10. The Proposed Draft Guidelines had been discussed at the Committee’s Fourth and Fifth Sessions[8] based on proposals prepared by the United States of America. The Delegation of the United States stated that the present text had been prepared in the light of these prior discussions and comments received. It was noted that the Guidelines stressed the practical requirements which needed to be taken into account in the establishment of equivalence agreements and that agreements based on recognition of mutual compliance with requirements had been excluded from the text as previously agreed by the Committee. The revised text covered several types of agreements, including those devoted to either single or multiple issues (food quality and safety issues) or single or multiple products. It also provided flexibility by recognizing that in some situations equivalent systems were already in place whereas in other situations the equivalence of systems had yet to be determined or systems were still being established. The use of several terms which were considered either unclear or open to misinterpretation had been discontinued.
General
11. The representative of FAO noted the work of that Organization with both developing and developed countries to establish effective control systems for food quality and safety based on Codex standards and related texts. Noting that Codex standards and other texts were used as benchmarks for international trade under both the WTO SPS and TBT Agreements, the representative pointed out that the text under discussion also needed to make clear and regular reference to Codex work. Moreover, in view of the real problems encountered in international trade in foods, as was evident from the available statistics on rejection of foods at the point of import, the scope of the agreements to be covered by the proposed draft Guidelines should explicitly refer to both food quality as well as safety issues and should emphasize integrated cost-effective food quality and safety systems. The representative also proposed a definition of “Objectives” linking the use of the term to food quality and safety systems which assure that food products meet Codex standards and related texts and any additional national requirements which were in conformity with the SPS and TBT Agreements. The Committee supported the principle that there should be significant reference to Codex standards and other texts in the Guidelines.
12. The Committee confirmed that the Guidelines should be limited to “Equivalence Agreements” and that “Conformity or Certification Agreements” should be excluded, forming perhaps the subject of a separate text.
13. In response to a question concerning the potential status of Codex Guidelines on equivalence, it was noted by the representative of the WTO that the measures referred to in the SPS Agreement included testing, inspection and certification. The representative of the WTO was of the opinion that the Guidelines would be applicable under the SPS Agreement.
Section 1 - Scope
14. The Committee extended this Section to provide an explanation of the nature of the agreements covered by the Guidelines, using text previously found in the Section on Definitions. Some Delegations expressed concern at the specific reference to Memoranda of Understanding as being among the instruments covered; other Delegations suggested the inclusion of a reference to “exchanges of letters” or “exchanges of diplomatic notes”.
Section 2 - Definitions
15. The previous definition of “Agreement” was removed on the basis of the decision recorded above. The Committee noted that most of the Definitions included in the Proposed Draft Guidelines were identical to definitions previously adopted by the Codex Alimentarius Commission in the Principles for Food Import and Export Inspection and Certification (CAC/GL 20-1995) and the Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems (CAC/GL 26-1997).
Section 3 - Purpose of Agreements
16. The Committee confirmed that Equivalence Agreements should cover food safety together with other legitimate requirements for consumer protection and assurance of fair practices in the food trade as specified in the Statutes of the Codex Alimentarius Commission and as recognized in the WTO SPS and TBT Agreements. The Committee recalled its decision, confirmed by the Codex Alimentarius Commission when it adopted the Principles for Food Import and Export Inspection and Certification, that the term “food quality” was understood to include food safety. However, it was generally understood that the aspects of quality which would be the subject of equivalency agreements would be those which were the subject of government regulations and would not extend to commercial quality considerations. In this regard, the Committee agreed to use the term “Requirements” as defined, wherever possible, as this term incorporated all standards and other measures relating to trade in foodstuffs covering the protection of public health, the protection of consumers and conditions of fair trading.
17. Several of the paragraphs in this section were re-arranged for the purposes of clarity.
Section 4 - Types of Agreements
18. The Committee agreed to simplify this section partly by transferring certain elements to Section 7 (Consultative Process) and partly by eliminating redundant text.
19. The Committee agreed that the decisions by the importing country as to whether the exporting country’s measures met the requirements of equivalence must be made on the basis of objective criteria. It also agreed to state explicitly that agreements may be limited to specific areas of trade or specific products. Bearing in mind that equivalence agreements would cover both food safety and other requirements for consumer protection and assurance of fair practices in the food trade, it was agreed to reflect this in the present Section.
