Transcript Slide 1

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
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
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Maximum Levels for
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Maximum Residue Limits for
Additives
Contaminants
Veterinary drugs
Pesticides
Pathogen microorganisms
+ toxins
Harmonized sanitary &
phytosanitary measures
based on
international standards
Codex Food safety provisions
recognized by the
WTO/SPS Agreement
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– Additives CCFA
– Contaminants CCCF
– Pesticides CCPR
– Veterinary Drugs
CCRVDF
Hygiene requirements  biological
hazards (pathogens/food CCFH
associated)
CCMAS
Methods of analysis and sampling
Inspection/Certification
CCFICS
WTO/TBT AGREEMENT & CODEX
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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
regulations based on
international standards
Codex Non-Food safety provisions
relevant to the
WTO/TBT Agreement
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Labelling
CCFL
Nutrition
CCFL
CCNFSDU
Quality provisions
COMMODITY
COMMITTEES
Methods of Analysis & Sampling
Inspection/Certification
CCFICS
CCMAS
WTO/SPS-TBT AGREEMENTS & CODEX
WTO/SPS
sanitary & phytosanitary
measures
• Reference point to solve disputes
in international trade (safety/nonsafety matters)
• Reference point to harmonize
WTO/TBT
technical
regulations & standards
national
– sanitary & phytosanitary measures
– standards & regulations
National
Sanitary & Phytosanitary measures
Technical regulations
consistent with CODEX
fulfil the requirements of the
WTO/SPS-TBT AGREEMENTS
JOINT FAO/WHO
FOOD STANDARDS PROGRAMME
CODEX ALIMENTARIUS COMMISSION
CODEX ALIMENTARIUS
COMMISSION
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Coordinating work on food
standards with other
international organizations
(INGOs & IGOs)
Facilitating
international trade
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Protecting consumers health –
WTO/SPS - TBT
Ensuring fair trade practices –
WTO/SPS - TBT
Dual Objective
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MANDATE
STRUCTURE
Joint FAO/WHO Food Standards Programme
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Codex Alimentarius
Commission
Subsidiary bodies
Management bodies
Technical bodies
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Executive Committee
Secretariat
General committees
Commodity committees
Task Forces
•• Regional committees
CAC & Subsidiary Bodies
• Commodity committees:
Vertical work  specific
matters (Non-safety)
• General committees:
applying to a food/group of
Horizontal work 
foods
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
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX ALIMENTARIUS COMMISSION
Executive Committee
General Committees
WTO
SPS - TBT
Secretariat
Commodity Committees
Task Forces
Regional Coordinating Committees
General Principles
Milk and Milk Products
Africa
(France)
(New Zealand)
(Ghana)
Antimicrobial Resistance
(Korea)
WTO/SPS
WTO/SPS
Food Additives
Processed Fruits and Vegetables
Asia
(China)
(United States of America)
(Indonesia)
Food Hygiene
(United States of America)
Meat Hygiene
(New Zealand)
Europe
(Switzerland)
ADJOURNED SINE DIE
WTO
SPS-TBT
Food Labelling
Fish and Fishery Products
(Canada)
(Norway)
WTO
SPS-TBT
Methods of Analysis and Sampling
(Hungary)
Fresh Fruits and Vegetables
WTO/SPS
Foods derived from Biotechnology
(Japan)
DISSOLVED
Latin America and the Caribbean
Animal Feeding
(Denmark)
DISSOLVED
(Mexico)
Near East
(Mexico)
Pesticide Residues
Fats and Oils
(China)
(Malaysia)
Residues of Veterinary Drugs in Foods
(United States of America)
(United Kingdom)
(Tunisia)
Quick Frozen Foods
(Thailand)
DISSOLVED
North America and South West Pacific
(Tonga)
Sugar
WTO/SPS
WTO
SPS-TBT
Food Import and Export Inspection and
Certification Systems
(Australia)
WTO
SPS-TBT
Nutrition and Food for Special Dietary Uses
WTO/SPS
Food Contaminants
(Germany)
(Netherlands)
ADJOURNED SINE DIE
WTO
SPS-TBT
Cereals, Pulses and Legumes
(United States of America)
ADJOURNED SINE DIE
Vegetable Proteins
(Canada)
ADJOURNED SINE DIE
Natural Mineral Waters
(Switzerland)
ADJOURNED SINE DIE
Cocoa and Chololate Productos
(Switzerland)
ADJOURNED SINE DIE
WTO
SPS-TBT
Standards development
Elaboration Procedure
Commission Decision to elaborate
a new text
STEP 1
Rapporteur develops
proposed draft text
STEP 2
Commission Decision to elaborate
a new text
STEP 1
normal
accelerated
two-third majority
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
Rapporteur develops
proposed draft text
STEP 2
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
Decision to omit
steps 6 and 7
Text is sent through CCEXEC
to the Commission for adoption
as draft standard
STEP 5
* Scientific basis
* Economic considerations
* Consensus when possible
* Voting – rare lower acceptance
of standards
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
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
CODEX & SAFETY MATTERS
(SPS ISSUES)
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)
Risk Analysis – Role Players
FAO/WHO
Risk Assessment
• Permanent Expert
Committees/Meetings
• Ad-Hoc Expert
Consultations
• Codex Alimentarius
RISK ANALYSIS
Risk Management
Commission
• subsidiary bodies
Risk Communication
• FAO/WHO
• Governments
FAO and WHO
Provision of Scientific Advice
ProScAd
• Permanent Expert
Risk Assessment
Committees/Meetings
• Ad-Hoc Expert
Consultations
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Hazard Identification
RISK ANALYSIS
2
Hazard Characterization
3
Exposure Assessment
4
Risk Characterization
Article 5 Risk Assessment –
Determination Appropriate Level Protection
Sanitary & Phytosanitary Measures
