Ensuring Food Safety and Fair Trade

Practices: JECFA and the Codex

Committee on Food Additives

Nick Gardner

International Food Additive Council

Presentation Overview

• IFAC Background

• Codex Alimentarius 101

• JECFA Background

• The JECFA Safety Evaluation

• Codex Committee on Food Additives

• International Harmonization through the GSFA

• IFAC’s Promotion of International Harmonization

The International

Food Additives Council (IFAC)

IFAC is an international association, representing companies who produce high quality substances used worldwide as food

ingredients.

www.foodadditives.org

IFAC Background

IFAC strives to promote science-based

regulation worldwide by:

• Participating in international regulatory processes

• Establishing IFAC as a source of credible scientific

information on food ingredients

• Organizing and sponsoring pertinent scientific

research on food ingredients

• Defending food ingredients and industry practices

Codex Alimentarius

A joint intergovernmental body of the Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO)

Mission: to create harmonized international food standards to protect the health of consumers and ensure fair trade practices.

Codex standards are voluntary and science based

• Development of standards assisted by independent international risk assessment bodies or ad-hoc consultations

Codex generally operates by consensus

Codex Objectives

Protect The health of consumers

Ensure Fair practices in the food trade

CoordinateAll work regarding food standards

To determinate the priorities

Initiate Preparation of standards

Publish Developed standards

Codex Members

186 Codex Members

• 185 Member Countries

• 1 Member Organization (European Union)

216 Codex Observers

• 49 International Government Organizations

• 151 Non-governmental Organizations

• 16 UN Organizations

IFAC holds NGO observer status and actively participates in relevant committees

Codex Scope

•Food additives and contaminants

•Microbiological standards, sampling and hazard analysis

•Labeling, marketing, certification systems, and more

•Pesticides, veterinary drug residues

Codex covers topics related

to food hygiene and quality

•Any substance, processed, partly processed or raw

•Intended for human consumption

• Includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of food

•Does not include cosmetics, tobacco or substances used solely as pharmaceuticals

At Codex, “food” means

Codex Structure

Codex Alimentarius Commission

General Committees (10)Commodity Committees

and Task Forces

Active Committees (7)

Ad Hoc Task Forces (none active)

Adjourned Committees (6)

Regional Committees (6)

Executive Committee Secretariat

Codex Alimentarius Commission

Ultimate decision-making body for all Codex matters

Meets annually in June/July in Geneva or Rome

Open to all UN member nations and organizations with observer status

Executive Committee structure

1 Chair, 3 vice chairs and 7others

Secretariat oversees Executive Committee Located at FAO in Rome

Other General Committees

CCFA-Food Additives (China)

CCGP-General Principles (France)

CCFL-Food Labelling (Canada)

CCMAS-Methods of Analysis and

Sampling (Hungary)

CCFH-Food Hygiene (U.S.)

CCPR-Pesticide Residues (China)

CCCF-Contaminants in Foods

(Netherlands)

CCFICS-Import and Export Inspection and Certification

Systems (Australia)

CCNFSDU-Nutrition and Foods for

Special Dietary Use (Germany)

CCRVDF-Residues of Veterinary Drugs in

Food (U.S.)

Codex Standards, Codes of Practice

and Other Guidelines

• Consistent

• Wholesome

• Free from adulteration

• Correctly labeled

• Properly presented

Codex standards set principles to ensure production of foods

that are

• Developed at Committee level, but approved by Commission

• Not necessarily intended to reflect national regulation

• Should be appropriate to global commerce

Standards ensure safety first, but must

be internationally acceptable/applicable

• 215 standards

• 49 codes of practice

• 72 guidelines

• 5 other miscellaneous

Codex maintains

Codex Process Map

The Codex Step Process

Step 1

• The project proposal is reviewed by the Executive Committee and compared against the criteria and priorities established by the Commission.

