1
DieNahrung
I
20
I
3
I 1976 I,
253-2258
I
Givaudan Diibendorf Ltd, Diibendorf, Schweiz
Nutrition and Flavour-Legislation W. SCHLEGEL
Our food laws have to provide for safety of food and to ensure that the consumer is not misled. We are no longer in a position to manufacture food without additives and especially without flavours. For physiological reasons, our food should be offered in a wide variety; an increasing number of food preparations has no natural flavour a t all and needs to be flavoured and the industrial manufacture of food requires the flavours to be properly developed in order t o withstand the sometimes rather drastic conditions of manufacture. The safety of flavours and flavouring substances is discussed. It is shown that the class of nature-identical flavouring substances has to be treated separately for practical purposes of food control and because the substances of this group offer more certainty with regard to their safety. Somesuggestions are made regarding the proper labelling of food which contains flavours. The IOFI (International Organization of the Flavour Industry) model law is discussed which should serve as a basic proposal for the international harmonisation of national food laws. The consumer of today acts very suspiciously towards all kind of food additives. Like all mass phenomena this feeling is not a t a11 a logical one; it is rather an emotion. On the other hand food technologists and scientists are aware of the fact that satisfactory nutrition for the world’s population cannot be attained without food additives. Obviously there is an information gap which has to be bridged. This bridging cannot be accomplished by food laws alone, it also needs our, the industry’s active contribution. There are two basic reasons why the consumer behaves as he does: The consumer is afraid of possible intoxication and he objects t o spending his money for something which is not what i t pretends t o be. And without any doubt he is fully entitled t o demand that his food is wholesome and safe and to know what he really gets. It is the objective of the food laws to guarantee safe food and to provide for proper labelling of it. In view of severe differences between US regulations and European food laws I would like t o cast some thoughts along these lines with special consideration to flavours and flavour legislation? The International Organization of the Flavour Industry (IOFI)’ has developed a certain philosophy towards the problems of safety, labelling and legislation.
Why do we need flavours ? Apart from the fact that flavour and taste-imparting preparations have been used for ages in food, there are more reasons indicating that the Flavour Industry will contribute considerably to overcome the nutritional problems of the world’s population. IOFI was founded in 1969under Belgian law. The objectives of this organization are: I, to establish and collect scientific data regarding flavouring substances, mainly concerning their safety, 2 . to collect and observe national and international reglementations for the use of flavours, 3. to distribute relevant information to member associations and to other international organizations IOFl’s members are national associations related to the flavour trade. At present IOFI counts 15 member countries. 18.
264
SCHLEGEL
Physiologists know t h a t not only fat, carbohydrates, proteins, vitamins and trace elements are essential constituents of food, but that food must also be appealing in taste and be available in a wide variety of textures and flavours in order t o be enjoyable and digestible. Today there exist already many food preparations which would not be consumed if no flavour had been added; for example, all kinds of desserts, ice cream, soft drinks and sweets. It is very likely that this collection will become larger in the future. As the possibility of stabilizing the growth-rate of our population is extremely remote, we have t o look for new, so far untapped, food sources and shall depend on them whether we like i t or not. I n this context the efforts to utilize soya, alfalfa, groundnuts, oil, coal, algae and fish for the industrial manufacture of human food must be mentioned. Such food preparations will be more or less tasteless and i t will be the contribution of the Flavour Industry to make them acceptable and enjoyable. Another aspect is the trend towards industrialized manufacture of fcmod. One of the nutritional problems of our day is the distribution of food. But to distribute food, including otherwise perishable foodstuffs, requires processing under adequate conditions and proper packaging in order to obtain good storage stability. These requirements are, no doubt, responsible for the fact that an increasingly larger share of our food is being manufactured b y industrial enterprises. To make food stabIe against microbiological, chemical or physical changes often requires rather drastic conditions, such as heat and rigid mechanical treatment. To expect that natural flavours, as supplied by nature, withstand these drastic conditions and that they always keep their flavouring properties over a period of months is certainly a n illusion. Natural flavours have t o be properly processed and then stabilized by the addition of suitable additives, such as antioxidants, in order t o obtain preparations suitable for some specific applications. But many times i t is found that better synthetic flavours may be used, which can be tailor made for a large number of applications. for which natural flavours normally fail for any reason, might it be a technological, a n economical or another one. The art of creating flavours by mixing a number of volatile chemicals is not new. What is new is t h a t we, nowadays, know much more about the composition of natural flavours. This knowledge enables the creative flavourist t o make flavours more similar t o the original than ever before and t o predict which flavour substances might exhibit an undesirable behaviour in the final food. Since there are hundreds of chemicals involved on the flavour side which may possibly interfere with another large amount of chemicals in the food, we still depend on empirical testing. Such extensive tests are preferably undertaken in collaboration with food manufacturers. A third reason for the need of flavours is an economical one. We have recently experienced the fact that large agricultural resources have been switched over from peppermint oil t o soya cultivation, thus giving rise t o an increasing shortage of mint oils. I n view of the importance of soya such a swing is very reasonable. Not as drastic is the situation with respect t o Italian lemon oil where we had t o cope with a price increase of more than 200% during the last 10years. The increasing shortage of natural raw materials will undoubtedly help t o improve the acceptance of synthetic flavours, which can be manufactured at low cost and which may be more suitable than natural flavours for a large number of applicati'ons. Nutritional, technological and economical considerations demand that the flavour industry continues its efforts to discover the composition of natural flavours, t o study the interactions of flavour and food constituents and t o develop more suitable, and hence better flavours for an ever increasing number of food preparations.
