Iofi Code of Practice 5th Revision

Code of Practice
Revision April 2020

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Code of Practice of the International Organization of

the Flavor Industry
IOFI has adopted the following Code of Practice:
Table of Contents
1. LIMITATION OF RESPONSIBILITY .............................................................................................. 6
2. PREFACE ....................................................................................................................................... 7
2.1 About IOFI ..............................................................................................................................7
2.2 Mission Statement................................................................................................................7
2.3 Strategic Objectives & Core Values ...................................................................................7
2.4 IOFI and the CODEX ALIMENTARIUS COMMISSION .......................................................7
2.5 The IOFI Global Reference List ...........................................................................................8
2.6 Application of the Code of Practice ............................................................................... 10
3 DEFINITIONS AND TERMINOLOGY ..................................................................................... 11
3.1 Introduction........................................................................................................................ 11
3.2 Flavor (CAC/GL 66-2008 item 2.1) ................................................................................... 11
3.3 Flavorings ............................................................................................................................ 11
4 THE ROLE AND FUNCTION OF FLAVORINGS IN FOOD ..................................................... 14
5 INGREDIENTS FOR FLAVORINGS ........................................................................................ 15
5.1 Introduction........................................................................................................................ 15
5.2 Flavoring Ingredients ........................................................................................................ 15
5.3 Non-Flavoring Food Ingredients .................................................................................... 15
6 FLAVORINGS AND INTELLECTUAL PROPERTY .................................................................. 17
6.1 Intellectual Property Protection ..................................................................................... 17
April 2020 – Final

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6.2 Requests for Flavoring Formula Disclosure.................................................................. 18
6.3 Disclosure Options ............................................................................................................ 20
6.4 Regulatory Requirements for Disclosure ...................................................................... 21
6.5 Conclusion .......................................................................................................................... 23
7 BASIC STANDARDS OF GOOD MANUFACTURING PRACTICE .......................................... 24
7.1 Background ........................................................................................................................ 24
7.2 Flavor Manufacturing Employers ................................................................................... 24
7.3 Employees .......................................................................................................................... 24
7.4 Premises and sanitation .................................................................................................. 24
7.5 Ingredients and raw materials ........................................................................................ 25
7.6 Manufacturing operations ............................................................................................... 25
7.7 Packaging............................................................................................................................ 26
7.8 GHS & IOFI/IFRA Labeling Manual .................................................................................. 26
8 LABELING .............................................................................................................................. 27
8.1 Introduction........................................................................................................................ 27
8.2 More Guidance on Labeling ............................................................................................ 27
9 CLAIMS MADE IN THE LABELING, PRESENTATION OR ADVERTISING OF FLAVORINGS28
9.1 Introduction........................................................................................................................ 28
10 QUALITY ASSURANCE AND MANAGEMENT ....................................................................... 29
10.1 Quality Assurance .............................................................................................................. 29
10.2 Quality Management ........................................................................................................ 29
11 QUALITY CONTROL AND SAMPLE STORAGE ..................................................................... 30
11.1 Quality Control ................................................................................................................... 30
11.2 Storage of Samples and Rejected Products................................................................. 30

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12 SHELF LIFE AND RE-TESTING ............................................................................................. 31
12.1 Shelf Life .............................................................................................................................. 31
12.2 Re-Testing ........................................................................................................................... 31
13 GUIDELINES ON THE IOFI INTERPRETATION OF THE TERM “NATURAL” ...................... 33
13.1 Introduction........................................................................................................................ 33
13.2 Source Materials ................................................................................................................ 33
13.3 Physical Production Processes ....................................................................................... 33
13.4 Biochemical Processes for Natural Flavoring Complexes & Natural Flavoring
Substances...................................................................................................................................... 34
13.5 Other Processes for Natural Flavoring Complexes and Natural Flavoring
Substances...................................................................................................................................... 34
13.6 Additional Provisions ........................................................................................................ 35
13.7 Classification of Salts ........................................................................................................ 35
14 IOFI GUIDELINES FOR THE PRODUCTION OF THERMAL PROCESS FLAVORINGS ........ 36
14.1 Introduction........................................................................................................................ 36
14.2 Scope ................................................................................................................................... 36
14.3 Definition ............................................................................................................................. 36
14.4 Basic Standards of Good Manufacturing Practice ...................................................... 36
14.5 Raw Materials that May Be Subject to Thermal Processing ...................................... 36
14.6 Ingredients that may be Added After Thermal Processing ....................................... 37
14.7 Manufacturing of Thermal Process Flavorings ............................................................ 37
15 IOFI GUIDELINES FOR THE PRODUCTION OF SMOKE FLAVORINGS .............................. 39
15.1 Introduction........................................................................................................................ 39
15.2 Scope ................................................................................................................................... 39

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15.3 Definition ............................................................................................................................. 39
15.5 Manufacturing of Smoke Flavorings .............................................................................. 40
15.6 Production Conditions ..................................................................................................... 41
16 IOFI GUIDELINES FOR ENZYMATIC AND MICROBIOLOGICAL PROCESSES FOR THE

PRODUCTION OF FLAVORINGS ................................................................................................... 42
16.1 Scope ................................................................................................................................... 42
16.2 Definition ............................................................................................................................. 42
16.4 Manufacturing of Flavorings by Enzymatic or Microbiological Processes ............. 42
16.5 General Requirements...................................................................................................... 44
16.6 Labeling ............................................................................................................................... 45
17 GUIDELINES FOR OCCUPATIONAL SAFETY AND HEALTH AND ENVIRONMENTAL

PROTECTION ................................................................................................................................. 46
17.1 Field of Application ........................................................................................................... 46
17.2 Basic Principles .................................................................................................................. 46
17.3 Definitions ........................................................................................................................... 46
17.4 Occupational Safety and Health .................................................................................... 46
17.5 Environmental Protection ............................................................................................... 47
17.6 Water Protection................................................................................................................ 48
17.7 Air protection...................................................................................................................... 48
17.8 Soil and Groundwater Protection .................................................................................. 48
17.9 Waste Disposal ................................................................................................................... 49
18 ANNEX I: LISTS OF FLAVORING AND NON-FLAVORING FOOD INGREDIENTS................ 50

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18.1 List of Flavoring Ingredients – Global Reference List of Flavorings (GRL) .............. 50
18.2 Lists of Non-flavoring Food Ingredients ........................................................................ 50
19 ANNEX II: LIST OF EXTRACTION SOLVENTS USED FOR THE PRODUCTION OF NATURAL
FLAVORINGS AND RESIDUE LIMITS............................................................................................. 59

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1 LIMITATION OF RESPONSIBILITY
The International Organization of the Flavor Industry (IOFI) has established the
IOFI Code of Practice (CoP) in good faith using the most accurate information
available. The IOFI Code of Practice is intended for use as a voluntary best
practices resource document by the entire IOFI membership. It is the
responsibility of the IOFI ordinary company members as well as of individual
company members affiliated to IOFI member associations to determine how they
may best use the information in the IOFI Code of Practice. IOFI and its members,
officers and employees are not responsible for the accuracy of the content of the
Code of Practice, nor are they responsible for any effects of the application and
use or misuse of the content of the Code of Practice.

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2 PREFACE
2.1 About IOFI
The International Organization of the Flavor Industry (IOFI) is an umbrella

association composed of ordinary association members, ordinary company
members and corresponding member associations. See list of members under:
www.iofi.org/members.
2.2 Mission Statement
The International Organization of the Flavor Industry advances the global trade
of safe, responsibly produced flavorings that respect the environment and enrich
the lives of consumers.
2.3 Strategic Objectives & Core Values
As the global flavor industry’s representative, IOFI:
2.3.1 Uses and promotes highly reliable, state-of-the-art science to assure the safe use
of flavoring materials.
2.3.2 Facilitates a harmonized approach to flavoring regulations that supports a global

industry.
2.3.3 Builds understanding and trust in flavorings and the flavor industry through
collaboration with member associations and other stakeholders.
2.3.4 Recognizes the impact of resource efficiency, biodiversity protection, circular

economy, human health and environmental issues which are prerequisites for
any responsible and sustainable business.
2.4 IOFI and the CODEX ALIMENTARIUS COMMISSION
2.4.1 The Codex Alimentarius Commission (CAC) was established by the United
Nation’s Food and Agriculture Organization (FAO) and World Health Organization
(WHO) to develop international food standards, guidelines and
recommendations to protect the health of consumers and to ensure fair practice
in food trade pursuant to the World Trade Organization (WTO) treaties. The CAC
has the responsibility for developing food standards that may be adopted by
member countries. The science-based standards take into consideration the

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expert advice provided by the Joint FAO/WHO Expert Committee on Food

Additives (JECFA), the group responsible for performing safety assessments of
food additives and flavoring substances for supporting CAC in its work in
developing global food standards.
2.4.2 IOFI serves as a non-governmental organization (NGO) and has been granted
Observer status with the CAC with a standing invitation to Codex meetings and
meetings of its subsidiary bodies such as the Codex Committee on Food Additives
(CCFA), the Codex Committee on Contaminants in Food (CCCF), and the Codex
Committee on Food Labeling (CCFL). See http://www.fao.org/fao-who-
codexalimentarius/en/ for more information on the Codex Alimentarius
Commission.
2.4.3 IOFI has been involved in the development of the Codex Guidelines for the Use of
Flavourings (CAC/GL 66-2008). IOFI supports the Codex Guidelines and recognizes
their value in providing principles for the safe use of components of flavorings
evaluated by JECFA and determined to present no safety concern at estimated
levels of intake.
2.5 The IOFI Global Reference List
The IOFI Secretariat maintains a Global Reference List (GRL) that is publicly
available under www.iofi.org.
The GRL is sub-divided in two parts: Part 1 contains a list of chemically defined
substances (CDS, see also 3.3.1.1 the definition of “flavoring substances”) and Part
2 contains a list of natural complex substances (NCS).
The GRL is subject to regular updates.
2.5.1 Chemically defined substances (CDS)
Generally, materials that have been included in the Part 1 of the IOFI GRL have
been reviewed and determined to be safe for flavor use in food by the European
Food Safety Authority (EFSA) 1 , the Council of Europe (CoE), the U.S. Food and
Drug Administration (FDA), the Expert Panel of the Flavor and Extract
Manufacturers Association of the United States (FEMA Expert Panel), the Joint
FAO/WHO Expert Committee on Food Additives (JECFA) or the Japanese Food
Safety Commission (FSC).
1
The Scientific Committee on Food (SCF), established in 1974, was the main committee providing the European
Commission with scientific advice on food safety (including flavorings). Its responsibilities have been
transferred to the European Food Safety Authority (EFSA) in 2003.

