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

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joint fao who food standards programme c odex alimentarius commission

The work of an international food standard-setting body

JOINT FAO/WHO FOOD STANDARDS PROGRAMMECodex Alimentarius Commission

Since 1963 until now

Gracia BriscoFood Standards OfficerCodex SecretariatCodex Alimentarius Commission

Acapulco, Mexico, November 2008

world trade organization
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/Certification

WTO/SPS AGREEMENT & CODEX

CCFA

CCCF

CCPR

CCRVDF

Harmonized sanitary & phytosanitary measures based on international standards

CCFH

CCMAS

CCFICS

wto tbt agreement codex
Codex Non-Food safety provisions relevant to the WTO/TBT Agreement

Labelling

Nutrition

Quality provisions

Methods of Analysis & Sampling

Inspection/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.

WTO/TBT AGREEMENT & CODEX

CCFL

CCFLCCNFSDU

COMMODITY COMMITTEES

CCMAS

CCFICS

Harmonized technical regulations based on international standards

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

WTO/SPS-TBT AGREEMENTS & CODEX

National Sanitary & Phytosanitary measuresTechnical regulations

consistent with CODEX fulfil the requirements of the WTO/SPS-TBT AGREEMENTS

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)

Facilitating international trade

MANDATE

CODEX ALIMENTARIUS COMMISSION

Dual Objective

structure joint fao who food standards programme
Codex Alimentarius Commission

Subsidiary bodies

Management bodies

Technical bodies

Executive Committee

Secretariat

General committees

Commodity committees

Task Forces

••Regional committees

STRUCTUREJoint FAO/WHO Food Standards Programme
cac subsidiary bodies
General committees: Horizontal work  general matters (SAFETY + non-safety) cross-cutting nature

Commodity committees: Vertical work  specific matters (Non-safety) applying to a food/group of foods

CAC & Subsidiary Bodies
  • TaskForces: Horizontal work  general matters (Safety and/or Non-safety) applying across food/group of foods
slide10

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

standards development elaboration procedure
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

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 ALIMENTARIUSOutputs
slide14

WTO/SPS AGREEMENT

  • Article 5 – Risk AssessmentAppropriate Level of Protection Sanitary/Phytosanitary Measures (ALOPs)
  • Members ensure sanitary & phytosanitary measures based risk assessmentdeveloped 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
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
fao and who
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

slide17

Article 5 Risk Assessment – Determination Appropriate Level Protection Sanitary & Phytosanitary Measures

JECFA

Chemical hazards

JMPR

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

safety standards food safety
Additives 

Contaminants

chemicals & mycotoxins

Agrochemicals

Veterinary Drugs

Radioactivity

Microorganisms + toxins

FAO/WHO

CODEX

SAFETY STANDARDSfood 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

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

codex alimentarius outputs1
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 ALIMENTARIUSOutputs
codex risk analysis codex committee on food import and export inspection and certification systems
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, testing 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 methods; [...]

Article 8 – Control, Inspection and Approval Procedures

Annex C Control, Inspection and Approval Procedures: include inter aliasampling, 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

WTO/SPS Agreement
slide22
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 & Export Inspection & Certification Systems
codex committee on food import and export inspection and certification systems
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

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

Codex Committee on Food Import and Export Inspection and Certification Systems

protect consumers’ health

ensure fair trading practices

facilitate international food trade

standards development elaboration procedure1
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

codex alimentarius outputs2
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 ALIMENTARIUSOutputs
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

CCFICS Texts
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

Risk-based Inspection
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

CCFICS & Food Safety

Intensity of the Inspection categorization of risk → no categorization of the safety standard

risk based inspection1
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

Risk-based Inspection

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

17 th 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

17th CCFICS Future WorkPhilippines, November 2008
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

Need for Guidance on Food Control Systems
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

Associated discussions
fao and who1
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

safety standards food safety1
Additives 

Contaminants

chemicals & mycotoxins

Agrochemicals

Veterinary Drugs

Radioactivity

Microorganisms + toxins

FAO/WHO

CODEX

SAFETY STANDARDSfood 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

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

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

Risk-based standards

science-based

slide37
CCFCIS – Risk-based inspection

CCGP – Risk-based standards

Scientific-basis 

Risk analysis