3.3. Safety of Food Additives

The safety level of food additives is determined on the basis of hygienic
regulation. The standards for the use of food additives specify
quantitative indicators characterizing their safe levels. When each
food additive is studied in a toxicological experiment, an
ADI (acceptable daily intake) is established [2, 5].
Based on the studies conducted, the no-effect dose of the additive and the ADI are determined – the amount of the substance that can be consumed daily
throughout life without risk to health. The ADI means not only the
amount of the substance added, but also the natural content of that substance in the
daily set of food products. Taking the ADI into account, the
maximum permissible level (MPL) of the food additive's presence in
each specific product is calculated [2, 5].
The maximum permissible level of the corresponding permitted additives
applies to all products sold on the territory of Ukraine or produced by food industry and public catering enterprises regardless of their departmental affiliation, subordination and forms of
ownership. Responsibility for compliance with the established norms rests with
the heads of food industry, public catering
and trade enterprises
Determining safe doses in food products has a number of peculiarities. The first of them is that the experiments are controlled by an international organization – JECFA (the Joint FAO/WHO Expert Committee on Food Additives). The experiments are conducted in 3 stages [2, 5].
Stage I – subchronic (subacute) experiment
For 90 days, the laboratory animal is fed ordinary laboratory food with the food additive. In this case attention is paid to the following:
1. Functional manifestations, that is, the general effect on the organism. The food
additive should not reduce the rate of weight gain in animals or lead to weight loss, or affect the animal's behavioral responses.
2. Morphological non-neoplastic manifestations, that is, effects on organs
and tissues, primarily of the gastrointestinal tract.
3. Neoplastic manifestations, that is, tumor formation. Substances that
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promote tumor formation are carcinogenic and are prohibited for use as food additives.
4. Effect on reproductive function and offspring development.
Females are used to determine this effect of the food additive.
The gestation period of rats is 20-26 days, and they produce up to 9 litters per year of 5-
9 rats.
In other words, during the course of the experiment a rat should
give birth at least twice.
5. Metabolism, that is, biotransformation of the original food additive
in the organism. Metabolites of the food additive must not be carcinogenic, mutagenic or persist in the organism for more than 24 hours. Indeed,
N-nitrosamines, carbamates, aromatic amines and polycyclic aromatic hydrocarbons whose carcinogenicity or that of
their metabolites has been proven are used as food additives. If the food additive or its metabolic products are not eliminated from the organism within 24 hours, this will lead to a cumulative effect, that is, to their accumulation in the organism. Therefore the use of
such an additive is prohibited.
Consequently, in the subchronic experiment the nature of the toxic action is determined. Already at the first stage some substances may be prohibited
for use as food additives.
Stage II – chronic (acute) experiment
The maximum duration of this experiment – 104 weeks – is determined by the toxic action of the food additive. If, at the subchronic
experiment stage, even very large doses of the substance produced no toxic effect, then
the substance may be permitted for use. At stage II the
maximum no-effect dose is determined – the dose that produces no toxic effect within
104 weeks. During this experiment the subchronic studies on the effect on reproductive function and offspring development continue. These studies continue over 6 generations.
Stage III. Based on the approved ADI (acceptable daily dose),
the diet structure (the share of particular products in the daily diet),
and also the natural content of the substance in that category of product,
the institutions of each country determine the estimated permitted dose of the additive in
food products. The diet structure varies from country to
country, and the natural content of the substance in the product also varies. Therefore
the estimated permitted dose of a food additive in the same product differs between countries.
In the territory of the USA, the body that determines the safe levels of food additives is the FDA (Food and Drug Administration).
FEMA (the Flavor and Extract Manufacturers' Association) has, since 1965, under the auspices of the FDA and with its permission,
published the journal “Food Technology”. The journal provides lists of GRAS substances
(generally recognized as safe). They are listed with their doses in various categories of food products in the territory of the USA. Each substance is assigned its own number. On the labels of food
products in the USA, when a food additive is used, the word
GRAS and its number are indicated.
On packaging materials of the European Union, additives must
be designated by the letter E (from Europe) with the corresponding number from
E100 and above. Designations E 700 – E 899 are not found today on food packaging, since these are reserve indices.
The E and GRAS indices may be indicated on food products
of Ukrainian manufacture. Products of foreign manufacture, on whose packaging the indices of additives permitted for use in
Ukraine are marked, may be sold on the territory of the country.
The indices confirm that the compound has been tested for safety.
For it, purity criteria and hygienic standards in food
products have been established (maximum permissible levels, acceptable daily dose, acceptable daily intake, etc.). In some cases, after the name of the food
additive or its index, its concentration may be indicated. In our country it is
given in milligrams per 1 kilogram or 1 liter of product, while abroad the abbreviation ppm (parts per million) is used.
This means that per 1 million weight or volume parts of the product there is
a certain amount of the food additive. For example, a value of 50 ppm indicates that
in one million parts of the product there are 50 parts of the corresponding additive,
that is, 50 mg/kg or 50 mg/L of product.
