Dedi Fardiaz FSC 410, Food Additives 1

Food Additives Regulation:

FA Safety and Maximum Use Level

Dedi Fardiaz
Department of Food Science and Technology,
Faculty of Agricultural Engineering and Technology
BOGOR AGRICULTURAL UNIVERSITY

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 Food Additive is a substance (intentionally) added to food
to alter the properties and/or the appearance of the food

Could you tell what kind of food additives may be present

in those foods?
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 WHY do we need to regulate food additives ?
WHAT is the most important criteria for a
chemical to be categorized as food additive?

HOW are food additives regulated?

Globally Codex Alimentarius Commission
Nationally National Agency for Drug and Food Control
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 As described by Paracelsus nearly 500 years ago, All substances
are poisons; there is none which is not a poison. The right dose
differentiates a poison and a remedy. This means that any
chemical substance is likely to produce some form(s) of harmful
effect, if taken in sufficient quantity.

The Codex definition of hazard is a biological, chemical or

physical agent with the potential to cause an adverse health
effect.

The likelihood or risk of that hazard actually occurring in

humans is dependent upon the quantity of chemical
encountered or taken into the body, i.e. the exposure.

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 WHY do we need to regulate food additives?
These chemicals may be harmful to your health (if consumed above the safety margin level)

Benford, D. 2000, ILSI Europe

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 Any possibility this food contains hazard that ?
How do you know?
Any food absolutely free of hazards?

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 Risk analysis is used:
to develop an estimate of the risks to human health,
to identify and implement appropriate measures to control the risks,
and
to communicate with stakeholders about the risks and measures
applied.

1. Hazard identification
2. Hazard characterization
Risk Analysis 3.
4.
Exposure assessment
Risk characterization
(Codex Alimentarius
Commission)
Science Based

Policy Based
Exchange of Information
Important step if we want
to regulate food additives
 Hazard: A biological, chemical or physical agent in, or
condition of, food with the potential to cause an
adverse health effect.

Hazard
We assume Food
Additive as a Chemical
Hazard that pose a risk
to your heath. Hazard is a fact
Therefore, this chemical Risk is a probability
should be evaluated to Analysis of food is to detect and
estimate its risk to your measure the hazard not the risk
health.

? Risk
Risk: A function of the probability of an adverse health
effect and the severity of that effect, consequential to
a hazard(s) in food.
How do we know the risk?
We need to know how much food (with hazard in it?) we eat
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 HOW are food additives regulated?
Globally Codex Alimentarius Commission

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ILSI Europe, 2000
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 It is important to determine the margin of safety of your food additive consumption

The Acceptable Daily Intake (ADI) is an estimate

by JECFA of the amount of a food additive,
expressed on a body weight basis (mg FA/kg
BW), that can be ingested daily over a lifetime
without appreciable health risk (standard man
60 kg)

ADI = Acceptable Daily Intake

Dose
(mg/kg body weight) 0 Consumption of food additive
No risk at all Higher Risk
Lower Risk
JECFA = Joint FAO/WHO Expert Committee on Food Additives
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 For contaminants, we use the term TDI (Tolerable Daily Intake) instead of ADI

The Tolerable Daily Intake (TDI) is an estimate

by JECFA of the amount of a contaminants,
expressed on a body weight basis (mg
Contam./kg BW), that can be ingested daily
over a lifetime without appreciable health risk

TDI = Tolerable Daily Intake

Dose
(mg/kg body weight) 0 Consumption of contaminants
No risk at all Higher Risk
Lower Risk

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Note:
The ADI is expressed in milligrams of the
additive per kilogram of body weight.
For this purpose, "without appreciable risk"
is taken to mean the practical certainty that The Acceptable Daily Intake (ADI) is an estimate
injury will not result even after a life-time's by JECFA of the amount of a food additive,
exposure (Report of the 1975 JMPR, TRS expressed on a body weight basis (mg FA/kg
592, WHO, 1976). BW), that can be ingested daily over a lifetime
The ADI is established over lifetime. A body without appreciable health risk (standard man
weight of 60 kg is usually taken to represent 60 kg)
the average weight of the population
(Report of the 1988 JECFA , TRS 776 sec.
2.2.3. WHO, 1989). ADI = Acceptable Daily Intake