Safety of flavouring chemicals Flavours, like food, are complicated mixtures of chemicals. For all chemicals Paracelsus' statement is applicable: Sola dosis facit venenum (Only the dose makes a poison). It is the flavour industry's firm opinion, that the safety of flavouring substances - especially of nature-identical synthetic products - has t o be looked at in a different manner than that used for other food additives. This belief is based on the following reasons: I . Flavouring substances are normally used at levels below IOO ppm - in fact a n average level is about 10ppm in food - whereas several other categories of food additives are used at levels up t o IOOOOO ppm (e.g. stabilizers, emulsifiers, sweeteners etc.). 2. Some food additives are used because of their toxic effect on biological life, for example antimicrobials, fungicides etc. No flavouring substance is used for such reasons. 3. No other food additive is as self-limiting with respect to dosage as a flavouring substance due to its organoleptic properties. An erroneous overdosing automatically ma.kes food unpalatable.
255
Nutrition and flavour-legislation
Flavours are also added to food to provide variety. There is very little chance that one and the same flavouring substance will be consumed day after day for years. In other words the risk is once again minimized by the distribution over hundreds of different substances. Many categories of food additives exhibit chemical structures which have absolutely no relationship to the structure of normally ingested material. Most flavouring substances are either “already known” to the human metabolism (nature-identical flavouring substances) or they are homologues of naturally occumng products (ethyl vanillin, ethylmaltol and others). The chemical structures of flavouring substances are generally very simple. For nature-identical flavouring substances we possess long term experience which must certainly be rated higher than any rat feeding study. With respect to natural flavours, such as preparations obtained from edible food by extraction, percolation, concentration, distillation or similar physical procedures, there is no doubt that as long as they are manufactured from food, there are good reasons to assume that such preparations are safe. Some doubt has been cast on a few products such as tonka, calamus oil, sassafras oil and some others. These products are of rather small importance in relation to the whole group of natural flavours. Of course we must be critical enough to admit that some of these materials which are used as natural flavours are not exactly derived from edible food, and it goes without saying that, consequently, they will no longer be used. Except for those natural products of which we know that there is some doubt regarding their safety, the rest of this flavour class can be considered safe on the basis of long tern] human experience. What is true for a mixture of chemicals must logically apply for the single components, provided that they are not consumed in excessively high amounts. From a scientific point of view, there is no reason why natural material should be less toxic than artificial. To the contrary, it was nature which was always mankind’s most important enemy in the early ages. The term “nature-identical’’ might be a little confusing in this respect. But as soon as we define “nature-identical substances” as constituents of traditional food, i t is very logical to argue that this class of substances can be considered as innocuous. Not toaccept this argumentation means doubting the safety of food in general. This argument is the first and most important point why some European food laws, the Codex Alimentarius and IOFI distinguish between nature-identical and artificial flavour substances. For artificial, that is man-made, flavouring substances which are not known to be part of human food, long term human experience cannot be claimed; their safety must be proved by classical methods, for example feeding studies, metabolic studies etc. It can be predicted that artificial flavouring substances become less and less important in the future. Flavour research is being more and more directed towards the analytical approach. And in fact, what is more logical than to make synthetic flavours by imitating nature ? This trend and the results of our own research efforts lead to another observation: With the dramatic improvement of analytical equipment and methods, flavour research is quickiy entering the “ppm” and “ppb’ range of flavour constituents. It is certainly true, that the quantitywise dominating portions of natural flavours were identified long ago. New discoveries can only be expected in the submicro area. This statement is not a hypothetical one, it can be supported by looking at the average use levels of synthetic flavouring substances as published in FEMA’s GRAS list No 3, 4,5 and 6.These listings can be considered as being a broad summary of world-wide flavour research activities. Disregarding the natural flavours and food additives which make part of list No 3 and calculating the overall average maximum level of nature-identical and artificial chemicals in food, as given in the lists, the following result is obtained: fema list
No 3 No 4 No 5 No 6
number of chemicals
1
overall average maximum use level (ice cream) [ppml
-
650
10.67
77
7.92 5.65
35 49 (48Y
9.61(5.64)
One of the 49 substances listed in GRAS 6 is used a t rather high levels, resulting in an unduly large average.
256
SCHLEGEL
A trend towards smaller use levels can clearly be established. This fact is certainly a very important aspect for all those who are actively engaged in food and flavour legislation.
