INTRODUCTION AND OPENING OF THE SESSION(Agenda Item 1)

1.   The Fifth Session of the Codex Committee on Food Import and Export Inspection and Certification Systems was held in Sydney, Australia, from 17 to 21 February 1997, at the kind invitation of the Government of Australia. Mr. Digby Gascoine, Australia Quarantine and Inspection Service, chaired the Session. The meeting was attended by 201 participants from 47 Member countries, 1 observer country and 8 international organizations. A List of Participants is attached to this report as Appendix I.

2.   The Session was opened by Senator David Brownhill, Australian Parliamentary Secretary to the Minister for Trade and to the Minister for Primary Industry and Energy. Referring to Australia's continuous efforts to supply safe and quality foods to consumers, he emphasized the importance of Codex and regional economic groups in the harmonization process of food import and export inspection and certification. Mr. Gregory D. Orriss, Chief of the Joint FAO/WHO Food Standards Programme and Secretary of the Codex Alimentarius Commission, thanked the Government of Australia for its support in hosting the Committee and reiterated the increasingly important role of Codex under the World Trade Organization (WTO) Agreements on the Application of Sanitary and Phytosanitary Measures (SPS) and on Technical Barriers to Trade (TBT).

ADOPTION OF THE AGENDA (Agenda Item 2)¹

3.   The Committee adopted the Provisional Agenda as proposed. It agreed that a document regarding Residue Management Initiatives in Codex would be discussed under Other Business and Future Work (see paras. 46–50).

4.   The delegation of India noted that notwithstanding the useful work of CCFICS, the Committee should take the needs of developing countries into account in the elaboration of guidelines and standards, so that the necessary infrastructures to facilitate their implementation could be established.

MATTERS REFERRED FROM CODEX COMMITTEES(Agenda Item 3)²

5.   The Committee noted that FAO and WHO had jointly convened an Expert Consultation on the Application of Risk Management to Food Safety Matters from 27–31 January 1997. The observer from Consumers International noted their desire to participate in expert Consultations and in this regard, informed the Committee that a document addressing various aspects of risk management issues was being prepared.

6.   On the subject of model certificates (see paras. 35–39), the delegation of Argentina informed the Committee that MERCOSUR countries had elaborated a model certificate for vegetables and were still working on certificates covering other commodities. The observer from the European Community informed the Committee that a directive concerning certification of animals and products of animal origin had been adopted in December 1996. The Committee was further advised that a draft model certificate in relation to dairy products was being prepared for consideration at the next session of the Codex Committee on Milk and Milk Products.

7.   The Committee was encouraged to submit comments on the draft Code of Practice for the Quality Inspection and Certification of Fresh Fruits and Vegetables currently under development by the Codex Committee on Fresh Fruits and Vegetables (ALINORM 97/35, Appendix XI).

¹ CX/FICS 97/1-Corrigendum and comments from India (CRD 3).
² CX/FICS 97/2 and comments from India (CRD 3).

DRAFT GUIDELINES FOR THE DESIGN, OPERATION, ASSESSMENT AND ACCREDITATION OF FOOD IMPORT AND EXPORT INSPECTION AND CERTIFICATION SYSTEMS AT STEP 7

(Agenda Item 4)³

8.   The Guidelines had been adopted by the 43rd Session of the Executive Committee at Step 5⁴. Comments were subsequently requested at Step 6 under CL 1996/28-FICS.

9.   The Committee reviewed the document and made the following substantial changes:

• The title of Section 1 was revised to “Objectives”, and paragraphs 1 and 2 were combined and simplified. The Committee agreed to add a footnote to “countries” at its first mention in the text to indicate that the term also included regional economic groupings within the context of the Guidelines. This decision was taken with the understanding that the Commission and the Legal Counsels of FAO and WHO would review the appropriateness of extending the application of the Guidelines to regional economic groupings.

• A footnote incorporating paragraph 18 of the Principles for Food Import and Export Inspection and Certification was added to indicate that importing countries should take the capabilities of developing countries into account.

• A statement was added to indicate that the expectations of consumers should be taken into account by governments when applying the Guidelines. The delegation of Malaysia indicated that the protection of consumers was already adequately covered in the Guidelines and the phrase “expectations of consumers” could be interpreted in different ways, and therefore, objected to this decision.

• Definitions for Risk Analysis, Risk Assessment, Risk Management and Risk Communication were added to the Definitions section on the basis of definitions developed by the Codex Committee on General Principles.⁵

• The Section concerning Risk Analysis was modified to indicate that the consistent and transparent application of risk analysis would enable inspection resources to be effectively targeted on hazards to public health.

