基于风险的进口食品监管手册.pdf

Risk Based impoRted Food ContRol manualFood saFety and quality seRies 1issn 2415-1173Risk Based impoRted Food ContRol manualFood and agRiCultuRe oRganization oF the united nations,Rome 2016The designations employed and the presentation of material in this information product do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations(FAO)concerning the legal or development status of any country,territory,city or area or of its authorities,or concerning the delimitation of its frontiers or boundaries.The mention of specific companies or products of manufacturers,whether or not these have been patented,does not imply that these have been endorsed or recommended by FAO in preference to others of a similar nature that are not mentioned.The views expressed in this information product are those of the author(s)and do not necessarily reflect the views or policies of FAO.ISBN 978-92-5-109070-1 FAO,2016FAO encourages the use,reproduction and dissemination of material in this information product.Except where otherwise indicated,material may be copied,downloaded and printed for private study,research and teaching purposes,or for use in non-commercial products or services,provided that appropriate acknowledgement of FAO as the source and copyright holder is given and that FAOs endorsement of users views,products or services is not implied in any way.All requests for translation and adaptation rights,and for resale and other commercial use rights should be made via www.fao.org/contact-us/licence-request or addressed to copyrightfao.org.FAO information products are available on the FAO website(www.fao.org/publications)and can be purchased through publications-salesfao.org.Cover photos(from left to right):Fao/sue price;Fao/alessandra Benedetti;daiva gailiute;Fao/olivier asselindesign and layout:pietro Bartoleschi,elisabetta Cremona and malica Worms(studio Bartoleschi)iiiRisk Based impoRted Food ContRol manualRisk Based impoRted Food ContRol manualContentsList of figures.viList of contributors.viiPreface.ixAcronyms.xiintroduCtion to the manual.1Scope and objectives of the manual.1Target audience.2Use of the manual.2Development of national capacities.4supporting tools and guidance 1CapaCity building and development assessment CheCklist.6Imported food control framework.7Legal and institutional frameworks.10Support services.12seCtion 1 objeCtive oF imported Food Controls.17Policy objectives.18Imported food controls principles and concepts.18Fitness for purpose.19Legal foundation and transparency.20Non-discrimination.20Clearly defined roles and responsibilities.21Risk based,science based and evidence based decision making.22Recognition of foreign food safety systems.22Design and implementation of imported food controls.22Risk based framework.22Legal and institutional frameworks.25Support functions.26seCtion 2 imported Food Control Framework.29Introduction.30Imported food controls.32Roles and responsibilities.32Information requirements.32Imported food,importer and exporting country profile.33Risk categorization.35Information exchange/communication.36Risk Based impoRted Food ContRol manualivRisk management actions.37Pre-border controls.37Border controls.41Post-border/in-country controls.52supporting tools and guidance 2.1 imported Food,importer and exporting Country proFiles.55Importer profile.56Imported food profile.57Exporting country profile.58supporting tools and guidance 2.2risk Categorization.61supporting tools and guidance 2.3 reCognition arrangements.69supporting tools and guidance 2.4 validation oF doCumentation.73supporting tools and guidance 2.5 good importing praCtiCes.78Food Products,specifications and procedures.79Buildings(Inside and Out),Sanitation,Utilities,Personnel.81seCtion 3 legal and institutional Frameworks.87Introduction.88Legal framework for imported food controls.88Basic legal concepts.88Technical elements.93Institutional framework for imported food control.101Coordination and information sharing.101Institutional framework.101seCtion 4 imported Food Controls support FunCtions.109Introduction.110Central management.111Information gathering,system analysis and planning.111Programme design and maintenance.114Programme management and response.115Scientific support.116Scientific advice.116Sampling strategy and annual sampling plans.117Laboratories.119Risk Based impoRted Food ContRol manualvInspection support.122Pre-border.122Border.123Post-border/in-country.124Other support functions.125Legal services support.125Administrative Support.127supporting tools and guidance 4.1 planning.132Programme planning:multi-year planning process.132Annual planning(operational).134supporting tools and guidance 4.2 programme design importer adviCe and inFormation.136Licensing.136Sourcing product.137Import product notification,control,storage,and identification.137Product control and inspection process.138supporting tools and guidance 4.3 developing standard operating proCedures.139supporting