Food labelling The need for proper labelling of food is undoubted. Only the fact tbat different criteria for the labelling prescriptions are applied from one country to another, makes it difficult to put forward a harmonized proposition. I n any case labelling must never be misleading, it must be informative and it must be honest. Excessive loading of the label with a large number of terms which mean nothing to the layman might be as misleading as no declaration a t all. The labelling of added flavours should be restricted to those cases where it becomes necessary in order t o avoid deception. This is particularly the case when the addition of flavours t o food ips0 facto could result in deception. In conclusion IOFI proposes the fo1:lowing criteria for flavour labelling: - t o use generic terms, such as natural flavour, (natufe-identical) flavour or artificial flavour; - t o omit flavour labelling where the added flavour is automatically a part of the food; . - t o declare added flavour where the lack of declaration would tend to deceive because the addition of flavours is not expected by the consumer; - t o declare always the addition of artificial flavouring substances.
Flavour legislation Since many years IOFI has proposed a differentiation between nature-identical synthetic and artificial flavouring substances. The exact definition of both terms is given below. This differentiation already exists in the legislation of Italy and the Federal Republic of Germany and i t has been consistently used by the Codex Alimentarius Committees. IOFI realizes that the splitting of man-made flavouring substances into two categories sounds strange, especially for those ears which are adjusted to the US practice. It seems necessary to outline again why such a differentiation is felt to be practical and justified, because we suspect t h a t our proposition was not always correctly understood in the past. - Nature-identical flavouring substances are identical with the naturally occurring substances, hence they f i t into food in a physiological manner. Artificials do not. - For practical analytical purposes no distinction can be made between an added nature-identical substance and the naturally occurring product. Artificials can easily be detected. - A listing of nature-identical substances will never be complete due t o our growing amount of knowledge. The number of these items is not limited. The number of artificials can be limited by regulations. They can easily be listed, and their addition t o food can be detected and controlled. - -4last, not unimportant point, which favours the proposed distinct:ion between the two classes, is t h a t we should not discourage our research t o look deeper into the nature of our food. If artificials and nature-identical flavouring substances would be equal in the eyes of the law, scientists would hardly be encouraged to further investigate our natural environment. The flavour industry and JOFI believe that these are very solid reasons t o adopt the difference between the two classes of man-made flavouring substances, a differentiation which facilitates the regulation of the use of flavours in food as well as the labelling, and last, but not least, the control of such amendments. I O F I has proposed the following:
“Suggested model flnvour regulation” “In view of the foregoing, i t is appropriate to suggest those key features which lead t o a n equitable and effective regulation for flavourings. For historical and linguistic reasons, uniform wording seems not appropriate in different countries, but the basic principles should be universalIy applicable.
Avticle I-Definitions I. Flavourings are concentrated preparations, with or without solvents or carriers, used exclusively t o impart flavour. They are not intended t o be consumed as such.
Kutrition and flavour-legislation 2.
257
Flavourings may contain the following flavouring ingredients: a ) Aromatic raw materials: vegetable or animal products used for their Ilavourinc: properties, cither as such or processed for human consumption. b) Natural flavours: concentrated preparations obtained exclu.;ively 1)s physical methods from aromatic raw materials. c) Natural flavouring substances : substanccs isolated from aromatic raw materials exclilsivc3lp b y physical methods. d ) Tature-identical flavouring substances: substances obtained by synthesis 01- isolated through chemical processes from aromatic raw materials and chemically identical to substances present 111 natural products intended for human consuinption, either proce.;sed or not e) .\rtificial flavouring substances: substances not yet identified in a natural product intended for human consumption, either processed or not.
A itlcLr 1 I-. I pprovul I.
2.
Aromatic raw materials, natural flavoiirs, natural flavouring substances. nature-identical flavouring substances are permitted t o be used in food for human consumption, provided t h a t : a ) they comply with the restrictions which are set forth in a restricted list (set lOFI list for the restriction of natural and nature-identical flavouring substances) and b) that the authorities niay obtain confidentially from industry, on request, available information on these products and substances. .irtificial flavouring substances may be used in foods oiily if they are listed in a positive list (see IOFI list of artificial flavouring substanccs).
