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1、CAC/GL 47-2003 Page 1 of 9 GUIDELINES FOR FOOD IMPORT CONTROL SYSTEMS CAC/GL 47-2003 SECTION 1 -SCOPE This document provides a framework for the development and operation of an import control system to protect consumers and facilitate fair practices in food trade while ensuring unjustified technical
2、 barriers to trade are not introduced. The Guideline is consistent with the Codex Principles for Food Import and Export Inspection and Certification1 and provides specific information about imported food control that is an adjunct to the Guidelines for the Design, Operation, Assessment and Accredita
3、tion of Food Import and Export Inspection and Certification Systems2. SECTION 2 DEFINITIONS 3 Appropriate Level of Protection (ALOP) is the level of protection deemed appropriate by the country establishing a sanitary measure to protect human life or health within its territory. (This concept may ot
4、herwise be referred to as the “acceptable level of risk”.) Audit* is a systematic and functionally independent examination to determine whether activities and related results comply with planned objectives. Certification* is the procedure by which official certification bodies and officially recogni
5、zed 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 examinati
6、on of finished products. 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. Legislation* includes acts, regulations, requirements o
7、r procedures, issued by public authorities, related to foods and covering the protection of public health, the protection of consumers and conditions of fair trading. Official accreditation* is the procedure by which a government agency having jurisdiction formally recognizes the competence of an in
8、spection 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. Officially recog
9、nized inspection systems and officially recognized certification systems* are systems which have been formally approved or recognized by a government agency having jurisdiction. Requirements* are the criteria set down by the competent authorities relating to trade in foodstuffs covering the protecti
10、on of public health, the protection of consumers and conditions of fair trading. Risk assessment* A scientifically based process consisting of the following steps (i) hazard identification, (ii) hazard characterisation, (iii) exposure assessment, and (iv) risk characterisation. 1 Principles for Food
11、 Import and Export Inspection and Certification (CAC/GL 20-1995) 2 Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems (CAC/GL 26-1997). 3 Definitions drawn from the Guidelines for the Design, Operation , Assessment and Ac
12、creditation of Food Import and Export Inspection and Certification Systems (CAC/GL 26-1997) are marked with *. Definitions drawn from Codex Alimentarius Commission, Procedural Manual (12th edition) are marked with *. CAC/GL 47-2003 Page 2 of 9 Risk analysis* A process consisting of three components:
13、 risk assessment, risk management and risk communication. SECTION 3 - GENERAL CHARACTERISTICS OF FOOD IMPORT CONTROL SYSTEMS Food import control systems should have the following main characteristics: requirements for imported food that are consistent with requirements for domestic foods; clearly de
14、fined responsibilities for the competent authority or authorities; clearly defined and transparent legislation and operating procedures; precedence to the protection of consumers; provision of the importing country for recognition of the food control system applied by an exporting countrys competent
15、 authority; uniform nationwide implementation; implementation that ensures the levels of protection achieved are consistent with those for domestic food. REQUIREMENTS FOR IMPORTED FOOD THAT ARE CONSISTENT WITH REQUIREMENTS FOR DOMESTIC FOODS Requirements are commonly expressed as end-point standards
16、 with specific limits and complementary sampling regimes. These requirements may consist of standards, provisions for sampling, process controls, conditions of production, transport, storage, or a combination of these. The extent and stringency of requirements applied in specific circumstances shoul
17、d be proportionate to risk, noting that risk may vary from one source to another because of factors such as specific and/or similar situations in the region of origin, technology employed, compliance history, etc. and/or examination of relevant attributes of a sample of products at import. As far as
18、 possible, requirements should be applied equally to domestically produced and imported food. Where domestic requirements include process controls such as good manufacturing practices, compliance may be determined or equivalence confirmed by auditing the relevant inspection and certification systems
19、 and, as appropriate, the facilities and procedures in the exporting country4. CLEARLY DEFINED RESPONSIBILITIES OF COMPETENT AUTHORITY OR AUTHORITIES The competent authority(ies) involved in any of the imported food inspection functions at the point or points of entry, during storage and distributio
20、n and/or at point of sale, should have clearly defined responsibilities and authority. Multiple inspection and duplicative testing for the same analyte(s) on the same consignment should be avoided to the extent possible. Some countries, for example those that are part of a regional economic grouping
21、, may rely on import controls implemented by another country. In such cases, the functions, responsibilities, and operating procedures undertaken by the country which conducts the imported food control should be clearly defined and accessible to authorities in the country or countries of final desti
22、nation with the aim of delivering an efficient and transparent import control system. Where the competent authorities of an importing country use third party providers as officially recognised inspection bodies and/or officially recognized certification bodies to implement controls, such arrangement
23、s should be conducted in the manner discussed in CAC/GL 26-1997, Section 8, Official Accreditation. The functions that can be conducted by such providers may include: 4 Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems (
24、CAC/GL 26-1997), Para. 54. CAC/GL 47-2003 Page 3 of 9 sampling of target consignments; analysis of samples; compliance evaluation of relevant parts or all of a quality assurance system that may be operated by importers in order to comply with official requirements. CLEARLY DEFINED AND TRANSPARENT LE
25、GISLATION AND OPERATING PROCEDURES The object of legislation is to provide the basis and the authority for operating a food import control system. The legal framework allows for the establishment of the competent authority(ies) and the processes and procedures required to verify the conformity of im
26、ported products against requirements. Legislation should provide the competent authority with the ability to: appoint authorised officers; require prior notification of the importation of a consignment of a foodstuff; require documentation; inspect, including the authority to enter premises within t
