The Impact of Codex Guidelines CAC/GL 66-2008 on the IOFI Code of Practice Dr. T. Cachet Seoul, 14 June 2010

Historical perspective on the creation of IOFI and the IOFI Code of Practice Up until 1969 the Flavo(u)r Industry had formed national associations (USA, Japan, Germany, France, Italy, UK, The Netherlands, Switzerland…) IOFI was created to respond to a clear need for harmonization of the flavo(u)r regulations, primarily in Europe, but also in the rest of the world.

The IOFI Code of Practice The first IOFI Code of Practice was published in 1978 to address mainly the fact that in numerous countries of the world there was no specific regulation on flavourings. One of the major issues was reaching agreement on the definition(s) for flavourings and how to best regulate the use of flavourings.

Definition of Flavourings: single substances and complex materials Single, chemically defined, substances 　　Preparations, complexes, 　complex materials Substances that are natural or synthetic 　　Essential oils, extracts and 　oleoresins Usually compounded (mixed) to form ‘formulated’ flavourings Compounded or used as is e.g. Citral, benzaldehyde,.. e.g. Lemongrass, Bitter almond oil

Traditional definitions for flavourings Flavouring substances Natural Nature - Identical Artificial *IOFI Code of Practice, EU 88/388, Codex Alimentarius

(Traditional) Definitions of flavouring substances Natural flavouring substance means a chemically defined substances used for its flavouring properties not intended to be consumed as such and suitable for human consumption at the level used, which is obtained by appropriate physical, microbiological or enzymatic processes from a foodstuff or material of vegetable or animal origin either as such or after processing by food preparation processes. Nature-identical flavouring substance means a flavouring substance obtained by synthesis or isolated through chemical processes from a natural aromatic raw material and chemically identical to a substances present in natural products intended for human consumption, either processed or not. Artificial flavouring substance means a flavouring substance, not yet identified in a natural product intended for human consumption, either processed or not. (IOFI Code of Practice 1978)

List(s) of Approved Flavouring Substances Up until around1990, IOFI was of the opinion that flavourings are best regulated by a so-called mix list system consisting of: A restrictive (negative) list for « biologically active principles » occurring naturally and known to be hazardous, (« restricted substances ») A positive list of artificial materials, permitted for use, to be considered as food additives, A general exemption from listing and reporting of natural and nature identical flavouring materials.

Lists of Approved Flavouring Substances (2010) The world is moving towards positive lists: P.R. China, Russia, Mexico, Europe (2011?)… Only substances that are specifically authorized can be used at the exclusion of other substances

Advantages of a Positive List Transparency to consumers and regulators Permits simple labeling (“flavourings”) Means for protection of the Intellectual Property Facilitates world commerce – free movement of goods (Assuming that positive list are globally harmonized!)

Codex Alimentarius Commission Created in 1963 by the United Nation Food and Agriculture 0rganization (FAO) and World Health Organization (WHO) and responsible for the development of global food standards (Joint FAO/WHO Food Standards Program). The Codex Alimentarius Commission provides governments with advice on the safety of food and develops standards and guidelines for food and food products, including food additives, based on scientific safety evaluations performed by the Joint FA0/WHO Expert Committee on Food Additives (JECFA). www.codexalimentarius.net

Codex Alimentarius Food Additives Definition Food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may reasonably expected to result, (directly or indirectly) in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods. (Codex Alimentarius Commission Procedural Manual, 19th Ed, 2010)

Flavourings in the Codex Alimentarius Hence, flavourings are considered as food additives in the Codex standards, However, the General Standard on Food Additives (GSFA) does not deal with flavouring substances! Meanwhile, JECFA has completed the safety evaluation of many chemically- defined flavouring substances- so far about 1900 substances were evaluated and the evaluation of an additional 134 substances will happen at the 73rd meeting (June 2010). A clear need to clarify the Codex status of flavourings!

Development of a “Codex Guideline on the Use of Flavourings” At the 37th meeting (2005) of the Codex Committee on Food Additives (CCFA) it was decided to develop a Codex Guideline for the Use of Flavourings, that establishes safe conditions of use for flavourings in food similar to the principles for the safe use of food additives contained in the GSFA, and with a reference to the evaluations completed by JECFA. The 38th meeting (2006) of the CCFA: start of drafting work. At the 40th meeting (2008) the CCFA completed the work and proposed adoption by the Codex Alimentarius Commission. Published in Codex Alimentarius as Codex Guideline for the Use of Flavourings (CAC/GL 66-2008).