Dose
(mg/kg body weight) 0

Lower Risk

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How do we estimate ADI? Groups of animals (e.g. rats) are given daily
diets containing different levels of the
additive under examination.
For example, levels of the additives in the
diet could be: 0.1%, 1%, 2%, 5%. If a toxic
effect is found at the 2% level and a "no
toxic effect" at 1% level, the 1% level
(expressed in mg/kg body weight) will be
the "no-observed-effect level (NOEL), and
it is from this level that the extrapolation to
humans is done.
0.1% 1% 2% 5%
In this case, the no-observed-effect level
(NOEL) lies between the 1% and 2% levels,
and if no toxicological evaluations are done
at intermediary levels (1.25%, 1.50%,
1.75%) the choice of the 1% level as the no-
observed-effect level introduces already a
first safety factor.
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 100
NOAEL
ADI =
80
10 X 10
Toxic effect
for animal
Response
60 experiment

40 ADI for human NOAEL

20
No Observed Adverse
Effect Level
0
0.01 0.1 1 10 100 1000
Dose (mg/kg BW/day)

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 The extrapolation from the no-observed-
effect level to an ADI is often done by using
a safety factor of 100 (10 x 10) which
assumes that humans are 10 times more
sensitive than experimental animals and
that there is a 10-fold variation in sensitivity
within the human population.
This safety factor of 100 is based on the
experience and common sense of
toxicologists and therefore cannot be
compared to a physical value such as the
boiling point of a pure substance. More
information regarding the no-observed-
effect level and the use of safety factors can
be found in "Principles for the Safety
Assessment of Food Additives and
contaminants in Food". (Environmental
Health Criteria No 70, WHO, Geneva 1987,
p. 77-79).
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Example: ADI (Acceptable Daily Intake) of several permitted preservatives

Chemical ADI
Preservatives INS No.
Structure (mg/kg BW)
Benzoic and its salts
a. Benzoic acid C7H602 210
b. Sodium benzoate C7H5NaO2 211 0-5
c. Potassium benzoate C7H5KO2 212
d. Calsium benzoate C14H10CaO4 213
Nitrate and its salts
a. Sodium nitrate NaNO3 251 0 3.7
b. Potassium nitrate KNO3 252
 Chemical ADI
Preservatives INS No.
Structure (mg/kg BW)

a. Methyl p-hydroksibenzoate COO-R

218
b. Ethyl p-hydroksibenzoate 0 - 10

c. Propyl p-hidroksibenzoate OH 216

Sulfite and its salts

a. Sulfur diokside SO2 220
b. Sodium sulfite Na2SO3 221
c. Sodium bisulfite NaHSO3 222
0 0.7
d. Sodium metabisulfite Na2S2O5 223
e. Potassium metabisulfite K2S2O5 224
f. Potassium sulfite K2SO3 225
g. Potassium bisulfite KHSO3 228
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 Maximum level (ML)
The Codex maximum level (ML) for a contaminant in a food
or feed commodity is the maximum concentration of that
substance recommended by the CAC to be legally permitted
in that commodity.
Maximum residue level (MRL)
The maximum concentration of residue in a food or animal
feed resulting from use of a veterinary drug or a pesticide,
(expressed in mg/kg or g/kg on a fresh weight basis).

Acceptable daily intake (ADI)

An estimate of the amount of a substance in food or drinking
water, expressed on a bodyweight basis, that can be ingested
daily over a lifetime without appreciable risk (standard
human = 60 kg). The ADI is listed in units of mg per kg of
body weight.
Tolerable daily intake (TDI)
Analogous to Acceptable Daily Intake. The term Tolerable is
used for agents which are not deliberately added such as
contaminants in food.
Who determines ML, MRL, ADI, TDI in Codex?
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 Codex Alimentarius Commission
Executive Committee

General Subject The Commission and The joint FAO/WHO expert

Committees its subsidiary bodies bodies and consultations
(risk managers) (risk assessors)

Food Hygiene (CCFH) JEMRA

Food Additives (CCFA)
General Principles (CCGP) JECFA JEMRA (Joint
Food Labelling (CCFL) FAO/WHO Expert
Methods of Analysis (CCMAS) Meetings on
Microbiological Risk
and Sampling JMPR Assessment)
Pesticide Residues (CCPR)
Residues of Veterinary JECFA (Joint
Drugs in Foods (CCRVDF) JECFA FAO/WHO Expert
Food Import and Committee on Food
Export Inspection and (CCFICS) Additives)
Certification Systems
JMPR (Joint
Nutrition and Foods FAO/WHO Meeting
for Special Dietary (CCNFSDU) on Pesticide Residues)
Uses
Dedi Fardiaz Contaminants in Food (CCCF)
FSC 410, Food Additives JECFA 22
Benzoic and its salts; Benzoic acid (INS. No. 210); Sodium benzoate (INS. No. 211); Potassium
benzoate (INS. No. 212); Calsium benzoate (INS. No. 213)
ML
(Maximum
No. Food Category Level)
(mg/kg)
Milk-based desserts (iced milk, puding, yoghurt with fruits, and
01.7 200
yoghurt witht flavorings)