27、he importing country, physically examine the food and its packaging; collect samples and initiate analytical testing; inspection of documentation provided by an exporting country authority, exporter or importer; and verification of product identity against documentary attestations; apply risk-based
28、sampling plans, taking into consideration the compliance history of the particular food, the validity of accompanying certification, and other relevant information; charge fees for the inspection of consignments and sample analysis; recognize accredited or accredit laboratories; accept; reject; deta
29、in; destroy; order to destroy; order reconditioning, processing, or re-export; return to country of export; designate as non-food use; recall consignments following importation; retain control over consignments in transit during intra-national transport or during storage prior to import clearance; a
30、nd, implement administrative and/or judicial measures when the specific requirements are not satisfied. In addition, the legislation may make provisions for: licensing or registration of importers; recognition of verification systems used by importers; an appeal mechanism against official actions; a
31、ssessing the control system of the exporting country; and certification and/or inspection arrangements with competent authorities of exporting countries. PRECEDENCE TO THE PROTECTION OF CONSUMERS In the design and operation of food import control systems, precedence should be given to protecting the
32、 health of consumers and ensuring fair practices in food trade over economic or other trade considerations. CAC/GL 47-2003 Page 4 of 9 PROVISION OF THE IMPORTING COUNTRY FOR RECOGNITION OF THE FOOD CONTROL SYSTEM APPLIED BY AN EXPORTING COUNTRYS COMPETENT AUTHORITY Food import control systems should
33、 include provisions for recognition as appropriate of the food control system applied by an exporting countrys competent authority. Importing countries can recognise the food safety controls of an exporting country in a number of ways that facilitate the entry of goods, including the use of memorand
34、a of understanding, mutual recognition agreements and equivalence agreements and unilateral recognition. Such recognition should, as appropriate, include controls applied during the production, manufacture, importation, processing, storage, and transportation of the food products, and verification o
35、f the export food control system applied. UNIFORM NATION-WIDE IMPLEMENTATION Uniformity of operational procedures is particularly important. Programmes and training manuals should be developed and implemented to assure uniform application at all points of entry and by all inspection staff. IMPLEMENT
36、ATION THAT ENSURES THE LEVELS OF PROTECTION ACHIEVED ARE CONSISTENT WITH THOSE FOR DOMESTIC FOOD As an importing country has no direct jurisdiction over process controls applied to food manufactured in another country, there may be a variation in approach to the compliance monitoring of domestic and
37、 imported food. Such differences in approach are justifiable provided they are necessary to ensure that the level of protection achieved is consistent with that of domestically produced food. SECTION 4 - IMPLEMENTATION OF THE CONTROL SYSTEM Operational procedures should be developed and implemented
38、to minimize undue delay at the point or points of entry without jeopardizing effectiveness of controls to meet requirements. Implementation should take into account the factors listed in this section and the possibility of recognizing guarantees at origin that includes implementation of controls in
39、the exporting countries. POINT OF CONTROL Control of imported food by the importing country can be conducted at one or more points including the points of : origin, where agreed upon with the exporting country; entry to the country of destination; further processing; transport and distribution; stor
40、age; and, sale, (retail or wholesale). The importing country can recognize controls implemented by the exporting country. The application of controls by the exporting country, during production, manufacture and subsequent transit should be encouraged, with the aim of identifying and correcting probl
41、ems when and where they occur, and preferably before costly recalls of food already in distribution are required. Pre-shipment clearance is a possible mechanism for ensuring compliance with requirements of, for example, valuable bulk packed products that if opened and sampled upon entry, would be se
42、riously compromised, or for products that require rapid clearance to maintain safety and quality. CAC/GL 47-2003 Page 5 of 9 If the inspection system encompasses pre-shipment clearance then the authority to conduct the clearance should be determined and procedures defined. The importing countrys com
43、petent authority may choose to conduct pre-shipment clearance from an exporting countrys official certification system or from officially recognised third party certification bodies working to defined criteria. The pre-shipment clearance should be based on the results of the documentary check on the
44、 consignments. INFORMATION ABOUT FOOD TO BE IMPORTED 5 The efficacy of the control system in applying efficient targeted control measures depends upon information about consignments entering the jurisdiction. Details of consignments that may be obtained include: date and point of entry; mode of tran
45、sport; comprehensive description of the commodity (including for example product description, amount, means of preservation, country of origin and/or of dispatch, identifying marks such as lot identifier or seal identification numbers etc); exporters and importers name and address; manufacturer and/
46、or producer, including establishment registration number; destination; and, other information. FREQUENCY OF INSPECTION AND TESTING OF IMPORTED FOOD The nature and frequency of inspection, sampling and testing of imported foods should be based on the risk to human health and safety presented by the p
47、roduct, its origin and the history of conformance to requirements and other relevant information. Control should be designed to account for factors such as: the risk to human health posed by the product or its packaging; the likelihood of non-compliance with requirements; the target consumer group;
48、the extent and nature of any further processing of the product; food inspection and certification system in the exporting country and existence of any equivalence, mutual recognition agreements or other trade agreements; and, history of conformity of producers, processors, manufacturers, exporters,
49、importers and distributors. Physical checks of imported product, preferably using statistically based sampling plans, should represent valid methods for the verification of compliance with requirements by the product as established by the importing country, or in the case of importing a product for the purposes of re- exportation, verification should be made on the requirements of the country of final destination and said requirements should be specified in the certificate