70. The Eighth Session of the CCFICS had requested[19] a drafting group under the direction of New Zealand to proceed with the development of proposed draft Guidelines on the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems for circulation and comment at Step 3 prior to its current meeting. In approving the elaboration of the Guidelines as new work, the 47th Session of the CCEXEC indicated that the document should emphasize systems requirements. The CCEXEC also recognized the need to develop guidelines for determining equivalence of food control systems covering not only safety, but also quality and conformity.[20]
71. The Guidelines were revised by a drafting group under the direction of New Zealand with the assistance of Argentina, Australia, Canada, France, Japan, the United States and the European Commission. In redrafting the document, particular attention was given by the drafting group to written and verbal comments provided at the 8th Session of the CCFICS. The Committee agreed to consider the document revised by the drafting group as the basis for its discussions at Step 4.
72. The Committee noted that the intention of the Guidelines was to give application to the Articles on Equivalence in the WTO SPS Agreement insofar as they concerned food import and export inspection and certification systems. It was noted that the Executive Committee had accorded a high priority to this work. It was further noted that these guidelines could provide the basis for work for other Codex Committees, especially the Committee on Food Hygiene in relation to the risk analysis of microbiological hazards in foods, and were of general interest to consumers and civil society.
PREAMBLE
73. Although the Committee noted that not all Members of the Codex Alimentarius Commission were members of the World Trade Organization, the reference to the WTO SPS Agreement was strengthened in view of this important linkage.
SCOPE
74. This Section was amended to reflect the wish of the Executive Committee that the guidelines should emphasize sanitary measures associated with food import and export inspection systems rather than measures per se.
DEFINITIONS
75. The Committee agreed that the definitions in this section should be either those already adopted by the Codex Alimentarius Commission in relation to risk analysis, or derived from the corresponding definitions of the WTO SPS Agreement amended to address food-related sanitary measures only. On this basis, the definition of Sanitary Measure was broadened to take into account diseases that may be carried by foods. Some delegations also suggested that the definition of sanitary measures should be based on the term “hazard”. Delegations stated that the definition of sanitary measure required further careful consideration at national level, and had to be considered in relation to the Scope of the Guidelines.
76. It was also noted that Codex had a significant existing body of work in relation to hazards transmitted through feedstuffs. The Committee therefore agreed to retain the reference to these matters within the context of the draft Guidelines.
77. The Codex definition of “Risk” was added and the definition of “Risk management” deleted, as the latter term was not used in the document.
78. The Committee noted that the determination of the Appropriate Level of Sanitary Protection (ALOP) by a country was essentially a value judgement rather than a scientific determination. Sanitary measures intended to achieve the ALOP should, however, be based on scientific principles. Attention was drawn to the applicable Articles 2, 3, 5 and 7 of the WTO SPS Agreement that indicated how such measures were to be established or maintained by WTO Members. It was further expressed by the delegation of India that this aspect may need to be suitably brought out in the definition of ALOP and the subject may require further reflection. Reference was also made to the Guidelines to Further the Practical Implementation of Article 5.5 (of the SPS Agreement), recently adopted by the WTO Committee on SPS Measures[21]. For the purpose of clarity in the Guidelines, it was agreed that reference to the Appropriate Level of Sanitary Protection would be indicated by the standard abbreviation “ALOP”.
SANITARY MEASURES AND THE DETERMINATION OF EQUIVALENCE
79. The Committee amended the Title of this Section.
80. In relation to the examples of sanitary measures and their partial categorization (paragraph 7), the Committee noted that the examples cited were consistent with those cited in the WTO SPS Agreement whereas the categorization was the basis for the further elaboration of the present document. Some delegations noted that not all of the examples cited had been included in the partial categorization. The Committee agreed to maintain the text as drafted but added references to transport infrastructures (paragraph 7a) and methods of sampling and inspection (paragraph 7c).
81. The Committee decided to strengthen the reference to the concept of a scientific basis for the comparison of sanitary measures including the use of a risk assessment where appropriate (paragraph 9d).
