JOINT FAO/WHO FOOD STANDARDS PROGRAMME Codex Alimentarius Commission Gracia Brisco Food Standards...

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


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


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



STEP 6


to the Committee

STEP 7


to the Commission

for final adoption

STEP 8

acceleratedaccelerated

two-third majoritytwo-third majority


a new text

STEP 1

Rapporteur develops

proposed draft text

STEP 2



STEP 3


to the Committee

STEP 4



as draft standard

STEP 5


to the Commission

for final adoption

STEP 8

Decision to omit

steps 6 and 7


to the Commission

for final adoption

STEP 8

omit steps 6 and 7omit steps 6 and 7


* 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


– 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



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








– Sampling,

– etc.



– etc.




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


a new text

STEP 1

Rapporteur develops

proposed draft text

STEP 2



STEP 3


to the Committee

STEP 4



as draft standard

STEP 5



STEP 6


to the Committee

STEP 7


to the Commission

for final adoption

STEP 8

acceleratedaccelerated



a new text

STEP 1

Rapporteur develops

proposed draft text

STEP 2



STEP 3


to the Committee

STEP 4



as draft standard

STEP 5


to the Commission

for final adoption

STEP 8

Decision to omit

steps 6 and 7


to the Commission

for final adoption

STEP 8

omit steps 6 and 7omit steps 6 and 7


* Scientific basis* Economic considerations* Consensus when possible* Voting – rare lower acceptance of standards







– Inspection/CertificationInspection/Certification

– Sampling,

– etc.


– IInspection/Certificationnspection/Certification

– etc.




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



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

JOINT FAO/WHO FOOD STANDARDS PROGRAMME Codex Alimentarius Commission Gracia Brisco Food Standards...

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