JOINT FAO/WHO FOOD STANDARDS PROGRAMME C odex Alimentarius Commission

The work of an international food standard-setting body JOINT FAO/WHO FOOD STANDARDS PROGRAMMECodex Alimentarius Commission Since 1963 until now Gracia BriscoFood Standards OfficerCodex SecretariatCodex Alimentarius Commission Acapulco, Mexico, November 2008

WORLD TRADE ORGANIZATION AGREEMENT ON THE APPLICATION OF SANITARY AND PHYTOSANITARY MEASURES SPS AGREEMENT AGREEMENT ON TECHNICAL BARRIERS TO TRADE TBT AGREEMENT

Sanitary & Phytosanitary Measures – protect human life and health (...) resulting from Additives Contaminants Veterinary drugs Pesticides Pathogen microorganisms + toxins Codex Food safety provisions recognized by the WTO/SPS Agreement Maximum Levels for Additives Contaminants Maximum Residue Limits for Pesticides Veterinary Drugs Hygiene requirements  biological hazards (pathogens/food associated) Methods of analysis and sampling Inspection/Certification WTO/SPS AGREEMENT & CODEX CCFA CCCF CCPR CCRVDF Harmonized sanitary & phytosanitary measures based on international standards CCFH CCMAS CCFICS

Codex Non-Food safety provisions relevant to the WTO/TBT Agreement Labelling Nutrition Quality provisions Methods of Analysis & Sampling Inspection/Certification Cover all aspects of consumer protection not contemplated under the WTO/SPS Agreement Standards and Technical Regulations Conformity Assessment Procedures (Quality Assurance Systems) Provisions for Packaging, Marking, Labelling, etc. WTO/TBT AGREEMENT & CODEX CCFL CCFLCCNFSDU COMMODITY COMMITTEES CCMAS CCFICS Harmonized technical regulations based on international standards

WTO/SPS sanitary & phytosanitary measures WTO/TBT technical regulations & standards Reference point to solve disputes in international trade (safety/non-safety matters) Reference point to harmonize national sanitary & phytosanitary measures standards & regulations WTO/SPS-TBT AGREEMENTS & CODEX National Sanitary & Phytosanitary measuresTechnical regulations consistent with CODEX fulfil the requirements of the WTO/SPS-TBT AGREEMENTS

JOINT FAO/WHO FOOD STANDARDS PROGRAMMECODEX ALIMENTARIUS COMMISSION

Protecting consumers health – WTO/SPS- TBT Ensuring fair trade practices – WTO/SPS - TBT Coordinating work on food standards with other international organizations (INGOs & IGOs) Facilitating international trade MANDATE CODEX ALIMENTARIUS COMMISSION Dual Objective

Codex Alimentarius Commission Subsidiary bodies Management bodies Technical bodies Executive Committee Secretariat General committees Commodity committees Task Forces ••Regional committees STRUCTUREJoint FAO/WHO Food Standards Programme

General committees: Horizontal work  general matters (SAFETY + non-safety) cross-cutting nature Commodity committees: Vertical work  specific matters (Non-safety) applying to a food/group of foods CAC & Subsidiary Bodies • TaskForces: Horizontal work  general matters (Safety and/or Non-safety) applying across food/group of foods

WTOSPS - TBT Antimicrobial Resistance(Korea) WTO/SPS WTO/SPS WTOSPS-TBT WTOSPS-TBT WTO/SPS WTO/SPS WTOSPS-TBT WTOSPS-TBT WTOSPS-TBT WTO/SPS WTOSPS-TBT

Standards development Elaboration Procedure Commission Decision to elaborate a new text STEP 1 Commission Decision to elaborate a new text STEP 1 normal accelerated two-third majority Rapporteur develops proposed draft text STEP 2 Rapporteur develops proposed draft text STEP 2 Text is sent for comments to members and observers STEP 3 Text is sent for comments to members and observers STEP 3 omit steps 6 and 7 two-third majority Comments are forwarded to the Committee STEP 4 Comments are forwarded to the Committee STEP 4 Text is sent through CCEXEC to the Commission for adoption as draft standard STEP 5 Decision to omit steps 6 and 7 Text is sent through CCEXEC to the Commission for adoption as draft standard STEP 5 Text is sent for comments to members and observers STEP 6 * Scientific basis* Economic considerations* Consensus when possible* Voting – rare lower acceptance of standards Comments are forwarded to the Committee STEP 7 Text is sent through CCEXEC to the Commission for final adoption STEP 8 Text is sent through CCEXEC to the Commission for final adoption STEP 8 Text is sent through CCEXEC to the Commission for final adoption STEP 8

Standards Commodity quality (+ safety) General  safety (+ quality) Codes of Practices Hygiene (GHP) Production Technology (GMP) = processing, handling, packaging, storage, transport, etc. Guidelines Labelling Inspection/Certification Sampling, etc. Principles Hygiene Inspection/Certification etc. Databases Maximum Residue Limits (MRLs) pesticides & veterinary drugs Miscelaneous Methods of Analysis & Sampling CODEX ALIMENTARIUSOutputs

CODEX & SAFETY MATTERS (SPS ISSUES)

