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WTO ANALYTICAL INDEX: SANITARY AND PHYTOSANITARY MEASURES

Agreement on Sanitary and Phytosanitary Measures

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> Preamble
> Article 1
> Article 2
> Article 3
> Article 4
> Article 5
> Article 6
> Article 7
> Article 8
> Article 9
> Article 10
> Article 11
> Article 12
> Article 13
> Article 14
> Annex A
> Annex B
> Annex C
> Relationship of the SPS Agreement with other WTO Agreements

 

> Analytical Index main page


Table of contents     back to top

I. Preamble     back to top

A. Text of the Preamble
B. Interpretation and Application of the Preamble

1. First recital: consistency of Members’ SPS measures with obligations within the SPS Agreement

2. Fifth and sixth recitals: “international standards, guidelines and recommendations”

(a) General
(b) Relevance of international standards in the SPS Agreement

(i) General

3. The relationship between the SPS Agreement and Article XX(b) of GATT 1994

4. The precautionary principle

(a) Status in international law

(b) Relationship of the precautionary principle with the SPS Agreement


II. Article 1

A. Text of Article 1
B. Interpretation and Application of Article 1

1. Article 1.1

(a) Scope of the SPS Agreement

(i) Application ratione materiae of the SPS Agreement

(ii) Temporal scope of the SPS Agreement

(iii) “Shall be developed and applied in accordance with the provisions of this Agreement”: relevance of the purpose of the measure at issue

(iv) Private Standards


III. Article 2

A. Text of Article 2
B. Interpretation and Application of Article 2

1. Scope of Article 2 obligations

2. Article 2.2

(a) The elements of Article 2.2

(b) The requirement that SPS measures not be maintained without sufficient scientific evidence

(i) General

(ii) Rationale for the requirement of sufficient evidence

(iii) “Sufficient”

(iv) “Scientific evidence”

(v) A rational and objective relationship between the SPS measure and the scientific evidence

(c) Burden of proof on sufficiency of the evidence

(i) General rule on allocation of burden of proof

(ii) Presumption of “no relevant studies or report”

(iii) Burden of proof determined by scope of claim

(iv) Burden of proof for both Articles 2.2 and 5.7

(d) Standard of review of a panel with respect to sufficiency of scientific evidence

(i) Panel to take into account the prudence commonly exercised by governments

(ii) Panel not to conduct own risk assessment

(iii) Panel to assess relevant allegations of fact

(iv) Panel to take into account views of experts while evaluating scientific evidence

(v) Panel not obliged to give precedence to importing Member’s approach to scientific evidence and risk

(e) Relationship with other Articles

(i) Article 1.1

(ii) Article 4

(iii) Article 5

3. Article 2.3

(a) Elements of violation

(b) Scope of discrimination

(c) Relationship with other Articles

(i) Article 1.1

(ii) Article 5.5

4. Relationship of Article 2 generally with other Articles

(a) Articles 3 and 5

(b) Articles 5, 6, 7 and 8


IV. Article 3

A. Text of Article 3
B. Interpretation and Application of Article 3

1. Object and purpose

2. Article 3.1

(a) General

(b) “base[d] … on”

(c) “international standards, guidelines or recommendations where they exist”

(i) Panel’s mandate

(ii) Relevance of international standards for individual diseases

(iii) Revision and adoption of OIE standards, guidelines and recommendations

(d) Burden of proof

(i) Establishing prima facie inconsistency on the complainant’s side

(e) Relationship with other paragraphs of Article 3

(i) Paragraphs 1, 2 and 3

3. Article 3.2

(a) General

(b) “conform to”

(c) Burden of proof

(i) Presumption of consistency

(d) Relationship with other paragraphs of Article 3

(e) Relationship with other Articles

(i) Article 5.1

(ii) Article 5.6

(iii) Article 5.7

4. Article 3.3

(a) General

(b) “based on”

(c) “relevant international standards, guidelines or recommendations”

(d) Compliance with risk assessment requirements

(e) “scientific justification”