GENERAL PRINCIPLES FOR THE DETERMINATION OF EQUIVALENCE
82. The Committee stressed that countries retained their sovereign right to establish their own ALOP, and noted that the ALOP may be stated in either quantitative or qualitative terms (paragraph 10.1). It was recalled that in establishing an ALOP, the rights and obligations of WTO Members were stated in the WTO SPS Agreement and that the WTO Committee on Sanitary and Phytosanitary Measures had established Guidelines for this purpose.[22]
83. The Committee also agreed to strengthen the provision dealing with transparency, by calling for consultations with all interested parties to the extent practicable and reasonable when judging equivalence.
GUIDELINES FOR THE DETERMINATION OF EQUIVALENCE
84. The Committee agreed to insert text regarding the exchange of information on the importing country’s sanitary measures and the review of this information by the exporting country (paragraph 11). The new text combined several themes under this section and as a result some paragraphs were deleted.
85. The Committee had an extended discussion on the issues of modalities of resolution of differences of opinion over judgement of a submission, but agreed that consideration of such modalities were beyond the scope of the Guidelines.
86. The Committee agreed to remove from paragraph 12.3 reference to the dialogue on an objective basis for comparison having the purpose of reaching agreement.
87. The Flow Chart (Figure 1) was amended to reflect the amended Procedure for the Determination of Equivalence.
JUDGEMENT
88. The Committee agreed to restate the need for transparency in the analytical process on which a judgement is based and the need for consultation with all interested parties to the extent practicable and reasonable. It decided to simplify the remaining paragraphs of this Section and in particular decided to delete the examples of the types of information to be taken into account in making a judgement on the basis that the examples were either repetitious of other material or insufficiently detailed to provide adequate guidance in the matter. The Committee agreed that development of examples of the information to be taken into account when making judgements could perhaps be developed in the future as an Annex.
STATUS OF THE PROPOSED DRAFT GUIDELINES ON THE JUDGEMENT OF EQUIVALENCE OF SANITARY MEASURES ASSOCIATED WITH FOOD INSPECTION AND CERTIFICATION SYSTEMS
89. The Committee noted that significant progress had been made in the consideration of the issues contained in the text and that all outstanding differences of opinion had been resolved. It therefore agreed to advance the proposed draft Guidelines to Step 5 of the Procedure and recommended that the 24th Session of the Commission omit Steps 6 and 7 and proceed to the adoption of the Guidelines at Step 8.
90. In view of extensive changes made to the document which was recently approved as new work at the 47th Session of the CCEXEC, the delegation of Malaysia was of the view that more time was needed to scrutinize the work through another round of comments at Step 6. It was suggested therefore that the document advance through the normal Codex step procedure. The delegation of India, supported by Brazil and Mexico, expressed the view that a number of new concepts and other changes had been introduced to the document. It was therefore necessary that the document be discussed with government and other interested parties in the country and therefore suggested that the document be progressed in the normal Codex step procedure. Brazil also proposed that the present Guidelines should be integrated with the proposed draft Guidelines on the Judgement of Equivalence of Technical Regulations Associated with Food Inspection and Certification Systems. The delegation of Botswana raised concern that in light of the limited participation of African countries due to the costs involved in attending Committee sessions, it would prefer that the document be advanced in the normal step procedure in order to benefit from further discussions and contributions in other fora. The Delegations of Argentina, Cuba and Uruguay generally supported these views and also drew attention to divergences in the revised Spanish text when compared to the English Version. The delegation of the United Kingdom noted in particular its concern regarding the scope of the document and the definition of sanitary measures and that it did not have the opportunity to discuss the document with other interested parties, including consumer groups. The Delegation of France noted discrepancies in the French version of the text.
91. The Committee noted that the recommendation to the Commission to omit Steps 6 and 7 meant that the option of returning the text for a further round of comments was available to the Commission if the comments received at Step 5 suggested that this would be appropriate. If, on the other hand, the comments received at Step 5 favored the advancement of the text, the Commission had the option to proceed directly to Step 8.
92. The revised text is given in Appendix III to the present report.
