FLAVOR REGULATIONS

IV. FLAVOR REGULATIONS

A. The Objectives of Flavor Regulations

The purpose of food laws is to assure safety for the consumer and prevent deception.

cessing, and the additives contained in it. These principles also apply to flavors. The vast number of flavoring raw materials makes this a difficult task for legislators, resulting in various countries taking different approaches.

1. Flavor Safety Flavorings are a part of food, and they must be safe for human consumption. Only regu-

lated ingredients that are recognized to be safe are permitted. The following is a review of the types of systems that regulate flavor components.

A positive list is composed of flavoring raw materials that are believed to be innocuous and safe for use in food. Positive lists are used mostly to regulate the use of food additives such as preservatives, colorants, and antioxidants. For such addi- tives, the number of products to be controlled is comparatively small. In the case of flavors, however, a positive list is rather voluminous.

a. Positive List System.

The advantage of a positive list system is its convenience in that it indicates exactly what is permitted. Forbidden substances are not listed. The disadvantage of the positive list is that it is voluminous and legally difficult to monitor.

A negative list records materials that shall not be used in flavorings because they are known to be harmful and also lists substances for which an upper consumption limit has been fixed.

b. Negative List System.

The advantage of a negative list system is that is usually short, providing a simple means for control of forbidden substances. The main disadvantage is the lack of informa- tion on the permitted materials, which are not included in the list. Thus, information on new innocuous substances does not get published.

c. Mixed System. The mixed system was introduced in some European countries to combine the advantages of the positive and negative list systems. The positive list includes approved artificial components (not reported in foods) based on their toxicological ap- praisal and their past safe use in foods, taking into account their recognizable risks. The negative list indicates forbidden natural flavorings and nature-identical flavoring sub- stances based on proof of adverse effects associated with their intake.

The advantage of the mixed system is the clear listing of forbidden substances, providing adequate consumer protection; it can be enforced in practice without undue cost. New artificial flavoring substances proven to be innocuous can be added to the positive list.

The legal aspects of regulating food additives through a listing system have been extensively discussed by Bigwood and Gerard (39). The Latin and South American countries mostly follow the mixed system with cer- tain associations to U.S. food laws. In some of these countries, only nature-identical sub- stances that are listed as GRAS by the United States are permitted.

2. Consumer Deception The purpose of flavoring a food is to add sensory value (pleasure) to that food without

altering its identity. Most food regulations are formulated to put a stop to practices where flavor might be used to give false values. The addition of a characterizing flavor is usually not permitted to compensate for the lack of natural flavor due to poor or improper pro- cessing. For example, butter or cheese flavors are not permitted to flavor natural butter

3. Consumer Information The labeling of foods in relation to added flavors is regulated in many countries. The

purpose is to label the flavors in conformity with their true nature so that consumers will

be properly advised as to the type of flavors used. Although regulations differ greatly from one country to another, the chief objective is to differentiate among the main types of flavors:

Natural flavors Nature-identical flavors (where applicable) Artificial flavors Mixtures of natural flavors and nature-identical or artificial flavors

This is a simplification of terminology. What is considered natural or artificial in one country is not necessarily perceived as such in another.

B. Nomenclature of Flavors

Since all flavors are compounded mixtures, it is imperative to classify the raw materials that are used in the industry. The IOFI defined classes of raw materials according to their origin and nature as follows (40):

A natural aromatic raw material is a vegeta- ble or animal product used for its flavoring properties, either as such or pro- cessed, and is acceptable for human consumption in the form in which it is used; for example, fruit, fruit juice, spices, herbs, balsams, roasted coffee, meat cheese, wine vinegar.

1. Natural aromatic raw materials .

2. Natural flavoring substances .

A natural flavoring substance is isolated from

a natural aromatic raw material by physical methods; for example, citral by fractionation from oil of lemongrass.

3. Nature-identical flavor substances . Nature-identical flavoring substances are obtained by synthesis or are isolated through chemical processes from a natural aromatic raw material and are chemically identical to a substance present in natural products intended for human consumption, either processed or not. Ex- amples include vanillin from lignin and citral obtained by chemical synthesis or from oil of lemongrass through its bisulfate derivative.

