JOINT FAO/WHO FOOD STANDARDS PROGRAMMECodex Alimentarius Commission
Gracia BriscoFood Standards OfficerCodex SecretariatCodex Alimentarius Commission
Acapulco, Mexico, November 2008
The work of an international food standard-setting body
Since 1963 until now
WORLD TRADE ORGANIZATION
AGREEMENT ON THE APPLICATION OF SANITARY
AND PHYTOSANITARY MEASURES
SPS AGREEMENT
AGREEMENT ON TECHNICAL
BARRIERS TO TRADE
TBT AGREEMENT
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/CertificationInspection/Certification
CCFA
CCCF
CCPR
CCRVDF
CCFH
CCMAS
CCFICS
Harmonized sanitary & Harmonized sanitary & phytosanitary measures phytosanitary measures
based on based on international standardsinternational standards
WTO/TBT AGREEMENT & CODEX
Codex Non-Food safety provisions
relevant to the
WTO/TBT Agreement
• Labelling
• Nutrition
• Quality provisions
• Methods of Analysis & Sampling
• Inspection/CertificationInspection/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.
Harmonized technical Harmonized technical regulations based on regulations based on
international standardsinternational standards
CCFL
CCFLCCNFSDU
COMMODITY COMMITTEES
CCMAS
CCFICS
WTO/SPS-TBT AGREEMENTS & CODEX
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
National National Sanitary & Phytosanitary measuresSanitary & Phytosanitary measures
Technical regulations Technical regulations
consistent with CODEX consistent with CODEX fulfil the requirements of the fulfil the requirements of the WTO/SPS-TBT AGREEMENTSWTO/SPS-TBT AGREEMENTS
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX ALIMENTARIUS COMMISSION
MANDATE
• Protecting consumers health – WTO/SPSSPS - TBT
• Ensuring fair trade practices – WTO/SPS - TBTTBT
• Coordinating work on food standards with other international organizations (INGOs & IGOs)
Facilitatin
g
intern
ation
al trade
Du
al O
bje
ctive
CODEX ALIMENTARIUS COMMISSION
STRUCTUREJoint FAO/WHO Food Standards Programme
Codex Alimentarius Commission
Subsidiary bodies
• Management bodies
• Technical bodies
• Executive Committee
• Secretariat
• General committeesGeneral committees
• Commodity committeesCommodity committees
• Task Forces
•• Regional committees
CAC & Subsidiary Bodies
• General committeesGeneral committees: HorizontalHorizontal work general matters (SAFETY + non-safety) cross-cutting nature
• Commodity committeesCommodity committees: VerticalVertical work specific matters (Non-safety) applying to a food/group of foods
• TaskTask ForcesForces: HorizontalHorizontal work general matters (Safety and/or Non-safety) applying across food/group of foods
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX ALIMENTARIUS COMMISSION
Executive Committee Secretariat
General Committees Commodity Committees Task Forces
General Principles
(France)
Food Additives
(China)
Food Hygiene
(United States of America)
Food Labelling
(Canada)
Methods of Analysis and Sampling (Hungary)
Pesticide Residues
(China)
Residues of Veterinary Drugs in Foods (United States of America)
Food Import and Export Inspection and Certification Systems
(Australia)
Nutrition and Food for Special Dietary Uses
(Germany)
Milk and Milk Products
(New Zealand)
Cocoa and Chololate Productos
(Switzerland) ADJOURNED SINE DIE
Processed Fruits and Vegetables
(United States of America)
Meat Hygiene
(New Zealand)
ADJOURNED SINE DIE
Fish and Fishery Products
(Norway)
Fresh Fruits and Vegetables
(Mexico)
Fats and Oils
(Malaysia)
Sugar
(United Kingdom)
ADJOURNED SINE DIE
Cereals, Pulses and Legumes (United States of America) ADJOURNED SINE DIE
Vegetable Proteins
(Canada) ADJOURNED SINE DIE
Natural Mineral Waters
(Switzerland) ADJOURNED SINE DIE
Africa
(Ghana)
Asia
(Indonesia)
Europe
(Switzerland)
Latin America and the Caribbean
(Mexico)
Near East
(Tunisia)
North America and South West Pacific (Tonga)
Regional Coordinating Committees
Food Contaminants
(Netherlands)
Quick Frozen Foods(Thailand)
DISSOLVED
Foods derived from Biotechnology(Japan)
DISSOLVED
Animal Feeding(Denmark)
DISSOLVED
WTO/SPS
WTOSPS-TBT
WTOSPS - TBT
WTOSPS-TBT
WTO
SPS-TBT
WTOSPS-TBT
WTO/SPS
WTOSPS-TBT