.4 y t i c l r I I I-labelling
1;ootl to which flavouring has been added shall be appropriately labelled where such labelling is nc'cessary to prevcnt deception of the consumer. Flavourings shall be labelled so as to pertnit the food manufacturer t o observe the requirements for correct labcl declaration imposed on him. .1rticle 1 l'-Superuision .\ Commission, composed of experts qualified by training and experience t o evaluate the safety of flavours i n food, shall have the responsibility of dealing with a11 qiiestkiis pertaining t o the evaluation of the safety of flavourings in food, and of making additions t o or deletions from the lists. The lOFl proposition is based on a pre-judgcment deri\.ed from both toxicological findings and human experience over the years in the use of foodstuffs and food flavours. I t allows, in principle, both natural flavouring substances and nature-identical flavouring iubstances. I t Loncentratcs regulatory and technical attention where necessary i n order t o restrict natural flavouring substanccs or permit artificial flavouring substances as, in each case. the current state of scientific knowledge permits. 'The data on which this pre-judgement of natural and nature-identical flavouring substances is based is extensive. Esscntially all major constituents of flavours are known and have been and will continue t o be critically evaluated. This is clone through national health authorities, by scientists of different disciplines and by consideration of the large volume of literature gathered 1)s different organizations both national and international, private and public. There are, of course, in food some natural flavouring substances which, in the interest of public hcalth. should not be used. The flavour industry should not and -11 not use such substances or, where tolerances are both safe and practical, should use them only at levels approved by the appropriate health authorities. Natural flavouring substances can then be placed on a restricted list. Substances are normally not intentionally added a t levels or in total amounts greatly higher than the range of natural occurrence in the diet. In cases where levels are in excess, the substances can be p u t on the restricted list, if for toxicological reasons a limitation seems to be necessary. However in most cases this limit would be considerably higher than the technologicallv useful level and since the self-limiting properties of flavouring substances prevent from an overdosage. it IS not necessary t o mention all these substances on the restricted list. A s discussed, research now and in the future will also be concerned with flavouring materials not yet found in nature but which will be of great significance for improving the qualities of flavourings. I t is obvious that such substances must be subjected t o appropriate evaluation for safety. They
258
SCHLEGEL
should be permitted only on the basis of adequate assurance of safety in use and should then be placed on a positive list. I t is clear, that the lists (restricted list, positive list) have t o be modified t o correspond to the current state of scientific knowledge. If for example a substance on the positive list is found to occur naturally in a food, then such a substance should be removed from the positive list and thereafter treated as nature-identical. If for this substance it restriction is necessairy in the interest of safety then it should be placed on a restricted list. As explained above, since these restricted and positive lists are enforceable, they ensure the workability of the principle of prejudgement, not only in theory, but also in practice. The number of substances mentioned on these lists is limited and their properties are known. The analytical methods for their determination are available, or where necessary can be developed without difficulty. The limited volume of the lists does not overburden the attention of the enforcing authorities and enforcement can be accomplished with reasonable personnel and financial effort. Zusammenfassung W. SCHLEGEL: Ernahrung und Flavour-Gesetzgcbung Unsere Lebensmittelgesetze mussen zwei Anforderungen genugen : Sie mussen die Unschadlichkcit der Lebensmittel sicherstellen und dafiir sorgen, daB die Konsumentcn nicht iiber die Zusammensetzung dcr Lebensmittel getiiuscht werden. Unsere Lebensmittel konnen ohnc Zusatzstoffe und insbesondere ohne Aromen nicht rnehr auskommen. Physiologischt-: Griinde sprechen fur eine im Geschmack moglichst abwechslungsreiche Diat ; eine immcr gr6Ser werdende Zahl von Lebensmitteln hat von Natur aus gar keinen Geschmack und bedarf deshalb der Aromatisicrung, und die industrielle Herstellung unserer Lebensmittel bedingt, daB die geschmacksgebenden Zubereitungen so formuliert werden milssen, daB sie den durch die verschiedensten Herstellungsverfahren diktierten Beanspruchungen standhalten. Die Unschadlichkeit der heute verwendcten Aromen und Aromastoffe wird diskutiert. Insbesondere m r d aufgezeigt, daI3 den ,,naturidentischen" Aromastoffen sowohl hinsichtlich Unschadlichkeit als auch aus praktischen Grunden der Kontrolle eine Sonderstellung cingeraumt werden mu& Fur die Warendeklaration werden Empfehlungen unterbreitet, die eine 'rauschung der Verbraucher weitgehend ausschalten. Die Modell-Vorschlage der IOFI (International Organization of the Flavour Industry) zeigen einen Weg zur internationalen Harmonisierung der nationalen Regelungen iiber die Verwendung von Aromen.
B. IUJIerenb:
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3aKOHOHaTeJlbCTBO rAP B O ~ J I ~ C T HIIHILleBbIX IIpOHyKTOB aOJIH.(RO yHOBnt?TBOp!RTb BBYM T p e 6 0 B a H A R M : OH0 AOJIEUIO 0 6 e C n e u H B a T b 6 e 3 B p e n H O C T b I l H u e B b I X IIPOAYHTOB kl Y C T p a H R T b B03MOlfEHOCTb BBejTeHMH B 3a6nywne~menOTpe6EITe~1fd B OTHOlIleHHH COCTaBa n n u e B u x n p o n y ~ ~ Hamn o ~ . n u u e ~ b ~I Ie~ O H ~ K T Hy H t e H ~ J I ~n p~e Ra c T a s m b ce6e 6e3 CIIeUEIfi, B OCO6eHHOCTH 6e3 apOMaTH3kipyIoILlliX B e m e C T B . @H3UOJlOrH¶eCKHe OCHOBaHHfl no B BKYCY RHeTLI TIIHTBHEIFI. T a K y W i 3 b I B a I o T Ha HeO6XOAHMOCTb BO3MOWHO p a 3 ~ 0 0 6 p a 3 ~ o I i a K B c e y B e m i w B a w q e e c I i ~ H C J I Onuwemix ~ P O Q J K T O B He m e e f C a M o c T o R T e n L H o r o B K y c a , TO OHO H y s n a e T c c r B a p o ~ a ~ m a uC~npyron n. CTOPOHH, n p o M H m n e m o e n p o ~ a BOHCTBO H a I U H X IIHrrIeBblX IIPOHYKTOB 06ycna~nti6ae~ 0 ~ 6 a0P O~M a T Y I 3 E i P Y I o ~ H Xnpn6aBOK C TaKHM paC¶eTOM, s ~ o 6 OHEl n OKa3bIBaJIEICb YCTOftWiBhIMH I l p H pa3JIHYHbIXBO3nefiCTBHAX, COnPOBOWBaIOJlIMX MeTOAbI IlPOH3BOnCTBa. B C T a T b e paCCMaTpEIBaeCTCS3 BOTIPOC 0 6 e 3 B p e B H O C T b I l p H i W H R e M b I X B HaCTOXJlIee B p e M I I a p O M a T O B H a p O M a T H 3 U p y I o 4 H X BeWeCTB. B ¶aCTHOCTki nOHa3hlBaeTCl3, ¶TO RMCiTHPYIoI4He I I p H p O R H b I e a p O M a T b I B e m e C T B a HOJIHtHbI 3 a H U M a T b oco6oe MeCTO K P K B OTHOlIleHHEI6e3BpeA~OCTU,TBH EI IIPaHTHYeCKOI'O IEOHTPOJIR. A J I R A e K J I a p a U H H IIkiUeBbIX n p o n y w r o B npennaramcx p e ~ o ~ e ~ ~ a BuO u BM n O, ~ E H Om ~ p o x oM c K n m ¶ a m u H e 3a6nymH e H m co CTOPOH~I no~pe6H~enei. MonenbHbIe npeanomeHus IOFI y~a3b1sam~ nyTa wexnyyHapomoro C o r n a c o B a H H c r aaunonanmbIx s a ~ o ~ o n a ~ e Bn Ob ~cJ ~I ~~C TnHp m e H e HllR apOMaTOB.
