitary measures shall not
be applied in a manner which would
constitute a disguised restriction on international trade.
4. Sanitary or phytosanitary measures
which conform to the relevant provisions of this Agreement
shall be presumed to be in accordance
with the obligations of the Members under the provisions of
GATT 1994 which relate to the use of
sanitary or phytosanitary measures, in particular the provisions
of Article XX(b).
Article 3
Harmonization
1. To harmonize sanitary and
phytosanitary measures on as wide a basis as possible, Members
shall base their sanitary or
phytosanitary measures on international standards, guidelines or
recommendations, where they exist,
except as otherwise provided for in this Agreement, and in particular
in paragraph 3.
2. Sanitary or phytosanitary measures
which conform to international standards, guidelines or
recommendations shall be deemed to be
necessary to protect human, animal or plant life or health,
and presumed to be consistent with the
relevant provisions of this Agreement and of GATT 1994.
3. Members may introduce or maintain
sanitary or phytosanitary measures which result in a higher
level of sanitary or phytosanitary
protection than would be achieved by measures based on the relevant
international standards, guidelines or
recommendations, if there is a scientific justification, or as a
consequence of the level of sanitary or
phytosanitary protection a Member determines to be appropriate
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in accordance with the relevant
provisions of paragraphs 1 through 8 of Article 5.2 Notwithstanding
the above, all measures which result in
a level of sanitary or phytosanitary protection different from
that which would be achieved by
measures based on international standards, guidelines or
recommendations shall not be
inconsistent with any other provision of this Agreement.
4. Members shall play a full part,
within the limits of their resources, in the relevant international
organizations and their subsidiary
bodies, in particular the Codex Alimentarius Commission, the
International Office of Epizootics, and
the international and regional organizations operating within
the framework of the International
Plant Protection Convention, to promote within these organizations
the development and periodic review of
standards, guidelines and recommendations with respect to
all aspects of sanitary and
phytosanitary measures.
5. The Committee on Sanitary and
Phytosanitary Measures provided for in paragraphs 1 and 4
of Article 12 (referred to in this
Agreement as the "Committee") shall develop a procedure to monitor
the process of international
harmonization and coordinate efforts in this regard with the relevant
international organizations.
Article 4
Equivalence
1. Members shall accept the sanitary or
phytosanitary measures of other Members as equivalent,
even if these measures differ from
their own or from those used by other Members trading in the same
product, if the exporting Member
objectively demonstrates to the importing Member that its measures
achieve the importing Member's
appropriate level of sanitary or phytosanitary protection. For this
purpose, reasonable access shall be
given, upon request, to the importing Member for inspection, testing
and other relevant procedures.
2. Members shall, upon request, enter
into consultations with the aim of achieving bilateral and
multilateral agreements on recognition
of the equivalence of specified sanitary or phytosanitary measures.
Article 5
Assessment of Risk and
Determination of the Appropriate Level
of Sanitary or
Phytosanitary Protection
1. Members shall ensure that their
sanitary or phytosanitary measures are based on an assessment,
as appropriate to the circumstances, of
the risks to human, animal or plant life or health, taking into
account risk assessment techniques
developed by the relevant international organizations.
2. In the assessment of risks, Members
shall take into account available scientific evidence; relevant
processes and production methods;
relevant inspection, sampling and testing methods; prevalence
2For
the purposes of paragraph 3 of Article 3, there is a scientific justification
if, on the basis of an examination and
evaluation of available scientific
information in conformity with the relevant provisions of this Agreement, a
Member determines
that the relevant international
standards, guidelines or recommendations are not sufficient to achieve its
appropriate level of
sanitary or phytosanitary protection.
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of specific diseases or pests;
existence of pest- or disease-free areas; relevant ecological and environmental
conditions; and quarantine or other
treatment.
3. In assessing the risk to animal or
plant life or health and determining the measure to be applied
for achieving the appropriate level of
sanitary or phytosanitary protection from such risk, Members
shall take into account as relevant
economic factors: the potential damage in terms of loss of production
or sales in the event of the entry,
establishment or spread of a pest or disease; the costs of control
or eradication in the territory of the
importing Member; and the relative cost-effectiveness of alternative
approaches to limiting risks.
4. Members should, when determining the
appropriate level of sanitary or phytosanitary protection,
take into account the objective of
minimizing negative trade effects.