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While the inclusion of a flavoring substance in the Part 1 of the IOFI GRL supports
the conclusion that it can be safely added to food, it does not in and of itself
confer regulatory authority to use in any specific regulatory jurisdiction.
Regulatory authority for the market of intended sale must be separately
determined.
2.5.2 Natural Complex Substances (NCS)
Materials of plant or animal origin (i.e., source materials) may be used to produce
flavorings. The constituents derived from these source materials (e.g., essential
oils, essences, extractives, etc.) are referred to as natural complex substances.
On Part 2 of the IOFI GRL, source materials and/or natural complex substances
that have undergone a safety evaluation by the FEMA Expert Panel or have been
recognized as safe by the US FDA and/or the Council of Europe are provided.
While the FEMA Expert Panel has evaluated the safety of numerous natural
complex substances (i.e., products derived from specific source materials), the US
FDA and the Council of Europe have considered only the source materials.
The safety recognition by US FDA and/or Council of Europe is based on the widely
accepted assumption that substances naturally occurring in food that have a long
history of use can be considered as safe. This principle has been enshrined in the
EU Flavouring Regulation (EC) No 1334/2008 and appears to be applied by
multiple national regulators around the world.
Natural flavoring complexes (as defined under CAC/GL 66-2008, 2.2.2) are
preparations that contain flavouring substances obtained by physical processes
(e.g., distillation and solvent extraction) that may result in unavoidable but
unintentional changes in the chemical structure of the flavouring, or by enzymatic
or microbiological processes, from material of plant or animal origin. Such material
may be unprocessed or processed for human consumption by traditional food-
preparation processes (e.g., drying, torrefaction (roasting) and fermentation).
Some jurisdictions have more precise descriptions of the acceptable processes

(e.g., EU Flavouring Regulation (EC) No 1334/2008).
Typically, many of the constituents contained within natural complex substances

are chemically defined substances that are also listed within Part 1 of the GRL.
Due to the way they are produced, natural complex substances may also contain
constituents that are naturally occurring in the source materials, e.g., intrinsic
fruit water, as well as food/food ingredients used during the manufacturing
process.

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National legislations stipulating specific provisions for undesirable substances

(e.g., biologically active principles) contained in source materials and natural
complex substances must be observed.
Natural flavoring complexes fulfilling the aforementioned prerequisites are safe

and therefore acceptable for use in and on foods, even though they may not be
listed in Part 2 of the Global Reference List.
2.6 Application of the Code of Practice
The Code of Practice consists of information describing best practices regarding

the safety, composition, manufacture, description and labeling of flavorings. The
application of the Code of Practice does not relieve individual manufacturers or
users of flavorings from the obligation to comply with all local, national, or
international regulations that pertain to their operations. These regulations take
precedence over this Code. In those countries where specific legislation and
regulations applicable to flavorings are not in force, the Code of Practice may
serve as a best practices resource.
Additionally, this Code of Practice is published and provided to IOFI members in

order to support fair and robust competition in the global marketplace. IOFI is an
international trade association and its members work together to accomplish
common goals that are appropriate under antitrust laws around the globe.
However, it is contrary to antitrust laws for IOFI members to use the association
to accomplish objectives that would benefit single members or select groups of
members by diminishing competition. Therefore, the IOFI Code of Practice must
not be used by members or groups of members to diminish competition or stifle
innovation in contravention of antitrust laws.

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3 DEFINITIONS AND TERMINOLOGY
3.1 Introduction
Definitions and terminology used in the IOFI Code of Practice are, where
applicable, in compliance with definitions and terminology as used in the current
Codex Guidelines for the Use of Flavourings (CAC/GL 66-2008). Key definitions and
Codex references are listed below, together with additional terms for which the
Codex Guidelines do not offer specific guidance or for which additional guidance
is necessary.
3.2 Flavor (CAC/GL 66-2008 item 2.1)
Flavour is the sum of those characteristics of any material taken in the mouth,
perceived principally by the senses of taste and smell, and also the general pain
and tactile receptors in the mouth, as received and interpreted by the brain. The
perception of flavour is a property of flavourings.
3.3 Flavorings
3.3.1 Flavorings (CAC/GL 66-2008 item 2.2) are products that are added to food to
impart, modify 2 , 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 within the conditions as referred to in section 3.5 of the Codex
Guidelines. They are not intended to be consumed as such.
3.3.1.1 Flavoring Substances (CAC/GL 66-2008 item 2.2.1) are chemically defined
substances (CDS) either formed by chemical synthesis, or obtained from materials
of plant or animal origin. (See also section 2.5.1)
2
Nowadays the demand for foods and beverages with lower sugar, fat or salt content increases. However, often
taste challenges come along with better-for-you products. There are flavoring ingredients with characteristics
that can help improve the consumer’s experience of these ‘lite’ products, for example by decreasing bitterness,
masking off-notes and restoring mouthfeel. They are called Flavorings with Modifying Properties (FMPs) and
they help to make healthier products taste great. They form an integral part of the ingredient group known as
flavorings.

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3.3.1.1.1 Natural flavoring substances (CAC/GL 66-2008 item 2.2.1.1) are

flavouring substances obtained by physical processes that may result in
unavoidable but unintentional changes in the chemical structure of the
components of the flavouring (e.g. distillation and solvent extraction), or by
enzymatic or microbiological processes, from material of plant or animal origin.
Such material may be unprocessed, or processed for human consumption by
traditional food-preparation processes (e.g., drying, torrefaction (roasting) and
fermentation). This means substances that have been identified / detected in a
natural material of animal or vegetable origin.
3.3.1.1.2 Synthetic flavoring substances (CAC/GL 66-2008 item 2.2.1.2) are

flavouring substances formed by chemical synthesis.
3.3.1.2 Natural flavoring complexes 3 (CAC/GL 66-2008 item 2.2.2) are preparations
that contain flavouring substances obtained by physical processes that may result
in unavoidable but unintentional changes in the chemical structure of the
flavouring (e.g. distillation and solvent extraction), or by enzymatic or
microbiological processes, from material of plant or animal origin. Such material
may be unprocessed, or processed for human consumption by traditional food-
preparation processes (e.g. drying, torrefaction (roasting) and fermentation).
Natural flavouring complexes include the essential oil, essence, or extractive,
protein hydrolysate, distillate, or any product of roasting, heating, or enzymolysis.
3.3.1.3 Thermal process flavorings (see also Chapter 14 of the CoP) are prepared
for its flavoring properties by heating raw materials that are foodstuffs or
constituents of foodstuffs. This process is analogous to the traditional home
cooking of ingredients of plant and animal origin.
3.3.1.4 Smoke flavorings (CAC/GL 66-2008 item 2.2.3) are complex mixtures of
components of smoke obtained by subjecting untreated wood to pyrolysis in a
limited and controlled amount of air, dry distillation, or superheated steam, then
subjecting the wood smoke to an aqueous extraction system or to distillation,
condensation, and separation for collection of the aqueous phase. The major
flavouring principles of smoke flavourings are carboxylic acids, compounds with
carbonyl groups and phenolic compounds.
3.3.2 Non-flavoring food ingredients (CAC/GL 66-2008 item 2.3) (see also Chapter 5.3 of
the CoP) 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
3
Commonly known as “Natural Complex Substances” by the industry – see e.g., under section 2.5.

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flavourings.
3.3.3 Flavorings produced by enzymatic and microbiological processes (see also

Chapter 16 of the CoP) are concentrated preparations, with or without non-
flavoring food ingredients, used to impart flavor. They are produced by
submitting a substrate or substrates to the action of enzymes or micro-
organisms.
3.3.4 Compounded flavoring 4 is a term often used to describe mixtures of flavoring

ingredients, some of them complex mixtures themselves, that are combined to
provide a particular taste sensation (See also Article 5.1(c) of CODEX STAN 107-
1981, rev. 2016). Other non-flavoring food ingredients, such as solvents,
emulsifiers and antioxidants are required to allow the compounded flavoring to
function properly in the food to which it is added.
The term “compounded flavorings” is consistent with the term “flavorings” as

defined under the Codex Guidelines. However, “compounded flavorings” is often
used to emphasize the complex mixture nature of flavorings over a single
flavoring substance and to protect the intellectual property.
4
Chapter 4: Hallagan J.B. and Hall R.L. Food and Chemical Toxicology. 47, 267. 2009.

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4 THE ROLE AND FUNCTION OF FLAVORINGS IN FOOD
The flavor of food is the most important attribute to the taste of that food and
plays an important role in its consumption and acceptance. In one form or
another, flavorings have been used since ancient times and are added to foods to
impart or modify their flavor (aroma and taste).
Flavoring substances are among the most thoroughly evaluated food ingredients
and as such, those that have been subject to a safety evaluation may be regarded
safe under their conditions of intended use. Many flavoring substances are self-
limiting in their use in food, adding larger amounts of the same flavoring
substance does not further improve the flavor of a final food product. The levels
of flavoring substances should be kept to the minimum needed to achieve the
desired flavor effect.
Flavorings are critical ingredients in foods because:
1. Consumer preferences for foods, and the recognition of them as the foods
that they expect, are largely based on the perception of taste.
2. The addition of flavorings can be necessary to compensate for the loss of

flavor during the processing and storage of foods such as pasteurized foods.
3. Flavorings can help balance the taste profiles of processed foods. This is
increasingly important as the demand for foods with less sugar, salt and fat
increases.
4. Flavorings help maintain desired flavor profiles and balance natural seasonal
or geographical variations in crops. The use of flavorings can compensate for
supply limitations by helping to obtain the desired flavor profile that
consumers will recognize.