• It was clarified that the term “inspection and certification” should be read as meaning “inspection and/or certification” at their first mention in the text.

• The Section concerning Equivalence was clarified to indicate that evaluations of inspection and certification systems carried out by importing countries should take account of exporting country evaluations performed by competent authorities or third party bodies recognized by the competent authority.

• The Sub-Section concerning Control Programmes and Operations was strengthened to indicate that official inspectors should be adequately trained in the application of the Hazard Analysis and Critical Control Point (HACCP) System and its assessment thereof.

• The Sub-Section concerning Decision Criteria and Action was revised to indicate that physical checks applied to imports should be based on the risk associated with the importation.

• The Sub-Section addressing Personnel was revised to indicate that official inspectors should be adequately trained and independent to ensure their impartiality.

³ ALINORM 97/30, Appendix 3 and comments from Australia, Denmark, Malaysia, Norway, Thailand, the United Kingdom and the European Community (CX/FICS 97/3), the United Kingdom and the United States (CRD 1), the European Community (CRD 2), and India (CRD 3).
⁴ ALINORM 97/3, Paragraph 18 and Appendix 3.
⁵ ALINORM 97/33, Paragraph 21 and Appendix III(b).

Status of the Draft Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems

10.   The Committee advanced the revised text to Step 8 of the Codex procedure for consideration by the 22nd Session of the Codex Alimentarius Commission. The Complete text of the Guidelines is attached as Appendix II.

11.   The delegations of Malaysia and India expressed their reservations with this decision because in their view another round of comments was necessary to allow countries to study the implementation and long term implications of the Guidelines. The delegation of the United States expressed concerns on issues related to food safety versus food quality, the equivalency of inspection systems utilized by different countries, third party inspection and certification and the need for additional time to review and further consider the substantive changes made to the Guidelines. The delegations of China, Mexico, the Philippines and Consumers International also expressed their reservations to the advancement of the Guidelines.

PROPOSED DRAFT GUIDELINES ON THE PRINCIPAL ELEMENTS IN AN ELECTRONIC DOCUMENTATION SYSTEM (Agenda Item 5)⁶

12.   The delegation of Australia introduced the document, which had been revised in light of discussions at the 4th Session of CCFICS.⁷.

13.   While recognizing the advantages of electronic documentation systems and the usefulness of the document, some delegations expressed their concern that electronic documentation systems were not yet universally used and the economic and technological resources available in developing countries should be taken into account so that such systems could be introduced gradually.

14.   Other delegations noted that the document should more effectively address solutions to security issues and that technical difficulties might arise in a multilingual environment or when the destination of cargoes was changed after electronic documents had been issued. It was also noted that the legal status of electronic documentation differed from country to country.

15.   A question was raised as to the status of the document under the WTO Agreements, in relation to the possible title of the document, which had been proposed to be either a “Guideline” or “Information Note”. The Committee was informed that the status of Codex documents under the WTO Agreements was discussed at the twelfth Session of the Codex Committee on General Principles,⁸ where it was stated that “all types of Codex texts when applied to foods in international trade would be covered either by the definitions of international standards, guidelines and recommendations under SPS or the definition technical regulation or standard under TBT, and any qualification proposed to the texts within Codex could not alter their status under the WTO Agreements”.

16.   Although several delegations supported further elaboration of the document, a number of delegations were of the opinion that further elaboration of the document as a Codex text would be inappropriate in view of the concerns expressed above and the uncertainty about the status of the document under the WTO Agreements.

⁶ CX/FICS 97/4 and comments from the European Community (CRD 2) and India (CRD 3).
⁷ ALINORM 97/30, paragraphs 10–13.
⁸ ALINORM 97/33, paragraphs 25–32.

Status of the Proposed Draft [Guideline/Information Note] on Export/Import Certification through Electronic Documentation Systems

17.   The Committee, thanking the delegation of Australia for its outstanding efforts, agreed that further elaboration of the document as an official Codex text be discontinued. The delegation of Australia indicated that after revision of the document in light of the comments received, it would be circulated as an independent Australian document to countries for information only.

PROPOSED DRAFT GUIDELINES ON THE APPLICATION OF THE ISO 9000 SERIES TO FOOD INSPECTION AND CERTIFICATION SYSTEMS

(Agenda Item 6)⁹

18.   The delegation of France introduced the document which had been revised on the basis of discussions at the 4th Session of CCFICS¹⁰ by expanding its scope to include other quality assurance systems than the ISO 9000 Series and by emphasizing the linkage between the HACCP system and other quality assurance systems, including the ISO 9000 Series.