5. With the objective of achieving
consistency in the application of the concept of appropriate
level of sanitary or phytosanitary
protection against risks to human life or health, or to animal and plant
life or health, each Member shall avoid
arbitrary or unjustifiable distinctions in the levels it considers
to be appropriate in different
situations, if such distinctions result in discrimination or a disguised
restriction on international trade.
Members shall cooperate in the Committee, in accordance with
paragraphs 1, 2 and 3 of Article 12, to
develop guidelines to further the practical implementation of
this provision. In developing the
guidelines, the Committee shall take into account all relevant factors,
including the exceptional character of
human health risks to which people voluntarily expose themselves.
6. Without prejudice to paragraph 2 of
Article 3, when establishing or maintaining sanitary or
phytosanitary measures to achieve the
appropriate level of sanitary or phytosanitary protection, Members
shall ensure that such measures are not
more trade-restrictive than required to achieve their appropriate
level of sanitary or phytosanitary
protection, taking into account technical and economic feasibility.3
7. In cases where relevant scientific
evidence is insufficient, a Member may provisionally adopt
sanitary or phytosanitary measures on
the basis of available pertinent information, including that from
the relevant international
organizations as well as from sanitary or phytosanitary measures applied by
other Members. In such circumstances,
Members shall seek to obtain the additional information necessary
for a more objective assessment of risk
and review the sanitary or phytosanitary measure accordingly
within a reasonable period of time.
8. When a Member has reason to believe
that a specific sanitary or phytosanitary measure introduced
or maintained by another Member is
constraining, or has the potential to constrain, its exports and the
measure is not based on the relevant
international standards, guidelines or recommendations, or such
standards, guidelines or
recommendations do not exist, an explanation of the reasons for such sanitary
or phytosanitary measure may be
requested and shall be provided by the Member maintaining the
measure.
3For
purposes of paragraph 6 of Article 5, a measure is not more trade-restrictive
than required unless there is another
measure, reasonably available taking
into account technical and economic feasibility, that achieves the appropriate
level of
sanitary or phytosanitary protection
and is significantly less restrictive to trade.
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Article 6
Adaptation to Regional
Conditions, Including Pest- or Disease-Free Areas
and Areas of Low Pest or
Disease Prevalence
1. Members shall ensure that their
sanitary or phytosanitary measures are adapted to the sanitary
or phytosanitary characteristics of the
area - whether all of a country, part of a country, or all or parts
of several countries - from which the
product originated and to which the product is destined. In assessing
the sanitary or phytosanitary
characteristics of a region, Members shall take into account, inter alia,
the level of prevalence of specific
diseases or pests, the existence of eradication or control programmes,
and appropriate criteria or guidelines
which may be developed by the relevant international organizations.
2. Members shall, in particular,
recognize the concepts of pest- or disease-free areas and areas
of low pest or disease prevalence.
Determination of such areas shall be based on factors such as
geography, ecosystems, epidemiological
surveillance, and the effectiveness of sanitary or phytosanitary
controls.
3. Exporting Members claiming that
areas within their territories are pest- or disease-free areas
or areas of low pest or disease
prevalence shall provide the necessary evidence thereof in order to
objectively demonstrate to the
importing Member that such areas are, and are likely to remain, pestor
disease-free areas or areas of low pest
or disease prevalence, respectively. For this purpose, reasonable
access shall be given, upon request, to
the importing Member for inspection, testing and other relevant
procedures.
Article 7
Transparency
Members shall notify changes in their
sanitary or phytosanitary measures and shall provide
information on their sanitary or
phytosanitary measures in accordance with the provisions of Annex B.
Article 8
Control, Inspection and
Approval Procedures
Members shall observe the provisions of
Annex C in the operation of control, inspection and
approval procedures, including national
systems for approving the use of additives or for establishing
tolerances for contaminants in foods,
beverages or feedstuffs, and otherwise ensure that their procedures
are not inconsistent with the
provisions of this Agreement.
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Article 9
Technical Assistance
1. Members agree to facilitate the
provision of technical assistance to other Members, especially
developing country Members, either
bilaterally or through the appropriate international organizations.