Step 2• A draft text is prepared

Step 3• Text circulated to member countries and all interested parties for comment

Step 4

• The draft and the comments are reviewed at Committee level (Step 4) and, if necessary, a new draft is prepared

Step 5

• Commission reviews progress made and agrees that the draft be finalized. Draft is also endorsed by the relevant Subject Committees so that it is consistent with Codex general standards.

• Sometimes the text is considered to be ready for final adoption at this stage - called Step 5/8

Step 6

• The approved draft is sent again to governments and interested parties for comment and finalized by the relevant Committee

Step 7• The draft is submitted to the Commission for adoption.

Step 8

• Following a final round of comments, the Commission adopts the draft as a formal Codex text. The standard, guideline or other text is then published by the Codex Secretariat.

Why Codex Standards Matter

Ultimately protect the health and safety of consumers, while instilling confidence in food supply

Following Codex standards facilitates trade and opens foreign markets to businesses

Codex standards are science based, which may be critically important to overcoming regional or national bias against new technologies or techniques

Codex process fosters consensus and ownership

Codex Committees have access to significant technical and scientific expertise not available to many nations domestically

Public/private, national/international organization that helps all stakeholders have a voice

Questions? Consult the Codex

Procedural Manual

Codex Procedural Manual helps stakeholders navigate the process and should be consulted by all meeting attendees

Explains Rules of Procedure, procedures for the elaboration of Codex standards and related texts, basic definitions and guidelines for the operation of Codex committees

Lists Codex members

In 23rd edition

The Joint FAO/WHO Expert Committee

on Food Additives (JECFA)

International expert scientific committee intended to evaluate the safety of food additives

• Codex risk management body for evaluation of all food additives

• Evaluations used by many national regulatory bodies

JECFA now also reviews contaminants, naturally occurring toxicants and residues of veterinary drugs in food

• “Gold standard” for safety evaluation

International food additive evaluation was initiated after a Joint FAO/WHO Conference on Food Additives held in 1955

• Recommended FAO and WHO establish expert committees to address the technical and administrative aspects of chemical additives and their safety in food.

• Provided basis for the first meeting of JECFA in 1956

• Predates Codex

JECFA: Unique Scope and Purpose• Not affiliated with any national body

• Many countries use JECFA reviews when establishing national food safety controls

Independent risk assessments

• Ensures health protection while promoting fair trade practices

• Perspective helps JECFA evaluate technologies controversial in certain regions/nations

Reliable with international perspective

• Not all countries have the expertise or funds to carry out separate risk assessments

• Publicly available in complete form and in timely fashion

Capability and expertise to review numerous substances

• Codex Committees do not manage risk, they defer to JECFA

• Requests for scientific advice initiated in Committees--ember States initiate requests

Source of scientific advice for Codex Committees

• JECFA evaluations help companies expand to new marketsHarmonizing force

JECFA Terms of Reference

For food additives, including enzymes and flavouring agents, contaminants and naturally occurring toxicants, the Committee:

• Elaborates principles for evaluating their safety and for quantifying their risks;

• Conducts toxicological evaluations and establishes acceptable daily intakes (ADIs) or tolerable intakes for chronic exposure and other guidance values for acute exposure;

• Assess the performance, quality and applicability of analytical methods;

• Prepares specifications of purity for food additives; and

• Assesses exposure of populations to chemical substances in food

JECFA’s Role as a Risk Assessor

For foods and food ingredients, JECFA preforms the following:

• Establishes ADIs on the basis of available toxicological data

• Develops specifications to identify substances

• Develops ‘tolerable’ intakes for contaminants and naturally occurring toxicants

• Establishes maximum residue limits (MRLs) in target animal tissues for vet drugs

Experts conduct extensive literature searches for consideration by the Committee, in addition to reviewing information submitted

JECFA develops general principles and methods for the risk assessment of chemicals in food

