Exposure Assessment of Food Additives Dr. V.Sudershan Rao Deputy Director (Scientist E) National Institute of Nutrition Hyderabad

Global food safety concerns

Microbiological Hazards

Pesticide Residues

Misuse Of Food Additives

Chemical Contaminants Biological Toxins

Adulteration

Genetically Modified Organisms

Allergens

Veterinary Drugs Residues

Growth Promoting Hormones

Food Additive

Any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging and transport .

The term does not include contaminants, or substances added to food for maintaining or improving nutritional qualities

Reactive approach

Main responsibility with

government

No structured risk analysis

Relies on end product

inspection and testing

Level of risk reduction: not

always satisfactory

Modern food safety

system

Preventive approach

Shared responsibility

Addresses farm-to table

continuum

Science based - Use of

structured risk analysis-

Establishes priorities Integrated

food control

Relies on process control

Level of risk reduction:

improved

Traditional food safety

system

Risk

Communication Interactive exchange of information and

opinions concerning risks

Risk

Assessment Science based

Risk

Management Policy based

Risk Analysis

Risk assessment

i) Hazard identification ii) Hazard characterization iii) Exposure assessment iv) Risk characterization

Basic requirements of dietary exposure assessment

(1)Concentration of the food additive in food (2) Amount of food consumed (3)Average body weight of the population (kg). The general equation for dietary exposure is: Dietary exposure = Σ (Concentration of food additive in food × Food consumption) Body weight (kg)

Exposure assessment Pre –Regulation Food additive concentration data from manufacturer Post- Regulation Specific foods containing the food additive in the market Actual use levels of the food additives from food manufacturers or food processors Analytical data on the concentrations of the food additive in food may also be used to more realistically estimate the levels of the food additive likely to be found in the diet as consumed Data can be derived from monitoring and surveillance data on food.

Theoretical Maximum Daily Intake

Average per capita daily food consumption

for each foodstuff or food group X legal maximum

use level of the additive established by Codex

standards/FSSAI

Assumptions for TMDI

(a) All foods in which an additive is permitted contain that additive

(b) Always present at the Maximum Permitted Level

(c) Foods containing the additive are consumed by people

each day of their lives at the average per capita level

(d) the additive does not undergo a decrease in level as a

result of cooking or processing techniques

(e) All foods permitted to contain the additive are ingested

and nothing is discarded.

Estimated Daily Intake

The Estimated Daily Intake (EDI) of a food additive is the amount of an additive ingested by the average consumer of the food based on

a) the actual use of the additive by industry

b) according to Good Manufacturing Practice (GMP)

c) an approximation as close as possible to the actual use level.

Data Quality

Survey type or design

Sampling procedures

Sample preparation

Analytical method

Analytical parameters ie limit of detection (LOD) or limit

of quantification (LOQ)

Quality assurance procedures

Approaches Food Consumption data Population based - per capita consumption Not generally useful for food additives Household based - Provides consumption at household level Not at individual level Individual based - More closely reflect actual consumption Bias

Food Mean Median 95th Percentile

Biscuits 6.79 5.71 24.0

Candies 2.00 2.00 2.00

Carbonated beverages

26.56

8.30 200.00

Chocolates 4.24 2.67 14.29

Malted & other beverages 52.72 20.00 250.0

Ice cream 7.99 5.00 28.57

Jam 4.62 1.43 20.00

Chips 8.90 4.29 28.57

Consumption of selected processed foods Urban-HIG(g/ml/day)

Food Mean Median 95th Percentile

Biscuits 18.06 8.14 52.0

Candies 1.17 0.50 4.57

Carbonated beverages

11.78

6.67 35.71

Chocolates 4.08 2.29 13.71

Malted & other beverages 29.12 5.0 200.0

Ice cream 4.63 1.67 14.29

Jam 1.22 0.86 4.29

Chips 6.74 2.83 22.86

Consumption of selected processed foods Rural (g/ml/day)

Authorized use Maximum use level Highest concentration Deemed to be functionally effective Agreed to be safe

But it does not usually correspond to the Optimum, Recommended or Typical level of use

Sample No Phosphoric acid mg/Litre

Mean (Range)

Caffeine

Mg/litre

Mean (Range)