Dr. W. SCHLEGEL, Givaudan Ltd. Diibendorf, 8600 Dtibendorf iiber Ziirich, Schweiz Eingegangen 21.7.1975
DieNahrung
I
20
I
3
I 1976 I,
253-2258
I
Givaudan Diibendorf Ltd, Diibendorf, Schweiz
Nutrition and Flavour-Legislation W. SCHLEGEL
Our food laws have to provide for safety of food and to ensure that the consumer is not misled. We are no longer in a position to manufacture food without additives and especially without flavours. For physiological reasons, our food should be offered in a wide variety; an increasing number of food preparations has no natural flavour a t all and needs to be flavoured and the industrial manufacture of food requires the flavours to be properly developed in order t o withstand the sometimes rather drastic conditions of manufacture. The safety of flavours and flavouring substances is discussed. It is shown that the class of nature-identical flavouring substances has to be treated separately for practical purposes of food control and because the substances of this group offer more certainty with regard to their safety. Somesuggestions are made regarding the proper labelling of food which contains flavours. The IOFI (International Organization of the Flavour Industry) model law is discussed which should serve as a basic proposal for the international harmonisation of national food laws. The consumer of today acts very suspiciously towards all kind of food additives. Like all mass phenomena this feeling is not a t a11 a logical one; it is rather an emotion. On the other hand food technologists and scientists are aware of the fact that satisfactory nutrition for the world’s population cannot be attained without food additives. Obviously there is an information gap which has to be bridged. This bridging cannot be accomplished by food laws alone, it also needs our, the industry’s active contribution. There are two basic reasons why the consumer behaves as he does: The consumer is afraid of possible intoxication and he objects t o spending his money for something which is not what i t pretends t o be. And without any doubt he is fully entitled t o demand that his food is wholesome and safe and to know what he really gets. It is the objective of the food laws to guarantee safe food and to provide for proper labelling of it. In view of severe differences between US regulations and European food laws I would like t o cast some thoughts along these lines with special consideration to flavours and flavour legislation? The International Organization of the Flavour Industry (IOFI)’ has developed a certain philosophy towards the problems of safety, labelling and legislation.
Why do we need flavours ? Apart from the fact that flavour and taste-imparting preparations have been used for ages in food, there are more reasons indicating that the Flavour Industry will contribute considerably to overcome the nutritional problems of the world’s population. IOFI was founded in 1969under Belgian law. The objectives of this organization are: I, to establish and collect scientific data regarding flavouring substances, mainly concerning their safety, 2 . to collect and observe national and international reglementations for the use of flavours, 3. to distribute relevant information to member associations and to other international organizations IOFl’s members are national associations related to the flavour trade. At present IOFI counts 15 member countries. 18.