• Continuous review and updates to risk evaluation process

• Contributes to international harmonization assessment techniques

JECFA Membership

FAO and WHO work together to seat committee

FAO selects members with chemical expertise for

development of specifications, assessment of veterinary drugs residue levels, assessment of

monitoring data

WHO selects members for toxicological evaluations to

establish acceptable daily intakes (ADIs), or other guidance values, or quantitative estimate of the

health risk

Experts are taken from all over the world

Panel typically includes 10 to 15 members and more than 20

secretariat

JECFA Food Additive Process

JECFA Priority List

• CCFA Maintains the JECFA Priority List

• A Member State must support applications

Data must be available

• Once on the list, data must be guaranteed

• Data can be generated by deadline

JECFA makes final decision

• JECFA decides which substances to review

• Decisions made based on panel and resources

JECFA Priority List CriteriaThe Codex Committee on Food Additives (CCFA) shall consider the

following when preparing its priority list of substances for JECFA review:

• Consumer health protection and prevention of unfair trade practices

• CCFA and JECFA’s Terms of Reference

• The Codex Strategic Plan, its relevant plans of work and Criteria for the Establishment of Work Priorities

• The quality, quantity, adequacy, and availability of data pertinent to performing a risk assessment, including data from developing countries

• The prospect of completing the work in a reasonable period of time

• The diversity of national legislation and any apparent impediments to international trade

• The needs and concerns of developing countries

• Work already undertaken by other international organizations

JECFA Reports/PublicationsFollowing each meeting, an electronic summary with the main findings and conclusions of the meeting is published, including the details of ADIs and MRLs recommended

Concise description of key data used in the assessments, the evaluation of data and the conclusions of the committee are published by WHO in the Technical Report Series.

Toxicological and exposure assessment monographs are published in the WHO Food Additive Series (FAS). These monographs contain the detailed description and evaluation of all the biological and toxicological data considered in the evaluation and provide references to the cited literature.

Specifications monographs on the identity and purity of food additives developed at meetings and agreed on are published in the Compendium of Food Additive Specifications

Monographs on veterinary drug residues, which summarize the data and the evaluations used for the recommendation of MRLs can also be accessed on the JECFA FAO website

JECFA and Fair Trade Practices

JECFA’s panels are international in nature

bringing together global expertise

Governments may request advice through Codex committees from

JECFA

Governments may align/defer to JECFA

evaluations when implementing regulations

SPS terms state scientific, risk based standards established by Codex must be employed in

international food trade

JECFA risk assessments help companies access

new markets

Positive JECFA evaluations can influence

existing national regulations

Stakeholder participation in the process through

submission of data

Priority assigned by CCFA and can be responsive to

trade issues or new substances

The Codex Committee on Food

Additives (CCFA)

Founded in 2007

• Now meets annually, one of the busiest committees

• Prior to 2007 it was the Codex Committee on Food Additives and Contaminants (CCFAC)

• CCFAC first met in 1964

CCFA hosted by China

• Dr. Junshi Chen (China) CCFA Chair

• Dr. Paul Honigfortof (U.S.) GSFA Physical Working Group Chair

47th meeting will be held March 14-18, 2016

• Location TBD, but will be in China

CCFA Terms of ReferenceTo establish or endorse permitted maximum levels for individual food additives

To prepare priority lists of food additives for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives

To assign functional classes to individual food additives

To recommend specifications of identity and purity for food additives for adoption by the Commission

To consider methods of analysis for the determination of additives in food

To consider and elaborate standards or codes for related subjects such as the labelling of food additives when sold as such.

Major CCFA Work Areas

General Standard for

Food Additives (GSFA)

International Numbering

System List (INS)

JECFA Priority List

Specifications referred by

JECFA

Alignment of Food Additive

Provisions from Commodity

Standards with GSFA

Note 161

Secondary Additives

Challenges for CCFA

Work load and prioritization

JECFA Resources/competing priorities

Regional differences in the use of food additives (Note 161)

Increasing consumer activism

Draft vs. Adopted provisions in the GSFA

Alignment of commodity standards with GSFA

Distractions (e.g., secondary additives)

General Standard for Food Additives

(GSFA)

Establishes conditions under which permitted food additives may be used in all foods