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5 INGREDIENTS FOR FLAVORINGS
5.1 Introduction
The present chapter describes the types of ingredients (as defined under Chapter
3 of the CoP) that may be used in food flavorings.
5.2 Flavoring Ingredients
Based on the Codex Guidelines for the Use of Flavourings (CAC/GL 66-2008, section
3. General Principles for the Use of Flavourings), the following flavoring ingredients
may be used in the manufacture of flavorings:
5.2.1 Flavoring ingredients that are listed on the IOFI GRL (see Chapter 2.5 and Annex I
/ Chapter18.1 of the CoP).
5.2.2 Natural flavoring complexes fulfilling the prerequisites as indicated under

Chapter 2.5.2, which are safe and therefore acceptable for use in and on foods,
even though they may not be listed in Part 2 of the Global Reference List.
5.2.3 Thermal process flavorings produced in compliance with the guidelines specified
in Chapter 14 of the Code of Practice and/or – if applicable – produced and
approved in accordance with national regulations.
5.2.4 Smoke flavorings produced in compliance with the guidelines specified in

Chapter 15 of the Code of Practice and/or – if applicable – produced and
approved in accordance with national regulations and/or as evaluated by one of
the bodies mentioned in Chapter 2.5.
5.3 Non-Flavoring Food Ingredients (as defined under Chapter 3)
Based on the Codex Guidelines for the Use of Flavourings (CAC/GL 66-2008, section
3. General Principles for the Use of Flavourings), the following groups of non-
flavoring food ingredients may be used in the manufacture of flavorings:
5.3.1 Carriers (including carrier solvents, listed under Annex I, Chapter 18.2.1) are used
to maintain uniformity and dilute concentrated flavorings in order to facilitate
their incorporation and dispersion in food products. Some carriers may also be
used for encapsulating flavorings with a view to protect them against evaporation

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and alterations during storage.
5.3.2 Antioxidants (listed under Annex I, Chapter 18.2.2) are indispensable for the
protection of certain essential oils, especially terpene-containing essential oils,
as well as other flavoring substances. To obtain best protection it is common
practice to add authorized antioxidants to most raw materials at the time of their
manufacture.
5.3.3 Sequestrants (listed under Annex I, Chapter 18.2.3) prevent the catalytic action of
certain metal ions and protect the flavoring against oxidation.
5.3.4 Preservatives (listed under Annex I, Chapter 18.2.4) are necessary to prevent
microbial growth in certain flavorings.
5.3.5 Emulsifiers (listed under Annex I, Chapter 18.2.5) and weighting agents (Annex I,
18.2.6) facilitate the homogenization of flavorings, or the incorporation of
flavorings in food products.
5.3.6 Acids, bases and salts (listed under Annex I, Chapter 18.2.7) are used to adjust the
pH of certain flavorings.
5.3.7 Anticaking agents (listed under Annex I, Chapter 18.2.8) may be necessary to keep
powdered flavorings free-flowing.
5.3.8 Extraction solvents (listed under Annex II, Chapter 19) are used for the
manufacturing of certain natural extracts. Only limited amounts of solvent
residues that are technically unavoidable are acceptable in food due to carry-over
unless the solvent is also a permitted carrier.
5.3.9 Any appropriate food (e.g., sugars, fats, oils or food ingredient) may be used to
dilute a flavoring and to facilitate its incorporation and dispersion in a food
product.

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6 FLAVORINGS AND INTELLECTUAL PROPERTY
6.1 Intellectual Property Protection
6.1.1 Respecting the integrity and ownership of intellectual property, especially

proprietary formulae, is a key commitment of the flavor industry in general and
IOFI members in particular.
6.1.2 The intellectual property of flavoring formulae belongs to the individual

companies that create the flavorings and is often the most significant asset of
these companies.
6.1.3 The process of creating flavoring formulae is very expensive and time-consuming
and requires significant elements of expertise, innovation and creativity. Each
flavoring formula is proprietary: it is a trade secret and a work of art and, as such,
deserves intellectual property protection.
6.1.4 IOFI recognizes the importance of the protection of intellectual property to

individual flavor manufacturers and their customers who often protect their
finished product formulae, including the flavor used in the product, as trade
secrets. Therefore, IOFI also recognizes the importance of trade secret
protections to the global flavor manufacturing industry as a whole.
6.1.5 Trade secret laws in virtually all countries protect any formula, pattern, device, or
compilation of information that provides a business advantage to the owner. A
trade secret, also known as confidential business information, is an item of
confidential information concerning the commercial practices or proprietary
knowledge of a business, which requires the maintenance of strict confidentiality
toward third parties and even within the creating company itself, where only a
limited number of employees have access to the complete formulae.
6.1.6 Intellectual property law is largely civil in nature; therefore, it is up to the owner
of the intellectual property to protect it, and to seek remedies if it is
misappropriated. Trade secrets protection of flavoring formulae thus preserve
the value of the flavoring formula for the trade secret owner.
6.1.7 Illegal misappropriation of trade secret formulae unfairly misappropriates highly

valuable flavoring formulae without bearing the original creation effort and
development costs. Unless duplication of third-party flavoring formulae is
necessary (e.g., inability of original supplier to supply) and permitted, IOFI
members shall refrain from illegal duplication of third-party flavorings. This will
contribute to ensure the recognition of the intellectual property of flavoring

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formulae.
6.1.8 IOFI members are committed to take all the actions necessary to promote and
encourage the protection, respect and defense of flavoring formulae intellectual
property and to discourage the infringement of flavoring manufacturers’
intellectual property rights.
6.1.9 IOFI and its members support legislative, regulatory or other appropriate actions
taken to reinforce, expand and protect the intellectual property of flavoring
formulae against third party infringement or misappropriation.
6.2 Requests for Flavoring Formula Disclosure
6.2.1 Many industrialized nations have laws and regulations covering the safe use and
labeling of flavoring substances. Except for a few specialized areas, such as
pharmaceutical products, none of these laws or regulations requires the
disclosure of complete flavoring formulae to authorities or customers. However,
there may be situations where disclosing certain parts of a flavoring formula to a
customer or to a government official may be required.
6.2.2 Because of the large number of individual flavoring substances used to create
flavorings, and the demonstrated safety of these substances, regulators do not
require that consumer products bear labeling identifying each individual
flavoring substance. Regulators around the world have generally adopted the
“class naming” approach to identifying flavorings in consumer products.
6.2.3 Companies wish to protect the confidentiality of their formulae, both from third
parties and often within the creating company itself, where only a limited number
of employees have access to the complete formula. Therefore, the flavoring
manufacturer operates in an environment of competing pressures: an internal
priority on protection of confidential formulae to maintain legal rights to trade
secret protection versus external requests and demands from end users,
consumers and government officials for disclosure. This section of the Code of
Practice provides guidance on balancing these competing pressures.
6.2.4 Evaluating requests for disclosure
The first step in responding to a request for some type of formula disclosure is to
establish the authority behind the request. Who is requesting the disclosure and
what position do they hold with the requesting organization? This is a sensitive
analysis that may require input from senior management or the company’s local
representative in a particular country, or others with special expertise or
understanding.

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After establishing that the requester is an authority in a position that is entitled to

receive confidential business information, then it should be confirmed that there
is a legitimate and perhaps legally justified reason to make a disclosure.
6.2.5 Understanding reasons for disclosure
There can be certain legitimate reasons for disclosing flavoring formula

information. The goal in this situation is to confirm the rationale for the request
and its appropriateness. Examples of legal justification for disclosure include
allergen labeling requirements or special product approval such as
pharmaceuticals. Even with special product approvals, individual companies
may pursue mechanisms to avoid complete formula disclose. Where disclosure
is required by law, disclosure may be limited to satisfy the legal disclosure or else
protected in a manner such that disclosure is confidential to the regulator only or
disclosure is protected under an appropriate confidentiality agreement
negotiated by competent legal counsel.
6.2.6 Verifying the source of the request
If the basis of the formula disclosure request is a statute or regulation, request a

copy of the relevant provisions so that it can be shared with colleagues, legal
counsel, or association contacts and be added to the company’s regulatory
database. View arbitrary requests that are not supported by documentation, such
as “the Ministry of Health requires the formula” with skepticism. If the Ministry of
Health or other requesting body has such a requirement, then it should be
codified somewhere, and the requestor should be able to provide it by fax or
email. The IOFI Secretariat is also available for consultation if necessary.
6.2.7 Considering disclosure options
While individual flavor companies, and by extension the global flavor industry,
have legitimate reasons to protect their intellectual property, there are several
approaches to consider when responding to requests for disclosure. They
include:
• Providing a basis for not disclosing formulae because of reliable safety
assessments
• Entering into nondisclosure agreements with requesting parties
• Exploring limited disclosure options
• Providing certificates of composition
• Identifying chemical family or class data as an alternative to full disclosure
• Using “does not contain” statements to comply with disclosure requests
The following sections explain each of these alternatives.

20
6.3 Disclosure Options
6.3.1 Safety Assurance of Flavoring Ingredients
Occasionally, questions about the safety of a product prompt requests for

disclosure of flavoring ingredients. There are globally recognized scientific expert
groups that conduct ongoing safety evaluation of flavoring substances. The
Expert Panel of the Flavor and Extract Manufacturers Association of the United
States (FEXPAN) and the Joint FAO/WHO Expert Committee on Food Additives
(JECFA) conduct ongoing evaluations and publish their findings regarding the
safe use of individual substances in foods and beverages. One strategy for
addressing formula disclosure requests related to safety is to provide assurance
that all of the ingredients used in the formula have been approved by respected
authorities such as Joint FAO/WHO Expert Committee on Food Additives (JECFA),
the FEMA Expert Panel (FEXPAN), the European Food Safety Authority (EFSA) and
the Japanese Food Safety Commission (FSC).
6.3.2 Nondisclosure Agreements
An important component of a limited disclosure of a flavoring formula is an

agreement not to further disclose the information, or a nondisclosure agreement
(NDA). The precise contents of a nondisclosure agreement should be established
by the company holding the trade secret formula and may vary in different
situations. The agreement should be a signed pledge by a specific individual(s) in
the receiving organization (governmental or private) having authority to legally
bind the organization agreeing that the organization shall not under the terms of
the NDA disclose the confidential information being provided. By signing an NDA,
the individual, and the company receiving the confidential information become
legally bound to keep the information secret. Disclosures that are inconsistent
with the terms of the NDA are a breach and should be dealt with through
appropriate local legal remedies or as specifically set forth in the NDA. In all cases,
the consideration, negotiation and execution of any NDA or any other agreement
affecting a company’s rights related to its trade secrets should be done in
consultation with competent legal counsel.
6.3.3 Types of Limited Disclosure
There are two general types of limited disclosure: quantitative and qualitative.
Quantitative disclosures relate to the quantity, amount or concentration of
ingredients in a flavoring formula. Companies may be able to limit the scope of
the disclosure, for example, by providing quantitative ranges of certain
ingredients or groups of ingredients rather than exact percentages of each