19.   Several delegations noted that the document's emphasis still focused on the ISO 9000 Series. They suggested the discontinuation of work on this matter, as it was considered inappropriate for Codex to endorse a particular quality assurance system, and that food safety issues were satisfactorily addressed by adherence to good manufacturing practices and to HACCP principles, the guidelines for which had been already adopted by Codex. It was also noted that the application of the HACCP system adequately addressed the needs of the WTO SPS Agreement.

20.   Other delegations stated that taking account of the ISO 9000 Standards and other quality assurance systems was in line with the Draft Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems¹¹ and would contribute to the efficient operation of official inspection services, and recalled that the development of guidelines for the utilization, as and when appropriate, of quality assurance systems in the context of inspection and certification was a part of the mandate of the Committee. They also stated that these systems would assist in increasing the confidence of consumers and could be implemented even in developing countries in some instances.

Status of the Proposed Draft Guidelines for the Taking into Account of Quality Assurance Systems, Particularly ISO 9000 Series Standards, by Official Systems for Food Import and Export Inspection and Certification

21.   The Committee, thanking the delegation of France for its outstanding efforts, agreed that the further elaboration of the document as an official Codex text be discontinued. The delegation of France indicated that after revision of the document in light of the comments received, it would be circulated as an independent French document to countries for information only.

⁹ CX/FICS 97/5 and comments from the European Community (CRD 2) and India (CRD 3).
¹⁰ ALINORM 97/30, Paragraphs 14–18.
¹¹ ALINORM 97/30A, Appendix II, Section 4.

PROPOSED DRAFT GUIDELINES FOR THE DEVELOPMENT OF AGREEMENTS REGARDING FOOD IMPORT AND EXPORT INSPECTION AND CERTIFICATION SYSTEMS

(Agenda Item 7)¹²

22.   The proposed draft Guidelines were prepared by the United States on the basis of discussions held at the 4th CCFICS.¹³

23.   The United States indicated that the document provided practical guidance for governments desiring to enter into bilateral or multilateral agreements concerning food import and export inspection and certification systems. It was noted that the types of agreements proposed were based on the recognition of equivalence with importing country requirements and the recognition of meeting national requirements.

24.   It was noted that procedures for concluding agreements should commence with the mutual comparison of food legislation systems. It was also stated that criteria for equivalency should be incorporated into the document (see para. 53).

25.   Concerns were expressed in the proposed Definition section for the term “agreements” because mechanisms such as the “exchange of letters” and “regulations” were subject to possible mis-interpretation. It was also suggested that the term “equivalency” should be further developed by taking concepts of harmonization and mutual recognition into account. It was noted that a definition for “agency” was also required. The delegation of Malaysia requested clarification on the objective of the Guidelines as to whether this would result in less inspection by the importing country at the point of entry.

26.   It was suggested to reference the expectation of consumers in helping to achieve international harmonization under the Section addressing the Purpose of Agreements. It was also stated that the Section concerning Types of Agreements should be restricted to equivalence agreements only, as agreements to meet national requirements based on bilateral arrangements could be contrary to the spirit of the provisions of the WTO SPS and TBT Agreements.

27.   It was noted that in the Section concerning the Consultative Process for Equivalence Agreements, the notion of the importing country identifying all of the individual health risks that its control measures address was unrealistic and overly broad. The maintenance of lists of “acceptable” establishments was noted to be the responsibility of both exporters and importers. It was also emphasized that participating agencies should provide the public an opportunity to comment on the basis for equivalence determinations.

28.   It was also suggested that once they had been further developed, the Guidelines could be considered for incorporation into the Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems.

Status of the Proposed Draft Guidelines for the Development of Agreements Regarding Food Import and Export Inspection and Certification Systems

29.   The United States agreed to revise the document based on the above discussions and other points made during the meeting for circulation and comment at Step 3 prior to the Committee's sixth Session, with the understanding that such guidelines might eventually be incorporated into the

¹² CX/FICS 97/6 and comments from the European Community (CRD 2) and India (CRD 3).
¹³ ALINORM 97/30, Paragraphs 19–20.

Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems.

IMPLICATIONS OF DELETING THE PHRASE “OR RISK OF CONTAMINATION” FROM THE PRINCIPLES FOR FOOD IMPORT AND EXPORT INSPECTION AND CERTIFICATION

(Agenda Item 8)¹⁴

30.   The Committee recalled that the 21st Session of the Codex Alimentarius Commission, when adopting the Principles for Food Import and Export Inspection and Certification with the deletion of the phrase “or risk of contamination” at the end of Paragraph 9¹⁵, asked CCFICS to give further consideration to the implications of this decision.