Such assistance may be, inter alia,
in the areas of processing technologies, research and infrastructure,
including in the establishment of
national regulatory bodies, and may take the form of advice, credits,
donations and grants, including for the
purpose of seeking technical expertise, training and equipment
to allow such countries to adjust to,
and comply with, sanitary or phytosanitary measures necessary
to achieve the appropriate level of
sanitary or phytosanitary protection in their export markets.
2. Where substantial investments are
required in order for an exporting developing country Member
to fulfil the sanitary or phytosanitary
requirements of an importing Member, the latter shall consider
providing such technical assistance as
will permit the developing country Member to maintain and expand
its market access opportunities for the
product involved.
Article 10
Special and Differential
Treatment
1. In the preparation and application
of sanitary or phytosanitary measures, Members shall take
account of the special needs of
developing country Members, and in particular of the least-developed
country Members.
2. Where the appropriate level of
sanitary or phytosanitary protection allows scope for the phased
introduction of new sanitary or
phytosanitary measures, longer time-frames for compliance should be
accorded on products of interest to
developing country Members so as to maintain opportunities for
their exports.
3. With a view to ensuring that
developing country Members are able to comply with the provisions
of this Agreement, the Committee is
enabled to grant to such countries, upon request, specified, timelimited
exceptions in whole or in part from
obligations under this Agreement, taking into account their
financial, trade and development needs.
4. Members should encourage and
facilitate the active participation of developing country Members
in the relevant international
organizations.
Article 11
Consultations and Dispute
Settlement
1. The provisions of Articles XXII and
XXIII of GATT 1994 as elaborated and applied by the
Dispute Settlement Understanding shall
apply to consultations and the settlement of disputes under
this Agreement, except as otherwise
specifically provided herein.
2. In a dispute under this Agreement
involving scientific or technical issues, a panel should seek
advice from experts chosen by the panel
in consultation with the parties to the dispute. To this end,
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the panel may, when it deems it
appropriate, establish an advisory technical experts group, or consult
the relevant international
organizations, at the request of either party to the dispute or on its own
initiative.
3. Nothing in this Agreement shall
impair the rights of Members under other international
agreements, including the right to
resort to the good offices or dispute settlement mechanisms of other
international organizations or
established under any international agreement.
Article 12
Administration
1. A Committee on Sanitary and
Phytosanitary Measures is hereby established to provide a regular
forum for consultations. It shall carry
out the functions necessary to implement the provisions of this
Agreement and the furtherance of its
objectives, in particular with respect to harmonization. The
Committee shall reach its decisions by
consensus.
2. The Committee shall encourage and
facilitate ad hoc consultations or negotiations among Members
on specific sanitary or phytosanitary
issues. The Committee shall encourage the use of international
standards, guidelines or
recommendations by all Members and, in this regard, shall sponsor technical
consultation and study with the
objective of increasing coordination and integration between international
and national systems and approaches for
approving the use of food additives or for establishing tolerances
for contaminants in foods, beverages or
feedstuffs.
3. The Committee shall maintain close
contact with the relevant international organizations in
the field of sanitary and phytosanitary
protection, especially with the Codex Alimentarius Commission,
the International Office of Epizootics,
and the Secretariat of the International Plant Protection Convention,
with the objective of securing the best
available scientific and technical advice for the administration
of this Agreement and in order to
ensure that unnecessary duplication of effort is avoided.
4. The Committee shall develop a
procedure to monitor the process of international harmonization
and the use of international standards,
guidelines or recommendations. For this purpose, the Committee
should, in conjunction with the
relevant international organizations, establish a list of international
standards, guidelines or
recommendations relating to sanitary or phytosanitary measures which the
Committee determines to have a major
trade impact. The list should include an indication by Members
of those international standards,
guidelines or recommendations which they apply as conditions for
import or on the basis of which imported
products conforming to these standards can enjoy access to
their markets. For those cases in which
a Member does not apply an international standard, guideline
or recommendation as a condition for
import, the Member should provide an indication of the reason
therefor, and, in particular, whether
it considers that the standard is not stringent enough to provide
the appropriate level of sanitary or
phytosanitary protection. If a Member revises its position, following
its indication of the use of a standard,
guideline or recommendation as a condition for import, it should
provide an explanation for its change
and so inform the Secretariat as well as the relevant international
organizations, unless such notification
and explanation is given according to the procedures of Annex B.
5. In order to avoid unnecessary
duplication, the Committee may decide, as appropriate, to use
the information generated by the
procedures, particularly for notification, which are in operation in
the relevant international organizations.