tools and guidance 4.4 examples oF sampling strategies.143Monitoring and Compliance Sampling Strategy.143Categorization Sampling Strategy.144supporting tools and guidance 4.5 inspeCtion and sampling proCedural guidanCe.145Inspection procedures.145Sampling procedures.146supporting tools and guidance 4.6job desCriptions and personnel Categories.148Scientific support.148Inspection support.149Central management support.149Administrative support.150supporting tools and guidance 4.7 training.151Glossary.153viRisk Based impoRted Food ContRol manuallist oF FiguresFigure 1.Illustration of a simplified imported food control framework.23Figure 2.Imported food control framework outlining key components (e.g.profiles,risk categorization)and potential risk management options.31Figure 3.Document review systematic approach.46Figure 4.Decision tree to support choice of inspection.48Figure 5.Documentation and certificate decision tree.74Figure 6.Key components of imported food control support functions.110Figure 7.Operational planning cycle.135viiRisk Based impoRted Food ContRol manuallist oF ContributorsThe Food and Agriculture Organization of the United Nations(FAO)would like to express its appreciation to the many people who provided advice and guidance during the preparation of this publication.The overall leadership and coordination was provided by Catherine Bessy,Food Safety and Quality Officer,who acted as technical editor,and by Renata Clarke,Head of the Food Safety and Quality Unit.The Food Safety and Quality Unit of FAO thank the lead author Mary Ann Green,FAO consultant;as well as Dennis Bittisnich,FAO consultant;and Carmen Bullon,Legal Officer,Legal Office,FAO,who worked with us to prepare this document.The early advice of the following people proved very useful in designing the structure and deciding the content of the manual:Dennis Bittisnich,FAO consultant Cathy Carnevale,FAO consultant Peggy Douglass,FAO consultant Alison Pinsent,Canada Ann Reason,United Kingdom Maria Eduarda de Serra Machado,Brazil Rima Zumot,FAO consultantA first draft review meeting was organized in FAO Headquarters,Rome,Italy,from 13 to 15 March 2012 with participation of:Dennis Bittisnich,FAO consultant Louis Carson,United States of America Hlne Coulibaly,FAO consultant Mary Ann Green,Canadian Food Inspection Agency,Canada Domenic Veneziano,US Public Health Service,United States of America Jack Vera,Netherlands Food and Consumer Product Safety Authority,the Netherlands.The final draft of the manual was peer reviewed by:Dennis Bittisnich,Australian Center for Agricultural Research,Australia Penny Campbell,Directorate:Food Control,Ministry of Health,South Africa Guilherme da Costa Junior,Department of Non-Tariff Negociations,Ministry of Agriculture,Livestock and Food Supply,Brazil Michael Glavin,Head Imports/Exports Policy,Food Standards Agency,United Kingdom Patricia Langhammer,Stephen Curzon and Bruno Saimour,DG Health and Food Safety,European Commission Hajime Toyofoku,Yamaguchi University,JapanviiiRisk Based impoRted Food ContRol manualThe contribution of many other FAO colleagues,including Anna Maria Bruno,in the early stages of conception,Cornelia Boesch,for the figures,and of Mary Kenny and Shashi Sareen in reviewing the final version of the manual,is also gratefully acknowledged.FAO would like to express appreciation to Canada for partial funding under project GCP/GLO/452/CAN.ixRisk Based impoRted Food ContRol manualpreFaCeIn 2013,food products accounted for more than 80 percent of total agricultural exports.They are the third most valuable commodity group traded internationally,after fuels and non-pharmaceutical chemical products1.A number of countries,including many developing countries,import a significant proportion of their food supplies.Some countries rely almost entirely on food imports to ensure food security.While developing systems of food import,countries progressively set up inspection measures in order to protect the health of their populations and ensure fair practices in trade.Over time,increasing volumes of imported foods,together with the diversification of origin and growing complexity of the technologies used for manufactured foods,have led to a need to revise the approach to food import control.Relying on a traditional approach,based on random or systematic product inspection at borders,is no longer considered effective.The approach for food controls in general has now shifted from being mostly reactive,based on end product inspection,to being preventative and risk based,taking into account the entire food chain.For imported food,the specific challenge is that competent authorities in charge of official controls have no direct oversight over the production process of their trading partners.The development of trading relationships,increased dialogue between competent authorities of importing and exporting countries,use of certification mechanisms and improved oversight of the importers community