21
ingredient or proprietary ingredients. Qualitative disclosures concern non-

quantitative information about the contents of a flavoring formula; such
disclosures mean revealing the identity of certain ingredients in the formula. Often
qualitative disclosures may satisfy requests for formula disclosure, especially if
accompanied by information demonstrating the safety of the flavoring
substances in the formula.
6.3.4 Certificates of Composition
A certificate or declaration of composition is another way to substantiate the

safety of a compounded flavoring without revealing the individual flavoring
ingredients. Such certificates or declarations usually contain the following
elements:
• A certification that the flavoring formula meets the legal requirements in

the country where the flavoring will be used.
• A declaration of some, but not all, of the individual ingredients used.
• The function of the ingredients listed, (e.g., flavoring, carrier, anticaking
agent).
• Percent range for each of the ingredients listed, (i.e., 21-26%).
6.3.5 Chemical Family and Class
Another approach to satisfying a request for disclosure is to provide a breakdown

of the formula by chemical family or chemical class. Examples of chemical
families include: acids; alcohols; aldehydes; ketones;
A limited disclosure might include a description of the chemical families

contained in the formula as well as a percentage range for each particular family.
This is an example of providing some additional information while still protecting
the complete formula.
A limited disclosure using chemical classes could be offered in the same manner
as a chemical family disclosure with the use of class names, such as: aliphatic
saturated acids; aromatic ketones; and other esters. Once again, if additional
information is requested, one could consider providing a percent range for each
particular chemical class together with safety data on the class such as published
JECFA and FEXPAN group summaries.
6.4 Regulatory Requirements for Disclosure
There are an increasing number of government requirements for limited

disclosure or labeling of individual flavoring ingredients. Perhaps the most

22
obvious example is the requirement to disclose on the label when certain

allergenic foods are present. Such requirements are a source of legitimate
questions about a flavoring formula. The following sections address typical
requests for disclosure, and strategies that both respond appropriately to
regulators and protect the intellectual property of the industry.
6.4.1 Allergen Disclosures
Certain ingredients when present in a flavoring formula must be disclosed on bulk

and consumer product labels because they have been shown to cause an allergic
reaction in a certain portion of the population and therefore their label disclosure
is required by law. At the publication of this edition of the Code of Practice there
is not a globally harmonized list of food allergens. The Codex Alimentarius, the
European Commission, the U.S. Food and Drug Administration and many other
authorities require the disclosure on the label when certain allergenic ingredients
are present. Although many of the lists have common ingredients there are also
distinctions among them. It is important to maintain an up-to-date list of
allergens that require labeling in a particular jurisdiction. IOFI regularly publishes
guidance on allergen labeling requirements for flavorings. Labeling for allergens
is an example where disclosure of specific ingredients in an otherwise trade secret
protected flavoring formula would be legally justified.
6.4.2 Oral Care Products
In the European Union, Cosmetic Regulation (EC) N° 1223/2009 requires the

identification on the label when any one of 26 so-called fragrance allergens is
present in a cosmetic product above certain concentrations. Due to the way some
oral care products are regulated in Europe, it is possible that the Cosmetics
Regulation requires that the manufacturer of the oral care product disclose the
presence of these ingredients when used in a flavoring formula in one of these
oral care products.
6.4.3 Pharmaceuticals
In many countries, products regulated as either prescription or “over the counter”

drugs require the disclosure of inactive ingredients such as flavorings to drug
registration and regulatory authorities. The authorities charged with reviewing
these products sometimes are required to ask for flavoring formula disclosures.
Once again, if not already known, it is important to request a copy of the statute
or regulation that requires or authorizes the disclosure. In addition, you may want
to consider the use of a nondisclosure agreement to limit the way the information
can be used.

23
6.4.4 Workplace safety
It is increasingly common for consumer product manufacturers to request

formula information related to the flavorings that they use to manufacture their
products so that they may comply with relevant regulations or requests from
regulators requiring the disclosure of possible workplace hazards. Workplace
exposure limits such as “permissible exposure limits” (PELs) for flavoring
substances may lead consumer product manufacturers to request formula
disclosure for these substances. In the absence of regulations requiring
disclosure of flavoring substances, flavoring manufacturers may choose to
employ one or more of the disclosure options described previously in this section
such as the use of “does not contain” statements, limited qualitative disclosure,
or the limited disclosure of some members of specific structural classes that may
be of interest (e.g. aldehydes, ketones, etc.). See also Chapter 7.8 on GHS and
IOFI/IFRA Labeling Manual.
6.4.5 Illegal Drug Precursors
Under an agreement of the United Nations, many countries regulate the

industrial use of chemicals that are precursors for illegal drugs. One example of
these chemicals is benzaldehyde. The regulations require registration, reporting
and recordkeeping depending on how the substance is used in a flavoring.
Compliance with these regulations sometimes requires flavoring manufacturers
to provide limited formula information to customers or regulatory authorities.
6.5 Conclusion
The examples directly above represent some of the legal frameworks under which
flavor formula disclosure may be justified. They are meant to demonstrate that
there are legal reasons why customers may need to sometimes ask about certain
contents of an otherwise confidential trade secret flavoring formula. However, it
is important to carefully consider the legal basis of any disclosure request, as in
many circumstances, disclosure can still be appropriately limited.
Helping to protect the intellectual property of the flavor industry is an important

goal for IOFI. Although there are some circumstances where disclosures are
warranted, measures can often be taken to focus a formula inquiry and minimize
or avoid disclosure, thus responding appropriately to requests while protecting
valuable trade secrets.

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7 BASIC STANDARDS OF GOOD MANUFACTURING PRACTICE
7.1 Background
Flavoring substances and flavorings are food ingredients and shall be treated as
such. Flavorings should be prepared and handled in accordance with the
appropriate sections of the Recommended International Code of Practice-
General Principles of Food Hygiene (CXC 1-1969 Rev.4 - 2003).
7.2 Flavor Manufacturing Employers
7.2.1 Employers are obligated to comply with all applicable workplace safety
regulations and are encouraged to explore and address aspects of flavoring
manufacturing that may not be explicitly covered by workplace safety regulations
but which may further foster a safe workplace for employees.
7.3 Employees
7.3.1 Employees responsible for the manufacturing of flavorings shall be adequately

qualified and trained to perform the duties required and shall be instructed
likewise.
7.3.2 All employees active in the departments of the manufacture and packaging of
flavorings shall be adequately and appropriately dressed, comply with all
personal hygiene requirements and avoid working if exhibiting symptoms of
illness or disease that create risk of spreading illness to colleagues or
contaminating the food supply.
7.4 Premises and sanitation
7.4.1 All manufacturing areas shall be clean, orderly and well-ventilated. Instructions
shall be issued indicating the areas to be cleaned, cleaning frequency, cleaning
procedures and personnel responsible for cleaning operations. Appropriate
cleaning equipment and cleaning materials shall be available.
7.4.2 Consumption of food and/or drinks, smoking and other unhygienic practices
shall not be allowed in manufacturing areas.
7.4.3 Sufficiently clean and well-ventilated sanitary facilities, including facilities for
hand washing and changing of clothes shall be available near the working areas

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for the use of manufacturing personnel.
7.4.4 Instructions on access to and behavior in manufacturing areas shall be visually

mounted at entrance areas.
7.4.5 Access to all manufacturing areas shall be restricted to authorized persons.
7.5 Ingredients and raw materials
7.5.1 Ingredients and raw materials used in the manufacture of flavorings should
comply with appropriate national law and shall be examined as to their fitness for
intended use by appropriately qualified personnel.
7.5.2 Ingredients and raw materials shall be stored under conditions that will maintain
their fitness for use.
7.5.3 Ingredients and raw materials deemed to be unfit for use shall be identified as
such and stored away from materials that are fit for use.
7.5.4 Ingredients and raw materials which are found to have a reasonable probability
to cause serious adverse health consequences (i.e., pathogen contamination,
presence of toxic contaminants) should be handled in accordance with local laws
and regulations regarding either regulatory reporting, recall and/or disposal.
7.6 Manufacturing operations
7.6.1 All manufacturing operations and quality control operations on intermediates

and final products shall be supervised by qualified personnel.
7.6.2 Appropriate cleaning instructions shall be issued for all equipment in use, and the
personnel responsible for executing these instructions and verifying the
cleanliness of equipment shall be designated.
7.6.3 All manufacturing equipment shall be designed and maintained to make it

suitable for its intended use.
7.6.4 All manufacturing equipment shall be installed in the production premises in

positions facilitating cleaning and maintenance, and minimizing contamination
during its use.

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7.6.5 Weighing and measuring equipment used in production and quality control shall
be calibrated and checked for accuracy at suitable intervals by appropriate
methods.
7.6.6 All vessels and containers holding raw materials, intermediates or finished
products shall bear suitable means of identifying their contents.
7.6.7 Records shall be maintained of each batch of material manufactured.
7.6.8 Each batch of manufactured material shall be examined as to its fitness for use
by appropriately qualified personnel.
7.6.9 All batch manufacturing records shall be retained for at least one year in such a
way that proper tracking and tracing systems are in place.
7.7 Packaging
7.7.1 In selecting, handling and control of all packaging materials, proper attention
shall be given to their condition, cleanliness and suitability for the product they
contain.
7.7.2 All packages and containers of finished products shall be identified by labels
mentioning the name, code and batch number of the product, its weight or
volume, and any special storage and handling instructions as well as any
directions for use, warnings and precautions which may be required.
7.7.3 All packaging material should comply with appropriate national law.
7.8 GHS & IOFI/IFRA Labeling Manual
7.8.1 The Globally Harmonized System (GHS) defines and classifies the hazards of
chemical products and communicates health and safety information on labels
and safety data sheets.
7.8.2 IOFI Members are encouraged to follow the IOFI/IFRA Labeling Manual. The
Labeling Manual provides guidance to the global membership in order to ensure
a consistent hazard classification and labeling for flavor and fragrance
ingredients.

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8 LABELING
8.1 Introduction
The labeling for bulk shipment of flavorings from a flavor manufacturer to a

customer (focusing on B2B 5 scenarios in this Chapter) shall comply with national
and local regulations of the Country of Origin and in the case of flavorings to be
exported, flavoring manufacturers shall make their best efforts to assure that their
labeling also complies with the labeling regulations of the Country of Destination
with the understanding that failure to do so may result in the denial of entry.
Where applicable, the labeling of flavorings shall also conform to the following:
8.1.1 Where the term “labeling” is used, it shall include the transmission of information
on relevant trade documents such as in Safety Data Sheets (SDS) or Product
Specifications Data Sheets.
8.1.2 The name and address of the flavoring manufacturer or the distributor, as well as
the name or the product code and the quantity shall be shown on the label.
8.1.3 Labeling of flavorings should comply with local regulations. Flavor labels on bulk
packaging sold and shipped to downstream customer companies must include
accurate and sufficient labeling information such that the downstream customer
company can comply with the legal requirements for the labeling of their
products. Particular attention should be paid to the labeling of non-flavoring food
ingredients in flavorings as these may be subject to different regulatory
requirements in different countries, especially in how such materials must be
labeled on food products.
8.2 More Guidance on Labeling
8.2.1 Additional guidance on labeling can be found in the Codex Alimentarius General
Standards for the Labeling of Food Additives When Sold As Such (CODEX STAN 107-
1981).
5
Business-to-Business

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9 CLAIMS MADE IN THE LABELING, PRESENTATION OR ADVERTISING OF

FLAVORINGS
9.1 Introduction
Flavoring manufacturers shall not make false or misleading statements when

promoting or labeling their products.
9.1.1 Specifically, flavoring manufacturers shall abstain from making any claim by way
of statement or representation with a view to promoting the sale of a flavoring
which implies or suggests that it possesses particular characteristics relating to
its nature, properties, composition, quantity, durability, origin or provenance,
method of manufacture or production which is untrue or misleading or which,
when such a claim relates to a measurable or objective characteristic, cannot be
substantiated.
9.1.2 For many decades the flavor industry has successfully worked through
associations to fund a strong scientific program to support the safety of our
industry’s products. Any claims that attempt to malign competitive products or
differentiate products based on safety should be discouraged as this practice
would suggest that our products are not, in fact, safe.