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6. The Committee may, on the basis of
an initiative from one of the Members, through appropriate
channels invite the relevant
international organizations or their subsidiary bodies to examine specific
matters with respect to a particular standard,
guideline or recommendation, including the basis of
explanations for non-use given
according to paragraph 4.
7. The Committee shall review the
operation and implementation of this Agreement three years
after the date of entry into force of
the WTO Agreement, and thereafter as the need arises. Where
appropriate, the Committee may submit
to the Council for Trade in Goods proposals to amend the text
of this Agreement having regard, inter
alia, to the experience gained in its implementation.
Article 13
Implementation
Members are fully responsible under
this Agreement for the observance of all obligations set
forth herein. Members shall formulate
and implement positive measures and mechanisms in support
of the observance of the provisions of
this Agreement by other than central government bodies. Members
shall take such reasonable measures as
may be available to them to ensure that non-governmental entities
within their territories, as well as
regional bodies in which relevant entities within their territories are
members, comply with the relevant
provisions of this Agreement. In addition, Members shall not take
measures which have the effect of,
directly or indirectly, requiring or encouraging such regional or
non-governmental entities, or local
governmental bodies, to act in a manner inconsistent with the
provisions of this Agreement. Members
shall ensure that they rely on the services of non-governmental
entities for implementing sanitary or
phytosanitary measures only if these entities comply with the
provisions of this Agreement.
Article 14
Final Provisions
The least-developed country Members may
delay application of the provisions of this Agreement
for a period of five years following
the date of entry into force of the WTO Agreement with respect
to their sanitary or phytosanitary
measures affecting importation or imported products. Other developing
country Members may delay application
of the provisions of this Agreement, other than paragraph 8
of Article 5 and Article 7, for two
years following the date of entry into force of the WTO Agreement
with respect to their existing sanitary
or phytosanitary measures affecting importation or imported
products, where such application is
prevented by a lack of technical expertise, technical infrastructure
or resources.
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ANNEX A
DEFINITIONS4
1. Sanitary or phytosanitary measure
- Any measure applied:
(a) to protect animal or plant life or
health within the territory of the Member from risks
arising from the entry, establishment
or spread of pests, diseases, disease-carrying
organisms or disease-causing organisms;
(b) to protect human or animal life or
health within the territory of the Member from risks
arising from additives, contaminants,
toxins or disease-causing organisms in foods,
beverages or feedstuffs;
(c) to protect human life or health
within the territory of the Member from risks arising
from diseases carried by animals,
plants or products thereof, or from the entry,
establishment or spread of pests; or
(d) to prevent or limit other damage
within the territory of the Member from the entry,
establishment or spread of pests.
Sanitary or phytosanitary measures
include all relevant laws, decrees, regulations, requirements and
procedures including, inter alia,
end product criteria; processes and production methods; testing,
inspection, certification and approval
procedures; quarantine treatments including relevant requirements
associated with the transport of
animals or plants, or with the materials necessary for their survival
during transport; provisions on
relevant statistical methods, sampling procedures and methods of risk
assessment; and packaging and labelling
requirements directly related to food safety.
2. Harmonization - The
establishment, recognition and application of common sanitary and
phytosanitary measures by different
Members.
3. International standards,
guidelines and recommendations
(a) for food safety, the standards,
guidelines and recommendations established by the Codex
Alimentarius Commission relating to
food additives, veterinary drug and pesticide
residues, contaminants, methods of
analysis and sampling, and codes and guidelines
of hygienic practice;
(b) for animal health and zoonoses, the
standards, guidelines and recommendations developed
under the auspices of the International
Office of Epizootics;
(c) for plant health, the international
standards, guidelines and recommendations developed
under the auspices of the Secretariat
of the International Plant Protection Convention
in cooperation with regional
organizations operating within the framework of the
International Plant Protection
Convention; and
4For
the purpose of these definitions, "animal" includes fish and wild
fauna; "plant" includes forests and wild flora;
"pests" include weeds; and
"contaminants" include pesticide and veterinary drug residues and
extraneous matter.
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(d) for matters not covered by the
above organizations, appropriate standards, guidelines
and recommendations promulgated by
other relevant international organizations open
for membership to all Members, as
identified by the Committee.