are some options that can help strengthen the effectiveness of imported food controls.Over the last two decades,international agreements(i.e.the World Trade Organizations(WTO)agreements on Sanitary and Phytosanitary Measures(SPS)and Technical Barriers to Trade(TBT)have defined a framework for control measures to protect the health of consumers and ensure fair practices in food trade.The joint FAO/World Health Organization(WHO)Codex Alimentarius Commission(CAC)sets the international standards referred to in WTOs two agreements for food safety and food standards,and has produced specific guidance for risk based official controls on imported foods,including CAC/GL 47-2003“Guidelines for Import food control systems”and other related texts2.Codex standards,guidelines and recommendations provide a useful overarching framework on which countries should base their control measures as appropriate to their situation,specific challenges and resources.However,many developing and transition countries have expressed the need for additional support and guidance on the practical elaboration of these measures.1 As reported in the World Trade Organizations International Trade Statistics 2014.2 See www.codexalimentarius.org/committees-and-task-forces/en/?provide=committeeDetail&idList=5.preventative approach to address priority risks,along to food chain.updated Fao guidance on imported food controls consistent with Codex alimentarius.xRisk Based impoRted Food ContRol manualUpon request of member countries,FAO has developed a global guidance for risk based imported food controls.The necessity of this guidance is based on the recognition that there is no“one size fits all”solution and that each country presents a particular set of challenges and opportunities.This FAO manual aims to support competent authorities in shaping a customized plan of action,based on an analysis of their specific country situation.It provides concrete illustrations of how Codex guidelines can be implemented in different ways.While respecting the principles,guidance and objectives agreed by the CAC,different options for control measures can be selected and combined to implement a coherent set of import controls to best fit the needs of each country.Different examples,as implemented by a number of countries,are provided to show that there are often several alternatives to reach a common goal.Particular emphasis is given to risk based programming in order to support countries in allocating available resources to target priority risks in the most appropriate manner.This takes into consideration trade and food security situation,institutional set up,legal framework,available support services etc.Based on Codex texts,this guidance focuses on import control over food products.FAO recognizes that the impact of feed safety on food safety is essential.It should be noted that the majority of approaches developed in this manual for imported food control could also apply to feed.The development of practical and widely applicable guidance was made possible by the experience gained by FAO through its many projects addressing food control issues,in particular imported food controls.More specifically,sections of this manual were tested in Gabon,India,Bangladesh and Jordan(regional approach).This manual complements other existing FAO guidance aimed at strengthening risk based food inspection services in its member countries.global guidance for customized plans of action.xiRisk Based impoRted Food ContRol manualaCronymsAOACAssociation of Analytical CommunitiesASEANAssociation of Southeast Asian NationsCACCodex Alimentarius CommissionCCFICSCodex Committee on Food Import and Export Inspection and Certification SystemsCS/ITComputer Systems/Information TechnologyEEAEuropean Economic AreaEUEuropean UnionFAOFood and Agriculture Organization of the United NationsFEFOFirst Expiry/First OutFIFOFirst In/First OutGAPGood Agricultural PracticesGATTGeneral Agreement on Tariffs and TradeGHPGood Hygienic PracticesGIPGood Importing PracticesGMPGood Manufacturing PracticesHACCPHazard Analysis Critical Control PointICMSFInternational Commission on Microbiological Specifications for FoodsIHRInternational Health RegulationsILACInternational Laboratory Accredited CooperationINFOSANInternational Food Safety Authorities NetworkIPPCInternational Plant Protection Convention ISOInternational Organization for StandardizationJECFAJoint FAO/WHO Expert Committee on Food AdditivesJEMRAJoint FAO/WHO Expert Meeting on Microbiological Risk AssessmentJMPRJoint FAO/WHO Meeting on Pesticides ResiduesMANCPMulti Annual National Control ProgrammeOECD/DACOrganisation for Economic Co-operation and Development-Development Assistance CommitteeOIEWorld Organization for Animal Health QAQuality AssuranceQCQuality ControlRASFFRapid Alert System for Feed and FoodSOPStandard Operating ProcedureSPSSanitary and Phytosanitary Measures(WTO Agreement)SWOTStrengths,Weaknesses,Opportunities and ThreatsTBTTechni