29
10 QUALITY ASSURANCE AND MANAGEMENT
10.1 Quality Assurance
10.1.1 Quality assurance procedures should define in sufficient detail sampling,

including the quantities, tests to be performed, sample retention, and the
schedule for release of the results to relevant audiences requiring such services.
10.1.2 The Quality Assurance department should maintain adequate records regarding
the specification and test results of each batch on file in paper copy or electronic
data for a suitable amount of time to comply with local regulation.
10.1.3 Quality assurance procedures should enable management or outside monitoring

agencies to check regularly whether all instructions and procedures for any stage
of manufacturing and quality control are being followed strictly.
10.2 Quality Management
10.2.1 Companies should compile a flow diagram for the production process that
monitors, ensures and documents the production of flavorings and flavoring
ingredients under consideration of general hygiene rules and, if needed, special
requirements on all steps. The process should prevent or minimize any hazards.
10.2.2 Flavour companies are requested to identify the food quality-relevant critical
points in the process operations and also establish, conduct, comply with and
monitor safety measures based on HACCP principles in accordance with the
annex of CXS 1-1969 (Rev.4 – 2003). Companies must also otherwise comply with
all local and/or regional laws and regulations pertaining to food safety.

30
11 QUALITY CONTROL AND SAMPLE STORAGE
11.1 Quality Control
11.1.1 A Quality Control department directed by a qualified person should monitor and
control predefined properties of all ingredients and finished products. This
department should operate according to defined procedures, with the
responsibility and authority to approve or reject the evaluated materials. During
the period between the arrival from the supplier or from the production center
and its use in flavor compounding or shipment to the customer, all ingredients
and finished products should be stored under conditions compatible with their
physical and chemical properties.
11.1.2 The laboratory facilities for Quality Control purposes should be staffed and
equipped commensurate with the requirements of effective quality control.
11.1.3 QC samples should be uniquely labeled, with reference to the date and batch
number for all ingredients and finished products. Records should be kept
permitting identification of the batch, the production history or origin, and
defining dates for the various control steps, including release by the Quality
Assurance department.
11.2 Storage of Samples and Rejected Products
11.2.1 Samples for external reference of a product in commerce should be stored under
suitable conditions for future reference for at least one year after manufacture or
as long as shelf life defines.
11.2.2 All ingredients to be used in flavor compounding and finished products should
be properly sampled, tested for compliance with organoleptic and analytical
specifications and released by the Quality Control department via defined
procedures.
11.2.3 Ingredients and finished products that have been rejected for any reason should
be designated accordingly, quarantined physically and treated in accordance
with the nature of the rejection.

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12 SHELF LIFE AND RE-TESTING
12.1 Shelf Life
12.1.1 The shelf life of flavorings is defined as the period from the date of production
during which the flavoring remains suitable for further use. This shelf life will be
indicated by an appropriate label description that indicates minimum durability
under appropriate storage conditions.
12.2 Re-Testing
12.2.1 Flavor manufacturers may engage in the common practice of re-testing flavorings
at regular intervals.
12.2.2 Instead of allocating one single extended shelf life, the intention of re-testing is to
ensure that the quality is checked at designated intervals and that the optimum
quality is maintained during storage and subsequent transportation to the
customer, and at the customer’s warehouse prior to final use. Typically, this
practice consists of managing a QA/QC program based on regular sensory,
physical, chemical and, if appropriate, microbiological analyses for determining
continued conformance with the product specifications.
12.2.3 Frequency of the evaluations is based on recommendations of material suppliers,

historical data on the product stability, and product experience or company
practice.
12.2.4 Test procedures and frequency of testing may vary from company to company.
Frequency of testing shall be based on the anticipated shelf life of the flavorings
and shall be indicated by label descriptions such as ‘best before [date]’, ‘re-
analyze by [date]’, ‘re-test by [date]’,‘expiry [date]’ or any other appropriate
wording.
12.2.5 Within the shelf life period, the quality of the flavoring should be in compliance
with sensory, physical, chemical and, if appropriate, microbiological
specifications established by the manufacturer. However, unused product can be
re-analyzed before or at the specified date to establish that the product is still in
compliance with the product specifications.
12.2.6 Descriptions such as ‘best before’, ‘re-analyze by’, ‘re-test by’ or ‘expiry date’
indicate a point in time at which the product should be re-analyzed against the
product specifications before it can be further used in flavor formulation and/or
food production. When the product is found in compliance the product will
receive a new ‘best before[date]’, ‘re-analyze by[date]’, ‘re-test by[date]’ or

32
‘expiry[date]’ description. Test data and results reflecting the re-qualification

shall be documented within a revalidation report issued by the QA/QC
Department(s).

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13 GUIDELINES ON THE IOFI INTERPRETATION OF THE TERM “NATURAL”
13.1 Introduction
The purpose of these Guidelines is to provide guidance on the IOFI interpretation

of the term “natural” as it relates to describing the character of a flavoring (see
Chapter 3 Definitions and Terminology of the CoP). The application of the Code
of Practice, including its Annexes, does not relieve individual manufacturers from
the obligation to comply with all national or international regulations that pertain
to their operations. These regulations, including governmental informal policies
and rulings and officially condoned practices, will take precedence over these
Guidelines. In those countries where corresponding specific regulations are not
in force, the Code of Practice may serve as a best practices resource.
The sections below provide a general overview of the relevant factors when
considering whether a flavor could be considered natural. Again, companies
must consider the local or regional regulatory rules regarding the determination
and labeling of natural flavor.
13.2 Source Materials
Source materials used as the starting material for natural flavorings, should be
materials of animal, plant or microbiological origin. Sources for natural flavoring
complexes and natural flavoring substances are the essential oils, oleoresins,
extractives, distillates, or products of roasting, heating or enzymatic
transformations of spices, fruit or fruit juice, vegetable or vegetable juice, edible
yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry,
eggs and other animal products, dairy products, or fermentation products
thereof.
13.3 Physical Production Processes
Physical processes may be used for the production of natural flavoring complexes
or natural flavoring substances. pH adjustment may be used for the isolation of
acidic and basic materials.

34
13.4 Biochemical Processes for Natural Flavoring Complexes and Natural Flavoring
Substances
13.4.1 Organisms and Enzymes
Biological entities capable of self-replication or resulting from biological

reproduction such as bacteria, yeast, fungi, plants and animals, in whole or in
part, and enzymes derived thereof, are permitted for producing natural
flavorings.
13.4.2 Substrates
If the substrates used to produce natural flavorings by biochemical processes are

natural, as defined in the other sections of this document, then the end products
isolated from such processes are considered natural flavorings.
13.4.3 Co-factors, Nutrients, Vitamins, Hormones and pH-adjusting Agents
Materials added to the substrate necessary for the growth and function of the
organism(s) such as co-factors, minerals, nutrients, vitamins, hormones, pH
adjusting agents and electromagnetic radiation are not restricted in origin, but
they may not exceed the levels required for the purpose of maintaining the
growth and function of the organism(s) or parts thereof.
13.4.4 Carrier System
The carrier system may be aqueous or non-aqueous. Natural substrates can be

used as carriers. Non-natural carriers can only be used if they do not react
irreversibly and do not serve as a substrate. Carriers may remain in the final
mixture provided they are permitted as carrier solvents for natural flavorings.
13.5 Other Processes for Natural Flavoring Complexes and Natural Flavoring
Substances
Processing methods are generally considered to support the production of

natural flavorings where they constitute typical or customary food processing or
in-home preparation, or occur in nature. See examples in Table 1.
List of examples of food preparation processes which are generally considered

to support the production of natural flavoring (non-exhaustive; subject to
update):

35
Absorption Filtration
Adsorption Grinding
Crystallization Heating
Cutting Mixing
Distillation Osmoses
Drying (spray-drying, freeze-drying etc.) Precipitation
Emulsification Roasting
Encapsulation Squeezing
Extraction Sublimation
Extrusion Ultrasonic treatment
13.6 Additional Provisions
The use of singlet oxygen or ozone is not allowed during processing of natural
flavor.
13.7 Classification of Salts
Salts of natural flavoring substances with the following cations NH4+, Na+, K+, Ca2+
and Fe3+, or the anions Cl-, SO42- and CO32- are classified as natural flavoring
substances.

36
14 IOFI GUIDELINES FOR THE PRODUCTION OF THERMAL PROCESS FLAVORINGS
14.1 Introduction
The Codex Alimentarius Guidelines (CAC/GL 66-2008) states that flavorings may
consist of flavoring substances, natural flavoring complexes, smoke flavorings or
thermal process flavorings. The purpose of this section is to provide guidance on
the production and use of thermal process flavorings in countries that have no
regulatory provisions covering this type of product. National regulations, if in
existence and even if they do not use a special term to define thermal process
flavorings, will always take precedence over these Guidelines.
14.2 Scope
14.2.1 These Guidelines deal with thermal process flavorings only. They do not apply to
foods, natural flavoring complexes, chemically defined flavoring substances or
mixtures of flavoring substances.
14.2.2 These Guidelines define those raw materials and process conditions which are
similar to the cooking of food and used to produce thermal process flavorings.
14.3 Definition
A thermal process flavoring is a product prepared for its flavoring properties by

heating raw materials that are foodstuffs or constituents of foodstuffs. This
process is analogous to the traditional home cooking of ingredients of plant and
animal origin.
14.4 Basic Standards of Good Manufacturing Practice
14.4.1 The requirements laid down in Chapter 7 of the IOFI Code of Practice are also
applicable to thermal process flavorings.
14.4.2 Thermal process flavorings shall be prepared in accordance with the Codex
Alimentarius General Principles of Food Hygiene (CAC/RCP 1-1969, Rev.4-2003)
14.5 Raw Materials that May Be Subject to Thermal Processing

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Raw materials for thermal process flavorings shall consist of one or more of the
following:
14.5.1 Protein nitrogen sources:

• Foods containing protein nitrogen (meat, poultry, eggs, dairy products,
fish, seafood, cereals, vegetable products, fruits, yeasts) and their extracts
• Hydrolysis products of the above, autolyzed yeasts, peptides, amino acids
and/or their salts
14.5.2 Reducing Sugars

• Examples: Maltose, glucose, fructose, galactose
14.5.3 Fat or fatty acid sources:

• Foods containing fats and oils
• Edible fats and oil from animal, marine or vegetable origin
• Hydrogenated, transesterified and/or fractionated fats and oils
• Hydrolysis products of the above.
14.5.4 Other raw materials listed in Table 1 below
14.6 Ingredients that may be Added After Thermal Processing
14.6.1 Flavorings as defined in CAC/GL 66-2008 and flavor enhancers as defined by

