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Active Participation to Codex Standard Setting Process

Hidetaka Kobayashi Codex Secretariat

Recent Topics of Standard Setting in Codex

12 June 2013

1

Codex Alimentarius Commission - What makes difference?

• Codex international food standards, guidelines and codes of practice contribute to the safety, quality and fairness of international food trade

• The reference made to Codex food safety standards in the World Trade Organizations' Agreement on Sanitary and Phytosanitary measures (SPS Agreement)

– Codex has far reaching implications for resolving trade disputes

– WTO members that wish to apply stricter food safety measures than those set by Codex may be required to justify these measures scientifically

2

Codex Standards

Product Definition

Food Additives

Contaminants

Pesticide Residues

Essential Characteristics

Product Classification

Food Labelling Traceability

Pathogenic Microorganisms

Bulk Transportation

TBT

SPS

Codex Standard and WTO 3

Codex Alimentarius Commission in Member Countries

• Most of Members use some of Codex Standards/ texts as the basis of their legislation/regulations/guidelines etc.

• Because

– Internationally recognized

– Based on sound science

4

Active participation in Codex

• Codex considers a standard/text that your country needs

• The standard/text reflect the information/data in your country

• The standard/text can be used in your regulation/guideline etc.

5

What to do?

• Submit information/data in respond to request from committees/JECFA/JMPR etc.

• Propose new work

• Comments on proposed draft/draft standards

• Establish the position of your country

6

Propose new work

• Identify a problem/ needs for a Standard

• Submit a discussion paper for consideration at the relevant committee

– w/ or w/o Project Document

• If the Committee agrees with developing a new standard, a project document will be submitted to the Commission through the CCEXEC

• The Commission approve the new work (Step 1)

7

Standard Setting Process (2)

• Drafting a proposed draft standard (Step 2)

– In many cases done by eWG

• Circulation of the proposed draft for comments (Step 3)

• Consideration of the proposed draft at a committee (Step 4)

• Adoption as a draft standard by CAC (Step 5)

8

Standard Setting Process (3)

• Circulation of a draft standard (Step 6)

• Consideration of a draft standard at a committee (Step 7)

• Submission of a draft standard to the CAC through CCEXEC and consideration at the CAC (Step 8)

• New Standard

9

Fast Track

• Accelerated Procedure – Final Adoption at Step 5

– The Commission/ committee identify at the new work proposal

• Step 5/8 – Skip Steps 6 and 7

– A committee may propose when submission to CAC at Step 5

10

If you identify the need to develop a standard, you need…

• Discussion paper for a committee

– Explanation of the problem/ needs that are identified

– Not mandatory, but better for discussion at a committee

• Project document

– Project document will be examined by CCEXEC

– Project document should follow a format

– New work will not be approved without good project document

11

Project document must include… 1. Purpose and scope of the standard

2. Relevance and timeliness

3. Main aspects to be covered

4. Criteria for the establishment of work priorities

5. Relevance to the Codex strategic objectives

6. Information on the relation between the proposal and other existing Codex documents

7. Expert scientific advice and its availability

8. Identification of any need for technical input to the standard from external bodies

9. Proposed timeline

12

Criteria for the Establishment of Work Priorities

• General Subjects a. Diversification of national legislations and apparent

resultant or potential impediments to international trade

b. Scope of work and establishment of priorities between the various sections of the work

c. Work already undertaken by other international organizations in this field and/or suggested by the relevant international intergovernmental bodies

d. Amenability of the subject of the proposal to standardization

e. Consideration of the global magnitude of the problem or issue

13

Criteria for the Establishment of Work Priorities (cont)

• Commodity Standards a. Volume of production and consumption in individual countries and volume

and pattern of trade between countries

b. Diversification of national legislations and apparent resultant or potential impediments to international trade

c. International or regional market potential

d. Amenability of the commodity to standardization

e. Coverage of the main consumer protection and trade issues by existing or proposed general standards

f. Number of commodities which would need separate standards indicating whether raw, semi-processed or processed

g. Work already undertaken by other international organizations in this field and/or suggested by the relevant international intergovernmental bodies

14

a) Volume of production and consumption in individual

countries and volume and pattern of trade between

countries • Volume of production and consumption in individual

countries • Volume and patterns of trade, including trends in trade

volume and patterns – Between coutries – In intra-regional trade – In inter-regional trade

• Credible sources or citations of information and/or references in order to support credibility of the above information (if possible)

• Expressed in monetary terms, tons, proportion of GDP etc.

