Toxicology and Legislative Aspects of Food Additives

 Food Additives are substances which are used and become components of
food, either directly or indirectly, affect the characteristics of the food.
 Substances that are added to food to maintain or improve the safety, freshness,
taste, texture, or appearance of food are known as food additives.
 Food additive is defined by the Food and Drug Administration (FDA) as any
substance used to provide a technical effect in foods.
 An expert committee made by FAO and WHO defined that, food additives are
non – nutritive substances added intentionally to food in small quantity, so as
to improve its appearance, flavour, texture and storage properties.
 This definition excludes the substances added primarily for their nutritive value
such as minerals and vitamins.
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 Toxicology and Legislative Aspects of Food Additives

Classification of food additives

WHO together with FAO, groups food additives into 3 broad categories based on
their function.
Flavouring agents
Flavouring agents – which are added to food to improve aroma or taste – make up
the greatest number of additives used in foods.
Enzyme preparations
Enzyme preparations are a type of additive that may or may not end up in the final
food product. They are mainly used in baking, for manufacturing fruit juices, in
wine making and brewing, as well as in cheese manufacturing.

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 Toxicology and Legislative Aspects of Food Additives

Other additives
Other food additives are used for a variety of reasons, such as preservation,
colouring, and sweetening.
Preservatives can slow decomposition caused by mould, air, bacteria, or yeast. In
addition to maintaining the quality of the food, preservatives help control
contamination that can cause foodborne illness, including life-threatening
botulism.
Colouring is added to food to replace colours lost during preparation, or to make
food look more attractive.
Non-sugar sweeteners are often used as an alternative to sugar because they
contribute fewer or no calories when added to food.

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 Toxicology and Legislative Aspects of Food Additives

Legislative aspects of Food

Additives
 The legislation on food additives is based on the principle that only those
additives that are explicitly authorized may be used.
 Most food additives may only be used in limited quantities in certain
foodstuffs.
 If no quantitative limits are foreseen for the use of a food additive, it must be
used according to good manufacturing practice, i.e. only as much as
necessary to achieve the desired technological effect.
Food additives may only be authorized if:
 there is a technological need for their use
 they do not mislead the consumer
 They present no health hazard to the consumer.
 They can be quantified by physical or chemical means of analysis 4
 Toxicology and Legislative Aspects of Food Additives

Legislative aspects of Food

Additives
Laws And Regulations Related To Food Additives
 Overview For those additives and processing aids which are not yet
established and published in food standards of Nepal, reference is made in
Codex and FSSAI.
Food Additives Definition and Functional classes
Flavors: natural and artificial flavors in processed foods are referred in Codex
and FSSAI publication. No detail on qualitative and quantitative is given in
Nepalese food standard.
Processing Aids: No specific definitions and quantitative limits are available in
the existing Food Act and Regulation regarding processing aids.
Carry Over: No specific requirements available but generally guided by Codex
requirements. 5
 Toxicology and Legislative Aspects of Food Additives
Functional Classes: There are many Additives coming up in internal and external
markets with specific claims as per their functional role. This has been one of
the important sectors for food regulation.
 In case of Nepal, Nepal Food Law has provided this condition; and an
authorized body deals such problem.
 The use of food additive beyond the prescribed limit would be illegal.
 In Nepal, Nepal Food Rules and Regulation deals and control the illegal
use of food additives.
However in the present context, only few classes such as food colors (natural
and artificial), preservatives (class I and Class II ) and few vitamins and minerals
are given with quantitative limits in Food Regulation and Standards in Nepal.
Detail given below.

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 Toxicology and Legislative Aspects of Food Additives
Use of Colour or Preservative in Food (Clause 22) No person shall, in a manner
contrary to the provisions contained in schedule-10, produce, sell, distribute or
export a food mixed with a colour, or keep such mixed substance for any of such
purposes.
Explanation: “Colour” means any natural or artificial colour to be mixed in a
food.
a. Coal Tar Colours (Synthetic Dyes) Allowed To Be Used In Food: No coal
tar colour (dye) except the following coal tar colours synthetically produced
or a mixture thereof shall be used in any food.
b. Maximum Limit of Permitted Color: The above-mentioned Coal Tar
Colors may be added to any food that is ready for consumption not in excess
of 200 milligram per kilogram.
c. Coal Tar Color to be Pure: The Coal Tar Colors specified in clause (a) to
be used in any food shall not contain any substance that is injurious to
health. 7
 Toxicology and Legislative Aspects of Food Additives

d. Prohibition of the use of Coal Tar Colors: Even the Coal Tar Colors
specified in clause (a) are not allowed to be used in any food to be eaten
after cooking.
e. Restriction on the Use of Coal Tar Colors: The Coal Tar Colors specified
in clause (a) shall be used only in the following food:
 All kinds of ice-cream.
 Cheese.
 Different preparations from egg.
 Biscuit, cake, pastry, and other sweets.
 Non – alcoholic beverages except tea, coffee, coca cola.
 Custard powder.
 Jelly powder.
 Processed or preserved fruits and green vegetables.
 Soup powder.
 Flavoring agents.
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f. Natural Colors allowed to be Used in Food: Natural colors other than

those mentioned above are not allowed to be used in any food
g. Restriction on use of Inorganic Colors and Pigments: No inorganic
colors or pigments are permitted to be used in food preparations

