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

CAC/GL 26-1997

SECTION 1 - OBJECTIVES

1. These guidelines provide a framework for the development of import and export inspection and certification systems consistent with the Principles for Food Import and Export Inspection and Certification[1]. They are intended to assist countries[2] in the application of requirements and the determination of equivalency, thereby protecting consumers and facilitating trade in foodstuffs.[3]

2. The document deals with the recognition of equivalence of inspection and/or certification systems and not with standards related to specific food products or their components (e.g., food hygiene, additives and contaminants, labeling and quality requirements).

3. Application by governments of the guidelines presented in this document should help build and maintain the necessary confidence in the inspection and certification system of an exporting country and facilitate fair trade, taking account of the expectations of consumers for an appropriate level of protection.

SECTION 2 - DEFINITIONS

Audit is a systematic and functionally independent examination to determine whether activities and related results comply with planned objectives.[4]

Certification is the procedure by which official certification bodies and officially recognized bodies provide written or equivalent assurance that foods or food control systems conform to requirements. Certification of food may be, as appropriate, based on a range of inspection activities which may include continuous on-line inspection, auditing of quality assurance systems, and examination of finished products.[5]

Equivalence is the capability of different inspection and certification systems to meet the same objectives.

Inspection is the examination of food or systems for control of food, raw materials, processing and distribution, including in-process and finished product testing, in order to verify that they conform to requirements.[6]

Official accreditation is the procedure by which a government agency having jurisdiction formally recognizes the competence of an inspection and/or certification body to provide inspection and certification services.

Official inspection systems and official certification systems are systems administered by a government agency having jurisdiction empowered to perform a regulatory or enforcement function or both.[7]

Officially recognized inspection systems and officially recognized certification systems are systems which have been formally approved or recognized by a government agency having jurisdiction.[8]

Requirements are the criteria set down by the competent authorities relating to trade in foodstuffs covering the protection of public health, the protection of consumers and conditions of fair trading.[9]

Risk analysis is a process consisting of three components: risk assessment, risk management and risk communication.[10]

Risk assessment is a scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment and (iv) risk characterization.[11]

Risk management is the process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures. [12]

Risk communication is the interactive exchange of information and opinions concerning risk among risk assessors, risk managers, consumers and other interested parties.[13]

SECTION 3 - RISK ANALYSIS

4. Consistent and transparent application of risk analysis will facilitate international trade by increasing confidence in the food safety and in the inspection systems of trading partners. It will also enable inspection resources to be targeted effectively on hazards to public health arising at any stage of the food production and distribution chain.

5. The principles of Hazard Analysis Critical Control Point (HACCP) developed by the Codex Committee on Food Hygiene[14] provide a systematic basis for the identification and control of hazards so as to ensure the safety of food. The use of a HACCP approach by food businesses should be recognized by governments as a fundamental tool for improving the safety of foodstuffs.

SECTION 4 - QUALITY ASSURANCE

6. The voluntary utilization of quality assurance by food businesses should also be encouraged in order to achieve greater confidence in the quality of products obtained. If safety and/or quality assurance tools are used by food businesses, the official inspection and certification systems should take them into account in particular through the adaptation of their control methodologies.

7. Governments do, however, retain the fundamental responsibility to ensure by official inspection and certification[15] the conformity of foodstuffs to requirements.

8. The degree to which industry effectively utilizes quality assurance procedures can influence the methods and procedures by which government services verify that requirements have been met, where official authorities consider such procedures to be relevant to their requirements.

SECTION 5 - EQUIVALENCE

9. The recognition of equivalence of inspection and certification should be facilitated where it can be objectively demonstrated that there is an appropriate system for inspection and certification of food by the exporting country in accordance with these guidelines.

10. For the determination of equivalence, governments should recognize that:

11. Controls on imported food and domestically produced foods should be designed to achieve the same level of protection. The importing country should avoid the unnecessary repetition of controls where these have been already validly carried out by the exporting country. In these cases a level of control equivalent to domestic controls should have been achieved at the stages prior to import.

12. The exporting country should provide access to enable the inspection and certification systems to be examined and evaluated, on request of the food control authorities of the importing country. Evaluations of inspection and certification systems carried out by the authorities of an importing country should take into account internal programme evaluations already carried out by the competent authority or evaluations performed by independent third-party bodies recognized by the competent authority in the exporting country.

13. Evaluations of inspection and certification systems by an importing country for purposes of establishing equivalence should take account of all relevant information held by the competent authority of the exporting country.

EQUIVALENCY AGREEMENTS

14. The application of equivalence principles may be in the form of agreements or letters of understanding established between governments either for inspection and/or certification of production areas, sectors or parts of sectors. Equivalence may also be established through the administration of a comprehensive agreement which would cover inspection and certification of all food commodity forms traded between two or more countries.