WTO/SPS AGREEMENT • Article 5 – Risk AssessmentAppropriate Level of Protection Sanitary/Phytosanitary Measures (ALOPs) • Members ensure sanitary & phytosanitary measures based risk assessmentdeveloped by international organizations • Factors to be taken into account  • scientific evidence, processes and production methods, inspection/sampling/testing methods, ecological/environmental conditions • economic factors = potential damage – loss of production/sales, cost-effectiveness of alternative approaches to limiting the risk • Determination of ALOP • minimizing negative trade effects = avoiding arbitrary/unjustifiable distinctions in different ALOPs = discrimination or disguised restriction on international trade • Insufficient scientific evidence  precautionary measures (interim basis – reasonable period of time)

Risk Analysis – Role Players • FAO/WHO • Permanent Expert Committees/Meetings • Ad-Hoc Expert Consultations Risk Assessment RISK ANALYSIS Risk Management • Codex Alimentarius Commission • subsidiary bodies Risk Communication • FAO/WHO • Governments

FAO and WHO Provision of Scientific Advice ProScAd • Permanent Expert Committees/Meetings • Ad-Hoc Expert Consultations Risk Assessment 1 Hazard Identification RISK ANALYSIS 2 Hazard Characterization 3 Exposure Assessment 4 Risk Characterization

Article 5 Risk Assessment – Determination Appropriate Level Protection Sanitary & Phytosanitary Measures JECFA Chemical hazards JMPR Provision of Scientific Advice – Risk Assessment FAO/WHO WTO/SPS Additives Contaminants (including mycotoxins) Veterinary drugs residues Food – pathogen combinations FAO/WHO Programme for the Provision of Scientific Advice JEMRA Microbiological Hazards Nutrition Pesticide residues Antimicrobial Resistance Biotechnology Previous Cargoes Ad hoc expert consultations Others Biotoxins Lactoperoxidase system Active Chlorine

Additives  Contaminants chemicals & mycotoxins Agrochemicals Veterinary Drugs Radioactivity Microorganisms + toxins FAO/WHO CODEX SAFETY STANDARDSfood safety Protect human life – protect consumers’ health Ensure fair trade practices  Facilitating (international) trade WTO/SPS Article 5 Risk Assessment – Determination of the Appropriate Level of Protection for Sanitary and Phytosanitary Measures Maximum levels of use – GMPs CCFA CCFC Maximum (residue) levels – GMPs & GAPs CCPR CCRVDF CCFH Food-pathogen combinations GHPs – GMPs - GAPs Biotechnology  TFBT Antimicrobial Resistance  TFAMR Ensuring consistent approach to Risk Analysis in Codex CCGP

Codex, Risk Analysis & Codex Committee on Food Import and Export Inspection and Certification Systems

Article 4 – Equivalence Equivalence Members shall accept the sanitary or phytosanitary measures of other Members as equivalent even if these measure differ from their own or from those use by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary or phytosanitary protection. For this purpose, reasonable access shal be given, upon request, to the importing Member for inspection, testing and other relevant procedures Article 5 – Assessment of Risk and Determination of the Appropiate Level of Sanitary or Phytosanitary Protection 2 In the assessment of risks, Members shall take into account available scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; [...] Article 8 – Control, Inspection and Approval Procedures Annex C Control, Inspection and Approval Procedures: include inter aliasampling, testing and certification Annex A – Definitions: SPS measures include all relevant laws, decrees, regulations, requirements & procedures including inter alia end product criteria; processes and production methods; testing, inspection, certification and approval produces; [...] provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements related to food safety WTO/SPS Agreement

Conformity with Standards/Regulations  Conformity Assessment = sampling, testing, inspection, assessment, verification and conformity assessment registration accrediation and approval any of the above combinations Committee on Methods of Analysis & Sampling (CCMAS) Committee on Food Import and Export Inspection and Certification Systems

Host Government: Australia 16th Sessions (until 2006) Coming up soon: 17th Session Cebu, Philippine, 24-28 November 2008 Codex Committee on Food Import & Export Inspection & Certification Systems

Inspection & Certification: Principles & Guidelines for harmonization of methods and procedures Assessment & Accreditation of Inspection & Certification Systems Information exchange on food import & export controls  rejections of foods Quality assurance systems: Principles for use for conformity assessment & promotion of the recognition of these systems for facilitation of trade under bilateral / multilateral agreements Development of official certificates: Guidelines & criteria for format, declarations and language of official certificates for international harmonization Codex Committee on Food Import and Export Inspection and Certification Systems protect consumers’ health ensure fair trading practices facilitate international food trade