31.   Some delegations were of the opinion that the deletion had resulted in narrowing the focus of the paragraph to microbial risks only and excluded chemical and physical risks. The delegation of Australia suggested an amendment so that the paragraph would read as follows:

“Inspection systems should be applied to particular commodities and processing methods in proportion to the assessed risks. In undertaking a risk assessment or in applying the principles of equivalence, importing countries should give due consideration to documented evidence statements by exporting countries of their status on a national or area basis of freedom with respect to particular food-borne hazards from food related disease.”

32.   A number of delegations supported this proposal, noting that exporting countries could only indicate the possible presence/absence of hazards and final risk management decisions should be taken by the importing countries on the basis of the information provided.

33.   Other delegations disagreed, however, being of the view that there had been little experience regarding recognition of “freedom” in defined geographical areas in relation to hazards other than infectious diseases including zoonoses and, therefore, the paragraph should remain as adopted. It was further commented that the phrase “documented evidence” could be open to misinterpretation.

34.   In light of this discussion, the Committee decided to make no proposal for amendment of the Principles already adopted by the Commission.

GUIDELINES AND CRITERIA FOR A GENERIC OFFICIAL CERTIFICATE FORMAT

(Agenda Item 9)¹⁶

35.   The Guidelines and Criteria were prepared by Australia on the basis of discussions at the 4th CCFICS.¹⁷ This issue was also discussed at the 22nd Session of the Codex Committee on Fish and Fishery Products¹⁸ and the 2nd Session of the Codex Committee on Milk and Milk Products.¹⁹

¹⁴ CX/FICS 97/7 and comments from the European Community (CRD 2) and India (CRD 3).
¹⁵ ALINORM 95/37, Paragraph 54. Paragraph 9 currently reads “Inspection systems should be applied to particular commodities and processing methods in proportion to the assessed risks. In undertaking a risk assessment or in applying the principles of equivalence, importing countries should give due consideration to statements by exporting countries on a national or area basis of freedom from food-related disease”.
¹⁶ CX/FICS 97/8 and comments from the European Community (CRD 2) and India (CRD 3).
¹⁷ ALINORM 97/30, Paragraphs 21–24.
¹⁸ ALINORM 97/18, Paragraphs 6–8.
¹⁹ ALINORM 97/11, Paragraph 89.

36.   Australia noted that the Guidelines were developed to assist Codex commodity committees as a basis for the elaboration of certificates specific to groups of commodities. It was stressed that the Model Certificate was based on work undertaken by other international organizations such as the UNECE.

37.   Several delegations noted that the development of commodity specific certificates by Codex commodity committees was a more logical approach in the control of specific groups of foods and that commodity committees could base their work on the UNECE format. The difficulty of developing a generic certificate intended for commodity wide application was also stressed, in view of the commodity specific elements required. The difficulty of one individual or agency certifying the various elements contained in the Model Certificate was also noted. It was suggested that the document be used as an information note only.

38.   Other delegations noted that the development of guidelines for the required minimum elements of a certificate would be useful for other Codex commodity committees in their elaboration of specific commodity based certificates. A delegation noted that the development of a model certificate was intended to identify essential fields which could be expanded by commodity committees to include other specific areas.

Status of the Guidelines and Criteria for a Generic Official Certificate Format

39.   In view of the diverse opinions expressed, the Committee decided to append the Criteria for a Generic Certificate for the Export of Food and Food Products and the Model Certificate to its report (see Appendix III) in order to facilitate Commission discussions as to the need for further consideration by CCFICS of this matter from the different perspective of Codex commodity committees.

GUIDELINES ON FOOD IMPORT CONTROL SYSTEMS

(Agenda Item 10)²⁰

40.   At its 4th Session, the Committee asked the Codex Secretariat and Mexico to develop a discussion paper on the feasibility of developing Guidelines on Food Import Control Systems for consideration at its present session.²¹

41.   The delegation of Mexico introduced the document, which proposed three options:

Option 1: Develop a list or inventory of references that are relevant to imported food control;

Option 2: Prepare a concise, stand-alone document which sets out the principles that an imported food control system should encompass;

Option 3: Update, consolidate and re-develop existing work as a Codex guideline document.

42.   Some delegations stressed the necessity of elaborating Codex Guidelines on Food Import Control Systems, which would particularly assist developing countries in meeting the requirements under the WTO Agreements, thereby facilitating trade and protecting consumers'health.

