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> List
of Abbreviations
> Article 1 General
Provisions
>Article 2 Basic
Rights and Obligations
> Article 3 Harmonization
> Article 4 Equivalence
> Article 5 Assessment
of Risk and Determination of the Appropriate Level of
Sanitary or Phytosanitary Protection
> Article 6 Adaptation
to Regional Conditions, Including Pest- or Disease-Free Areas and
Areas of Low Pest or Disease Prevalence
> Article 7 Transparency
> Article 8 Control,
Inspection and Approval Procedures
> Article 9 Technical Assistance
> Article 10 Special
and Differential Treatment
> Article 11 Consultations
and Dispute Settlement
> Article 12 Administration
> Article 13 Implementation
> Article 14 Final
Provisions
> Annex A
Definitions
> Annex B Transparency Of Sanitary And Phytosanitary
Regulations
> Annex C Control,
Inspection And Approval Procedures
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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 back to top
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 back to top
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 back to top
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.
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
back to top
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 back to top
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:
Adaptation
to Regional Conditions, Including Pest- or Disease-Free Areas and
Areas of Low Pest or Disease Prevalence back to top
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 back to top
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 back to top
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: Technical Assistance back to top
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 back to top
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 back to top
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.
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Notes:
1.
In
this Agreement, reference to Article XX(b) includes also the
chapeau of that Article. back to text
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.
back to text
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. back to text
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