Food Additives & Contaminants

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Food additives intake M. Fondu To cite this article: M. Fondu (1992) Food additives intake, Food Additives & Contaminants, 9:5, 535-539, DOI: 10.1080/02652039209374107 To link to this article: http://dx.doi.org/10.1080/02652039209374107

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FOOD ADDITIVES AND CONTAMINANTS, 1992, VOL. 9, NO. 5, 5 3 5 - 5 3 9

Food additives intake M. FONDU Food Law Research Center, Institute of European Studies, Free University of Brussels, Brussels, Belgium The role of intake studies in the safety assurance process is discussed with reference to food preservatives and related to the variations in the authorizations for use.

Food Additives & Contaminants 1992.9:535-539.

Keywords: food additives, intake

The first question which has to be raised and answered when speaking on intake studies for additives is: Are studies needed, especially for those additives which have received an Acceptable Daily Intake (ADI)? This is not an absurd question. Indeed, although the ADI concept is used in most of the European countries as a basic tool for the elaboration of food additive regulations, very few countries have built up a structure for those evaluations. Does this mean that these studies are not needed? That people having within their responsibilities the protection of the health of the consumers have only understood a part of the philosophy which lies behind the ADI concept, or that they have not received the means to start such studies? To try to answer this question, we have to go back to the definition of the ADI. The A.D.I, is defined as an estimate of the amount of a food additive, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk. (WHO 1987) In order to evaluate the risk, if any, a comparison has to be made between the ADI and the potential amount ingested. Does this potential amount represent 20% or 200% of the ADI? The elaboration of an ADI for an additive is followed by the authorization for use of this additive in different foodstuffs. It should be follwed by an evaluation, if even a rough one, of the potential intake. If not, it resembles someone who starts to build a house and stops after having made the basement. But the intake value does not need to be obtained from peaks of ingestion, like those peaks which can be found in the 95 percentiles of a 24-h recall study. The ADI is not related to an intake of a few days or even a few months. It is related to the daily intake over a lifetime. This means that we have to take into consideration the personal variation of the ingestions for the people who are regular eaters of those foodstuffs which contain the additive. A good example of this can be found with the intake of soft drinks. If we calculate the mean intake of the whole population for soft drinks, we obtain a daily, per capita intake of about 150 ml/day. This figure of 150 ml is, in fact, the mean between two groups of the population; those who almost never use soft drinks and those who are regular 0265-203X/92 $3.00 © 1992 Taylor & Francis Ltd.

536

M. Fondu Table 1. The level of intake and the type of authorization. —Type of Foodstuffs —Level of Authorizations ex: 300 mg Benzoic acid/litre -»180 mg Benzoic acid/day in a soft drink (600 ml/day mean intake of consumers of soft drinks) 180 mg = 2/3 ADI for 60 kg bw (ADI = 60 x 5 = 300 mg/day) Reference: Codex Committee Food Additives

Food Additives & Contaminants 1992.9:535-539.

(1984).

drinkers. When considering the consumers only (in this case those who regularly drink this type of beverage), an intake value of 600 ml/day, based on a two week time period, is obtained. The level of intake is also closely related to the type of authorization. When looking at the intake of an additive, three questions have to be raised: —is the additive authorized in a large number of foodstuffs or in a restricted number? —are those foodstuffs ingested in rather large amounts; grams a day, like mustard, or a few hundred grams a day, like bread, or an even greater amount as in the case of soft drinks? —is the level of authorized use a question of a few ppm or a few thousand ppm and, closely related to this point, is the additive really used in all the foodstuffs where it is authorized and is it used at the maximum foreseen level, knowing that very often the industry tries to get higher levels than those really needed? In a number of cases, complex and precise evaluations are not needed. Table 1 gives an example of an approximation study. The first and easiest part of the task consists of looking at the authorizations for use and, with regard to preservatives, looking at those which are authorized only in some types of foodstuffs (tables 2-4). Looking at these tables we can say that sulphur dioxide, having a rather low ADI and being widely used, is a first priority, followed directly by benzoic acid and salts. Nitrates also need to be considered. They are present in large amounts as contaminants in some types of

Table 2. Preservatives with wide authorization. Preservative Benzoic acid + Ca, K, Na p OH benzoic acid esters methyl') ethyl I + Na propyl) Sorbic acid + Ca, K SO2 and sulphites

ADI (JECFA) (mg/kg body weight/day)

0-70

(17-27) (17)

0-25 0-0-7

(17) (30)

0-5

Food additives intake

537

Table 3. Specific authorizations for use of preservatives. Preservative

Authorized use

Propionic acid + Ca, K, 1Na Formic acid + Na, Ca Boric acid + Na Dimethylcarbonate Nitrates Nitrites Nisin

Some breads Ketchup, salads Caviar Soft drinks ^Contaminants j Cheese (^Meat products 'Cheese'

ADI (JECFA) (mg/kg body weight/day) Not limited

(17) (17)

0-3

No ADI allocated GMP up to 250mg/l 0-5

0-0-2

(37) (17) (20) (12)

O-33OOO Units

JECFA report.

Food Additives & Contaminants 1992.9:535-539.