(i) Rational relationship

(f) Relationship with other paragraphs of Article 3

(g) Relationship with other Articles

(i) Article 1.1

(ii) Article 5.1

5. Article 3.5

(a) Relationship with other Articles


V. Article 4

A. Text of Article 4
B. Interpretation and Application of Article 4

1. Obligation to determine appropriate level of protection

2. Decision on equivalence

(a) General

(b) Concept of equivalence

(c) Explanation of SPS measures taken by importing Member

(d) Procedure for the recognition of equivalence

(i) General

(ii) Accelerated procedure

(iii) Duty not to interrupt or suspend imports

(iv) Comparison of level of protection

(v) Technical assistance

(e) International cooperation outside the WTO

(f) Notification

3. Specific programme for the further implementation of Article 4

4. Relationship with other Articles

(a) General

(b) Article 2.2


VI. Article 5

A. Text of Article 5
B. Interpretation and Application of Article 5

1. General

(a) Standard of review

(b) Risk assessment versus risk management

2. Article 5.1

(a) General

(b) “based on” an assessment of the risks

(i) General

(ii) SPS measure based on a divergent opinion contained in the risk assessment

(iii) Rational relationship between the SPS measure and the risk assessment

(iv) Scientific uncertainty

(v) Determination of relationship on “a case-by-case” basis

(c) “risk assessment”

(i) General

(ii) Definition of a risk assessment

(iii) Types of risk assessment

(iv) Elements of the risk assessment process

(v) Format of the risk assessment

(vi) Whether a Member should carry out its own risk assessment

(vii) Relevance of the timing of publication of the risk assessment

(viii) Studies not sufficiently specific to the case at hand

(ix) Scope of the risk assessment

(x) No threshold level of risk required

(xi) The concept of “zero risk”

(xii) Completing the Panel’s analysis of a risk assessment

(d) “as appropriate to the circumstances”

(i) Flexibility

(ii) Does not supersede the duty to base a measure on a risk assessment

(iii) Direct causality between the substance and the possibility of adverse health effects

(e) Taking into account risk assessment techniques

(i) Risk assessment techniques of international organizations

(ii) Whether risk was assessed versus how risk was assessed

(iii) Mention of scientific studies in the domestic directive

(f) The appropriate level of protection

(g) Relevance of precautionary principle to Article 5.1

(h) Relationship with other paragraphs of Article 5

(i) Article 5.2

(ii) Article 5.5

(iii) Article 5.7

(i) Relationship with other Articles

(i) Article 1.1

(ii) Article 2.2

3. Article 5.2

(a) Scope of application

(b) Risk factors to be taken into account

(i) Not a closed list

(ii) Risk ascertainable by scientific and non-scientific processes

(iii) Risks arising from difficulties of compliance with certain requirements

(iv) Risks arising from abuse of controlled substances

(c) Relationship with other Articles

(i) Article 5.1

(ii) Articles 2.2 and 5.1

4. Article 5.3

(a) General

(b) Relationship with other Articles

(i) Article 5.1

(ii) Annex A(1)(d)

5. Article 5.4

(a) Objective of minimizing negative trade effects

(b) The appropriate level of protection

(c) Relationship with other paragraphs of Article 5

(i) Article 5.1

(ii) Articles 5.4 to 5.6 and Articles 2.2 and 2.3

6. Article 5.5

(a) The elements of Article 5.5

(b) The definition of an “implementing measure” for the purposes of Article 5.5

(c) Standard of review

(d) “appropriate level of protection”

(i) Whether the first element of Article 5.5 establishes a legal obligation to achieve consistency

(ii) Determination of the appropriate level of protection

(iii) “Arbitrary or unjustifiable” distinctions in levels of protection

(iv) Distinctions which “result in discrimination or a disguised restriction on international trade”

(e) Guidelines to further the practical implementation of Article 5.5

(f) Relationship with other paragraphs of Article 5

(g) Relationship with other Articles

(i) Article 1.1

(ii) Article 2.2

(iii) Article 5.6

(h) Relationship with other Agreements

7. Article 5.6

(a) Applicability

(b) Three cumulative elements

(i) General

(ii) Burden of proof

(iii) Order of analysis

(c) Alternative measure

(i) is reasonably available

(ii) taking into account technical and economic feasibility

(iii) achieves the Member’s appropriate level of sanitary or phytosanitary protection

(iv) is significantly less restrictive to trade than the SPS measure contested

(d) Burden of proof

(e) Relationship with other paragraphs of Article 5

(i) Article 5.1

(f) Relationship with other Articles

(i) Article 1.1

(ii) Article 2.2

(iii) Articles 5.4 to 5.6 and Articles 2.2 and 2.3

(g) Relationship with other Agreements

8. Article 5.7

(a) Whether Article 5.7 operates as a qualified exemption or an autonomous right

(b) Scope

(c) Four cumulative requirements

(i) where relevant scientific evidence is insufficient

(ii) adopted on the basis of available pertinent information

(iii) seek to obtain the additional information necessary for a more objective assessment of risk