CAC/GL 36-1989.
14.6.2 Suitable non-flavoring food ingredients as defined by CAC/GL 66-2008. Please see
also the non-flavoring food ingredients listed in Annex I / Chapter 18.
14.7 Manufacturing of Thermal Process Flavorings
Thermal process flavorings are manufactured by processing together raw

materials listed under 14.5 as follows:
14.7.1 The product temperature during processing shall not exceed 180°C.
14.7.2 The processing time shall not exceed ¼ hour at 180°C, with correspondingly
longer times at lower temperatures, i.e., a doubling of the heating time for each
decrease of temperature by 10°C.
14.7.3 The pH during processing shall not exceed 8.
14.7.4 Additional flavorings (see Chapter 14.6.1) and non-flavoring food ingredients (see

38
Chapter 14.6.2) shall only be added after processing is completed.
List of other raw materials that may be subject to thermal processing
Foodstuffs, herbs, spices, their extracts and flavoring substances identified therein.
Water
Thiamine and its hydrochloric acid salt
Ascorbic acid
Citric acid
Lactic acid
Fumaric acid
Malic acid
Succinic acid
Tartaric acid
The sodium, potassium, calcium, magnesium and ammonium salts of the above acids
Guanylic acid and inosinic acid and its sodium, potassium and calcium salts
Inositol
Sodium, potassium- and ammonium sulfides, hydrosulfides and polysulfides
Lecithin
Acids, bases and salts as pH, regulators:
• Acetic acid, hydrochloric acid, phosphoric acid, sulfuric acid
• Sodium, potassium, calcium and ammonium hydroxide
The salts of the above acids and bases
Polymethylsiloxane as antifoaming agent (not participating in the process)

39
15 IOFI GUIDELINES FOR THE PRODUCTION OF SMOKE FLAVORINGS
15.1 Introduction
The Codex Alimentarius Guidelines (CAC/GL 66-2008) states that flavorings may
consist of flavoring substances, natural flavoring complexes, smoke flavorings or
thermal process flavorings. The purpose of this section is to provide guidance on
the production and use of smoke flavorings in countries that have no regulatory
provisions covering this type of product. National regulations, if in existence and
even if they do not use a special term to define smoke flavorings, will always take
precedence over these Guidelines.
15.2 Scope
These guidelines deal with flavorings used for the purpose of imparting a smoke-
type flavor to foodstuffs. These guidelines do not apply to foods, flavorings
extracted from smoked foodstuffs or to flavorings obtained by compounding
chemically defined flavoring substances. National regulations, if in existence, will
always take precedence over these Guidelines. This includes the existence of
specific definitions, rulings and officially condoned practices.
15.3 Definition
Smoke flavorings are complex mixtures of components of smoke obtained by

subjecting untreated wood to pyrolysis in a limited and controlled amount of air,
dry distillation, or superheated steam, then subjecting the wood smoke to an
aqueous extraction system or to distillation, condensation, and separation for
collection of the aqueous phase. The major flavoring principles of smoke
flavorings are carboxylic acids, compounds with carbonyl groups and phenolic
compounds.
applicable to smoke flavorings.
15.4.2 Smoke flavorings shall be prepared in accordance with the Codex Alimentarius
General Principles of Food Hygiene (CAC/RCP 1-1969, Rev.4-2003).

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15.5 Manufacturing of Smoke Flavorings
15.5.1 Raw materials
Untreated wood, bark and twigs of the following non-exhaustive list of species
are used for the generation of smoke.
Latin name English name

Acer negundo L. Maple tree
Betula pendula Roth. (syn. B. verrucosa Ehrh.) Silver birch or European white birch
Betula pubescens Ehrh. (syn. B.alba L.) Downy birch or white birch
Carpinus betulus L. Hornbeam
Carya ovata (Mill.) K.Koch Shagbark hickory
Carya alba (L.) Nutt. ex Elliott Mockernut hickory
Castanea sativa Mill. Chestnut tree
Eucalyptus spp. Eucalyptus
Fagus grandifolia Ehrh. American beech
Fagus sylvatica L. European beech
Fraxinus excelsior L. Common ash
Juglans regia L. Walnut tree
Malus pumila Mill. Apple
Prosopis juliflora (Sw.) DC. & P. velutenia Mesquite wood
Wooton
Prunus avium L. Cherry tree
Quercus alba L. White oak
Quercus ilex L. Holm oak or Evergreen oak
Quercus robur L (syn. Q. pedunculata Hoffm.) Common oak or European oak
Frangula alnus Mill. (syn. Rhamnus frangula L.) Alder buckthorn
Robinia pseudoacacia L. Black locust
Ulmus rubra Muhl. (syn. Ulmus fulva Michx.) Slippery elm
Herbs and spices may also be added as well as twigs of Juniper (Juniper
communis) and twigs, needles and cones of Pine species.

41
15.5.2 Non-flavoring food ingredients
Suitable non-flavoring food ingredients as defined by CAC/GL 66-2008. Please see

also the non-flavoring food ingredients listed in Annex I / Chapter 18.
15.6 Production Conditions
Smoke flavorings are prepared as follows:
15.6.1 By subjecting various untreated hardwoods (see Chapter 15.5.1) to

• controlled burning, or
• dry distillation, or
• treatment with superheated steam and condensation, and
• capturing of those fractions which have the desired flavor potential.
15.6.2 Then by applying further isolation techniques to the fractions obtained under
15.6.1 in order to retain only the flavor-important fractions or components.
15.6.3 The temperature during dry distillation is between 200°C and 600°C, and the
treatment with superheated steam is between 300°C and 600°C
15.6.4 The solvents used for extraction and their residues are listed in Chapter 19, Annex
II of this Code.

42
16 IOFI GUIDELINES FOR ENZYMATIC AND MICROBIOLOGICAL PROCESSES FOR THE

PRODUCTION OF FLAVORINGS
16.1 Scope
These Guidelines deal with enzymatic and microbiological processes used for the
production of flavorings. These Guidelines do not apply to flavoring substances
(as defined under Chapter 3) that are produced by these methods, provided that
they are safe for the intended use as flavoring (see Chapter 5) and comply with
existing purity requirements (e.g., as reported in JECFA specifications) and are
devoid of detectable residual enzymatic or microbiological activity. National and
regional regulations always take precedence over these Guidelines. This includes
the existence of specific definitions, rulings and officially accepted practices.
16.2 Definition
Flavorings produced by enzymatic and microbiological processes are

concentrated preparations, with or without non-flavoring food ingredients, used
to impart flavor. They are produced by submitting a substrate or substrates to the
action of enzymes or micro-organisms.
applicable to flavorings produced by enzymatic or microbiological processes.
16.3.2 Flavorings produced by enzymatic and microbiological processes shall be

prepared in accordance with the Codex Alimentarius General Principles of Food
Hygiene (CAC/RCP 1)1969, Rev.4-2003)
16.4 Manufacturing of Flavorings by Enzymatic or Microbiological Processes (see also

Chapter 13.4)
Flavorings produced by enzymatic or microbiological processes shall be

prepared from or in the presence of one or more of the following and in
accordance with the conditions cited hereafter:

43
16.4.1 Substrates
These include source materials (both food source and non-food source
materials) and isolated constituents of source materials (both food and non-
food).
Note: Materials added to the substrate necessary for the growth and function of
the organism(s) such as co-factors, minerals, nutrients, vitamins, hormones, pH
adjusting agents and electromagnetic radiation are not restricted in origin, but
they may not exceed the levels required for the purpose of maintaining the
growth and function of the organism(s) or parts thereof.
16.4.2 Enzymes
16.4.2.1 Enzymes obtained from source materials that are normally considered
as foods, traditionally accepted constituents of food, or normally used in the
preparation of food.
16.4.2.2 Other enzymes
16.4.3 Micro-organisms
16.4.3.1 Micro-organisms that are traditionally used in the preparation of certain

food products and/or that are (resulting from their traditional use) traditionally
present in certain food products (where they contribute to their characteristics,
taste and nutritional value, e.g., mold in blue cheeses or other cheeses, yeast in
beer, micro-organisms in other fermented drinks, bacteria in yoghurts and other
dairy products…)..
16.4.3.2 Other micro-organisms
16.4.4 Non-flavoring food ingredients
16.4.4.1 Suitable non-flavoring food ingredients as defined by CAC/GL 66-2008.

Please see also the non-flavoring food ingredients listed in Annex I / Chapter 18.
16.4.5 Production Conditions
16.4.5.1 Enzymes (16.5.2) and micro-organisms (16.5.3) shall be used either as

such or immobilized on a carrier. The carrier shall not release harmful substances.
16.4.5.2 Enzymes (16.5.2) and micro-organisms (16.5.3) shall be used as part of a

fermentation medium, or in a more purified form.

44
16.4.5.3 The substrates (16.5.1) (see also 14.4) may be processed in the presence
of enzymes (16.5.2) or micro-organisms (16.5.3). Non-flavoring food ingredients
(16.5.4) may be present provided that they are added subsequent to enzymatic or
microbiological processing, or provided that they are not modified in any way by
such processing in accordance with the relevant requirements.
16.4.5.4 Enzymes (16.5.2) shall be separated from the flavoring, or inactivated,

once the process is terminated. In the case of chemically defined flavoring
substances, enzymes will be typically removed/separated as a result of a
distillation step which takes place for the purification of the flavoring substance;
also in case of natural flavoring complexes, further purification and heating
processes take place which will either remove or at least denature the enzymes.
16.4.5.5 Micro-organisms (16.5.2) shall be separated from the flavoring or

inactivated or destroyed once the process is terminated.
16.4.5.6 Micro-organisms shall not be used under conditions where they lead to
products containing toxins or antibiotics. It is the responsibility of the
manufacturer/producer to analyze the final flavoring and confirm the absence of
any (myco-)toxins or antibiotic residues.
16.4.5.7 Other materials: Materials such as co-factors, minerals, nutrients, feed

stock, vitamins, hormones may be added only if they are necessary for the growth
and function of the organism(s) or parts thereof, but their use may not exceed the
levels required to maintain growth and function.
16.5 General Requirements
The safety in use of flavorings produced with the following materials and
processes should be adequately established:
Materials or processes described above and specifically for the following:

• Substrates described under 16.5.1.2. and 16.5.1.4 and/or
• Enzymes described under 16.5.2.2 and/or
• Micro-organisms described under 16.5.3.2 and/or which may contain
incompletely inactivated enzymes (see 16.5.5.4) and/or micro-
organisms (see 16.5.5.5)

45
16.6 Labeling
In the absence of specific national regulations, the labeling of flavorings

produced by enzymatic or microbiological processes can be considered as
natural, provided the substrates from which they are derived are also natural (See
13.4.2) and all other conditions for natural flavorings are fulfilled (see Chapter 13).