4. Risk assessment - The
evaluation of the likelihood of entry, establishment or spread of a pest
or disease within the territory of an
importing Member according to the sanitary or phytosanitary measures
which might be applied, and of the
associated potential biological and economic consequences; or the
evaluation of the potential for adverse
effects on human or animal health arising from the presence
of additives, contaminants, toxins or
disease-causing organisms in food, beverages or feedstuffs.
5. Appropriate level of sanitary or
phytosanitary protection - The level of protection deemed
appropriate by the Member establishing
a sanitary or phytosanitary measure to protect human, animal
or plant life or health within its territory.
NOTE: Many Members otherwise refer to
this concept as the "acceptable level of risk".
6. Pest- or disease-free area -
An area, whether all of a country, part of a country, or all or parts
of several countries, as identified by
the competent authorities, in which a specific pest or disease does
not occur.
NOTE: A pest- or disease-free area may
surround, be surrounded by, or be adjacent to an area - whether
within part of a country or in a
geographic region which includes parts of or all of several countries -
in which a specific pest or disease is
known to occur but is subject to regional control measures such
as the establishment of protection,
surveillance and buffer zones which will confine or eradicate the
pest or disease in question.
7. Area of low pest or disease
prevalence - An area, whether all of a country, part of a country,
or all or parts of several countries,
as identified by the competent authorities, in which a specific pest
or disease occurs at low levels and
which is subject to effective surveillance, control or eradication
measures.
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ANNEX B
TRANSPARENCY OF SANITARY AND
PHYTOSANITARY REGULATIONS
Publication of regulations
1. Members shall ensure that all
sanitary and phytosanitary regulations5 which have been adopted
are published promptly in such a manner
as to enable interested Members to become acquainted with
them.
2. Except in urgent circumstances,
Members shall allow a reasonable interval between the publication
of a sanitary or phytosanitary
regulation and its entry into force in order to allow time for producers
in exporting Members, and particularly
in developing country Members, to adapt their products and
methods of production to the
requirements of the importing Member.
Enquiry points
3. Each Member shall ensure that one
enquiry point exists which is responsible for the provision
of answers to all reasonable questions
from interested Members as well as for the provision of relevant
documents regarding:
(a) any sanitary or phytosanitary
regulations adopted or proposed within its territory;
(b) any control and inspection
procedures, production and quarantine treatment, pesticide
tolerance and food additive approval
procedures, which are operated within its territory;
(c) risk assessment procedures, factors
taken into consideration, as well as the determination
of the appropriate level of sanitary or
phytosanitary protection;
(d) the membership and participation of
the Member, or of relevant bodies within its
territory, in international and
regional sanitary and phytosanitary organizations and
systems, as well as in bilateral and
multilateral agreements and arrangements within
the scope of this Agreement, and the
texts of such agreements and arrangements.
4. Members shall ensure that where
copies of documents are requested by interested Members,
they are supplied at the same price (if
any), apart from the cost of delivery, as to the nationals6 of the
Member concerned.
5Sanitary
and phytosanitary measures such as laws, decrees or ordinances which are
applicable generally.
6When
"nationals" are referred to in this Agreement, the term shall be
deemed, in the case of a separate customs territory
Member of the WTO, to mean persons,
natural or legal, who are domiciled or who have a real and effective industrial
or
commercial establishment in that
customs territory.
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Notification procedures
5. Whenever an international standard,
guideline or recommendation does not exist or the content
of a proposed sanitary or phytosanitary
regulation is not substantially the same as the content of an
international standard, guideline or
recommendation, and if the regulation may have a significant effect
on trade of other Members, Members
shall:
(a) publish a notice at an early stage
in such a manner as to enable interested Members
to become acquainted with the proposal
to introduce a particular regulation;
(b) notify other Members, through the
Secretariat, of the products to be covered by the
regulation together with a brief
indication of the objective and rationale of the proposed
regulation. Such notifications shall
take place at an early stage, when amendments
can still be introduced and comments
taken into account;
(c) provide upon request to other
Members copies of the proposed regulation and, whenever
possible, identify the parts which in substance
deviate from international standards,
guidelines or recommendations;
(d) without discrimination, allow
reasonable time for other Members to make comments
in writing, discuss these comments upon
request, and take the comments and the results
of the discussions into account.