WTO/SPS
WTO/SPS
WTO/SPS
WTOSPS-TBT
Antimicrobial Resistance(Korea)
Standards development Elaboration Procedurenormalnormal
Commission Decision to elaborate
a new text
STEP 1
Rapporteur develops
proposed draft text
STEP 2
Text is sent for comments to
members and observers
STEP 3
Comments are forwarded
to the Committee
STEP 4
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
Comments are forwarded
to the Committee
STEP 7
Text is sent through CCEXEC
to the Commission
for final adoption
STEP 8
acceleratedaccelerated
two-third majoritytwo-third majority
Commission Decision to elaborate
a new text
STEP 1
Rapporteur develops
proposed draft text
STEP 2
Text is sent for comments to
members and observers
STEP 3
Comments are forwarded
to the Committee
STEP 4
Text is sent through CCEXEC
to the Commission for adoption
as draft standard
STEP 5
Text is sent through CCEXEC
to the Commission
for final adoption
STEP 8
Decision to omit
steps 6 and 7
Text is sent through CCEXEC
to the Commission
for final adoption
STEP 8
omit steps 6 and 7omit steps 6 and 7
two-third majoritytwo-third majority
* Scientific basis* Economic considerations* Consensus when possible* Voting – rare lower acceptance of standards
CODEX ALIMENTARIUSOutputs
• 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 & SAFETY MATTERS (SPS ISSUES)
WTO/SPS AGREEMENTArticle 5 – Risk Assessment
Appropriate Level of Protection Sanitary/Phytosanitary Measures (ALOPs)
Members ensure sanitary & phytosanitary measures based risk assessmentrisk assessment developed by international organizationsFactors 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 riskDetermination of ALOP
minimizing negative trade effects = avoiding arbitrary/unjustifiable distinctions in different ALOPs = discrimination or disguised restriction on international tradeInsufficient scientific evidence precautionary measures (interim basis – reasonable period of time)
Risk Analysis – Role Players
Risk Assessment
Risk Management
Risk Communication
RISK ANALYSIS
FAO/WHO
• Permanent Expert Committees/Meetings
• Ad-Hoc Expert Consultations
• Codex Alimentarius Commission
• subsidiary bodies
• FAO/WHO
• Governments
FAO and WHO
Risk Assessment
RISK ANALYSIS
• Permanent Expert Committees/Meetings
• Ad-Hoc Expert Consultations
Hazard Identification
Risk Characterization
Exposure Assessment
Hazard Characterization
1
3
2
4
Provision of Scientific Advice ProScAd
FAO/WHO Programme for the Provision of Scientific Advice
JEMRA
Nutrition
Ad hoc expert consultations
BiotechnologyPrevious Cargoes
Antimicrobial Resistance
Biotoxins Active Chlorine Lactoperoxidase system
Others
JECFA
JMPR
Chemical hazards
Microbiological Hazards
Additives
Contaminants (including mycotoxins)
Veterinary drugs residues
Pesticide residues
Food – pathogen combinations
WTO/SPS FAO/WHO
Article 5 Risk Assessment – Determination Appropriate Level Protection
Sanitary & Phytosanitary Measures
Provision of Scientific Advice – Risk Assessment
SAFETY STANDARDSfood safety
• Additives
• Contaminants
– chemicals & mycotoxins
• Agrochemicals
• Veterinary Drugs
• Radioactivity
• Microorganisms + toxins
CCFA
CCPR
CCRVDF
CCFH
CCFC
Maximum (residue) levels – GMPs & GAPs
Maximum levels of use – GMPsGMPs
Food-pathogen combinations GHPsGHPs – GMPs - GAPs – GMPs - GAPs
FAO/WHO
Protect human life – protect consumers’ health
Ensure fair trade practices Facilitating (international) trade
CODEX
Ensuring consistent approach to Risk Analysis in Codex CCGP
Article 5 Risk Assessment – Determination of the Appropriate Level of Protection
for Sanitary and Phytosanitary Measures
Biotechnology TFBT
Antimicrobial Resistance TFAMR
WTO/SPS
CODEX ALIMENTARIUSOutputs
• 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, Risk Analysis &
Codex Committee on Food Import and Export Inspection and
Certification Systems
WTO/SPS Agreement
• 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, inspection,
testing and other relevant procedurestesting 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 methodsinspection, sampling and testing methods; [...]