15. Agreements on the recognition of equivalence of inspection and certification systems may include provisions concerning:

16. Agreements should include mechanisms to provide for periodic review and updating and include procedural mechanisms for resolving differences arising within the framework of the agreement.

SECTION 6 - INSPECTION AND CERTIFICATION SYSTEM INFRASTRUCTURE

17. Countries should identify the main objectives to be addressed through import and export inspection and certification systems.

18. Countries should have in place the legislative framework, controls, procedures, facilities, equipment, laboratories, transportation, communications, personnel and training to support the objectives of the inspection and certification programme.

19. Where different authorities in the same country have jurisdiction over different parts of the food chain, conflicting requirements must be avoided to prevent legal and commercial problems and obstacles to trade. For example, while provincial or state laws may exist there should be a competent authority at the national level capable of ensuring uniform application. However, an importing country authority may recognize a sub-national competent authority for purposes of inspection or certification where this arrangement is acceptable to the national authorities concerned.

LEGISLATIVE FRAMEWORK

20. For the purposes of this section, legislation includes acts, regulations, requirements or procedures, issued by public authorities, related to foodstuffs and covering the protection of public health, the protection of consumers and conditions of fair trading.

21. The effectiveness of controls related to foodstuffs depends on the quality and completeness of legislation for foods. Legislation should provide authority to carry out controls at all stages of production, manufacture, importation, processing, storage, transportation, distribution and trade.

22. Legislation may also include provisions as appropriate for the registration of establishments or listing of certified processing plants, establishment approval, licensing or registration of traders, equipment design approval, penalties in the event of non-compliance, coding requirements and charging of fees.

23. The national competent authority in the exporting or importing country should have the ability to enforce and take action based on adequate legislation. It should take all necessary steps to insure the integrity, impartiality and independence of official inspection systems and officially recognized inspection systems and to ensure that the inspection programme contained in national legislation is delivered to a prescribed standard.

CONTROL PROGRAMMES AND OPERATIONS

24. Control programmes help to ensure that inspection actions relate to objectives, since the results of these programmes can be assessed against the objectives set for the inspection and certification system. Inspection services should draw up control programmes based on precise objectives and appropriate risk analysis. In the absence of detailed scientific research, control programmes should be based on requirements developed from current knowledge and practice. Every effort should be made to apply risk analysis based on internationally-accepted methodology, where available.

25. In particular, countries should require or encourage the use of a HACCP approach by food establishments. Official inspectors should be trained in the assessment of the application of HACCP principles. Where programmes include the drawing and analysis of samples, adequate sampling and appropriately validated analytical methods should be established to ensure that the results are representative and reliable in relation to the specific objectives.

26. The elements of a control programme should include, as appropriate:

27. Administrative procedures should be in place to ensure that controls by the inspection system are carried out:

28. Controls should cover, as appropriate:

29. The elements of the control programme should be formally documented including methods and techniques.

DECISION CRITERIA AND ACTION

30. The controls programme should be targeted at the most appropriate stages and operations, depending on the specific objectives. Control procedures should not compromise the quality or safety of foods, particularly in the case of perishable products.

31. The frequency and intensity of controls by inspection systems should be designed so as to take account of risk and the reliability of controls already carried out by those handling the products including producers, manufacturers, importers, exporters, and distributors.

32. Physical checks applying to import should be based on risks associated with the importation. Countries should avoid systematic physical checks on imports except in justified cases such as products associated with a high level of risk; a suspicion of non-conformity for a particular product; or a history of non-conformity for the product, processor, importer or country.

33. When physical checks are to be undertaken, sampling plans for imported products should take into account the level of risk, the presentation and type of commodity to be sampled, the reliability of controls of the exporting country and of those responsible for handling the product in the importing country.

34. Where an imported product is found not to be in conformity, the resulting measures should take into account the following criteria to ensure that any action is proportionate to the degree of public health risk, potential fraud or deception of consumers:

35. The specific measures applied may be cumulative if necessary and may include:

In respect of the product not in conformity-

In respect of future imports-

36. Where possible, and upon request, the importer or their representative should be given access by the relevant food control authority of the importing country to a rejected or detained consignment and in the latter case, the opportunity to contribute any relevant information to assist the control authorities of the importing country to make their final decision.

37. Where product is rejected, information should be exchanged in accordance with the Codex Guidelines for the Exchange of Information between Countries on Rejections of Imported Food.[16]

FACILITIES, EQUIPMENT, TRANSPORTATION AND COMMUNICATIONS

38. Inspection staff should have access to adequate facilities and equipment to undertake inspection procedures and methodologies.

39. Reliable transportation and communication systems are essential to ensure delivery of inspection and certification services when and where they are needed and for the transmission of samples to laboratories.