264
SCHLEGEL
Physiologists know t h a t not only fat, carbohydrates, proteins, vitamins and trace elements are essential constituents of food, but that food must also be appealing in taste and be available in a wide variety of textures and flavours in order t o be enjoyable and digestible. Today there exist already many food preparations which would not be consumed if no flavour had been added; for example, all kinds of desserts, ice cream, soft drinks and sweets. It is very likely that this collection will become larger in the future. As the possibility of stabilizing the growth-rate of our population is extremely remote, we have t o look for new, so far untapped, food sources and shall depend on them whether we like i t or not. I n this context the efforts to utilize soya, alfalfa, groundnuts, oil, coal, algae and fish for the industrial manufacture of human food must be mentioned. Such food preparations will be more or less tasteless and i t will be the contribution of the Flavour Industry to make them acceptable and enjoyable. Another aspect is the trend towards industrialized manufacture of fcmod. One of the nutritional problems of our day is the distribution of food. But to distribute food, including otherwise perishable foodstuffs, requires processing under adequate conditions and proper packaging in order to obtain good storage stability. These requirements are, no doubt, responsible for the fact that an increasingly larger share of our food is being manufactured b y industrial enterprises. To make food stabIe against microbiological, chemical or physical changes often requires rather drastic conditions, such as heat and rigid mechanical treatment. To expect that natural flavours, as supplied by nature, withstand these drastic conditions and that they always keep their flavouring properties over a period of months is certainly a n illusion. Natural flavours have t o be properly processed and then stabilized by the addition of suitable additives, such as antioxidants, in order t o obtain preparations suitable for some specific applications. But many times i t is found that better synthetic flavours may be used, which can be tailor made for a large number of applications. for which natural flavours normally fail for any reason, might it be a technological, a n economical or another one. The art of creating flavours by mixing a number of volatile chemicals is not new. What is new is t h a t we, nowadays, know much more about the composition of natural flavours. This knowledge enables the creative flavourist t o make flavours more similar t o the original than ever before and t o predict which flavour substances might exhibit an undesirable behaviour in the final food. Since there are hundreds of chemicals involved on the flavour side which may possibly interfere with another large amount of chemicals in the food, we still depend on empirical testing. Such extensive tests are preferably undertaken in collaboration with food manufacturers. A third reason for the need of flavours is an economical one. We have recently experienced the fact that large agricultural resources have been switched over from peppermint oil t o soya cultivation, thus giving rise t o an increasing shortage of mint oils. I n view of the importance of soya such a swing is very reasonable. Not as drastic is the situation with respect t o Italian lemon oil where we had t o cope with a price increase of more than 200% during the last 10years. The increasing shortage of natural raw materials will undoubtedly help t o improve the acceptance of synthetic flavours, which can be manufactured at low cost and which may be more suitable than natural flavours for a large number of applicati'ons. Nutritional, technological and economical considerations demand that the flavour industry continues its efforts to discover the composition of natural flavours, t o study the interactions of flavour and food constituents and t o develop more suitable, and hence better flavours for an ever increasing number of food preparations.
Safety of flavouring chemicals Flavours, like food, are complicated mixtures of chemicals. For all chemicals Paracelsus' statement is applicable: Sola dosis facit venenum (Only the dose makes a poison). It is the flavour industry's firm opinion, that the safety of flavouring substances - especially of nature-identical synthetic products - has t o be looked at in a different manner than that used for other food additives. This belief is based on the following reasons: I . Flavouring substances are normally used at levels below IOO ppm - in fact a n average level is about 10ppm in food - whereas several other categories of food additives are used at levels up t o IOOOOO ppm (e.g. stabilizers, emulsifiers, sweeteners etc.). 2. Some food additives are used because of their toxic effect on biological life, for example antimicrobials, fungicides etc. No flavouring substance is used for such reasons. 3. No other food additive is as self-limiting with respect to dosage as a flavouring substance due to its organoleptic properties. An erroneous overdosing automatically ma.kes food unpalatable.
255
Nutrition and flavour-legislation
Flavours are also added to food to provide variety. There is very little chance that one and the same flavouring substance will be consumed day after day for years. In other words the risk is once again minimized by the distribution over hundreds of different substances. Many categories of food additives exhibit chemical structures which have absolutely no relationship to the structure of normally ingested material. Most flavouring substances are either “already known” to the human metabolism (nature-identical flavouring substances) or they are homologues of naturally occumng products (ethyl vanillin, ethylmaltol and others). The chemical structures of flavouring substances are generally very simple. For nature-identical flavouring substances we possess long term experience which must certainly be rated higher than any rat feeding study. With respect to natural flavours, such as preparations obtained from edible food by extraction, percolation, concentration, distillation or similar physical procedures, there is no doubt that as long as they are manufactured from food, there are good reasons to assume that such preparations are safe. Some doubt has been cast on a few products such as tonka, calamus oil, sassafras oil and some others. These products are of rather small importance in relation to the whole group of natural flavours. Of course we must be critical enough to admit that some of these materials which are used as natural flavours are not exactly derived from edible food, and it goes without saying that, consequently, they will no longer be used. Except for those natural products of which we know that there is some doubt regarding their safety, the rest of this flavour class can be considered safe on the basis of long tern] human experience. What is true for a mixture of chemicals must logically apply for the single components, provided that they are not consumed in excessively high amounts. From a scientific point of view, there is no reason why natural material should be less toxic than artificial. To the contrary, it was nature which was always mankind’s most important enemy in the early ages. The term “nature-identical’’ might be a little confusing in this respect. But as soon as we define “nature-identical substances” as constituents of traditional food, i t is very logical to argue that this class of substances can be considered as innocuous. Not toaccept this argumentation means doubting the safety of food in general. This argument is the first and most important point why some European food laws, the Codex Alimentarius and IOFI distinguish between nature-identical and artificial flavour substances. For artificial, that is man-made, flavouring substances which are not known to be part of human food, long term human experience cannot be claimed; their safety must be proved by classical methods, for example feeding studies, metabolic studies etc. It can be predicted that artificial flavouring substances become less and less important in the future. Flavour research is being more and more directed towards the analytical approach. And in fact, what is more logical than to make synthetic flavours by imitating nature ? This trend and the results of our own research efforts lead to another observation: With the dramatic improvement of analytical equipment and methods, flavour research is quickiy entering the “ppm” and “ppb’ range of flavour constituents. It is certainly true, that the quantitywise dominating portions of natural flavours were identified long ago. New discoveries can only be expected in the submicro area. This statement is not a hypothetical one, it can be supported by looking at the average use levels of synthetic flavouring substances as published in FEMA’s GRAS list No 3, 4,5 and 6.These listings can be considered as being a broad summary of world-wide flavour research activities. Disregarding the natural flavours and food additives which make part of list No 3 and calculating the overall average maximum level of nature-identical and artificial chemicals in food, as given in the lists, the following result is obtained: fema list
No 3 No 4 No 5 No 6
number of chemicals
1
overall average maximum use level (ice cream) [ppml
-
650
10.67
77
7.92 5.65
35 49 (48Y
9.61(5.64)
One of the 49 substances listed in GRAS 6 is used a t rather high levels, resulting in an unduly large average.