Standards development Elaboration Procedure Commission Decision to elaborate a new text STEP 1 Commission Decision to elaborate a new text STEP 1 normal accelerated two-third majority Rapporteur develops proposed draft text STEP 2 Rapporteur develops proposed draft text STEP 2 Text is sent for comments to members and observers STEP 3 Text is sent for comments to members and observers STEP 3 omit steps 6 and 7 two-third majority Comments are forwarded to the Committee STEP 4 Comments are forwarded to the Committee STEP 4 Text is sent through CCEXEC to the Commission for adoption as draft standard STEP 5 Decision to omit steps 6 and 7 Text is sent through CCEXEC to the Commission for adoption as draft standard STEP 5 Text is sent for comments to members and observers STEP 6 * Scientific basis* Economic considerations* Consensus when possible* Voting – rare lower acceptance of standards Comments are forwarded to the Committee STEP 7 Text is sent through CCEXEC to the Commission for final adoption STEP 8 Text is sent through CCEXEC to the Commission for final adoption STEP 8 Text is sent through CCEXEC to the Commission for final adoption STEP 8

Principles for Food Import & Export Inspection & Certification Guidelines for Food Import Control Systems Guidelines for the Design, Operation, Assessment and Accreditation of Food Import & Export Inspection & Certification Systems Guidelines on the Judgement of Equivalence of SPS Measures associated with Food Inspection and Certification System Guidelines for Design, Production, Issuance of Information in Food Safety Emergency situations Guidelines for the Exchange of Information between countries on rejections of imported food Principles for Traceability/Product Tracing as a tool within a food inspection and certification system CCFICS Texts

Need for transparency & harmonization with international science-based standard Need to ensure consistency between import and domestic requirements Consideration of the exporting country’s inspection controls in determining the level of inspection needed at import Need for expeditious processing of commodities at import Importance of coordination among border control agencies to share information and reduce delays Importance of science-based decision-making to: identify risk and appropriate inspection establish sampling frequencies based on the risk inherent to the product Risk-based Inspection

CCFICS: Food Safety Risk Analysis  new frontier Risk-based Inspection Guidelines for Food Import Control Systems Annex: Principles & Guidelines for Imported Food Inspection based on Risk CCFICS & Food Safety Intensity of the Inspection categorization of risk → no categorization of the safety standard

Principles Design of a Risk-based Food Import Inspection Programme Development of Requirements & Procedures Implementation of the Risk-based Import Inspection Programme Factors determining the level of risk Risk-based Inspection Nature & Frequency of the Imported Food Inspection Factors determining the changes in the level of risk level of risk  review periodally  proportion nature & frequency inspection / risk assessed

Principles & Guidelines for the Conduct of On-Site Audits & Inspections Generic Model Health Certificate Discussion on: Need for guidance for national food inspection systems Need for further guidance on traceability / product tracing Development of guidance on the prevention of international contamination of food 17th CCFICS Future WorkPhilippines, November 2008

Guidelines for National Food Control Systems Components of a national food control system not describing in detail as provided by existing CCFICS documents for import and export food control systems development of legislation specific details of a food control system guidance on sampling and other enforcement activities These elements could be addressed further to provide additional assistance to competent authorities in the context of a national food control system WTO – Codex international reference for internatinal food safety standards. FAO/WHO : Assuring Food Safety and Quality: Guidelines for Strengthening Food Control Systems Describing general proceures involved in establishing a national food control system Elements of a national food control system Strengthening national food control systems Guidelines for developing a national food law Selected organizational components of a national food control agency Possible activities to be undertaken during the establishment of a national food control agency Need for Guidance on Food Control Systems

WTO/SPS Agreement: Article 5 Codex → Committee on General Principles: New definitions of Risk Analysis Terms related to Food Safety - Definition Uses Legal implications vis-a-vis WTO/SPS Agreement Science-based standards Hazard-based standards Risk-based standards Risk assessment based standards Risk - ? standards Associated discussions

FAO and WHO Provision of Scientific Advice ProScAd • Permanent Expert Committees/Meetings • Ad-Hoc Expert Consultations Risk Assessment 1 Hazard Identification RISK ANALYSIS 2 Hazard Characterization 3 Exposure Assessment 4 Risk Characterization

Additives  Contaminants chemicals & mycotoxins Agrochemicals Veterinary Drugs Radioactivity Microorganisms + toxins FAO/WHO CODEX SAFETY STANDARDSfood safety Protect human life – protect consumers’ health Ensure fair trade practices  Facilitating (international) trade WTO/SPS Article 5 Risk Assessment – Determination of the Appropriate Level of Protection for Sanitary and Phytosanitary Measures Maximum levels of use – GMPs CCFA CCFC Maximum (residue) levels – GMPs & GAPs CCPR CCRVDF CCFH Food-pathogen combinations GHPs – GMPs - GAPs Biotechnology  TFBT Antimicrobial Resistance  TFAMR Ensuring consistent approach to Risk Analysis in Codex CCGP

Safety Standards – Based on risk assessment and other measures to ensure consumers’ health & fair trade practices when risk assessment is not available/applicable  enabling standard e.g. risk-based standards Risk assessment anavailable/not applicable  Application of risk analysis principles  Risk Management Framework Microbiological Risk Assessment Can be applied to Chemical Risk Analysis no categorization of the safety standard WTO/SPS-TBT – Relevant: Content Not format of the texts Risk-based standards science-based

CCFCIS – Risk-based inspection CCGP – Risk-based standards Scientific-basis  Risk analysis

Thank you for your attention

JOINT FAO/WHO FOOD STANDARDS PROGRAMME C odex Alimentarius Commission