Consequences of CAC/GL 66-2008 Major changes and additions in the definitions of flavourings! “Flavourings are products that are added to food to impart, modify, or enhance the flavour of food (with the exception of flavour enhancers considered as food additives under the Codex Class Names and the International Numbering System for Food Additives-CAC/GL 36-1989). Flavourings do not include substances that have an exclusively sweet, sour, or salty taste (e.g. sugar, vinegar, and table salt). Flavourings may consist of flavouring substances, natural flavouring complexes, thermal process flavourings or smoke flavourings and mixtures of them and may contain non-flavouring food ingredients. They are not intended to be consumed as such”. (Definition 2.2 of CAC/GL 66-2008)

Consequences of CAC/GL 66-2008 (cont’d) “Non-flavouring food ingredients are food ingredients, such as food additives and foodstuffs that can be added to flavourings and are necessary for dissolving, dispersing, or diluting flavourings, or are necessary for the production, storage, handling and use of flavourings”. (Definition 2.3 of CAC/GL 66-2008) The traditional definitions for ‘nature-identical’ and ‘artificial’ flavouring substances have disappeared.

Codex Guidelines: a Paradigm Shift ORIGIN ORIGIN Physical or Biochemical process Physical or Biochemical process Natural Natural Nature identical Synthetic origin Chemical process Synthetic Artificial

CODEX Alimentarius Codex Guidelines CAC 66-2008 Flavourings Natural Synthetic

US Definitions Flavoring agent Natural Flavoring Artificial Flavoring *21 CFR 101.22

Artificial flavorings Or Chemical synthetic additives JAPAN Flavorings Natural sources Or Natural flavorings Artificial flavorings Or Chemical synthetic additives * Regulations of the Food Sanitation Law

New EU Regulations (EC 1334/2008) Flavourings Natural Flavouring Substances and Preparations Flavouring Substances Thermal Process Flavourings Smoke Flavourings Flavouring Precursors Other Flavourings

Conclusions- Codex Guidelines CAC/GL 66-2008 Expand and clarify the definition(s) of flavourings in line with global developments. Provide principles for the safe use of components of flavourings evaluated by JECFA and determined to present no safety concern at estimated levels of intake.

Consequences for the IOFI Code of Practice The IOFI Code of Practice, published in 1978, and its amendments needed a major upgrade to account for the developments at Codex. Do we still need an IOFI Code of Practice?........ YES! CAC/GL 66-2008 requires additions and clarifications. E.g. the Codex Guidelines do mention the use of “thermal process flavourings”, but do not provide a definition. CAC/GL 66-2008 refers to the JECFA evaluations of flavourings and their specifications. This is a “reference list”, not a positive list as implied in footnote 1: “This guideline does not imply that the uses of flavouring components that have not yet been evaluated by JECFA are unsafe or otherwise unacceptable for use in food”

IOFI Code of Practice - 2010 The new IOFI Code of Practice addresses open questions such as: - what are acceptable flavouring substances other than these evaluated byJECFA - what are acceptable non-flavouring food ingredients - how to deal with intellectual property issues and other issues, e.g. shelf- life requirements,… The new Code of Practice has been approved at the 22nd April 2010 meeting of the IOFI Board! The new Code of Practice will be available on the public section of the IOFI website (www.iofiorg.org).

Conclusions- IOFI Code of Practice The IOFI Code of Practice has adopted all Codex definitions for flavourings from the Codex Guidelines CAC/GL 66-2008 and provides additional information whenever relevant. The Codex Guidelines were developed in order to establish safe conditions of use for flavourings and to establish a reference to the safety evaluations completed by JECFA. Similarly, the IOFI Code of Practice provides the basis for the IOFI Global Reference List of (Chemically-Defined) Flavourings that are safe for the intended use.

IOFI Global Reference List IOFI Global Reference List: the flavour industry’s global, open, positive list “Global” “Open”: flavourings are added whenever the safety of a specific flavouring is scientifically established and documented “Positive list”: linked to the IOFI Code of Practice (2010)- the flavour industry commits itself to only using chemically-defined substances present on the IOFI Global Reference List (GRL).