Article 8 –
Control, Inspection and Approval Procedures • Annex C Control, Inspection and Approval
Procedures: include inter alia sampling, testing and sampling, testing and certificationcertification
Annex A – Definitions: • SPS measures include all relevant laws, decrees,
regulations, requirements & procedures including inter alia end product criteria; processes and processes and production methodsproduction methods; testing, inspection, testing, inspection, certification and approval producescertification and approval produces; [...] provisions on relevant statistical methods, sampling procedures and methods of risk assessmentrisk assessment; and packaging and labelling requirements related to food safety
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
Codex Committee on Food Import & Export
Inspection & 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 and Export Inspection and Certification Systems
• Inspection & Certification: Inspection & Certification: Principles & Guidelines for Principles & Guidelines for harmonization of methods harmonization of methods and proceduresand 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
protect consumers’ health
ensure fair trading practicesfacilitate international food trade
Standards development Elaboration Procedurenormalnormal
Commission Decision to elaborate
a new text
STEP 1
Rapporteur develops
proposed draft text
STEP 2
Text is sent for comments to
members and observers
STEP 3
Comments are forwarded
to the Committee
STEP 4
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
Comments are forwarded
to the Committee
STEP 7
Text is sent through CCEXEC
to the Commission
for final adoption
STEP 8
acceleratedaccelerated
two-third majoritytwo-third majority
Commission Decision to elaborate
a new text
STEP 1
Rapporteur develops
proposed draft text
STEP 2
Text is sent for comments to
members and observers
STEP 3
Comments are forwarded
to the Committee
STEP 4
Text is sent through CCEXEC
to the Commission for adoption
as draft standard
STEP 5
Text is sent through CCEXEC
to the Commission
for final adoption
STEP 8
Decision to omit
steps 6 and 7
Text is sent through CCEXEC
to the Commission
for final adoption
STEP 8
omit steps 6 and 7omit steps 6 and 7
two-third majoritytwo-third majority
* Scientific basis* Economic considerations* Consensus when possible* Voting – rare lower acceptance of standards
CODEX ALIMENTARIUSOutputs
• Standards– Commodity quality (+ safety)
– General safety (+ quality)
• Codes of Practices– Hygiene (GHP)
– Production Technology (GMP) = processing, handling, packaging, storage, transport, etc.
• Guidelines– Labelling
– Inspection/CertificationInspection/Certification
– Sampling,
– etc.
• Principles– Hygiene
– IInspection/Certificationnspection/Certification
– etc.
• Databases– Maximum Residue Limits
(MRLs) pesticides & veterinary drugs
• Miscelaneous– Methods of Analysis &
Sampling
CCFICS Texts• Principles for Food Import &
Export Inspection & Certification
• GuidelinesGuidelines for Food Import for Food Import Control SystemsControl 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
Risk-based Inspection• Need for transparency &
harmonization with international
science-based standardscience-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
CCFICS & Food Safety
CCFICS: Food Safety Risk
Analysis new frontiernew frontierRisk-based InspectionRisk-based Inspection
Guidelines for Food Import Control Systems
Annex: Principles & Guidelines for Imported Food Inspection
based on Riskbased on Risk
Intensity of the Inspection categorization of risk →
no categorization of the safety standard
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
Factors determining the changes
in the level of risk
Nature & Frequency of the Imported Food
Inspection
level of risk review periodally proportion nature & frequency inspection / risk assessed
17th CCFICS Future Work
Philippines, November 2008
• 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
Need for Guidance on Food Control SystemsGuidelines 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 activitiesThese 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
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
FAO and WHO
Risk Assessment
RISK ANALYSIS
• Permanent Expert Committees/Meetings
• Ad-Hoc Expert Consultations
Hazard Identification
Risk Characterization
Exposure Assessment
Hazard Characterization
1
3
2
4
Provision of Scientific Advice ProScAd
SAFETY STANDARDSfood safety
• Additives
• Contaminants
– chemicals & mycotoxins
• Agrochemicals
• Veterinary Drugs
• Radioactivity
• Microorganisms + toxins
CCFA
CCPR
CCRVDF
CCFH
CCFC
Maximum (residue) levels – GMPs & GAPs
Maximum levels of use – GMPs
Food-pathogen combinations GHPs – GMPs - GAPs
FAO/WHO
Protect human life – protect consumers’ health
Ensure fair trade practices Facilitating (international) trade
CODEX
Ensuring consistent approach to Risk Analysis in Codex CCGP
Article 5 Risk Assessment – Determination of the Appropriate Level of Protection
for Sanitary and Phytosanitary Measures
Biotechnology TFBT
Antimicrobial Resistance TFAMR
WTO/SPS
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-basedscience-based
• CCFCIS – Risk-based inspection
• CCGP – Risk-based standards
Scientific-basis
Risk analysis
Thank you for your attention