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 Toxicology and Legislative Aspects of Food Additives
Table List of Coal Tar Colors (Dye) Permitted to be Used in Food (clause a)
Type Color Index No. Common name Other name
Red 16185 Amaranth Food Red 9
Red 16255 Ponceau 4R  
Red 45430 Erythrosine Food red 14
Red 14720 Carmoisine (Azo Rubin)
Red 16045 Fast red E  
Yellow 19140 Tartrazine Food yellow 4
Yellow 15985 Sunset yellow FCF  
Blue 73015 Indigo Carmine Food I
Blue 44090 Brilliant blue FCF  
Green 44090 Wool green B.S.   10
Green 42053 Fast green FCF  
 Toxicology and Legislative Aspects of Food Additives

Table List of Permitted Natural Colors

Type Colour Index Common Name

Yellow 75.120 Annato
-do- 75.130 Carotine
-do- 75.100 Saffron
-do- - Riboflavin or lactoflavin
-do- 75.150 Turmeric or curcumin
-do- - Lentophil
Gray - Caramel
Red 75.470 Cochineal, carmine or carmine acid
-do- - Ratanjot, hamatoxilin
-do- - Arrayal (atsin)
-do- 75.520 Alkanet, alkaline 11
Green 75.810 Chlorophyll
 Toxicology and Legislative Aspects of Food Additives

Use of Preservative in Food

No person shall, in a manner contrary to the provisions contained in Schedule-
11, produce, sell, distribute or export a food mixed with a preservative, or keep
such mixed substance for any of such purposes.
Explanation: “Preservative” means any substance used to prevent, suppress or
retard fermentation or acidification in, or any other process of decomposition
of, any food
1. First Class Preservatives
2. Second class Preservatives

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1. First Class Preservatives

According to food rule 2027, the following preservatives shall be deemed to be
the first class preservatives, and these preservatives may be added in any
quantity to any food.
 Common salt
 Sugar/sugar candy
 Dextrose
 Glucose
 Wood smoke
 Spices
 Vinegar or acetic acid
 Honey
 Hops, and
 Alcohol
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2. Second Class Preservatives

Explanation:
(1) Part per million (ppm) means one part of One Million parts.
(2) Sodium or potassium nitrites shall be used only in the meat of any other
types which may be used to preserve hams or bacons.
(3) Prohibition on the use of more than one second class preservative: The
use of more than one Second Class Preservative in any food is
prohibited.
The following substances shall be deemed to be the Second Class
Preservatives.
(a) Sodium or potassium nitrites.
(b) Benzoic acid and salts thereof. (
(c) Sulphurous acid and sulphur dioxide.
The preservatives mentioned above have to be used in the following food in
a quantity not exceeding the following 14
 Toxicology and Legislative Aspects of Food Additives

S.N Article of food Preservatives Quantity, ppm

1. Sausage meat containing raw Sulphur dioxide Not more than 450
meat, condiment
2. Fruit pulp and juice used for Sulphur dioxide Not more than 1000
preparation of other products
3. Fruit juice concentrate Sulphur dioxide Not more than 1500

4. Dried fruits Sulphur dioxide Not more than 1500

Raisins, Sultanas ,, ,, ,, ,, ,, 750
Apricots peach and apples ,, ,, ,, ,, ,,
2000
5. Fruit juice squash, fruit juices, cordials, Sulphur dioxide Not more than 350
alcohol-less wine, barley water Benzoic acid ,, ,, ,, 600 15
6. Jam, jelly ,marmaled, preserve canned Sulphur dioxide Not more than 40
cherry Benzoic acid ,, ,, ,, 200
 Toxicology and Legislative Aspects of Food Additives
7. Crystallized, glaced or cured fruits Sulphur dioxide Not more than 150
including candied fruit and peel
8. Refined sugar Sulphur dioxide Not more than 40
9. White sugar cube, sugar, jaggery Sulphur dioxide Not more than 70
10 Corn syrup Sulphur dioxide Not more than 450
11 Canned Rusbary Sulphur dioxide Not more than 100
12. Gelatin Sulphur dioxide Not more than 1000