Brand 1 (n=10) 394.3 (163.0-543.0) 74.00(44.0-88.0)

Brand 2 (n=10) 481.4 (447.0-554.0) 66.50(59.0-72.0)

Brand 3 (n=10) 486.7(417.0-581.0) 73.90(66.0-81.0)

Brand 4 (n=10) 3.56 (2.0-6.2) 99.10(60.0-117.0)

Analytical data of four leading brands of carbonated beverages

Maximum permitted limits : Phosphoric acid 600mg/ltr Caffeine 145mg/ltr

Risk Characterization

An estimate of the likelihood of adverse health effects in human populations as a consequence of the exposure. For threshold acting agents, population risk is characterized by comparison of the ADI (or other measures) with exposure. The likelihood of adverse health effects is notionally zero when exposure is less than the ADI. INS (International Numbering System)

"All things are poisons; nothing is without poison; only the dose makes a thing not a poison“.

It is the dose

Paracelsus

(16th Century alchemist )

Safety Evaluation

Toxicity Tests - Acute toxicity, Short term toxicity

Long term toxicity, Mutagenicity,

Carcinogenicity,Tertogenecity,

Multigeneration etc

Establishment of Low Observed Adverse Effect Level (LOAEL)

Establishment of No Observed Adverse Effect Level(NOAEL)

Acceptable Daily Intake (ADI)

Threshold -Non threshold ( No ADI)

International Numbering System (INS no )

Acceptable Daily Intake

The Acceptable Daily Intake (ADI) is an estimate by JECFA 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(standard man - 60 Kg) (WHO Environmental Health Criteria document N° 70, Principles for the SafetyAssessment of food Additives and Contaminants in Food, Geneva, 1987). 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 certaintycertainty that injury will not result even after a life-time's exposure (Report of the 1975 JMPR, TRS 592, WHO, 1976).

A group of 700 substances categorized as GRAS ("generally recognized as safe"), which are so classified because of extensive past use without harmful side effects

Acceptable Daily Intake "Not Specified"

A term applicable to a food substance of very low toxicity for which, on the basis of the available data (chemical, biochemical, toxicological, and other), the total dietary intake of the substance, arising from its use at the levels necessary to achieve the desired effect and from its acceptable background levels in food, does not, in the opinion of JECFA, represent a hazard to health.

1 2 3 4

ADI Mg

/kg

bw

/da

y

LOAEL

NOAEL

Relation between ADI, NOAEL and LOAEL

10X10 =100

Half life is short -No cumulative toxicity expected Occasional excursion of ADI no health concern, but long period excursion is undesirable

Reference body weights used for risk characterization Average body weight 60kg for adult 15 kg for children Average body weight 55 kg for adult for Asian population

Percentiles Body weight (in Kg)

5 34.90

10 37.40

25 41.80

50 48.00

75 55.60

95 69.00

Body weights of Adult women* (>18yrs) Rural

* n= 4029

Percentiles Body weight ( in Kg )

5 41.10

10 43.70

25 49.17

50 55.85

75 63.02

95 76.30

Body weights of Adult men* (>18yrs) Rural

* n=3538

Percentiles Body weight (in Kg)

5 44.84

10 48.20

25 54.00

50 62.40

75 70.30

95 86.00

Body weights of Adult men* (>18yrs) Urban

* n= 1647

Percentiles Body weight (in Kg)

5 38.50

10 41.50

25 47.90

50 55.30

75 62.90

95 76.50

Body weights of Adult women* (>18yrs) Urban

* n=1921

A review on risk assessment of selected food additives (2000-2015) Food colours Sulphites Benzoates Nitrites

Australia, China, France,India, Korea , Norway, Taiwan, Thailand and New Zealand Exposures are below ADI at average consumers At 95th Percentile some were crossing the ADI

Jain & Mathur, 2015

S.No Name of the food colour INS

No

ADI

(mg/ kg bw)