(iv) review the SPS measure accordingly within a reasonable period of time

(d) Burden of proof

(i) Relevance of characterization of Article 5.7 as a right rather than an exception

(ii) Burden of proof when Article 5.7 is argued in the alternative

(iii) Consolidated burden of proof for Articles 2.2 and 5.7

(e) Precautionary principle

(f) Relationship with other paragraphs of Article 5

(i) Article 5.1

(g) Relationship with other Articles

(i) Article 2.2

(ii) Article 3.2

(iii) Similarity of relationships between Articles 3.1 and 3.3 and Articles 2.2 and 5.7

9. Article 5.8

(a) General

(b) Relationship with other paragraphs of Article 5

(i) Article 5.1

(c) Relationship with other Articles

(i) Article 2.2

10. Relationship of Article 5 generally with other Articles

(a) Articles 2 and 3


VII. Article 6

A. Text of Article 6
B. Interpretation and Application of Article 6

1. General

2. Guidelines to further the practical implementation of Article 6

(a) General

(b) Recognition


VIII. Article 7

A. Text of Article 7
B. Interpretation and Application of Article 7

1. Scope of application

2. Notification requirements

(a) Obligation to “provide information on SPS measures”

(b) Obligation to “notify changes” in SPS measures

3. Recommended notification procedures

4. Recommended procedures for implementing the transparency obligations of the SPS Agreement

5. Relationship with other provisions of the SPS Agreement

(a) Annex B


IX. Article 8

A. Text of Article 8
B. Interpretation and Application of Article 8

1. General

2. Relationship with other Articles

(a) Annex C

(b) Article 5.2 and Annex C


X. Article 9

A. Text of Article 9
B. Interpretation and Application of Article 9


XI. Article 10

A. Text of Article 10
B. Interpretation and Application of Article 10

1. General

2. The Procedure to Enhance Transparency of Special and Differential Treatment in Favour of Developing Country Members

(a) General

(b) Notification

(c) Entry into force of a new measure

(d) Transparency

3. Article 10.1

(a) Members shall “take account of” the special needs of developing country Members

(b) Burden of proof

(c) Relationship with other Agreements

4. Article 10.2

(a) longer time-frame for compliance

(b) where phased introduction of SPS measures is not possible


XII. Article 11

A. Text of Article 11
B. Interpretation and Application of Article 11

1. Articles of the SPS Agreement invoked in panel and Appellate Body proceedings

2. Article 11.2

(a) General

(b) Scope of application

(c) Role and value of experts

(d) Selection of experts

(i) The need for experts

(ii) Importance of selection process

(iii) Consultation with the parties to the dispute

(iv) Individual experts or expert review group

(v) Number of experts

(vi) International organizations

(vii) Conflict of interest

(e) Obligations of individual experts

(f) Consultation with experts

(i) Significant investigative authority

(ii) Due process

(g) Relationships with other provisions of WTO Agreements

(i) Article 14 of the TBT Agreement

(ii) Article 13 of the DSU

(iii) Rules of Conduct


XIII. Article 12

A. Text of Article 12
B. Interpretation and Application of Article 12

1. Article 12.1

(a) General

(b) Relationship with other Articles

(i) Article 3.5

(ii) Article 5.5

2. Article 12.2

(a) General

(b) Relationship with other Articles

(i) Article 5.5

3. Article 12.3

(a) General

(b) Relationship with other Articles

(i) Article 5.5

4. Article 12.4

(a) General

(b) Relationship with other Articles

(i) Article 3.5

5. Article 12.7


XIV. Article 13

A. Text of Article 13
B. Interpretation and Application of Article 13

1. Scope of the SPS Agreement

2. SPS-related private standards


XV. Article 14

A. Text of Article 14
B. Interpretation and Application of Article 14


XVI. Annex A

A. Text of Annex A
B. Interpretation and Application of Annex A

1. Annex A(1): sanitary or phytosanitary measure

(a) The definition of an SPS measure

(i) Relevance of trade effects of a measure

(ii) Purpose, form and nature

(iii) Principal and ancillary measures

(iv) Substantive SPS measures and procedural requirements

(v) SPS measures’ identification in terms of their purpose

(vi) Whether a law, or a requirement contained therein, may be deemed to embody an SPS measure as well as a non-SPS measure