02.2.1.2 Margarine and related products (mixed butter and margarine) 1000

02.2.2 Emulsion with fat content of less than 80% 1000

02.3 Emulsion of fat other than category 02.2.2 1000
02.4 Fat-based desserts 1000
04.1.2.5 Jam, jelly (spread) and marmalade 200
Fruit-based spread (example: chutney) not covered in category
04.1.2.6 1000
04.1.2.5

04.1.2.8 Fruits-based raw materials which includes fruit sauce, puree, fruit 1000
topping and coconut milk
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 Food Category System (GSFA, 2005)
Check GSFA or national standards for ML of food additives
in food
No. Name of Food
01.0 Dairy products and analogues, excluding products of food category 02.0
02.0 Fats and oils, and fat emulsions
03.0 Edible ices, including sherbet and sorbet
04.0 Fruits and vegetables (including mushrooms and fungi, roots and tubers, pulses
and legumes, and aloe vera), seaweeds, and nuts and seeds
05.0 Confectionary
06.0 Cereals and cereal products, derived from cereal grains, from roots and tubers,
pulses and legumes, excluding bakery wares of food category 07.0
07.0 Bakery wares
08.0 Meat and meat products, including poultry and game
09.0 Fish and fish products, including mollusks, crustaceans, and echinoderms
10.0 Eggs and egg products
11.0 Sweeteners, including honey
12.0 Salts, spices, soups, sauces, salads, protein products (including soybean protein
products) and fermented soybean products
13.0 Foodstuffs intended for particular nutritional uses
14.0 Beverages, excluding dairy products
15.0 Ready-to-eat savouries
16.0 Composite foods - foods that could not be placed in categories 01 - 15.
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HOW are food additives regulated?
Nationally National Agency for Drug and Food Control

Law No. 18/2012 on Food (Undang-Undang No.18 Tahun 2012 tentang Pangan)
Government Regulation No. 28/2004 on Food Safety, Quality, and
Nutrition (Peraturan Pemerintah No. 28 tahun 2004 tantang Keamanan, Mutu,
dan Gizi Pangan)
Government Regulation No. 69/1999 on Food Label and Advertisement
(Peraturan Pemerintah No. 69 tahun 1999 tentang Label dan Iklan Pangan)

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Law No. 18/2012 on Food
Part Three
Control of Food Additive
Article 73
Food Additive is a substance added to Food to alter the properties and/or the appearance of the food
Article 74
(1) Government has the obligation to examine the safety of substances that will be used as food additives
with unknown effect to human health in Food Production process or activity for distribution.
(2) Additives safety examination as intended in paragraph (1) is performed to obtain distribution license.
Article 75
(1) Everyone who carry out Food Production to be distributed is prohibited from using:
a. Food additives in excess of established maximum limit; and/or
b. Prohibited materials as Food additives.
(2) Provision regarding maximum limit and prohibited materials as intended in paragraph (1) is regulated
by or based on Government Regulation.
Article 76
(1) Everyone that violates the provision as intended in Article 75 paragraph (1) is subject to administrative
sanction.
(2) Administrative sanction as intended in paragraph (1) is in the form of:
a. fine;
b. temporary suspension from activity, production and/or distribution;
c. withdrawal of Food from circulation by producer;
d. compensation; an/or
e. revocation of license.
(3) Further provision regarding type, amount of fine, process and administrative sanction mechanism as
intended
Dedi Fardiaz in paragraph (1) and (2) is regulated
FSCin
410,Government
Food Additives Regulation. 34
 Government Regulation No. 28/2004 on Food Safety, Quality, and Nutrition

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 ML (Maximum Level) for the use of Curcumin, CI. No. 75300, INS. 100(i) ADI: 0-3 mg/kgBW
food additive in food: Coloring agent
No. Food Category ML
(mg/kg)

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 No. Food Category ML
(mg/kg)

CPPB (Cara Produksi Pangan yang Baik) =

GMP (Good Manufacturing Practices)

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 Thank You

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