Percentage of ADI at

Mean value

Percentage of ADI at

95th percentile value

1 Erythrosine 127 0-0.1 96 % 537.6 %

2 Ponceau 4R 124 0-4 3.11 % 15.44 %

3 Carmoisine 122 0-4 2.4 % 13.44 %

4 Sunset Yellow FCF 110 0-4 2.4 % 13.44 %

5 Indigo carmine 132 0-5 1.92 % 10.75 %

6 Tartrazine 102 0-7.5 1.28 % 7.1 %

7 Brilliant blue FCF 133 0-12.5 0.7 % 4.3 %

8 Fast green FCF

143 0-25 0.38 % 2.15 %

FREQUENCY CONSUMPTION OF TABLETOP SWEETENERS AMONG TYPE 2 DIABETIC, OVERWEIGHT AND OBESE INDIVIDUALS

82.70%

14.90%

1.10%

60.60%

21.20%

3.00%

0%10%20%30%40%50%60%70%80%90%

DAILY OCCASIONALLY RARELY/VERY

RARELY

TYPE II DIABETIC

OVERWEIGHT AND

OBESE

Quantity And Type Of Sweetener Added In Commonly Available Diet Beverages And Energy Drinks

Diet beverages Sweetener

used

Quantity of

sweetener

(mg)

Net

quantity

(ml)

Brand 1 Aspartame 115.5 330

Acesulfame-k 49.5

Brand 2 Aspartame 87.5 250

Acesulfame-k 37.5

Brand 3 Aspartame 105 300

Acesulfame-k 45

Brand 4 Sucralose 75 250

Acesulfame-k 37.5

Brand 5 Sucralose 142.5 475

Commonly Prepared Sugar Free Sweets Sweets Sweetener used Weight of each

sweet (g)

Amount of sweetener

in one unit of sweet

(mg)

1.Sugarfree angeer rolls

2.Sugarfree ragi laddu

3.Sugarfree badusha

4.Sugarfree agmeri kalakanda

5.Sugarfree kaju barfi

6.Sugarfree kajukathli

7.Sugarfree gondh laddu

8.Sugarfree mothichurladdu

9.Sugarfree mysore pak

10.Sugarfree sunnunda

11.Sugarfree kova pure

12. Sugarfree kalakanda

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

relish(sucralose)

29.16±3.76

45.83±3.76

52.66±5.35

45±6.32

40±3.16

9.83±0.40

50.16±1.60

44.83±2.56

35±5.17

42.33±2.58

47.66±2.33

45±6.32

7.29±0.94

18.79±1.54

21.96±2.23

3.6±0.50

6.67±0.54

6.67±0.54

20.56±0.65

7.62±0.43

11.68±1.72

14.13±0.86

11.91±0.58

3.6±0.50

Mean daily intake of individual sweeteners among overweight and obese individuals [n=33] and its percentage

comparison with ADI

Sweetener Percentage

consumption

n (%)

Intake (mg/kg/day)

Mean±SD

Range JECFA

(mg/kg/day)

% ADI

Aspartame 21(63.6) 0.65±0.52 0.06-1.38 40 1.62

Sucralose 23 (69.6) 0.41±0.11 0.29-0.61 15 2.73

Saccharin 0(0) - - 5 -

Acesulfame-k 16(48.4) 0.15±0.05 0.04-0.21 15 1.0

Total number of subjects exceeds, because some people were having more than one

sweetener through their diet foods

Comparison of mean daily intake of type 2 diabetic individuals [n=87] with ADI

Sweetener Percentage

consumption

n (%)

Intake

(mg/kg/day)

Mean±SD

Range JECFA

(mg/kg/day)

% ADI

Aspartame 52(59.7) 0.85±0.74 0.01-2.89 40 2.1

Sucralose 34(39) 0.41±0.46 0.01-1.87 15 2.6

Saccharin 1(1.1) 0.002±0.0 0-0.002 5 0.04

Acesulfame-k 2(2.2) 0.035±0.007 0.03-0.04 15 0.2

Total number of subjects exceed because, people had more than one sweetener

through their diet foods

European Food Safety Authority

Tier I Theoretical Food Consumption X Maximum Permitted usage of additive Tier II Actual Food Consumption X Maximum Permitted usage of additive Tier III Actual Food consumption X Actual use of usage of Additive

Other methods Total Diet Studies Statistical models

To conclude

Exposure assessment of food additives is the critical component of risk assessment of food additives Need to identify models to capture the food additive intake Food safety is shared responsibility of all stake holders but the major responsibility lies with food industry in case of food additives

Thank you for your attention