15

a) Volume of production and consumption in individual countries and volume and pattern of trade between countries

(cont) • For Regional Standards to avoid the development of

more than one standard for the same product:

• Well-documented and objective evidence of – Significant intra-regional trade

– No significant trade between or within other regions

• If there is substantial production and trade of a regional commodity in countries outside the region, CCEXEC should recommend to the concerned commodity committee to consider elaborating a global standard taking into account its work program

16

b) Diversification of national legislations and apparent

resultant or potential impediments to international trade

• Existence of diverse national legislation that may lead to potential or actual impediments to international trade

• Evidence of impediments may be provided as quantitative information on volume and/or frequency of rejection of consignments (absolute numbers or rates of rejection)

17

c) International or regional market potential

• International and/or regional market potential

• Potential of regional products to enter international trade, including an analysis of current production trends as well as market potential in the foreseeable future

18

d) Amenability of the commodity to

standardization

• Which quality factors are essential for the identity of the product (definition, composition etc)

• Characteristics of the commodity that would have to be accomodated in the standard – differences in definition

– Composition

– Other quality factors that may vary across countries and regions

19

e) Coverage of the main consumer protection and trade

issues by existing or proposed general standards

• Whether there are overlaps or gaps with existing standards – If gaps or overlaps are identified, the new work

proposal should explain why revision of the existing standard is not sufficient

– If overlaps are identified, it may be possible to propose that new work should be started, while suggesting that existing standards should also be considered for revision to avoid inconsistency or overlap

20

f) Number of commodities which would need separate

standards indicating whether raw, semi-processed or

processed

• Commodity standards should preferably be developed in a generic manner to cover the relevant products concerned

• Rationale for the need to develop separate standards indicating whether raw, semi-processed or processed

21

g) Work already undertaken by other international

organizations in this field and/or suggested by the

relevant international intergovernmental bodies

• Activities that have been already undertaken by other relevant international organizations, including an analysis of areas of potential complementarities, gaps, duplication, or conflict with the above activities

22

Approval of new work ≠ Goal

• Other Members may not agree with your proposed draft

• Compromise for consensus

• Good luck!

23

What to do?

• Submit information/data in respond to request from committees/JECFA/JMPR etc.

• Propose new work

• Comments on proposed draft/draft standards

• Establish the position of your country

24

Comments on drafts

• Your comments are not always reflected in the final text

• However, the Committee will consider your comments as long as the comments are reasonable and constructive

25

Preparation

• Study documents

– Read the working documents and written comments carefully (if available)

– Review the discussion at the previous sessions

26

Preparation

• Submit written comments

– It is difficult to make your comments understood without written documents, especially when it is complicated

– Ideally comments on time, to be included in working documents

– If you have supporting data/information, why don’t you introduce them to the Committee?

27

What to do?

• Submit information/data in respond to request from committees/JECFA/JMPR etc.

• Propose new work

• Comments on proposed draft/draft standards

• Establish the position of your country

28

Establish the position of your

country

• Consult with stakeholders

– Government

– Consumers

– Industry

– Academy etc.

• Establish national Codex Committees

29

Recent Topics of Standard Setting in Codex

30

General Principles (France)

Food Additives (China)

Contaminants in Foods (Netherlands)

Food Hygiene (USA)

Organizational Chart

Food Labelling (Canada)

Methods of Analysis and Sampling (Hungary)

Pesticide Residues

(China)

Residues of Veterinary Drugs in Foods

(USA)

General Subject Committees Commodity Committees

Milk and Milk Products (New Zealand)

Processed Fruits

and Vegetables (USA)

Meat Hygiene

(New Zealand)

Fish and Fishery

Products (Norway)

Fresh Fruit and

Vegetables (Mexico)

Fats and Oils

(Malaysia)

Nutrition and Foods for Special Dietary Uses

(Germany) Cereals, Pulses and Legumes

(USA)

Vegetable Proteins

(Canada)

Natural Mineral Waters

(Switzerland)

Cocoa Products and Chocolate (Switzerland)

ad hoc Intergovernmental Task Forces

Fruit and Vegetable Juices

(Brazil)

Antimicrobial Resistance

(Republic of Korea)

Processing and Handling of Quick Frozen Foods

(Thailand)

Regional Coordinating Committees

Africa

(Cameroon)

Asia

(Japan)

Europe

(Poland)

Latin America and the Caribbean

(Costa Rica)

Near East

(Lebanon)

North America and the Southwest Pacific (Papua New Guinea)

Executive Committee Secretariat

CODEX ALIMENTARIUS COMMISSION

-Food Import and Export Inspection and Certification Systems

(Australia)

Sugars

(Colombia)

active

adjourned

Biotechnology (Japan)

active

dissolved

Animal Feeding (Switzerland)

31

General Principles CCGP – hosted by France

Work recently finalized

– Revision of Code of Ethics for International Trade in Food including Concessional and Food Aid Transactions (2010)