The institution that determines the doses of food additives in food products in Ukraine is the Institute of Nutritional Hygiene (Kyiv).
Until 1991, all the above-mentioned stages of experimental research on food additives were carried out on the basis of the established MPLs and ADIs described in the all-union document “Sanitary Rules and Norms No. 1923-
78. Every food additive included in this document had all the specified characteristics.
Food additives included in Sanitary Rules and Norms No. 1923-78 and
supplements to them were included in the list of food additives permitted for
use in Ukraine (approved by Resolution of the Cabinet of Ministers
of Ukraine No. 12 of 04.01.1999). Into this list the following supplements were introduced
by Resolutions of the Cabinet of Ministers No. 342 (342-2000) of 17.02.2000, No. 1140
(1140 – 2000) of 21.07.2000, No. 1656 (1656-2000) of 08.11.2000, No. 674 (674
– 2001) of 21.06.2001, No. 143 (143-2004) of 11.02.2004.
A supplement to this list is introduced on the basis of an examination of documentation, which must characterize each specific food additive. In addition,
for the registration of a food additive in Ukraine, information is required about
its registration and permission for its use in the manufacturing country and in Europe. In
this case, differences in the regulations for the use of food
additives in different countries are taken into account. Indeed, artificial colorants used for
the production of long-storage confectionery products have different regulations for use in Ukraine and European countries. In Ukraine there are significantly
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lower permissible concentrations of colorants, as well as a narrower range of products that may be colored. These differences, although they hinder the entry of some foreign-made food products.
into the Ukrainian market, nevertheless comply with one of the principles of Ukrainian
legislation on preventing the misleading of the consumer regarding product quality. For example, some types of ketchup produced abroad (based on tomato paste or tomato sauce), contain the artificial red
colorant Ponceau 4R. Such products are not manufactured in Ukraine, and it should not be imported, because, according to current legislation,
tomato paste and tomato sauce are included in the "List of products not subject to coloring/tinting".
Practice has shown that many artificial food additives are not
always studied in detail before the start of their widespread practical use. Only later, as research methods develop and epidemiological and other data accumulate, does data emerge on how
food additives act on the human organism, in particular how they harm the health
of humans.
On this basis, the FAO/WHO Committee on Food Additives in 1980
formulated the "Concept of Periodic Review of Food Additives".
Its essence lies in conducting a repeat review of a specific food additive as
information about its effect on the human or animal organism accumulates.
Indeed, the conditions of use of the food additives E 216
(propyl ester of p-hydroxybenzoic acid, preservative) and E 217 (sodium salt of the propyl ester of p-hydroxybenzoic acid, preservative)
were revised when new data on their use were obtained. The use of E 216
and E 217 was discontinued in many countries and repeated toxicological
studies were conducted.
The use of paraffins for glazing confectionery products
leads to their entry into the human organism, since such coatings
are difficult to separate from food products. The accumulation of paraffins may cause the development of neoplasms, as evidenced by research results. It should be kept in mind that some well-known food additives (E) are prohibited for use in Ukraine, and the food products containing them are also prohibited. Thus, in Ukraine the following food additives are prohibited: E121 – citrus red 2 colorant, E123 – amaranth red colorant, E 240 –
formaldehyde preservative. The unresolved status of the use of the additives listed below is related to the fact that the complex of tests on them has not yet been completed: E103, E107, E125, E127, E128, E155, E 174, E182, E203, E209, E 212-
219, E221, E225-228, E230-233, E237, E238, E241, E242, E249, E261, E264-
266, E280-283, E297, E302, E303, E310-315, E317-319, E323, E328, E329,
E343, E345, E439-350, E352-357, E359, E365-368, E375, E380-385, E387,
E391, E409, E419, E425, E430, E442, E446, E459, E462-465, E467-469, E474,
E 478-480, E482-484, E491, E493-496, E505, E517, E5218, E520-523, E528,
E529, E535, E538, E541, E542, E550, E552-556, E560, E574, E576-578, E580,
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E620, E622-626, E628-630, E632-635, E640-642, E906, E911, E921, E927a,
E928, E942, E943a, E943b, E944-946, E948, E955, E957-960, E962, E966,
E1000, E1001, E1200, E1201, E1202, E1401-1403, E1405, E1411, E1421,
E1423, E1443, E1451, E1503, E1505, E1521 [2, 5].
Reviewing the list of food additives and the regulations for their use is
one of the working principles of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). At the same time, it should be noted that, according to
European Commission data, over the past 15 years not a single proven case of danger from «official» food additives has been recorded.
In Ukraine, the regulations for the use of each specific food additive in food products are approved at the level of the Ministry of Health by rulings of the Chief State Sanitary Doctor of Ukraine.
The regulations are aimed at ensuring the safe use of the additive and reducing
the content of foreign substances in the human organism