6. However, where urgent problems of
health protection arise or threaten to arise for a Member,
that Member may omit such of the steps
enumerated in paragraph 5 of this Annex as it finds necessary,
provided that the Member:
(a) immediately notifies other Members,
through the Secretariat, of the particular regulation
and the products covered, with a brief
indication of the objective and the rationale of
the regulation, including the nature of
the urgent problem(s);
(b) provides, upon request, copies of
the regulation to other Members;
(c) allows other Members to make
comments in writing, discusses these comments upon
request, and takes the comments and the
results of the discussions into account.
7. Notifications to the Secretariat
shall be in English, French or Spanish.
8. Developed country Members shall, if
requested by other Members, provide copies of the
documents or, in case of voluminous
documents, summaries of the documents covered by a specific
notification in English, French or
Spanish.
9. The Secretariat shall promptly
circulate copies of the notification to all Members and interested
international organizations and draw
the attention of developing country Members to any notifications
relating to products of particular interest
to them.
10. Members shall designate a single
central government authority as responsible for the
implementation, on the national level,
of the provisions concerning notification procedures according
to paragraphs 5, 6, 7 and 8 of this
Annex.
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General reservations
11. Nothing in this Agreement shall be
construed as requiring:
(a) the provision of particulars or
copies of drafts or the publication of texts other than
in the language of the Member except as
stated in paragraph 8 of this Annex; or
(b) Members to disclose confidential
information which would impede enforcement of
sanitary or phytosanitary legislation
or which would prejudice the legitimate commercial
interests of particular enterprises.
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ANNEX C
CONTROL, INSPECTION AND APPROVAL
PROCEDURES7
1. Members shall ensure, with respect
to any procedure to check and ensure the fulfilment of sanitary
or phytosanitary measures, that:
(a) such procedures are undertaken and
completed without undue delay and in no less
favourable manner for imported products
than for like domestic products;
(b) the standard processing period of
each procedure is published or that the anticipated
processing period is communicated to
the applicant upon request; when receiving an
application, the competent body promptly
examines the completeness of the
documentation and informs the applicant
in a precise and complete manner of all
deficiencies; the competent body
transmits as soon as possible the results of the
procedure in a precise and complete
manner to the applicant so that corrective action
may be taken if necessary; even when
the application has deficiencies, the competent
body proceeds as far as practicable
with the procedure if the applicant so requests;
and that upon request, the applicant is
informed of the stage of the procedure, with
any delay being explained;
(c) information requirements are
limited to what is necessary for appropriate control,
inspection and approval procedures,
including for approval of the use of additives or
for the establishment of tolerances for
contaminants in food, beverages or feedstuffs;
(d) the confidentiality of information
about imported products arising from or supplied
in connection with control, inspection
and approval is respected in a way no less
favourable than for domestic products
and in such a manner that legitimate commercial
interests are protected;
(e) any requirements for control,
inspection and approval of individual specimens of a
product are limited to what is
reasonable and necessary;
(f) any fees imposed for the procedures
on imported products are equitable in relation to
any fees charged on like domestic
products or products originating in any other Member
and should be no higher than the actual
cost of the service;
(g) the same criteria should be used in
the siting of facilities used in the procedures and
the selection of samples of imported
products as for domestic products so as to minimize
the inconvenience to applicants,
importers, exporters or their agents;
(h) whenever specifications of a
product are changed subsequent to its control and inspection
in light of the applicable regulations,
the procedure for the modified product is limited
to what is necessary to determine
whether adequate confidence exists that the product
still meets the regulations concerned;
and
7Control,
inspection and approval procedures include, inter alia, procedures for
sampling, testing and certification.
Page 83
(i) a procedure exists to review
complaints concerning the operation of such procedures
and to take corrective action when a
complaint is justified.
Where an importing Member operates a
system for the approval of the use of food additives or for
the establishment of tolerances for
contaminants in food, beverages or feedstuffs which prohibits or
restricts access to its domestic
markets for products based on the absence of an approval, the importing
Member shall consider the use of a
relevant international standard as the basis for access until a final
determination is made.
2. Where a sanitary or phytosanitary
measure specifies control at the level of production, the Member
in whose territory the production takes
place shall provide the necessary assistance to facilitate such
control and the work of the controlling
authorities.
3. Nothing in this Agreement shall
prevent Members from carrying out reasonable inspection within
their own territories.