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
Traditional food safety Modern food safety system system Preventive approach Reactive approach Shared responsibility Main responsibility with Addresses farm-to table government continuum No structured risk analysis Science based - Use of Relies on end product structured risk analysis- inspection and testing Establishes priorities Integrated food control Relies on process control Level of risk reduction: not Level of risk reduction: always satisfactory improved
Risk Analysis Risk Risk Management Assessment Policy based Science based Risk Communication Interactive exchange of information and opinions concerning risks
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
Consumption of selected processed foods Urban-HIG(g/ml/day) Food Mean Median 95 th Percentile Biscuits 6.79 5.71 24.0 Candies 2.00 2.00 2.00 Carbonated 26.56 8.30 200.00 beverages 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 Rural (g/ml/day) Food Mean Median 95 th Percentile Biscuits 18.06 8.14 52.0 Candies 1.17 0.50 4.57 Carbonated 11.78 6.67 35.71 beverages 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
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
Analytical data of four leading brands of carbonated beverages Sample No Phosphoric acid mg/Litre Caffeine Mg/litre Mean (Range) 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) 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)
Paracelsus (16th Century alchemist ) "All things are poisons; nothing is without poison; only the dose makes a thing not a poison“. It is the dose
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.
Relation between ADI, NOAEL and LOAEL Mg/kgbw/day LOAEL NOAEL 10X10 =100 ADI 1 2 3 4 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
Body weights of Adult women* (>18yrs) Rural Percentiles Body weight (in Kg) 5 34.90 10 37.40 25 41.80 50 48.00 75 55.60 95 69.00 * n= 4029
Body weights of Adult men* (>18yrs) Rural Percentiles Body weight ( in Kg ) 5 41.10 10 43.70 25 49.17 50 55.85 75 63.02 95 76.30 * n=3538
Body weights of Adult men* (>18yrs) Urban Percentiles Body weight (in Kg) 5 44.84 10 48.20 25 54.00 50 62.40 75 70.30 95 86.00 * n= 1647
Body weights of Adult women* (>18yrs) Urban Percentiles Body weight (in Kg) 5 38.50 10 41.50 25 47.90 50 55.30 75 62.90 95 76.50 * 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 95 th Percentile some were crossing the ADI Jain & Mathur, 2015
S.No INS ADI Percentage of ADI at Percentage of ADI at Name of the food colour 95 th percentile value No (mg/ kg bw) Mean value 1 127 0-0.1 96 % 537.6 % Erythrosine 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 %
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