40. Communications facilities should be provided to ensure adequate compliance action and to address potential recalls. Consideration should be given to developing electronic information exchange systems, in particular to facilitate trade, protect consumer health, and to combat fraud.

LABORATORIES

41. Inspection services should utilize laboratories that are evaluated and/or accredited under officially recognized programmes to ensure that adequate quality controls are in place to provide for the reliability of test results. Validated analytical methods should be used wherever available.

42. Inspection systems' laboratories should apply the principles of internationally accepted quality assurance techniques to ensure the reliability of analytical results[17].

PERSONNEL

43. Official inspection services should have, or have access to, a sufficient number of qualified personnel as appropriate in areas such as: food science and technology, chemistry, biochemistry, microbiology, veterinary science, human medicine, epidemiology, agronomic engineering, quality assurance, audit and law. Personnel should be capable and appropriately trained in the operation of food inspection and control systems. They should have a status which ensures their impartiality and have no direct commercial interest in the products or establishments being inspected or certified.

SECTION 7 - CERTIFICATION SYSTEMS

44. An effective certification system depends on the existence of an effective inspection system as described above in Section 6.

45. Demand for certification should be justified by risk to health or risk of fraud or deception. Alternatives to certification should be considered wherever possible, in particular where the inspection system and requirements of an exporting country are assessed as being equivalent to those of the importing country. Bilateral or multilateral agreements, such as mutual recognition agreements or pre-certification agreements, may provide for dispensing with certification and/or the issuance of certificates which were previously required in certain cases.

46. Certification should provide assurance of the conformity of a product or batch of products, or that a food inspection system conforms to specified requirements, and will be based, as appropriate, on:

47. Competent authorities should take all necessary steps to ensure the integrity, impartiality and independence of official certification systems and officially-recognized certification systems. They should ensure that personnel empowered to validate certificates are appropriately trained and fully aware, if necessary from notes of guidance, of the significance of the contents of each certificate which they complete.

48. Certification procedures should include procedures to ensure the authenticity and validity of certificates at all the relevant stages and to prevent fraudulent certification. In particular, personnel:

SECTION 8 - OFFICIAL ACCREDITATION

49. Countries may officially accredit inspection or certification bodies to provide services on behalf of official agencies.

50. To be officially accredited, an inspection or certification body must be assessed against objective criteria and must comply at least with the standards set out in these guidelines, particularly in relation to the competence, independence and impartiality of personnel.

51. The performance of officially accredited inspection or certification bodies should be regularly assessed by the competent authority. Procedures should be initiated to correct deficiencies and, as appropriate, enable withdrawal of official accreditation.

SECTION 9 - ASSESSMENT AND VERIFICATION OF INSPECTION AND CERTIFICATION SYSTEMS

52. A national system should be subject to audit separate from routine inspection. Inspection and certification services should be encouraged to carry out self-evaluation or have their effectiveness evaluated by third parties.

53. Self-assessment or third-party audits should be carried out periodically at various levels of the inspection and certification system, using internationally-recognized assessment and verification procedures. The inspection services of a country may undertake self-assessment for such purposes as assuring the adequacy of consumer protection and other matters of national interest, improving internal efficiency or facilitating exports.

54. A prospective importing country may undertake a review with the agreement of the exporting country of the inspection and certification systems of an exporting country as part of its risk analysis process, with a view to determining requirements for imports from that country. Periodic assessment reviews may be appropriate following the commencement of trade.

55. For the purpose of assisting an exporting country to demonstrate that its inspection or certification systems is equivalent, the importing country should make readily available adequate information on its system and its performance.

56. Exporting countries should be able to demonstrate adequate resources, functional capabilities and legislative support in addition to effective administration, independence in the exercise of their official function and, where relevant, performance history.

57. Guidelines on procedures for conducting an assessment and verification of the systems of an exporting country by an importing country are in the Annex.

SECTION 10 - TRANSPARENCY

58. Consistent with the principles on transparency contained in the Principles for Food Import and Export Inspection and Certification, and in order to promote consumer confidence in the safety and quality of their food, governments should ensure that the operations of their inspection and certification systems are as transparent as possible, while respecting any legitimate constraints of professional and commercial confidentiality and avoiding the creation of new barriers to trade by giving a misleading impression of the quality or safety of imported products in comparison with domestic products.

ANNEX: GUIDELINES ON PROCEDURES FOR CONDUCTING AN ASSESSMENT AND VERIFICATION BY AN IMPORTING COUNTRY OF INSPECTION AND CERTIFICATION SYSTEMS OF AN EXPORTING COUNTRY

1. INTRODUCTION

1.1 Assessment and verification should concentrate primarily on effectiveness of the inspection and certification system in operation in the exporting country rather than on specific commodities or establishments.