46
17 GUIDELINES FOR OCCUPATIONAL SAFETY AND HEALTH AND ENVIRONMENTAL

PROTECTION
17.1 Field of Application
17.1.1 These Guidelines shall apply to the manufacture and handling of all flavorings
and raw materials used for their production, including storage, production and
plant design, in the flavor industry.
17.1.2 These Guidelines may require revision if future developments in the industry
make it necessary.
17.1.3 The application of these Guidelines does not exempt individual manufacturers
from the obligation to comply with all national or international regulations which
are relevant to their operations.
17.2 Basic Principles
The protection of health in the workplace and the protection of the environment
are of primary concern to the flavor industry. These Guidelines express a desire
by the flavor industry to prioritize occupational safety and the environment by
advancing measures which may be additional to those required to comply with
national or international regulations.
17.3 Definitions
17.3.1 Manufacturing: All operations involved in the production of a flavor material

including processing, compounding, packaging and labeling (see 7.6).
17.3.2 Environment: Water, air and soil and their inter-relationship as well as
relationship between them and any living organisms.
17.3.3 Waste: Any unavoidable material, resulting from an industrial process, which
must be disposed of.
17.4 Occupational Safety and Health
17.4.1 All personnel involved in the manufacture and handling of flavorings and raw
materials used for their production shall have appropriate training and notice of
and access to personal protective equipment where necessary to be protected

47
from recognized health hazards (e.g., skin irritants, respiratory toxins, irritants and
sensitizers, etc.), physical hazards (e.g., noise, radiation, vibration) and chemical
and detrimental health effects of gases, vapors or dusts, etc., in accordance with
all relevant regulations. Employers have a legal duty to provide safe workplaces
for their employees.
17.4.2 Companies shall make their best efforts to eliminate or minimize exposure to
health and physical hazards by taking those precautions which are necessary
under the prevailing regulations.
17.4.3 Priority should be given to reducing exposures to chemicals in the workplace

emphasizing engineering controls, processes that minimize the potential for
exposure, local ventilation, substitution of less hazardous chemicals when
possible, and other means to reduce exposures.
17.4.4 If necessary, in addition to exposure control measures, appropriate personal

protective equipment should be worn when appropriate such as respiratory
protection (gas mask, breathing apparatus, etc.), eye and ear protection (safety
glasses, face visor, ear plugs, etc.), hand and body protection (gloves, suit, apron,
shoes, etc.).
17.4.5 Specific information and instructions on required protective measures should be

provided to personnel in order to avoid inappropriate handling of classified
physical or health hazards in the workplace. Adequate and appropriate
workplace training as well as providing all required documentation including SDS
for each material handled in the flavor manufacturing workplace should be
provided and updated as necessary.
17.4.6 Companies should periodically audit their workplaces that have potential health
and physical hazards. If necessary, exposure-monitoring surveys should be
carried out.
17.4.7 In all cases, recommendations on safe storage and handling should be provided
to both employees and the employees of downstream customers who will handle
products.
17.5 Environmental Protection
17.5.1 The environment should be protected from adverse effects by appropriate

organizational and technical measures. Companies should comply with all
relevant regulations and avoid pollution that affects water, air, soil and public

48
health.
17.5.2 Emissions that can have an adverse effect on the environment should be
identified, assessed and, if feasible, reduced.
17.5.3 Provision should be made to avoid accidental discharges into the environment
that could pose a risk to health of personnel or the general public, or that could
adversely affect the environment.
17.5.4 Companies should create awareness of environmental protection among all

personnel handling materials through documented training and instruct them on
emergency procedures in case of accidental discharge.
17.5.5 Recommendations should be provided to customers on storage and handling

precautions in those cases where this is required to protect the environment.
17.6 Water Protection
17.6.1 Technical and administrative measures should be taken to make sure that
discharged wastewater complies with the legal requirements relevant to the
receiver (water stream, public or private sewer, or treatment plant).
17.6.2 Provision should be made to avoid discharging polluting materials into surface
water drains.
17.7 Air protection
17.7.1 The emission of inorganic or organic materials into the atmosphere must be kept
within the levels specified in national or local regulations, whichever are most
stringent.
17.7.2 Technical and administrative measures should be taken to avoid the accidental
discharge into the atmosphere of quantities of materials hazardous to health or
to the environment.
17.8 Soil and Groundwater Protection
17.8.1 The soil shall be protected from adverse contamination by inorganic or organic
materials.
17.8.2 Technical and organizational measures shall be taken to avoid contamination of

49
groundwater arising from soil contamination.
17.9 Waste Disposal
17.9.1 Priority should be given to reducing the quantity of waste material produced.
Efforts should be made to recycle waste where practical as feedstock, to use it for
energy production or for other purposes.
17.9.2 Chemical wastes shall be disposed of according to national or international legal

requirements. Only officially approved disposal sites shall be used.
17.9.3 The most appropriate disposal methods should be selected for each waste so as
to ensure adequate protection of the public and the environment.
17.9.4 Appropriate waste management methods should be applied. Adequate records

of all disposed wastes should be kept. Landfill disposal records should be
maintained in accordance with relevant regulations.

50
18 ANNEX I: LISTS OF FLAVORING AND NON-FLAVORING FOOD INGREDIENTS
18.1 List of Flavoring Ingredients – Global Reference List of Flavorings (GRL)
The GRL can be consulted and downloaded under www.iofi.org.
For further explanations, please refer to Chapter 2.5 and Chapter 5.3.
Note on Isomers
1. In flavor manufacturing, during the isolation of naturals and/or chemical

synthesis, pure stereoisomers, geometric isomers or positional isomers
can be obtained, as well as mixtures of isomers of variable compositions.
2. Authoritative bodies involved in the safety assessment of flavoring

substances may have reviewed the safety of the stereo-, geometric or
positional isomers, or mixtures thereof, as can be deduced from the
name, the structural formula or the specifications of the evaluated
substance.
3. In assessing whether a particular component or isomer has been

positively evaluated, it is important to investigate whether the safety
assessment related to the mixture, or to one of the individual
components.
• If the assessment occurred on the mixture, it can be assumed that this
assessment remains valid for the safety assessment of the individual
components or isomers.
• In situations where the safety assessment only related to a specific
component or isomer, it cannot simply be assumed that this
assessment is valid for the mixture or a different isomer of the related
compound. In this case a specific safety assessment may be required
to cover either the related isomer or the mixture of isomers.
18.2 Lists of Non-flavoring Food Ingredients
For definitions and further explanations regarding the various types of non-
flavoring food ingredients listed under this chapter, please refer to Chapter 5.3.
Note:
1. The following lists of non-flavoring ingredients are non-exhaustive, and
they shall not be the only source of information for the IOFI members in
this regard.

51
2. IOFI members must perform their own due diligence to confirm the
regulatory authority of the listed ingredient for the intended use in
flavorings and food within the appropriate jurisdiction.
3. The INS numbers indicated in the following lists refer to those identified
in the Codex Class Names and the International Numbering System (INS)
for Food Additives (CAC/GL 36-1989). If a certain INS number listed here is
not in line with that used in CAC/GL 36-1989, one shall refer to the latter.
18.2.1 List of Carriers (including Carrier Solvents)
Substance INS No.

Acetic acid INS 260
Agar agar INS 406
Alginic acid INS 400
Beeswax INS 901
Benzyl alcohol INS 1519
beta-Cyclodextrine INS 459
Calcium carbonate INS 170
Calcium silicate INS 552
Calcium sulphate INS 516
Candelilla wax INS 902
Carboxymethyl cellulose, Na salt INS 466
Carnauba wax INS 903
Carrageenan INS 407
Cellulose, microcrystalline INS 460(i)
Dextran -
Dextrin -
Diammonium phosphate INS 342(ii)
Distarch phosphate INS 1412
Edible fats -
Edible oils -
Elemi resin -
Ethyl alcohol -
Ethyl lactate -
Ethyl cellulose INS 462
Ethyl hydroxyethyl cellulose INS 467

52
Ethyl tartrate -
Gelatin INS 428
Gellan gum INS 418
Ghatti gum INS 419
Glucose -
Glycerol INS 422
Glyceryl diacetate -
Mono- and di- glycerides of fatty acids INS 471
Glyceryl triacetate (Triacetin) INS 1518
Glyceryl triesters of aliphatic fatty acids C6-C18 -
Glyceryl tripropanoate -
Guar gum INS 412
Gum arabic INS 414
Hydrogenated vegetable oils -
Hydrolyzed vegetable protein -
Hydroxyproply methyl cellulose INS 464
Hydroxypropyl cellulose INS 463
Hydroxypropyl distarch phosphate INS 1442
Hydroxypropyl starch INS 1440
iso-Propylalcohol -
Karaya gum INS 416
Konjac flour INS 425
Lactic acid INS 270
Lactose -
Locust bean gum (Carob bean gum) INS 410
Magnesium carbonate INS 504(i)
Magnesium salts of fatty acids INS 470(iii)
Maltodextrin -
Mannitol INS 421
Methyl cellulose INS 461
Medium chain triglyceride -
Modified Starches -
Acetylated distarch adipate INS 1422
Acetylated oxidized starch INS 1451
Acid-treated starch INS 1401
Alkaline treated starch INS 1402
Bleached starch INS 1403

53
Dextrins, roasted starch INS 1400

Acetylated distarch phosphate INS 1414
Monostarch phosphate INS 1410
Oxidized starch INS 1404
Phosphated distarch phosphate INS 1413
Starch acetate INS 1420
Starch sodium octenyl succinate INS 1450
Starches, enzyme treated INS 1405
Mono-, di- and tri-Calcium orthophosphate INS 341(i), (ii), (iii)
Na, K, NH4 and Ca alginate INS 401-404
Pectins INS 440
Processed euchema seaweed INS 407a
Propylene glycol INS 1520
Propylene glycol alginate INS 405
Sodium chloride (salt) -
Silicon dioxide, amorphous INS 551
Sodium aluminium diphosphate INS 541
Sodium aluminium silicate INS 554
Sodium, potassium and calcium salts of fatty acids INS 470(i), (ii)
Sorbitol INS 420(i)
Sorbitol sirup INS 420(ii)
Starch -
Sucroglycerides INS 474
Sucrose -
Sucrose esters of fatty acids INS 473
Sucrose oligoesters, type I and type II INS 473a
Tara gum INS 417
Tragacanth gum INS 413
Triethyl citrate INS 1505
Water -
Whey powder -
Xanthan gum INS 415
Xylitol INS 967

54
18.2.2 List of Antioxidants
Substance INS No.

Ascorbic acid INS 300
Na and Ca salts of ascorbic acid INS 301-302
Ascorbyl palmitate INS 304
BHA (Butylated hydroxyanisole) INS 320
BHT (Butylated hydroxytoluene) INS 321
Dodecyl gallate INS 312
Erythorbic acid INS 315
Sodium, potassium, calcium erythorbate INS 316, 317, 318
Octyl gallate INS 311
Propyl gallate INS 310
TBHQ (tert-Butyl hydroquinone) INS 319
Tocopherols (natural & synthetic) INS 307-309
18.2.3 List of Sequestrants
Substance INS No.

