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Article
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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
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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 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.
Article
6
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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, pest— or 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
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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
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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.
Article
9
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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
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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, time-limited 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
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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, 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
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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.
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
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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
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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.
ANNEX
A
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DEFINITIONS (4)
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
(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.
Annex
B
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Transparency Of Sanitary And Phytosanitary Regulations
Publication
of regulations
1.
Members shall ensure that all sanitary and phytosanitary
regulations (5)
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 nationals (6)
of the Member concerned.
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.
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.
ANNEX
C
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CONTROL, INSPECTION AND APPROVAL PROCEDURES (7)
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
(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.
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