43.   While recognizing the rationale for the proposed guidelines, other delegations stated that such guidelines would not be essential as most of the important principles were already included either in existing Codex texts, namely the Principles for Food import and Export Inspection and Certification²², or in the WTO SPS and TBT Agreements. It was also stated that it was within the mandate of FAO and WHO, and not that of Codex, to assist countries in building and improving their food import control systems and new guidelines might duplicate existing work in this area.

²⁰ CX/FICS 97/9 and comments from the European Community (CRD 2) and India (CRD 3).
²¹ ALINORM 97/30, Paragraphs 30–31.
²² CAC/GL 20–1995.

44.   The Committee did not reach agreement on whether or not to elaborate the guidelines. To facilitate its future decision making, the Committee requested the delegation of Mexico, with assistance from the delegation of the United States, to further develop the discussion paper in line with Option 3, but taking account of the need to avoid an excessive level of detail or the duplication of other work in this area. It was agreed that the Committee would revisit this issue at its next session, while asking further guidance from the Commission.

OTHER BUSINESS AND FUTURE WORK (Agenda Item 11)

Rules Relating to the Production and Issue of Certificates

45.   In view of time constraints, the Committee decided to discuss at its next Session the proposal of the United Kingdom that the above mentioned text²³ be incorporated into or annexed to the draft Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems.

Residue Management Initiatives in Codex²⁴

46.   The document was submitted by Australia on the basis of discussions held at the 43rd Session of the Executive Committee²⁵. Subsequent to the CCEXEC meeting, the 10th Session of the Codex Committee on Residues of Veterinary Drugs in Foods²⁶ had examined a similar proposal and decided not to pursue its recommendations further, especially in consideration of steps already taken by the Committee to expedite the MRL setting process. It was noted that the document, which was a revised version of the text examined by the CCRVDF, was also scheduled for discussion at the forthcoming 29th Session of the Codex Committee on Pesticide Residues.

47.   The delegation of Australia stated that the paper explored various options for further facilitating international trade by the elaboration of appropriate guidelines which, while not compromising the level of public health protection, could be applied in situations when either Codex MRLs were non-existent or when importing countries apply default tolerances (frequently zero or near to zero) which were not scientifically based. The delegation of Australia further suggested this was an appropriate proposal for consideration by CCFICS, in view of the expertise in international trade embodied in the Committee.

48.   Several delegations noted that as the subject proposal had not been accepted by the CCRVDF and was scheduled for discussion by the CCPR, the question of its further elaboration should be left to experts participating in these committees, which had responsibility for such matters. It was also suggested that the document was outside the mandate of CCFICS.

49.   It was also stated that the document did not adequately address science or the extent to which other factors should be taken into account, failed to embrace a precautionary approach and did not consider consumer concerns.

²³ Conference Room Document 1.
²⁴ CX/FICS 97/2-Add. 1 and comments from the European Community (CRD 2).
²⁵ ALINORM 97/3, Paragraphs 34–38.
²⁶ ALINORM 97/31A, Paragraphs 67–68.

50.   In view of the above discussion, the Committee decided not to pursue its consideration.

Development of a Data Base on Rejections of Foods

51.   The observer of Consumers International requested the Committee to consider the development of a data base on rejections of foods, in view that the Principles for Food Import and Export Inspection and Certification²⁷ state that the principles and operations of food inspection and certification systems should be open to scrutiny by consumers and their representative organizations.

52.   Some delegations supported the establishment of such a data base. The Committee noted that Consumers International could independently develop such a proposal for further consideration at a future meeting. Other delegations recalled that the matter was previously discussed by the Committee, which at that time had not chosen to take any consequential action.

Judgement of Equivalence

53.   The Committee agreed that a discussion paper on issues relating to the process of judgement of equivalence would be prepared for circulation and comment prior to its next Session. The delegation of New Zealand agreed to take the lead on this proposal, with assistance provided by Australia, Canada and the United States.

DATE AND PLACE OF NEXT SESSION (Agenda Item 12)

54.   The Committee was informed that its 6th Session was tentatively scheduled to be held in Australia from 16 to 20 March 1998, with the location to be determined between the Codex and Australian Secretariats. The delegation of Germany, supported by the United Kingdom, expressed the view that there was no need for any early meeting of the Committee.

²⁷ CAC/GL 20-1995.

ANNEX

CODEX COMMITTEE ON FOOD IMPORT AND EXPORT INSPECTION AND CERTIFICATION SYSTEMS

CURRENT STATUS OF WORK