(b) Annex A(1)(a)

(i) General

(ii) “to protect animal or plant life or health”

(iii) “risks arising from”

(iv) “entry, establishment or spread”

(v) “pests”

(vi) “diseases, disease-carrying organisms or disease-causing organisms”

(c) Annex A(1)(b)

(i) General

(ii) “foods, beverages or feedstuffs”

(iii) “additives”

(iv) “contaminants”

(v) “toxins”

(d) Relationship between Annex A(1)(a) and Annex A(1)(b)

(e) Annex A(1)(c)

(i) The issue of presence of allergens in the environment

(ii) Possible health effects from increased herbicide use associated with GMOs

(f) Annex A(1)(d)

(i) “other damage”

(ii) Relationship with other provisions of the SPS Agreement

(g) Annex A(1) second paragraph

(i) General

(ii) “all relevant laws, decrees, regulations”

(iii) “requirements and procedures”

(iv) “labelling requirements”

(v) “directly related to food safety”

2. Annex A(3): “international standards, guidelines and recommendations”

(a) Relationship with Articles 3.1 and 3.2

3. Annex A(4): “risk assessment”

(a) General

(b) First part of Annex A(4): First definition of risk assessment

(i) Types of risks

(ii) Elements of a risk assessment

(iii) Identifying risk on a disease-specific basis

(iv) “likelihood”

(v) “according to the [SPS] measures which might be applied”

(vi) “Evaluation of likelihood of entry, establishment or spread of a pest or disease”

(c) Second part of Annex A(4): Second definition of risk assessment

(i) Distinction from the first definition of risk assessment

(ii) No requirement to quantify the level of risk

(iii) Methodology of risk assessment

(d) Distinction between “risk assessment” and “risk management”

(e) Relationship with other provisions of the SPS Agreement

4. Annex A(5): “appropriate level of protection”

(a) General

(i) Right to determine the appropriate level of protection

(ii) Relationship between the “risk assessment” and the “appropriate level of protection”

(iii) Relationship between the “SPS measure” and the “appropriate level of protection”

(b) Relationship with other provisions of the SPS Agreement

(i) Article 3.3

(ii) Article 5.4

(iii) Article 5.5

(iv) Article 5.6

(v) Article 5.7


XVII. Annex B

A. Text of Annex B
B. Interpretation and Application of Annex B

1. Annex B(1): publication requirements

(a) Footnote to Annex B(1)

(b) Scope of application of publishing requirements

(c) Publication versus information

2. Annex B(2): “reasonable interval”

3. Annex B(3): enquiry points

(a) General

(b) Paragraph 3(d)

4. Annex B(5): conditions for notification requirements

5. Recommended procedures for implementing the transparency obligations of the SPS Agreement (Article 7)

C. Relationship with other Provisions of the SPS Agreement

1. Article 7


XVIII. Annex C

A. Text of Annex C
B. Interpretation and Application of Annex C

1. Annex C(1)

(a) General

(b) Application of Annex C(1)

(i) General

(ii) Temporal scope

(c) Annex C(1)(a) first clause

(i) Rationale of the provision

(ii) “undertake and complete”

(iii) “without undue delay”

(d) Annex C(1)(a) second clause

(e) Annex C(1)(b)

(i) General

(ii) First obligation in Annex C(1)(b): publication or communication of processing period

(iii) Second obligation in Annex C(1)(b): completeness of documentation

(iv) Third obligation in Annex C(1)(b): transmission of results

(v) Fourth obligation in Annex C(1)(b): processing of deficient applications

(vi) Fifth obligation in Annex C(1)(b): explanation of delay

(f) Annex C(1)(c)

(g) Annex C(1)(e)

2. Relationships with other provisions of the SPS Agreement

(a) Article 4

(b) Article 8


XIX. Relationship of the SPS Agreement with other WTO Agreements

A. WTO Agreement

1. Article XVI:4

B. TBT agreement

C. GATT 1994

1. Order of analysis

2. Article III and Article XI

(a) The Panel’s exercise of judicial economy

3. Article XX(b)

4. Articles XXII and XXIII

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