JOINT FAO/WHO FOOD STANDARDS PROGRAMME Codex Alimentarius Commission

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JOINT FAO/WHO FOOD STANDARDS PROGRAMMECodex
Alimentarius Commission
The work of an international food
standard-setting body
Since 1963 until now
Gracia BriscoFood Standards OfficerCodex
SecretariatCodex Alimentarius Commission
Acapulco, Mexico, November 2008
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WORLD TRADE ORGANIZATION
AGREEMENT ON THE APPLICATION OF SANITARY AND
PHYTOSANITARY MEASURES SPS AGREEMENT
AGREEMENT ON TECHNICAL BARRIERS TO TRADE TBT
AGREEMENT
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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
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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
CCFLCCNFSDU
COMMODITY COMMITTEES
CCMAS
CCFICS
Harmonized technical regulations based on
international standards
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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
measuresTechnical regulations consistent with
CODEX fulfil the requirements of the
WTO/SPS-TBT AGREEMENTS
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JOINT FAO/WHO FOOD STANDARDS PROGRAMMECODEX
ALIMENTARIUS COMMISSION
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MANDATE
CODEX 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)

Dual Objective

• Facilitating international trade

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STRUCTUREJoint 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

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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

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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
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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
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 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
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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

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CODEX SAFETY MATTERS (SPS ISSUES)
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WTO/SPS AGREEMENT Article 5 Risk
AssessmentAppropriate 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)
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Risk Analysis Role Players

• FAO/WHO
• Permanent Expert Committees/Meetings
• Ad-Hoc Expert Consultations

Risk Assessment
Risk Management
RISK ANALYSIS

• Codex Alimentarius Commission
• subsidiary bodies

Risk Communication

• FAO/WHO
• Governments

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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
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Risk Characterization
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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
JEMRA
Microbiological Hazards
Nutrition
Pesticide residues
Antimicrobial Resistance
Biotechnology
Previous Cargoes
Ad hoc expert consultations
Others
Biotoxins
Lactoperoxidase system
Active Chlorine
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SAFETY STANDARDSfood safety
FAO/WHO
CODEX
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
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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

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

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• 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
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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

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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
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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
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 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
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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

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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

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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 countrys
  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

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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
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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
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17th CCFICS Future WorkPhilippines, 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

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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.

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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

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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
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SAFETY STANDARDSfood safety
FAO/WHO
CODEX
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
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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
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• CCFCIS Risk-based inspection

Scientific-basis ? Risk analysis

• CCGP Risk-based standards

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Thank you for your attention