13 Beer Sulphur dioxide Not more than 70

14 Cider Sulphur dioxide Not more than 200
15 Alcoholic wine Sulphur dioxide Not more than 450
16 Ready to serve beverages (RTS) Sulphur dioxide Not more than 70
Benzoic acid ,, ,, ,, 120
17 Brewed ginger beer Benzoic acid Not more than120
Coffee extract Benzoic acid Not more than 450
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 Toxicology and Legislative Aspects of Food Additives
19 Pickles/chutney Sulphur dioxide Not more than 250
Benzoic acid ,, ,, ,, 100
20 Tomato or other sauce Benzoic acid Not more than 750
21 Pickled meat and bacon Sodium or potassium nitrite Not more than 200
as sodium nitrite
22 Luncheon meat cooked ham Sodium or potassium nitrite Not more than 200
as sodium nitrite
23 Dehydrated vegetables Sulphur dioxide Not more than 2000
24 Tomato puree and paste Benzoic acid Not more than 750
25 Syrup, squash, sherbet Sulphur dioxide Benzoic acid Not more than 350
,, ,, ,, 600
26 Cheese and processed Sorbic acid or its salt of  
cheese potassium, sodium or calcium  
and expressed as sorbic acid Not more than 3000
27 Flour confectionary Sorbic acid or its potassium,   17
sodium or calcium salt as Not more than 1500
sorbic acid
 Toxicology and Legislative Aspects of Food Additives
GRAS vs. Non – GRAS Additives
 Food additives proved safe by the scientific evaluation or from experience based
on long time common usage in food were generally recognized as safe by
acknowledge experts.
 These “generally recognized as safe” substances have been referred by the
abbreviation GRAS. GRAS ingredients can be added to food without FDA
approval.

Typical GRAS substances included were the common spices, numerous flavorings
materials, baking powder, chemicals additives such as sulphur dioxide, sodium
benzoate, nitrate and nitrite sodium bicarbonate and monocalcium phosphate, fruit
and beverage acid, gummy substances such as agar – agar and gum karaya,
emulsifiers, stabilizers colorings, flavorings etc.
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 A non-GRAS ingredient (food additive) can be added to food, however it is

subject to premarket review and approval by the FDA.
 Also, food additives typically have limitations for use.  For example, a food
additive may be safe at very low levels but harmful at high levels.
 In the case of non-GRAS substances, approval by the FDA is granted upon the
submission of scientific data clearly showing that the intended chemical is
harmless in the intended food application at the intended use level.
 The FDA then sets limits with respect to the kind of foods in which the
additive may be used and the maximum concentration that may be employed.

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Toxicology and Legislative Aspects of Food Additives

Comparing GRAS to Food Additives

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 Toxicology and Legislative Aspects of Food Additives

Evaluation of safety
 During the evaluation of safety aspects of additives, it has to be proved that
harmful effects have not occurred with the addition of additives.
 As it is difficult to carry out toxicity studies with human beings; so experiments
are carried out with the animal.

 The simplest way to express toxicity is by the value of LD50, i.e., the dosage
(lethal dosage) necessary to kill 50% of a population of test animals under stated
condition.

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 Toxicology and Legislative Aspects of Food Additives

The four following types of toxicity studies are employed

1. Acute toxicity or single dose experiment.

2. Sub – acute toxicity or multiple doses experiments (Daily ingestion for
days or weeks).
3. Chronic toxicity (daily ingestion for weeks to month or year)
4. Studies of carcinogenicity, mutagenicity, teratogenicity and reproduction
on test animal

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 Toxicology and Legislative Aspects of Food Additives

Acute toxicity or single dose experiment

 In acute toxicity studies, groups of animal (two species) are given a wide
range of single dose of the additives orally or by injection into the blood
stream.
 Then LD50 values in a specified period of time (24hours, 7 days) and
abnormalities seen are observed, which may provide clues about the
toxicity of additive.

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 Toxicology and Legislative Aspects of Food Additives

Sub – acute toxicity

 In sub – acute toxicity test, two or more species of animals are used.
 The duration of test is 90 days.
 The study is made at different dose levels.
 The dose may vary near zero to sufficiently high to produce some adverse
effects, after that study of the test animal should be continued for several days.
 Regular evaluation of the state of the health of the test animal is made and
physiological and biological tests are carried out.
 These studies help to determine the acceptable daily intake, in milligrams per
kilograms of the body weight allowed for human being.

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 Toxicology and Legislative Aspects of Food Additives

Chronic toxicity (daily ingestion for weeks to month or year)

And studies of carcinogenicity, mutagenicity, teratogenicity and
reproduction on test animal

 Chronic toxicity tests are conducted for duration of one to two year or long.
 Numbers of animals are used for number of dose and several physiological
and biological tests are carried out.
 This type’s tests help to determine the carcinogenicity (cancer causing)
mutagenicity (heritable change in genetic material) of the additives.
 Long term tests also help to study the effect of additives on the permanent
structural or functional change induced on embryo and reproduction i.e., male
or female fertility, litter size, litter weight, and the number of the surviving
young.
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