20. The Committee noted that equivalence agreements should cover control and certification systems designed to ensure conformity with requirements rather than design agreements which would attempt to determine equivalence with requirements directly. This was considered particularly important so that Codex standards, codes of practice, guidelines and other recommendations would not be undermined.
21. The Committee also agreed to retain the notion that agreements could be concluded when equivalence had not been established in respect of all requirements.
Section 5 - Considerations Before Entering into Bilateral or Multilateral Discussions
22. The Committee agreed to remove an explicit reference to the use of the Hazard Analysis and Critical Control Point System (HACCP) as an example of a building block towards the development of agreements, because this system had been identified by the Codex Alimentarius Commission as one risk management option with the possibility of using other food safety management systems.
23. The consideration of the provision of technical assistance to developing exporting countries, to facilitate development of an equivalence agreement, was included.
Section 6 - Initiating Discussions Toward an Equivalence Agreement
24. The Committee agreed that in the case of a refusal of a request to prepare an agreement, the statement of reasons why such a request was refused should be accompanied by any relevant recommendations which could facilitate the development of future agreements.
Section 7 - Consultative Process for Equivalence Agreements
25. The Committee noted that the paragraph in this Section concerning assessment and verification of control systems was based on parts of the adopted Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems (CAC/GL 26-1997). It agreed that it would be inappropriate to attempt to reword or to condense this carefully constructed text, and decided instead to make clear reference to the appropriate Sections of CAC/GL 26-1997.
26. The Committee agreed to expand the details of some of the examples of types of information to be exchanged between parties to facilitate the consultation process. It also agreed that an exchange of information on the structure and operation of rapid alert systems would be useful to this process.
27. The Committee redrafted the paragraph dealing with provisions for lists of establishments (“firms” in the previous draft) so as to clearly define the rights and obligations of the parties to the agreement in the establishment and maintenance of such lists. The delegation of Brazil stated its view that the right of the importing country to refuse imports should be qualified by an obligation to adequately demonstrate to the exporting country the basis for refusal. The delegation of Malaysia called for the deletion of the words “in addition to or in lieu of certificates” as they were not consistent with the wording of Paragraph 16 of the text. The delegation of Malaysia was informed that the statement recognized that equivalence agreements may result in dispensing with certificates.
28. The Committee noted that the text provided for exchange of information on the evaluation and accreditation of analytical (test) laboratories, where this was appropriate and that the word “accreditation” had not as yet been defined by Codex. It was noted that the Commission had adopted several texts in this area as Codex recommendations and that the Codex Committee on Methods of Analysis and Sampling (CCMAS) was continuing its work in this area. It was agreed that appropriate references, including in relation to the meaning of “accreditation”, arising from the work of the CCMAS would be made in the Guidelines.
Section 8 - Pilot Studies
29. Following a question posed by one Delegation, the Committee agreed that the text of these paragraphs should be worded to indicate that the elements to be covered by pilot studies were optional, for example, any provisions to establish pilot procedures for inspection and certification. It agreed that only those private organizations which had been officially recognized by the competent authorities should be involved in pilot studies.
30. The Committee did not accept a proposal to include provisions concerning confidentiality in view of its commitment to transparency as expressed in other sections of the text under discussion.
Section 10 - Implementing the Agreement
31. The Committee agreed to include provisions relating to the maintenance and further operation of equivalence agreements, and their period and termination.
Appendix - Contents of Agreements
32. The Committee accepted a number of proposals for clarification of the proposed draft text.
Status of the Proposed Draft Guidelines for the Development of Equivalence Agreements Regarding Food Import and Export Inspection and Certification Systems
33. Several Delegations expressed their opinion that the text should be returned to Step 3 for further comments and further discussion at the Committee’s next Session. Noting that the Codex Step Procedure provided for a further round of comments and further discussion and Steps 6 and 7, the Committee decided to advance the Proposed Draft Guidelines to Step 5 for consideration by the 45th Session of the Executive Committee. The text of the Proposed Draft Guidelines may be found in Appendix II to this report.