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A trend towards smaller use levels can clearly be established. This fact is certainly a very important aspect for all those who are actively engaged in food and flavour legislation.
Food labelling The need for proper labelling of food is undoubted. Only the fact tbat different criteria for the labelling prescriptions are applied from one country to another, makes it difficult to put forward a harmonized proposition. I n any case labelling must never be misleading, it must be informative and it must be honest. Excessive loading of the label with a large number of terms which mean nothing to the layman might be as misleading as no declaration a t all. The labelling of added flavours should be restricted to those cases where it becomes necessary in order t o avoid deception. This is particularly the case when the addition of flavours t o food ips0 facto could result in deception. In conclusion IOFI proposes the fo1:lowing criteria for flavour labelling: - t o use generic terms, such as natural flavour, (natufe-identical) flavour or artificial flavour; - t o omit flavour labelling where the added flavour is automatically a part of the food; . - t o declare added flavour where the lack of declaration would tend to deceive because the addition of flavours is not expected by the consumer; - t o declare always the addition of artificial flavouring substances.
Flavour legislation Since many years IOFI has proposed a differentiation between nature-identical synthetic and artificial flavouring substances. The exact definition of both terms is given below. This differentiation already exists in the legislation of Italy and the Federal Republic of Germany and i t has been consistently used by the Codex Alimentarius Committees. IOFI realizes that the splitting of man-made flavouring substances into two categories sounds strange, especially for those ears which are adjusted to the US practice. It seems necessary to outline again why such a differentiation is felt to be practical and justified, because we suspect t h a t our proposition was not always correctly understood in the past. - Nature-identical flavouring substances are identical with the naturally occurring substances, hence they f i t into food in a physiological manner. Artificials do not. - For practical analytical purposes no distinction can be made between an added nature-identical substance and the naturally occurring product. Artificials can easily be detected. - A listing of nature-identical substances will never be complete due t o our growing amount of knowledge. The number of these items is not limited. The number of artificials can be limited by regulations. They can easily be listed, and their addition t o food can be detected and controlled. - -4last, not unimportant point, which favours the proposed distinct:ion between the two classes, is t h a t we should not discourage our research t o look deeper into the nature of our food. If artificials and nature-identical flavouring substances would be equal in the eyes of the law, scientists would hardly be encouraged to further investigate our natural environment. The flavour industry and JOFI believe that these are very solid reasons t o adopt the difference between the two classes of man-made flavouring substances, a differentiation which facilitates the regulation of the use of flavours in food as well as the labelling, and last, but not least, the control of such amendments. I O F I has proposed the following:
“Suggested model flnvour regulation” “In view of the foregoing, i t is appropriate to suggest those key features which lead t o a n equitable and effective regulation for flavourings. For historical and linguistic reasons, uniform wording seems not appropriate in different countries, but the basic principles should be universalIy applicable.
Avticle I-Definitions I. Flavourings are concentrated preparations, with or without solvents or carriers, used exclusively t o impart flavour. They are not intended t o be consumed as such.
Kutrition and flavour-legislation 2.
257
Flavourings may contain the following flavouring ingredients: a ) Aromatic raw materials: vegetable or animal products used for their Ilavourinc: properties, cither as such or processed for human consumption. b) Natural flavours: concentrated preparations obtained exclu.;ively 1)s physical methods from aromatic raw materials. c) Natural flavouring substances : substanccs isolated from aromatic raw materials exclilsivc3lp b y physical methods. d ) Tature-identical flavouring substances: substances obtained by synthesis 01- isolated through chemical processes from aromatic raw materials and chemically identical to substances present 111 natural products intended for human consuinption, either proce.;sed or not e) .\rtificial flavouring substances: substances not yet identified in a natural product intended for human consumption, either processed or not.
A itlcLr 1 I-. I pprovul I.
2.