Table 4. Preservatives authorized for surface treatment. ADI (JECFA) (mg/kg body weight/day)

Preservative Natamycin Diphenyl o-Phenylphenol + Na Thiabendazole

Dried, cured sausages; hard cheese Some fruit Some fruit Some fruit

0-0-3

(20)

0-0-05 0-0-2 —

(8) (8)

vegetables (e.g. salads, carrots, spinach, cabbage). The point here is to know the risk of reduction of nitrates to nitrites and where this reduction can occur. When looking at the intake of additives, we must not forget that within a short period of time (1 January 1993, in theory) we will have a Common Market harmonization for the specific authorization of food additives. Table 5 gives the authorization for benzoic acid and salts in France and Belgium and presents the results of a discussion paper for possible EC harmonization for other additives. This discussion paper has probably already been modified but it gives a trend of what type of harmonization could be proposed. When looking at this table, the following comments have to be made: —It is difficult to calculate the intake of an additive when many additives are authorized in the same foodstuff and for the same reason (preservative). In some countries, due to its higher ADI, sorbic acid is authorized in more foodstuffs than benzoic acid. When both acids are authorized in the same foodstuff, the easiest approach is to consider that benzoic acid is the only one which is used. With this hypothesis, if the theoretical Maximum Daily Intake (see tables 2 and 6) remains below the ADI, one can consider that, taking into account the overestimation used, the actual intake will remain well below the ADI. However, if the intake figure lies above the ADI, then information has to be gained with regard to the type of acid and the levels used in the different foodstuffs. —Taking into account different production techniques, different climates, and other basic approaches for the authorizations, it is quite normal to see that the Commission documents will propose authorizing the additives in more foodstuffs

M. Fondu

538

Table 5. Authorizations of benzoic acid and salts: level of use (mg/kg) and authorized commodity.

Foodstuffs Non-alcoholic drinks Water based flavoured Fruit juice-based Dairy-based Alcohol-free wine Alcoholic drinks Fish Crustaceans, fresh, frozen Semi-preserves

France

Belgium

160, sodas

100 100

200") Ba + 200 Sa+ 200J 200 PHB

300, Cider (8000, shrimp) 1000, fish roe 2000, shrimp

(8000, fish roe) (1000, semi-preserves)

Fruit Jams, jellies, marmalade

Food Additives & Contaminants 1992.9:535-539.

EC in discussion

1000") Ba + 3000

400")

Sa + PHB

Ba +

Sa+ PHB Vegetables Sour vegetable preserves

2000, red beets

300, onions, gherkins, red beets

Confectionery Sugar, sugar-free Cocoa, non-dairy, fat, starch Fillings or creams for nut or fat-based sandwich spreads Others Emulsified sauces Non-emulsified sauces Mayonnaise Mustard

400~) Ba +

Sa + PHB 1000")

Ba + 1000J Sa + 2000 PHB 2000 1000 1000 250

Table 6. Definitions of terms. Theoretical maximum daily intake (TMDI) Obtained by taking the average per capita daily food consumption for each food and multiplying it be the legal maximum use level of the additive and then summing these figures. Estimated daily intake (EDA) Amount of an additive ingested by the average consumer based on: —the actual use of the additive OR —an approximation as close as possible to the actual level

2000") Ba + lOOOJ Sa + 1000 PHB 1000

Food additives intake

539

Food Additives & Contaminants 1992.9:535-539.

than what is foreseen in the national regulations. This does not necessarily mean more additives will be ingested but there is a possibility that the liberality of the authorization will be used by a number of companies. It seems necessary therefore, to have a look, within the different countries, at the possible intakes, especially in those countries like Italy, France, and Belgium where the authorizations are rather strictly regulated. —Another point to be raised is that due to the rapid change in food habits that has occurred during recent years, increased by the eruption of light foods on the market, we will need an evaluation of the intakes which would be done on a regular basis so as to be able to follow (and control) the trends. But, from the beginning to the end of the intake studies, we must not forget that the ADI is not an exact figure, nor is it a mathematical value. It gives an estimate of what can be ingested daily. Intake figures are also not exact figures. They aim to give a level of possible intake for those groups of consumers who regularly eat foods containing the additive which has been examined. This evaluation can be done step-by-step in an attempt to get more exact figures when needed. Looking first at the list of foodstuffs where the additive is authorized, a quick calculation indicates those foodstuffs which are the most important carriers of the additive. This calculation can be ameliorated with a comparison between regulation and actual use, including the actual level of use. The mean intake figures for eaters of those foods which are important carriers of the additive will finally give the answer to the question: 'Is the actual intake below or above the ADI?' Some people will say that this approach which is, in fact, proposed by the Codex Alimentarius Commission (1989), is not a very scientific one. It has at least, the merit of being flexible and inexpensive. If one tries to obtain exact intake figures, the day they are finalized, having spent a lot of time and money, these perfect exact figures will be outdated and will probably no longer reflect the actual situation for a number of additives. References CODEX COMMITTEE ON FOOD ADDITIVES, 1984.

CODEX ALIMENTARIUS COMMISSION, 1989, Guidelines for the simple evaluation of food additive intake, Supplement 2 to Codex Alimentarius, XIV. WHO, 1987, Principles for the Safety Evaluation of Food Additives and Contaminants in Foods. Environmental Health Criteria No. 70 (Geneva: World Health Organization).

Food additives intake.

The role of intake studies in the safety assurance process is discussed with reference to food preservatives and related to the variations in the auth...
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