IOFI Global Reference List IOFI considers as acceptable flavouring substances materials that meet one or more of the following requirements and these materials comprise the IOFI Global Reference List of Flavourings: Flavourings accepted by JECFA to represent “no safety concern under conditions of intended use” Flavourings that were evaluated by authoritative bodies such as the European Food Safety Authority (EFSA) and the Japanese Food Safety Commission (FSC) using the same or similar methodology as used by JECFA. Flavourings that are Generally Recognized As Safe (GRAS) by the US Food and Drug Administration (US FDA) including GRAS determinations published by the Expert panel of the Flavor and Extract Manufacturers Association of the United States (FEMA-GRAS) (IOFI Code of Practice- 2010)

IOFI Global Reference List The IOFI Global Reference List is now contained in the IOFI Database for Chemically-Defined Substances (www.iofidatabase.org). All IOFI Members can have access to the IOFI Database upon request sent to the IOFI secretariat.

Joint FAO/WHO Expert Committee on Food Additives (JECFA) International scientific expert committee created in 1956 to evaluate the safety of food additives, including flavouring substances Because of the large number of flavouring substances JECFA developed a special methodology for the safety evaluation of flavouring substances based on grouping of substances. This approach is now also used by other expert authorities such as the FEMA Expert Panel (FEMA-GRAS) and the European Food Safety Authority (EFSA).

The JECFA Methodology for the Evaluation of Flavouring Substances Safety Evaluation of flavouring substances based on: Exposure (“How much is eaten”) Metabolism of flavouring substances (“How is the flavouring digested in the body”) Evaluation in groups of substances (“Alcohols”, “Esters”, “Aldehydes”,… i.e. JECFA recognized > 50 groups of flavouring substances so far) Structure activity relationships (“Similar molecular structures typically give the same level of potential toxicity”) Conclusions provided: “no safety concern under conditions of intended use”

Tools for the Development of a Global Positive List FEMA GRAS (US FDA) JECFA (CODEX Alimentarius ) FEMA Expert Panel Group GRAS JECFA List EU List Japanese EU Evaluations (EFSA) Japanese Evaluations (FSC)

Submission for Evaluation by JECFA FEMA- GRAS List US-FDA Codex Committee on Food Additives (CCFA) JECFA

Evaluations by the European Food Safety Authority 2000: Regulation providing measures for the adoption of the evaluation programme and defining data requirements with a focus on avoiding duplication with JECFA evaluations. JECFA evaluated substances < 2000 and Council of Europe “Class A” (no safety concern for the intended use) accepted without a need for additional evaluation. (About 800 substances) 2002: Dossier submissions begun by European Flavour and Fragrance Association (EFFA) covering about 750 “EU-only” substances. Since 2004: Ongoing evaluations by EFSA panels of EU-only substances. 2008: EFSA CEF Panel started “consideration” of JECFA evaluated substances (JECFA evaluated substances > 2000) covering about 1000 substances. Status 2010: EFSA has requested additional data on over 530 flavouring substances (20% of the total number).

Evaluations by the European Food Safety Authority About 400 (out of 530) substances are substances with JECFA consideration: “no safety concern” All substances are listed on the European Register and lawfully on the European market None of these substances removed from the European Register Industry commitment to provide additional data to complete EFSA considerations Focus is primarily on JECFA evaluated materials! Additional testing by industry and evaluation by EFSA will require 3-5 years to complete European Commission and Member States are currently investigating solutions for publishing the “Union List of Flavourings” by the end of 2010 which is required by the new European Regulation on Flavourings (EC 1334/2008). Union List will likely contain all substances currently on the European market with specific transitional measures to allow completion of the EFSA evaluations.

Evaluations by the Japan Food Safety Commission The Food Safety Commission (FSC) is conducting evaluations of flavouring substances that are in the international commerce All substances have a JECFA evaluation (and FEMA-GRAS) with “no safety concern for the intended use” Unlike JECFA, the FSC is using a single substance approach following a specific procedure that was established in 2003-2004 requiring additional testing and data submission In 2003-2004 an initial list for evaluation by the FSC was established containing 54 JECFA evaluated substances So far the FSC completed the evaluation of 30 substances with the re-affirmation of “no safety concern for the intended use as a flavouring substance”, confirming the initial JECFA opinion Evaluations of the FSC based on additional test data have strengthened the JECFA evaluations!

CONCLUSIONS The Codex Guidelines on the Use of Flavourings (CAC/GL 66-2008) represent an important milestone for the global flavour industry The new IOFI Code of Practice has fully endorsed CAC/GL 66-2008 and provides additional clarification for industry practice The IOFI Global Reference List builds on the JECFA list, but also contains substances which were evaluated by the US FEMA Expert Panel, and the European Food Safety Authority using the JECFA evaluation approach IOFI and its members will continue to support and promote legislation and regulation that will enhance industry’s ability to provide safe flavors worldwide.