Aromatic raw materials, natural flavoiirs, natural flavouring substances. nature-identical flavouring substances are permitted t o be used in food for human consumption, provided t h a t : a ) they comply with the restrictions which are set forth in a restricted list (set lOFI list for the restriction of natural and nature-identical flavouring substances) and b) that the authorities niay obtain confidentially from industry, on request, available information on these products and substances. .irtificial flavouring substances may be used in foods oiily if they are listed in a positive list (see IOFI list of artificial flavouring substanccs).
.4 y t i c l r I I I-labelling
1;ootl to which flavouring has been added shall be appropriately labelled where such labelling is nc'cessary to prevcnt deception of the consumer. Flavourings shall be labelled so as to pertnit the food manufacturer t o observe the requirements for correct labcl declaration imposed on him. .1rticle 1 l'-Superuision .\ Commission, composed of experts qualified by training and experience t o evaluate the safety of flavours i n food, shall have the responsibility of dealing with a11 qiiestkiis pertaining t o the evaluation of the safety of flavourings in food, and of making additions t o or deletions from the lists. The lOFl proposition is based on a pre-judgcment deri\.ed from both toxicological findings and human experience over the years in the use of foodstuffs and food flavours. I t allows, in principle, both natural flavouring substances and nature-identical flavouring iubstances. I t Loncentratcs regulatory and technical attention where necessary i n order t o restrict natural flavouring substanccs or permit artificial flavouring substances as, in each case. the current state of scientific knowledge permits. 'The data on which this pre-judgement of natural and nature-identical flavouring substances is based is extensive. Esscntially all major constituents of flavours are known and have been and will continue t o be critically evaluated. This is clone through national health authorities, by scientists of different disciplines and by consideration of the large volume of literature gathered 1)s different organizations both national and international, private and public. There are, of course, in food some natural flavouring substances which, in the interest of public hcalth. should not be used. The flavour industry should not and -11 not use such substances or, where tolerances are both safe and practical, should use them only at levels approved by the appropriate health authorities. Natural flavouring substances can then be placed on a restricted list. Substances are normally not intentionally added a t levels or in total amounts greatly higher than the range of natural occurrence in the diet. In cases where levels are in excess, the substances can be p u t on the restricted list, if for toxicological reasons a limitation seems to be necessary. However in most cases this limit would be considerably higher than the technologicallv useful level and since the self-limiting properties of flavouring substances prevent from an overdosage. it IS not necessary t o mention all these substances on the restricted list. A s discussed, research now and in the future will also be concerned with flavouring materials not yet found in nature but which will be of great significance for improving the qualities of flavourings. I t is obvious that such substances must be subjected t o appropriate evaluation for safety. They
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SCHLEGEL
should be permitted only on the basis of adequate assurance of safety in use and should then be placed on a positive list. I t is clear, that the lists (restricted list, positive list) have t o be modified t o correspond to the current state of scientific knowledge. If for example a substance on the positive list is found to occur naturally in a food, then such a substance should be removed from the positive list and thereafter treated as nature-identical. If for this substance it restriction is necessairy in the interest of safety then it should be placed on a restricted list. As explained above, since these restricted and positive lists are enforceable, they ensure the workability of the principle of prejudgement, not only in theory, but also in practice. The number of substances mentioned on these lists is limited and their properties are known. The analytical methods for their determination are available, or where necessary can be developed without difficulty. The limited volume of the lists does not overburden the attention of the enforcing authorities and enforcement can be accomplished with reasonable personnel and financial effort. Zusammenfassung W. SCHLEGEL: Ernahrung und Flavour-Gesetzgcbung Unsere Lebensmittelgesetze mussen zwei Anforderungen genugen : Sie mussen die Unschadlichkcit der Lebensmittel sicherstellen und dafiir sorgen, daB die Konsumentcn nicht iiber die Zusammensetzung dcr Lebensmittel getiiuscht werden. Unsere Lebensmittel konnen ohnc Zusatzstoffe und insbesondere ohne Aromen nicht rnehr auskommen. Physiologischt-: Griinde sprechen fur eine im Geschmack moglichst abwechslungsreiche Diat ; eine immcr gr6Ser werdende Zahl von Lebensmitteln hat von Natur aus gar keinen Geschmack und bedarf deshalb der Aromatisicrung, und die industrielle Herstellung unserer Lebensmittel bedingt, daB die geschmacksgebenden Zubereitungen so formuliert werden milssen, daB sie den durch die verschiedensten Herstellungsverfahren diktierten Beanspruchungen standhalten. Die Unschadlichkeit der heute verwendcten Aromen und Aromastoffe wird diskutiert. Insbesondere m r d aufgezeigt, daI3 den ,,naturidentischen" Aromastoffen sowohl hinsichtlich Unschadlichkeit als auch aus praktischen Grunden der Kontrolle eine Sonderstellung cingeraumt werden mu& Fur die Warendeklaration werden Empfehlungen unterbreitet, die eine 'rauschung der Verbraucher weitgehend ausschalten. Die Modell-Vorschlage der IOFI (International Organization of the Flavour Industry) zeigen einen Weg zur internationalen Harmonisierung der nationalen Regelungen iiber die Verwendung von Aromen.
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Dr. W. SCHLEGEL, Givaudan Ltd. Diibendorf, 8600 Dtibendorf iiber Ziirich, Schweiz Eingegangen 21.7.1975