4. Artificial flavor substances . Artificial flavoring substances are substances that have not yet been identified in a natural product intended for human consump- tion, either processed or not; for example, ethyl vanillin.

Although these definitions for raw materials are acceptable to most countries, the naming of flavors made from such raw materials differs within some countries in their label decla- ration.

C. Label Declaration of Flavors

Flavors are declared in finished food products according to national food labeling regula- tions. A brief summary of the flavor labeling regulations for some major countries is given

1. Australia Flavors are considered as a food rather than as food additives. There are references to

FEMA, FDA lists, and the Council of Europe book for approved artificial flavoring sub- stances. There is also a negative list of prohibited substances which may not be used in flavors. Flavors may contain designated solvents, carriers, emulsifiers, stabilizers, thicken- ers, acids, colors, and preservatives, all within prescribed maximum use levels.

When used in standardized food products flavors must, with some exceptions (e.g., cocoa, chocolate, cheese, confectionery, cakes, and other products using flour except breads), be labeled as ‘‘artificially flavored.’’

2. Brazil Flavors are declared as natural, nature-identical, or artificial. There is a short list of ap-

proved artificial flavoring ingredients. There is also a negative list of substances considered harmful and not permitted in food. Additionally there is a list of approved food additives with maximum use levels given for each category of food product in which they are permitted.

3. Canada Canadian Food and Drug Regulations define flavors or essences as natural, naturally forti-

fied (containing at least 51% of the name flavor), or artificial. The term ‘‘imitation’’ may

be used in place of ‘‘artificial.’’ The absence of the words ‘‘artificial’’ or ‘‘imitation’’ in the description of a flavor indicates that the flavor or essence is of natural origin. There is a list of nineteen standardized extracts, essences, and flavors. The term ‘‘nature-identi- cal’’ has no official status in Canada.

There are fifteen tables of various food additives along with the foods in which they are used, the purpose of use and maximum use levels as part of the Canadian Food Regulations, and this includes a table of approved solvents for use in flavors and extracts.

4. Japan Natural flavorings are regarded as foods and are not directly regulated. All permitted food

additives, including nature-identical and artificial flavoring substances are listed as specific chemical compounds and by chemical group. Maximum use levels are stipulated although flavoring substances are listed ‘‘for the purpose of flavor.’’

5. Switzerland All natural and nature-identical flavoring substances are permitted; artificial flavoring sub-

stances are permitted if they are on a recognized official list (e.g., FEMA GRAS).

6. United States

a. Natural Flavors. In the United States natural flavors are defined in the Code of Federal Regulations 21CFR101.22(a)(3) as follows:

The term ‘‘natural flavor’’ or ‘‘natural flavoring’’ means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymoly- sis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegeta- ble or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, The term ‘‘natural flavor’’ or ‘‘natural flavoring’’ means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymoly- sis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegeta- ble or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat,

b. Natural With Other Natural Flavor (WONF). This is a class of natural flavorings, containing characterizing and other natural flavoring substances that simulate, resemble, or reinforce the characterizing flavor substance. The criteria here is that the flavor must contain some of the name flavor.

c. Flavor. When the term ‘‘flavor’’ is used in the United States, it strictly means that the flavor is natural, since an artificial flavor must always have the adjective ‘‘artificial’’ used in its name.

d. Artificial Flavors. Artificial flavorings are made from synthetic components. In the United States, as in Canada, the regulations do not make a distinction for the synthetic components known to occur in nature recognized by the term ‘‘nature-identical’’ in Eu- rope.

7. European Community Flavor Directive 88/388 has been adopted by all member countries for the labeling of

flavors. There are six categories of flavorings:

1. Natural flavoring substances

2. Nature-identical substances

3. Artificial (non–nature-identical)

4. Processed flavorings

5. Smoke flavorings

6. Flavoring preparations The rules for what may be considered as a natural flavor are in Flavor Directive

88/388 and the declaration of a flavor in a food is mandatory as ‘‘flavor.’’ A more specific description such as ‘‘nature-identical’’ or ‘‘artificial’’ is permitted but not mandatory. There are complicated rules concerning the declaration of ‘‘natural flavors.’’