Ongoing works

– To deal with procedural and general matters as referred to it by the CAC

Works in progress

– Standard held at Step 8

– Issues related to economic impact statements

– Codex/OIE cooperation

32

Food Additives CCFA – hosted by China

Work recently finalized

– Revision of the Standard for Food Grade Salt (2012)

– Principles for Risk Analysis applied by the CCFA (Procedural Manual, 2012)

Ongoing works

– Food Additive Provisions of the General Standard for Food Additives (GSFA)

– International Numbering Systems of Food Additives

– Specifications for the identity and purity of food additives arising from JECFA

33

CCFA

New work

– Revision of the Guidelines for the Simple Evaluation of Food Additive Intakes (CAC/GL 3-1989)

34

Contaminants in Foods CCCF – hosted by the Netherlands

Works recently finalized

– ML for lead in fruit juices and nectars, ready-to-drink; canned fruits and canned vegetables (2013)

– ML for DON in cereal-based foods for infants and young children (2013)

– Code of Practice for the prevention and reduction of OTA contamination in cocoa (2013)

– Code of practice to reduce the presence of hydrocyanic acid in cassava and cassava products (2013)

– ML for Melamine in Food (liquid infant formula) (2012)

– Maximum Level for Total Aflatoxins in Dried Figs including Sampling Plan (2012)

35

CCCF Work in progress

– ML for DON in raw cereal grains and flour, semolina, meal and flakes

– Code of Practice for Weed Control to Prevent and Reduce Pyrrolizidine Alkaloid Contamination in Food and Feed

– Annex for Prevention and Reduction of Aflatoxins and Ochratoxin A in Sorghum to the Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals

– ML for arsenic in rice and rice products

– ML for fumonisins in maize and maize products

– ML for lead in fruits, vegetables, milk products and infant formula, follow-up formula and formula for special medical purposes for infants

36

Food Hygiene CCFH – hosted by USA

Works recently finalized

– Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods (2013)

– Code of Hygienic Practice for Fresh Fruits and Vegetables (Annexes on Berries: 2013, Melons: 2012)

– Guidelines on the Application of General Principles of Food Hygiene to the Control of Viruses in Food (2012)

37

CCFH

Works in Progress

– Guidelines for Control of Specific Zoonotic Parasites in Meat: Trichinella spiralis and Cysticercus bovis

– Revision of Code of Hygienic Practice for Spices and Dried Aromatic Herbs

New Work

– Code of Hygienic Practice for Low-Moisture Foods

38

Codex Committee on Food Import and Export Inspection and Certification

Systems – hosted by Australia

Work recently finalized:

• Principles and Guidelines for National Food Control Systems

• Principles and guidelines for the conduct of foreign on-site audits and inspections (Annex to the Guidelines for the design, operation, assessment and accreditation of food import and export inspection and certification systems)

39

Methods of Analysis and Sampling CCMAS – Hosted by Hungary

Works recently finalized

– Principles for the Use of Sampling and Testing in international food trade (2013)

– The Use of Proprietary Methods in Codex Standards (Procedural Manual, 2012)

– Revised Guidelines on Measurement Uncertainty (2011)

Works in progress

– Principles for the Use of Sampling and Testing in International Food Trade – explanatory notes

40

Pesticide Residues CCPR – hosted by China

Works recently finalized

– Revision of the Guidelines on the Estimation of Uncertainty of Results for the Determination of Pesticide Residues (2011)

Ongoing works

– MRLs for pesticides

– Establishment of Codex Priority Lists of Pesticides

41

CCPR Works in progress

– Revision of the Classification of Food and Animal Feed

– Principles and Guidance for the Selection of Representative Commodities for the Extrapolation of Maximum Residue Limits for Pesticides to Commodity Groups

– Risk Analysis Principles applied by the CCPR

– Discussion on criteria for the establishment of MRLs for pesticides in minor crops

New work

– Guidance document on performance criteria specific for methods for determination of pesticide residues

42

Residues of Veterinary Drugs in Foods CCRVDF – hosted by USA

Works recently finalized

– Maximum Residue Limits for veterinary drugs: narasin, monensin, amoxicillin

– Sampling plan for residue control in aquatic animals

– Revision of the Risk Analysis Principles Applied by the CCRVDF and of the Risk Assessment Policy for Residues of Veterinary Drugs in Foods

43

CCRVDF

Works in progress

– Maximum Residue Limits: monepantel, apramycin and derquantel

– Guidelines on Performance Characteristics for Multi-residues Methods

– Risk Management Recommendations for Residues of Veterinary Drugs for which no ADI and/or MRLs has been recommended by JECFA due to Specific Human Health Concerns

Ongoing works

– Priority List of Veterinary Drugs Requiring Evaluation or Re-evaluation by JECFA

44

Food Labelling CCFL – hosted by Canada

Work recently finalized

– Guidelines on Nutrition Labelling (2010 - 2013)

– Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods (some parts) (2012, 2013)

– Guidelines for Use of Nutrition and Health Claims (2012, 2013)

– Compilation of Codex Texts Relevant to Labelling of Foods Derived from Modern Biotechnology (2011)

45

CCFL

Works in progress

– Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods – Organic Aquaculture

– Review of the General Standard for the Labelling of pre-packaged Food (regarding date marking)

46

Nutrition and Foods for Special Dietary Uses CCNFSDU – hosted by Germany

Works recently finalized

– Revision of the Guidelines on Formulated Supplementary Foods for Older Infants and Young Children (2013)

– Nurtrient Reference Values (2013)

– General Principles for Establishing Nurtient Reference Values for Nurtients Associated with Risk of Diet-Related Non-Communicable Diseases for General Population (2013)

– Revised Nutrient Reference Values for Labelling Purposes in the Codex Guidelines on Nutrition Labelling (2013)

– Annex to the Guidelines on Nutrition Labelling: General Principles for Establishing Nutrient Reference Values of Vitamins and Minerals for General Population (2011)

47

CCNFSDU Works in progress

– Additional / Revised NRVs for Labelling Purposes in the Codex Guidelines on Nutrition Labelling

– Revision of the General Principles for the Addition of Essential Nutrients to Foods

– Amendment of the Standard for Processed Cereal-Based Foods for Infants and Young Children to include a New Part B for Underweight Children

New work

– Review of the Standard for follow-up formula

48

Fresh Fruits and Vegetables CCFFV – hosted by Mexico

Works recently finalized

– Revision of Standard for Avocado (2013)

– Standard for Pomegranate (2013)

– Standard for Tree Tomatoes (2011)

– Standard for Chilli Peppers (2011)

– Standard for Apple (2010)

– Standard for Bitter Cassava (2010)

49

CCFFV Works in Progress

– Standard for Golden Passion Fruit

– Standard for Durian

New Work Proposals

– Standard for Okra

– Standard for Ware Poteto

50

Processed Fruits and Vegetables CCPFV – hosted by USA

Works recently finalized

– Revision of the Standard for Table Olives (2013)

– Revision of Standard for Desiccated Coconut (2011)

– Revision of Standard for Certain Canned Vegetables (2009, sections on Certain Mushrooms, 2011)

– Revision of Standard for Canned Bamboo Shoots (2011)

51

CCPFV Works in Progress

– Standard for Certain Canned Fruits (general provisions) and Annex (Mangoes, Pears, Pineapples)

– Standard for Quick Frozen Vegetables (general provisions) and Annex (Leek)

– Sampling Plans including metrological provisions for controlling minimum drained weight in canned fruits and vegetawbles in packing media

New work

– Extension of the territorial application of the Regional Standard for Ginseng Products

52

Fats and Oils CCFO – hosted by Malaysia

Works recently finalized

– Standard for Named Vegetable Oils (Rice Bran Oil) (2013)

– Amendment to the Standard for Named Vegetable Oils (Sections on Palm Kernel Olein and Palm Kernel Stearin (2011) and Rice Bran Oil (2009))

– Code of Practice for the Storage and Transport of Edible Fats and Oils in Bulk (2011)

Works in Progress

– Standard for Fish Oils

53

Fish and Fishery Products CCFFP – hosted by Norway

Works recently finalized

– Standard for Smoked Fish, Smoke-Flavoured Fish and Smoke-Dried Fish (2013)

– Standard for Live Abalone and for Raw Fresh Chilled or Frozen Abalone for direct consumption or for further processing (2013)

– Revision of the procedure for the inclusion of additional species in Standards for Fish and Fishery Products (2013)

– Standard for Fish Sauce (2011)

– Code of Practice for Fish and Fishery Products (sections on smoked fish (2011), water (2011), Lobsters and Crabs (2010))

– Amendment to the Standard for Quick Frozen Fish Sticks (2011)

– Standard for Sturgeon Caviar (2010)

54

Fish and Fishery Products CCFFP – hosted by Norway

Works in progress

– Performance criteria for reference and confirmatory methods for marine biotoxins in the Standard for Live and Raw Bivalve Molluscs

– Standard for Raw, Fresh and Quick Frozen Scallop

– Code of Practice on the Processing of Scallop Meat

– Code of Practice for fish and fishery products (Sturgeon Caviar)

New work

– Code of Practice for Processing of Fish Sauce

55

Sugars CCS – hosted by Colombia

Re-activated by 34CAC (2011)

Works in Progress

– Standard for Panela

56

Animal Feeding TFAF – hosted by Switzerland

Works recently finalized

– Guidelines on Application of Risk Assessment for Feed

– Guidance for Use by Governments in Prioritizing the National Feed Hazards

57

For more information

• All documents are on the web

http://www.codexalimentarius.org/

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