1. JOINT FAO/WHO FOOD STANDARDS PROGRAMME Codex Alimentarius Commission
The work of an international food standard-setting body
JOINT FAO/WHO FOOD STANDARDS PROGRAMME Codex Alimentarius Commission
Since 1963 until now
Gracia Brisco Food Standards Officer Codex Secretariat Codex Alimentarius Commission
Acapulco, Mexico, November 2008

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

3. WTO/SPS AGREEMENT & CODEX
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
CCFA
CCCF
CCPR
CCRVDF
Harmonized sanitary & phytosanitary measures based on international standards
CCFH
CCMAS
CCFICS

4. WTO/TBT AGREEMENT & CODEX
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.
Codex Non-Food safety provisions relevant to the WTO/TBT Agreement
Labelling
Nutrition
Quality provisions
Methods of Analysis & Sampling
Inspection/Certification
CCFL
CCFL CCNFSDU
COMMODITY COMMITTEES
CCMAS
CCFICS
Harmonized technical regulations based on international standards

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

6. JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX ALIMENTARIUS COMMISSION

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

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

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

10. Antimicrobial Resistance (Korea)
WTO SPS - TBT
Antimicrobial Resistance (Korea)
WTO/SPS
WTO/SPS
WTO SPS-TBT
WTO SPS-TBT
WTO/SPS
WTO/SPS
WTO SPS-TBT
WTO SPS-TBT
WTO SPS-TBT
WTO/SPS
WTO SPS-TBT

11. 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

12. CODEX ALIMENTARIUS Outputs
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

13. CODEX & SAFETY MATTERS (SPS ISSUES)

14. WTO/SPS AGREEMENT
Article 5 – Risk Assessment Appropriate Level of Protection Sanitary/Phytosanitary Measures (ALOPs)
Members ensure sanitary & phytosanitary measures based risk assessment developed 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)

15. 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

16. Provision of Scientific Advice ProScAd
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

17. FAO/WHO Programme for the Provision of Scientific Advice
Article 5 Risk Assessment – Determination Appropriate Level Protection Sanitary & Phytosanitary Measures
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
JECFA
JMPR
Chemical hazards
JEMRA
Microbiological Hazards
Nutrition
Pesticide residues
Antimicrobial Resistance
Biotechnology
Previous Cargoes
Ad hoc expert consultations
Others
Biotoxins
Lactoperoxidase system
Active Chlorine

18. SAFETY STANDARDS food safety
FAO/WHO
CODEX
SAFETY STANDARDS food 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
Additives 
Contaminants
chemicals & mycotoxins
Agrochemicals
Veterinary Drugs
Radioactivity
Microorganisms + toxins
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

19. CODEX ALIMENTARIUS Outputs
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

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

21. Article 8 – Control, Inspection and Approval Procedures
WTO/SPS Agreement
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 alia sampling, 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
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

22. 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

23. 17th Session Cebu, Philippine, 24-28 November 2008
Codex Committee on Food Import & Export Inspection & Certification Systems
Host Government: Australia
16th Sessions (until 2006)
Coming up soon:
17th Session Cebu, Philippine, November 2008

24. facilitate international food trade
Codex Committee on Food Import and Export Inspection and Certification Systems
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
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
protect consumers’ health
ensure fair trading practices
facilitate international food trade

25. 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

26. CODEX ALIMENTARIUS Outputs
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

27. CCFICS Texts
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

28. Risk-based Inspection
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

29. Guidelines for Food Import Control Systems
CCFICS & Food Safety
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
Intensity of the Inspection  categorization of risk → no categorization of the safety standard

30. Risk-based Inspection
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
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

31. 17th CCFICS Future Work Philippines, November 2008
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
Principles & Guidelines for the Conduct of On-Site Audits & Inspections
Generic Model Health Certificate

32. Need for Guidance on Food Control Systems
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
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.

33. Associated discussions
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

34. Provision of Scientific Advice ProScAd
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

35. SAFETY STANDARDS food safety
FAO/WHO
CODEX
SAFETY STANDARDS food 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
Additives 
Contaminants
chemicals & mycotoxins
Agrochemicals
Veterinary Drugs
Radioactivity
Microorganisms + toxins
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

36. no categorization of the safety standard
Risk-based standards
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
science-based

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

38. Thank you for your attention