At present, the individual member countries are working together to establish a list of approved flavoring substances and their respective natures. This list is expected to be completed by 2004. Until the EU list of approved flavoring substances is complete and in effect in the EU countries, each individual member state is following their respective list of flavoring substances.

D. Flavors and National Food Laws

1. The United States The use of flavors in food is regulated in the United States by the Food and Drug Adminis-

tration. Relevant chapters in the Code of Federal Regulations refer to the definition of flavors, labeling provisions, and lists of permitted flavoring materials and substances. In addition to the FDA regulations, the Flavor and Extracts Manufacturers’ Association (FEMA) issues regularly updated lists of flavoring substances that have been generally recognized as safe by an independent expert panel.

Founded in 1909, FEMA is well known internationally for its contribution to the industry. It is appropriate to devote a few lines to this association to highlight its various

Safety Evaluation Coordination Committee . This committee directs an extensive safety testing program through its Expert Panel. This is a panel of independent expert pharmacologists and toxicologists who pass on the safety of current or new ingredients and whose unanimous conclusion that a substance is generally recognized as safe is published shortly thereafter. Such data and publications ben- efit several national and international organizations.

Technical Committee . Through its members, this committee has been instrumental in proofing analytical techniques and adapting methods of establishing standards and detection of adulteration.

2. National Flavor Associations Abroad Not only do flavor regulations vary from one country to another, but the application for

flavors to foods is also regulated in various ways. For precise information on flavor regula- tions and food laws in a particular country, the reader is advised to contact the respective authorities of that country. The local flavor associations are well prepared to supply infor- mation on local food laws and on import/export regulations. The national associations in

21 countries are listed in the appendix at the end of this chapter.

E. International Regulatory Organizations

1. Codex Alimentarius Shortly after World War II, it became evident that rapidly growing international trade

would largely be facilitated by a harmonization of the individual national food laws. One of the first organizations to study this problem was Codex Alimentarius. This organization was founded in 1962 jointly by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO). In order to establish generally accept- able food standards for a number of internationally traded food items (e.g., meat, frozen food, fats and oils, soups and sauces, cocoa, and chocolate), it maintains international committees on these various food categories. Each of the food committees possesses state- of-the-art expertise in its respective field. In stepwise procedures, specifications for differ- ent food items are elaborated and finally adopted. All member countries of the Codex Alimentarius are obligated to accept these international standards, at least for imported food.

As to the needs and technological aspects of food additives, the Codex Alimentarius Committee on Food Additives is consulted. Their objective is to elaborate and to propose standards for food additives in order to harmonize their regulations. With respect to the food additives, the Codex Alimentarius Food Additive Committee has only a consulting function. The final decision as to whether flavors should be permitted in chocolate products rests entirely with the Committee on Cocoa and Chocolate. Concerning flavors, the Food Additive Committee realizes that positive lists for the large number of available flavorings are not practical, and for this reason, and in view of the self-limiting nature of flavors, they have not reached a final decision on how flavorings are to be listed. The delegates of this committee agree, however, that there should be a distinction between natural, nature- identical, and artificial flavoring raw materials.

2. Joint Expert Committee on Food Additives Safety aspects of individual additives are the exclusive responsibility of the Joint Export 2. Joint Expert Committee on Food Additives Safety aspects of individual additives are the exclusive responsibility of the Joint Export

3. The Common Market Commission Within the Common Market countries, the situation is similar. The Commission of the

European Community in Brussels accepts the principle of dividing flavoring substances into three groups, natural, nature-identical, and artificial. A final decision has not been reached; still open is the question of what form a future harmonization in the Common Market countries should take. Whether a positive list will be established or the mixed system, as presently used in continental Europe, will be adopted is uncertain. Both options are still under decision. Nightingale (41) pointed out that the introduction of positive list systems in Europe would not be legally possible because of the constitutional provisions of the Treaty of Rome.

