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