•Maximum use levels in specific food categories based on JECFA evaluations and CCFA recommendations

Preamble of the GSFA contains information for interpreting the data and proper use of additives

•Specifies general principles for the use of additives and food safety

•Explains justifications for use

Annexes provide outline of food categories and guidelines to assist in calculating whether use will result in exceedance of ADI

•Should be consulted as a screening tool

Formally listed as Codex STAN 192-1995

GSFA Food Categories

The Standard is organized by hierarchical food categories

• Categories help to assess food additive usage

• When an additive is permitted in a general category, it is permitted in all its sub-categories, unless otherwise noted

Categories based on product descriptors of foods products as marketed, unless otherwise stated

• Not legal definitions

• Not intended for labeling

Takes into account carry-over unless the compound food needs an additive that is not endorsed for use in any of its components

• I.e. frozen pizza may contain all additives endorsed for use in its constituents

Used to simplify the reporting of food additive uses for assembling and constructing this standard

16 parent categories with dozens of subcategories

GSFA Tables

Table 1

•Specifies, for each food additive or food additive group with a numerical JECFA ADI, the food categories where the additive may be used, the maximum use levels for each food or food category, and its technological function

Table 2

•Contains the same information as Table 1, but the information is arranged by food category number

Table 3

•Lists additives with Not Specified or Not Limited JECFA ADIs that are acceptable for use in foods in general when used at quantum satis levels and in accordance with the principles of good manufacturing practice described in Section 3.3 of this Preamble

Annex to Table 3

•Lists food categories and individual food items excluded from the general conditions of Table 3. The provisions in Tables 1 and 2 govern the use of additives in the food categories listed in the Annex to Table 3

Sample GSFA Food Category

Description (Annex B, Part 2)

• Cheese and cheese analogues are products that have water and fat included within a coagulated milkprotein structure. Products such as cheese sauce (12.6.2), cheese-flavoured snacks (15.1), and composite prepared foods containing cheese as an ingredient (e.g. macaroni and cheese; 16.0) are categorized elsewhere.

01.6 Cheese and

analogues

• Product containing the protein extracted from the whey component of milk. These products are principally made by coagulation of whey proteins.26 Example: ricotta cheese. Different from whey cheese (01.6.3).

01.6.6 Whey protein cheese

Sample GSFA Food Additive Listing

(Table 1)

Sample GSFA Food Category Listing

(Table 2)

Sample of Table 3 Listings

GSFA and International Trade

GSFA facilitates international trade

• Provides level playing field for international trade

• Many national governments refer to the GSFA in regulations or otherwise reference it

• Formulators consult the GSFA when developing formulations to ensure maximum acceptability of products

• Furthers product development/innovation

• Simplifies purchase and sales agreements

Impediments to Adoption of GSFA

Perception of food additive overuse in

some regions

Constant state of annual revision

Lengthy process for addition to the

standard

Preference for positive lists/recipe standard concept

(status quo)

Limited control over substances entered

Preference for national review of

additives

IFAC’s Promotion of International

HarmonizationPart of IFAC’s mission is to promote harmonization to

expand opportunities for members’ products

• Codex is a very powerful force; IFAC is an active participant

• SPS Agreement cites Codex as basis for science based regulation of food, IFAC uses this

• U.S. government and foreign governments are allies

• Anticipate regulatory drift and other trends

• Be mindful of private standards and their influence on regulatory decisions

• Maximize influence in key regions

IFAC and International Harmonization:

Tactics

Use tools at hand (e.g., WTO) and engage when

necessary

Prioritize key regions and assess capabilities

there

Identify active or influential countries and

try to engage

Focus on educating foreign governments

about Codex and JECFA

Consistently reference GSFA when commenting

on regulations

Work with Codex stakeholders

Multi-national companies can help, but

there is strength in numbers and coalitions

Ally with other organizations,

particularly in priority regions

Quantify regulatory impacts and include country specific data

Consider finding products that would be

out of compliance available in the market

place

Thank you.

Any Questions??