Citric acid multifunctional INS 330
Calcium disodium ethylenediaminetetraacetate INS 385
Disodium ethylenediaminetetraacetate INS 386
Tartaric acid INS 334
Tetrasodium diphosphate INS 450(iii)
Other phosphates INS 450, 451
18.2.4 List of Preservatives
Substance INS No.

Benzoic acid INS 210
Na, K and Ca salts of benzoic acid INS 211-213
Ethyl p-hydroxybenzoate INS 214
Sodium ethyl p-hydroxybenzoate INS 215
Methyl p-hydroxybenzoate INS 218
Sodium propyl p-hydroxybenzoate INS 217
Propyl p-hydroxybenzoate INS 216
Propionic acid INS 280,
Na and K salts of propionic acid INS 281, 283

55
Sorbic acid INS 200

Na, K and Ca salts of sorbic acid INS 201-203
Sulphur dioxide INS 220
Na, K, Ca sulphites, bisulphites, hydrogen sulphite and INS 221-228
metabisulphites
Sodium methyl p-hydroxybenzoate INS 219
18.2.5 List of Emulsifiers and Stabilizers
Substance INS No.

Agar-Agar INS 406
Alginic acid INS 400
Na, K, NH4 and Ca salts of alginic acid INS 401-404
Carageenan INS 407
Citric and fatty acid esters of glycerol INS 472c
Diacetyl tartaric and fatty acid esters of glycerol INS 472e
Mono- and di- glycerides of fatty acids INS 471
Guar gum INS 412
Gum arabic INS 414
Gum ghatti INS 419
Tragacanth gum INS 413
Lactic and fatty acid esters of glycero INS 472b
Lecithin INS 322
Locust bean gum (Carob bean gum) INS 410
Methyldihydroabietate -
Modified Starches -
Acetylated distarch adipate INS 1422
Acetylated oxidized starch INS 1451
Acid-treated starch INS 1401
Alkaline treated starch INS 1402
Bleached starch INS 1403
Dextrins, roasted starch INS 1400
Acetylated distarch phosphate INS 1414
Monostarch phosphate INS 1410
Oxidized starch INS 1404

56
Phosphated distarch phosphate INS 1413

Starch acetate INS 1420
Starch aluminium octenyl succinate INS 1452
Starches, enzyme treated INS 1405
Pectins INS 440
Polyglycerol esters of fatty acids INS 475
Polyoxyethylene (20) sorbitan monolaurate INS 432
Polyoxyethylene (20) sorbitan monooleate INS 433
Polyoxyethylene (20) sorbitan monopalmitate INS 434
Polyoxyethylene (40) stearate INS 431
Polyoxyethylene (20) sorbitan tristearate INS 436
Polyoxyethylene (8) stearate INS 430
Polyoxyethylene (20) sorbitan monostearate INS 435
Processed euchema seaweed INS 407a
Propylene glycol alginate INS 405
Propylene glycol stearate -
Propyleneglycol esters of fatty acids INS 477
Sodium citrate INS 331
Sodium stearoyl-2-lactate INS 481(i)
Sorbitan monolaurate INS 493
Sorbitan monooleate INS 494
Sorbitan monopalmitate INS 495
Sorbitan monostearate INS 491
Sorbitan tristearate INS 492
Stearyl tartrate INS 483
Sucroglycerides INS 474
Sucrose acetate isobutyrate INS 444
Sucrose esters of fatty acids INS 473
Xanthan gum INS 415
18.2.6 List of Weighting Agents
Substance INS No.

Glycerol ester of wood rosin (Ester gum) INS 445(iii)
Glyceryl tribenzoate -
Glyceryl ester of hydrogenated rosin -
Hydrogenated colophonium -
Methyldihydroabietate -

57
Methylester of hydrogenated rosin -

Propylene glycol dibenzoate -
Sucrose acetate isobutyrate INS 444
18.2.7 List of Acids, Bases, Salts
Substance INS No.

Acetic acid INS 260
Acetic acid, Na, K and Ca salts INS 261-263
Adipic acid INS 355
Adipic acid, Na and K salts INS 356-357
Calcium carbonate INS 170, 170(i), 170(ii)
Citric acid INS 330
Citric acid, Na, K and Ca salts INS 331-333
Fumaric acid INS 297
Hydrochloric acid INS 507
K and Na mono-and dibasic orthophosphates INS 339-340
K, Ca, NH4 and Mg chlorides INS 508-511
K, Ca, NH4 and Mg hydroxides INS 525-528
Lactic acid INS 270
Lactic acid, Na, K and Ca salts INS 325-327
Magnesium carbonate INS 504
Malic acid INS 296
Malic acid, Na, K and Ca salts INS 350-352
Na, K, Ca, NH4 and Mg sulphates INS 514-518
Phosphoric acid INS 338
Potassium carbonate INS 501
Sodium carbonate INS 500
Sodium hydroxide INS 524
Succinic acid INS 363
Succinic acid, Na INS 364
Succinic acid, K -
Sulphuric acid INS 513
Tartaric acid INS 334
Tartaric acid, Ca salt INS 354
Tartaric acid, Na and K salts INS 335-337

58
18.2.8 List of Anticaking Agents
Substance INS No.

Aluminium silicate (Kaolin) INS 559
Calcium aluminium silicate INS 556
Calcium carbonate INS 170
Calcium silicate INS 552
Magnesium carbonate INS 504
Magnesium silicate INS 553
mono-, di-and tri-Calcium orthophosphate INS 341
Potassium aluminium silicate INS 555
Silicon dioxide, amorphous (silicic acid, colloidal) INS 551
Sodium aluminium silicate INS 554
Stearic acid, salts INS 470, 470(i), 470(iii)

59
19 ANNEX II: LIST OF EXTRACTION SOLVENTS USED FOR THE PRODUCTION OF

NATURAL FLAVORINGS AND RESIDUE LIMITS (see also Chapter 5.3)
Note:
1. The following list is non-exhaustive, and it shall not be the only source of
information for the IOFI members in this regard.
2. IOFI members must perform their own due diligence to confirm the
regulatory authority of the listed substances for the intended use as
extraction solvents for the production of natural flavorings and the
corresponding residue limits within the appropriate jurisdiction.
3. The following list (including the residue limits) is subject to update by the
IOFI Secretariat. For IOFI members, the updates are communicated via
Information Letters whenever available. For non-members, please
contact the IOFI Secretariat for the latest update.
Substance Residue limit (ppm) 6 7

Butane 1
Propane 1
Isobutane 1
Toluene 1
Cyclohexane 1
Hexane 1
Heptane 1
Light petroleum 1
Methanol 10
Butan-1-ol 10
Acetone 2
Ethylmethylketone 2
Ethyl acetate 10
Diethyl ether 2
Dibutyl ether 2
Methyl tert.-butyl ether 2
Dichloromethane 2
Supercritical carbon dioxide GMP
6
This refers to the level of residue limits as in finished food.
7
Some of these substances exist in the environment as pollutant/contaminants, as a result, certain level of
these substances may be detected in finished food even though they are not used for extracting the flavorings
added to the finished food.

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Code of Practice

Revision April 2020

Code of Practice of the International Organization of

2.1 About IOFI ..............................................................................................................................7

2.2 Mission Statement................................................................................................................7

2.3 Strategic Objectives & Core Values ...................................................................................7

2.4 IOFI and the CODEX ALIMENTARIUS COMMISSION .......................................................7

2.5 The IOFI Global Reference List ...........................................................................................8

2.6 Application of the Code of Practice ............................................................................... 10

3 DEFINITIONS AND TERMINOLOGY ..................................................................................... 11

3.2 Flavor (CAC/GL 66-2008 item 2.1) ................................................................................... 11

3.3 Flavorings ............................................................................................................................ 11

4 THE ROLE AND FUNCTION OF FLAVORINGS IN FOOD ..................................................... 14

5 INGREDIENTS FOR FLAVORINGS ........................................................................................ 15

5.2 Flavoring Ingredients ........................................................................................................ 15

5.3 Non-Flavoring Food Ingredients .................................................................................... 15

6 FLAVORINGS AND INTELLECTUAL PROPERTY .................................................................. 17

6.1 Intellectual Property Protection ..................................................................................... 17

April 2020 – Final

6.2 Requests for Flavoring Formula Disclosure.................................................................. 18

6.3 Disclosure Options ............................................................................................................ 20

6.4 Regulatory Requirements for Disclosure ...................................................................... 21

6.5 Conclusion .......................................................................................................................... 23

7 BASIC STANDARDS OF GOOD MANUFACTURING PRACTICE .......................................... 24

7.1 Background ........................................................................................................................ 24

7.2 Flavor Manufacturing Employers ................................................................................... 24

7.3 Employees .......................................................................................................................... 24

7.4 Premises and sanitation .................................................................................................. 24

7.5 Ingredients and raw materials ........................................................................................ 25

7.6 Manufacturing operations ............................................................................................... 25

7.8 GHS & IOFI/IFRA Labeling Manual .................................................................................. 26

8.2 More Guidance on Labeling ............................................................................................ 27

9 CLAIMS MADE IN THE LABELING, PRESENTATION OR ADVERTISING OF FLAVORINGS28

10 QUALITY ASSURANCE AND MANAGEMENT ....................................................................... 29

10.1 Quality Assurance .............................................................................................................. 29

10.2 Quality Management ........................................................................................................ 29

11 QUALITY CONTROL AND SAMPLE STORAGE ..................................................................... 30

11.1 Quality Control ................................................................................................................... 30

11.2 Storage of Samples and Rejected Products................................................................. 30

April 2020 – Final

12 SHELF LIFE AND RE-TESTING ............................................................................................. 31

12.1 Shelf Life .............................................................................................................................. 31

12.2 Re-Testing ........................................................................................................................... 31

13 GUIDELINES ON THE IOFI INTERPRETATION OF THE TERM “NATURAL” ...................... 33

13.2 Source Materials ................................................................................................................ 33

13.3 Physical Production Processes ....................................................................................... 33

13.6 Additional Provisions ........................................................................................................ 35

13.7 Classification of Salts ........................................................................................................ 35

14 IOFI GUIDELINES FOR THE PRODUCTION OF THERMAL PROCESS FLAVORINGS ........ 36

14.2 Scope ................................................................................................................................... 36

14.3 Definition ............................................................................................................................. 36

14.4 Basic Standards of Good Manufacturing Practice ...................................................... 36

14.5 Raw Materials that May Be Subject to Thermal Processing ...................................... 36

14.6 Ingredients that may be Added After Thermal Processing ....................................... 37

14.7 Manufacturing of Thermal Process Flavorings ............................................................ 37

15 IOFI GUIDELINES FOR THE PRODUCTION OF SMOKE FLAVORINGS .............................. 39

15.2 Scope ................................................................................................................................... 39

April 2020 – Final

15.3 Definition ............................................................................................................................. 39