4. The Council of Europe The Council of Europe, with headquarters in Strasbourg, France, announced 20 years ago

that a special ad hoc working group would be formed to study the flavor situation. In 1974, this body released a publication entitled National Flavoring Substances, Their Sources and Added Artificial Flavoring Substances , referred to as the Blue Book (42), which lists ad- mitted and temporarily admitted flavoring raw materials. For each listed product, some identifying specifications are given. Only natural and artificial flavoring substances are listed. No distinction, however, is made between nature-identical and artificial flavoring substances. Since the Council of Europe has no constitutional power in Europe, this book must be regarded as a state-of-the-art compilation. Its main drawback is the fact that it is not regularly updated, which is a basic requirement for the flavor industry. On the basis of this publication, the Council of Europe has nevertheless proposed a project for a flavor regulation that would distinguish between natural, nature-identical, and artificial flavoring raw materials. For the natural materials, a negative list is envisaged, whereas nature-identi- cal and artificial raw materials would have to be included in a positive list. Due to its liaison with the Common Market Commission in Brussels, the proposal of the Council of Europe has a good chance of becoming official.

5. International Organization of the Flavor Industry Founded in 1989, IOFI represents the national flavor manufacturer associations of 21

countries. The members of the national associations are either national flavor houses or internationally operating flavor companies with local representatives or manufacturing facilities. Only national flavor associations can become members of IOFI; individual com- panies are not accepted. The headquarters of IOFI are located in Geneva, Switerland.*

The objectives of IOFI are to encourage a harmonization of the different flavor regulations to assist in formulating flavor regulations in countries that so far have no or insufficient food laws, and to supply information on raw materials, products, and proce- dures to authorities on a confidential basis. In 1972, a symposium on the safety evaluation of flavoring substances was organized in Geneva. The proceedings of this symposium, in which more than 20 toxicologists of international reputation participated, were compiled in a small brochure, ‘‘Basic Features of Modern Flavor Regulation,’’ which IOFI pub- The objectives of IOFI are to encourage a harmonization of the different flavor regulations to assist in formulating flavor regulations in countries that so far have no or insufficient food laws, and to supply information on raw materials, products, and proce- dures to authorities on a confidential basis. In 1972, a symposium on the safety evaluation of flavoring substances was organized in Geneva. The proceedings of this symposium, in which more than 20 toxicologists of international reputation participated, were compiled in a small brochure, ‘‘Basic Features of Modern Flavor Regulation,’’ which IOFI pub-

The technical committee, at regular intervals, edits the IOFI Code of Practice for the flavor industry, which contains, among other features, a regularly updated list of all artificial flavoring substances not yet found in nature permitted for use in the United States.

Today, IOFI enjoys a worldwide reputation as an independent association. It attends the Codex Alimentarius meetings as well as the Council of Europe sessions as an observer. In some Latin American countries and in Europe, many of the existing food laws were introduced with the help of IOFI or are based on its recommendations.

F. Adulteration of Flavors

Food adulteration is as old as humankind. During the days of the Roman Empire, the trade with water and food was strictly controlled, but it was nevertheless common practice to improve the acceptability of food, for example, by the addition of spices or by aeration. In 1524, Martin Luther called all merchants robbers and thieves (43), complaining mainly about measuring practices and the adulteration of food.

Recent scientific advances have assisted in achieving better safety and quality of flavors. The few cases of adulteration are encountered mainly in the area of extending expensive natural flavors with artificial nature-identical or other inexpensive natural ingre- dients. Such practice has diminished in the last two decades due to advances in analytical techniques that make it possible to detect them. Vanilla extract, as an example, used to

be extended with the less expensive extract of St. John’s Bread or carob. This type of adulteration stopped long ago due to easy detection of such adulteration by chromato- graphic analysis. Synthetic vanillin from lignin was also added to boost natural vanillin in vanilla extracts. Thanks to Bricout et al. (44), who applied stable isotopic rations

[ 13 C 12 C] to differentiate between the two types of vanillin and helped in preventing exten- sive adulteration with added synthetic vanillin. Carbon dating analysis, known as 14 C analysis (43) has also helped in the determina- tion of the authenticity of some natural materials. Due to this new technique, synthetic benzaldehyde, as an example, is easily differentiated from natural sources (15).

Flavor houses play an important role in ensuring the quality and authenticity of flavors offered to their customers. They work very closely with scientists from various disciplines to help them establish new and reliable analytical methods. Through its associa- tions (IOFI and FEMA), the industry works to establish self-policing procedures and to promote good manufacturing practices and goodwill among its members.