Articles
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.
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.
1. In this Agreement, reference to Article XX(b) includes also the chapeau of that Article.
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 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.
2. For 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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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 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.
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.
3. For 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.
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, 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:
Transparency
1. 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 1. 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
Sanitary and Phytosanitary Measures 33
otherwise ensure that their procedures are not inconsistent with the provisions of this
Agreement.
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, 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:
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:
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
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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:
Implementation
1. 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
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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 nongovernmental entities for implementing sanitary or phytosanitary
measures only if these entities comply with the provisions of this Agreement.
Article 14:
Final Provisions
1. 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.