WTO/SPS
Provision of Scientific Advice –
Risk Assessment
FAO/WHO
Additives
Contaminants
(including
mycotoxins)
FAO/WHO Programme for the
Provision of Scientific Advice
Veterinary
drugs
residues
JECFA
JEMRA
Food –
pathogen
combinations
Microbiological
Hazards
Chemical hazards
JMPR
Pesticide
residues
Biotechnology
Previous Cargoes
Biotoxins
Nutrition
Antimicrobial
Resistance
Ad hoc expert consultations
Active Chlorine
Lactoperoxidase
system
Others
FAO/WHO
SAFETY STANDARDS
CODEX
food safety
Protect human life – protect consumers’ health
WTO/SPS
Ensure fair trade practices  Facilitating (international) trade
Article 5 Risk Assessment –
Determination of the Appropriate Level of Protection
for Sanitary and Phytosanitary Measures
Maximum levels of use –
• Additives 
CCFA
GMPs
• Contaminants CCFC
– chemicals & mycotoxins
Maximum (residue) levels
• Agrochemicals CCPR
– GMPs & GAPs
• Veterinary Drugs CCRVDF
• Radioactivity
• Microorganisms + toxins
CCFH
Food-pathogen combinations
GHPs – GMPs - GAPs
Biotechnology  TFBT
Antimicrobial Resistance  TFAMR
Ensuring consistent approach to Risk Analysis in Codex
CCGP
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
Codex,
Risk Analysis &
Codex Committee on Food Import
and Export Inspection and
Certification Systems
WTO/SPS Agreement
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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
Article 8 –
trading in the same product, if the
exporting Member objectively
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; [...]
Control, Inspection and Approval Procedures
•
demonstrates to the importing Member
Annex C Control, Inspection and Approval
Procedures: include inter alia sampling, testing and
certification
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
•
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
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Conformity with
Standards/Regulations
 Conformity
Assessment =
sampling,
Committee on Methods of
Analysis & Sampling (CCMAS)
testing,
inspection,
Committee on Food Import
assessment,
and Export Inspection and
verification and conformity
Certification Systems
assessment
registration
accrediation and approval
any of the above
combinations
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
• Quality assurance systems:
Principles for use for conformity
assessment & promotion of the
recognition of these systems for
facilitation of trade under bilateral /
• Assessment & Accreditation of
multilateral agreements
Inspection & Certification
• Inspection & Certification:
Principles & Guidelines for
harmonization of methods
and procedures
Systems
• Information exchange on food
import & export controls 
rejections of foods
• Development of official certificates:
Guidelines & criteria for format,
declarations and language of official
certificates for international
harmonization
protect consumers’ health
ensure fair trading practices
facilitate international food trade
Standards development
Elaboration Procedure
Commission Decision to elaborate
a new text
STEP 1
Rapporteur develops
proposed draft text
STEP 2
Commission Decision to elaborate
a new text
STEP 1
normal
accelerated
two-third majority
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
Rapporteur develops
proposed draft text
STEP 2
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
Decision to omit
steps 6 and 7
Text is sent through CCEXEC
to the Commission for adoption
as draft standard
STEP 5
* Scientific basis
* Economic considerations
* Consensus when possible
* Voting – rare lower acceptance
of standards
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
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
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
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
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
Risk-based Inspection
• Principles
• Design of a Risk-based
Food Import Inspection
Programme
• Development of
Requirements &
Procedures
• Implementation of the Riskbased 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
17th CCFICS
Future Work
Philippines, November 2008
Discussion on:
• Principles & Guidelines
for the Conduct of OnSite Audits & Inspections
• Generic Model Health
Certificate
• 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 Systems
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
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
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•
•
•
Science-based standards
Hazard-based standards
Risk-based standards
Risk assessment based
standards
• Risk - ? standards
FAO and WHO
Provision of Scientific Advice
ProScAd
• Permanent Expert
Risk Assessment
Committees/Meetings
• Ad-Hoc Expert
Consultations
1
Hazard Identification
RISK ANALYSIS
2
Hazard Characterization
3
Exposure Assessment
4
Risk Characterization
FAO/WHO
SAFETY STANDARDS
CODEX
food safety
Protect human life – protect consumers’ health
WTO/SPS
Ensure fair trade practices  Facilitating (international) trade
Article 5 Risk Assessment –
Determination of the Appropriate Level of Protection
for Sanitary and Phytosanitary Measures
Maximum levels of use –
• Additives 
CCFA
GMPs
• Contaminants CCFC
– chemicals & mycotoxins
Maximum (residue) levels
• Agrochemicals CCPR
– GMPs & GAPs
• Veterinary Drugs CCRVDF
• Radioactivity
• Microorganisms + toxins
CCFH
Food-pathogen combinations
GHPs – GMPs - GAPs
Biotechnology  TFBT
Antimicrobial Resistance  TFAMR
Ensuring consistent approach to Risk Analysis in Codex
CCGP
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
science-based
• 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
• CCFCIS – Risk-based
inspection
Scientific-basis 
• CCGP – Risk-based
standards
Risk analysis
Thank you
for your attention