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

All work regarding food standards Coordinate 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

Codex covers •Food additives and contaminants topics related •Microbiological standards, sampling and hazard analysis •Labeling, marketing, certification systems, and more to food hygiene •Pesticides, veterinary drug residues and quality

•Any substance, processed, partly processed or raw •Intended for human consumption At Codex, •Includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of food “food” means •Does not include cosmetics, tobacco or substances used solely as pharmaceuticals Codex Structure

Codex Alimentarius Commission

Executive Committee Secretariat

Commodity Committees General Committees (10) Regional Committees (6) and Task Forces

Active Committees (7)

Ad Hoc Task Forces (none active)

Adjourned Committees (6) 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 1 Chair, 3 vice chairs and 7others Committee structure Secretariat oversees Executive Committee Located at FAO in Rome Other General Committees

CCMAS-Methods of CCFA-Food CCGP-General CCFL-Food Labelling Analysis and Additives (China) Principles (France) (Canada) Sampling (Hungary)

CCFICS-Import and CCCF-Contaminants CCFH-Food Hygiene CCPR-Pesticide Export Inspection in Foods (U.S.) Residues (China) and Certification (Netherlands) Systems (Australia)

CCNFSDU-Nutrition CCRVDF-Residues of and Foods for Veterinary Drugs in Special Dietary Use Food (U.S.) (Germany) Codex Standards, Codes of Practice and Other Guidelines

Codex standards set • Consistent principles to ensure • Wholesome • Free from adulteration production of foods • Correctly labeled that are • Properly presented

Standards ensure safety first, but must • Developed at Committee level, but approved by Commission • Not necessarily intended to reflect national regulation be internationally • Should be appropriate to global commerce acceptable/applicable

• 215 standards • 49 codes of practice Codex maintains • 72 guidelines • 5 other miscellaneous Codex Process Map The Codex Step Process • The project proposal is reviewed by the Executive Committee and compared against the Step 1 criteria and priorities established by the Commission.

• A draft text is prepared Step 2

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

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

• 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. Step 5 • Sometimes the text is considered to be ready for final adoption at this stage - called Step 5/8 • The approved draft is sent again to governments and interested parties for comment and Step 6 finalized by the relevant Committee

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

• Following a final round of comments, the Commission adopts the draft as a formal Codex Step 8 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 23 rd 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

Independent risk • Not affiliated with any national body • Many countries use JECFA reviews when establishing national assessments food safety controls

Reliable with international • Ensures health protection while promoting fair trade practices • Perspective helps JECFA evaluate technologies controversial in perspective certain regions/nations

• Not all countries have the expertise or funds to carry out Capability and expertise to separate risk assessments review numerous substances • Publicly available in complete form and in timely fashion

Source of scientific advice for • Codex Committees do not manage risk, they defer to JECFA • Requests for scientific advice initiated in Committees--ember Codex Committees States initiate requests

Harmonizing force • JECFA evaluations help companies expand to new markets 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 selects members with WHO selects members for chemical expertise for toxicological evaluations to FAO and WHO work together to development of specifications, establish acceptable daily intakes seat committee assessment of veterinary drugs (ADIs), or other guidance values, residue levels, assessment of or quantitative estimate of the monitoring data health risk

Panel typically includes 10 to 15 Experts are taken from all over members and more than 20 the world secretariat JECFA Food Additive Process • CCFA Maintains the JECFA Priority List JECFA • A Member State must support applications Priority List

• Once on the list, data must be guaranteed Data must be • Data can be generated by deadline available

• JECFA decides which substances to review JECFA makes • Decisions made based on panel and resources final decision JECFA Priority List Criteria The 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/Publications Following 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 Governments may Governments may international in nature request advice through align/defer to JECFA bringing together global Codex committees from evaluations when expertise JECFA implementing regulations

SPS terms state scientific, Positive JECFA risk based standards JECFA risk assessments evaluations can influence established by Codex help companies access existing national must be employed in new markets regulations international food trade

Priority assigned by CCFA Stakeholder participation and can be responsive to in the process through trade issues or new submission of data 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 47 th meeting will be held March 14-18, 2016 • Location TBD, but will be in China CCFA Terms of Reference To 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

Alignment of General Food Additive Standard for JECFA Priority Provisions from Secondary Food Additives List Commodity Additives (GSFA) Standards with GSFA

International Specifications Numbering referred by Note 161 System List (INS) JECFA 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

•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 Table 1 food category, and its technological function

•Contains the same information as Table 1, but the information is arranged by food category number Table 2

•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 Table 3 of good manufacturing practice described in Section 3.3 of this Preamble

•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 Annex to listed in the Annex to Table 3 Table 3 Sample GSFA Food Category Description (Annex B, Part 2)

• Cheese and cheese analogues are products that have 01.6 Cheese water and fat included within a coagulated milkprotein structure. Products such as cheese sauce (12.6.2), and cheese-flavoured snacks (15.1), and composite prepared foods containing cheese as an ingredient (e.g. analogues macaroni and cheese; 16.0) are categorized elsewhere.

01.6.6 Whey • Product containing the protein extracted from the whey component of milk. These products are protein principally made by coagulation of whey proteins.26 Example: ricotta cheese. Different from whey cheese cheese (01.6.3). 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 Lengthy process for Constant state of additive overuse in addition to the annual revision some regions standard

Preference for Preference for positive lists/recipe Limited control over national review of standard concept substances entered additives (status quo) IFAC’s Promotion of International Harmonization Part 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., Prioritize key regions Identify active or Focus on educating WTO) and engage when and assess capabilities influential countries and foreign governments necessary there try to engage about Codex and JECFA

Multi-national Ally with other Consistently reference Work with Codex companies can help, but organizations, GSFA when commenting stakeholders there is strength in particularly in priority on regulations numbers and coalitions regions

Consider finding Quantify regulatory products that would be impacts and include out of compliance country specific data available in the market place Thank you.

Any Questions??