1.2 Assessment and verification may be conducted by officials of the importing country. The subject of assessment and verification may be an exporting country's inspection and certification infrastructure, or a specific inspection and certification regime applied to a single producer or group of producers.

2. PREPARATION

2.1 Those responsible for conducting the audit should prepare a plan that covers the following points:

2.2 This plan should be reviewed in advance with representatives of the country and, if necessary, the organization(s) being audited.

2.3 Where different authorities of an importing country have jurisdiction over different aspects of food control in the importing country, such authorities should coordinate their conduct of an audit in order to avoid any duplication of visits in the assessment of the exporting countries' inspection and certification infrastructure.

3. OPENING MEETING

An opening meeting should be held with representatives of the exporting country, including officials responsible for the inspection and certification programmes. At this meeting the auditor will be responsible for reviewing the audit plan and confirming that adequate resources, documentation, and any other necessary facilities are available for conducting the audit.

4. EXAMINATION

This may comprise both the examination of documentary material and an on-site verification.

4.1 Document Review

The document review may consist of a preliminary review of the national food inspection and certification system, with emphasis on the implementation of elements of the system of inspection and certification for commodity(ies) of interest. Based upon this preliminary review, the auditors may examine inspection and certification files relevant to these commodities.

4.2 On-site Verification

4.2.1 The decision to proceed to this step should not be automatic but should be based upon a variety of factors such as risk assessment of the food commodity(ies), history of conformity with requirements by the industry sector or exporting country, volume of product produced and imported or exported, changes within a country's infrastructure, changes to the food inspection and certification systems, and training (theoretical and practical) of inspectors.

4.2.2 On-site verification may involve visits to manufacturing facilities and food handling or storage areas to check on compliance with the information contained in the documentary material referred to in 4.1.

4.3 Follow-up Audit

Where a follow-up audit is being conducted in order to verify the correction of deficiencies, it may be sufficient to examine only those points which have been found to require correction.

5. WORKING DOCUMENTS

Forms for reporting assessment findings and conclusions should be standardized as much as possible in order to make the approach to audit, reporting and assessment more uniform and efficient. The working documents also include any checklists of elements to evaluate. Such checklists may cover:

6. CLOSING MEETING

A closing meeting should be held with representatives of the exporting country, including officials responsible for the inspection and certification programmes. At this meeting the auditor will be responsible for presenting the findings of the audit as well as, where appropriate, an analysis of conformity. The information should be presented in a clear, concise manner so that the conclusions of the audit are clearly understood. If possible, an action plan for correction of any deficiencies should be agreed.

7. REPORT

The draft report of the audit should be forwarded to the appropriate authorities in both countries as soon as possible. It should include a report of the audit findings with supporting evidence for each conclusion, along with any details of significance discussed during the closing meeting. The final report should incorporate the comments by the appropriate authorities of the exporting country.

8. FREQUENCY OF AUDITING

The potential importing country shall decide the frequency of auditing in agreement with the exporting country. Factors to be taken into account include the findings of previous audits and the existence and effectiveness of self-audit systems or third party audit of the exporting country's control systems.


[1] CAC/GL 20-1995
[2] For the purpose of these guidelines, "countries" includes regional economic integration organizations to which a group of countries have transferred competences as regards food import and export inspection and certification systems and/or the negotiation of equivalency agreements with other countries.
[3] The Principles for Food Import and Export Inspection and Certification includes that in the design and application of food inspection and certification systems, importing countries should take into account the capabilities of developing countries to provide the necessary safeguards (Paragraph 18).
[4] Consistent with the Principles for Food Import and Export Inspection and Certification (CAC/GL 20-1995).
[5] Consistent with the Principles for Food Import and Export Inspection and Certification (CAC/GL 20-1995).
[6] Consistent with the Principles for Food Import and Export Inspection and Certification (CAC/GL 20-1995).
[7] Consistent with the Principles for Food Import and Export Inspection and Certification (CAC/GL 20-1995).
[8] Consistent with the Principles for Food Import and Export Inspection and Certification (CAC/GL 20-1995).
[9] Consistent with the Principles for Food Import and Export Inspection and Certification (CAC/GL 20-1995).
[10] Codex Alimentarius Procedural Manual, Tenth Edition, 1997
[11] Codex Alimentarius Procedural Manual, Tenth Edition, 1997
[12] Codex Alimentarius Procedural Manual, Tenth Edition, 1997
[13] Codex Alimentarius Procedural Manual, Tenth Edition, 1997
[14] Hazard Analysis and Critical Control Point System and Guidelines for its Application, Annex to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1 -1969, Rev. 3, 1997).
[15] For the purpose of these guidelines, "inspection and certification" means "inspection and/or certification"
[16] CAC/GL 25-1997
[17] Guidelines for the Assessment of the Competence of Testing Laboratories Involved in the Import and Export Control of Foods (CAC/GL 27-1997).

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