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

Transcription

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

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3 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

4 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

5 Traditional food safety system 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

6 Risk Analysis Risk Assessment Science based Risk Management Policy based Risk Communication Interactive exchange of information and opinions concerning risks

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

8 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)

9 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.

10 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

11 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.

12 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.

13 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

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

15 Consumption of selected processed foods Urban-HIG(g/ml/day) Food Mean Median 95 th Percentile Biscuits Candies Carbonated beverages Chocolates Malted & other beverages Ice cream Jam Chips

16 Consumption of selected processed foods Rural (g/ml/day) Food Mean Median 95 th Percentile Biscuits Candies Carbonated beverages Chocolates Malted & other beverages Ice cream Jam Chips

17 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

18 Analytical data of four leading brands of carbonated beverages Sample No Phosphoric acid mg/litre Mean (Range) Caffeine Mg/litre Mean (Range) Brand 1 (n=10) ( ) 74.00( ) Brand 2 (n=10) ( ) 66.50( ) Brand 3 (n=10) 486.7( ) 73.90( ) Brand 4 (n=10) 3.56 ( ) 99.10( ) Maximum permitted limits : Phosphoric acid 600mg/ltr Caffeine 145mg/ltr

19 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)

20 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

21 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 )

22 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

23 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.

24 Relation between ADI, NOAEL and LOAEL Mg/kgbw/day 10X10 =100 NOAEL ADI LOAEL Half life is short -No cumulative toxicity expected Occasional excursion of ADI no health concern, but long period excursion is undesirable

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

26 Body weights of Adult women* (>18yrs) Rural Percentiles Body weight (in Kg) * n= 4029

27 Body weights of Adult men* (>18yrs) Rural Percentiles Body weight ( in Kg ) * n=3538

28 Body weights of Adult men* (>18yrs) Urban Percentiles Body weight (in Kg) * n= 1647

29 Body weights of Adult women* (>18yrs) Urban Percentiles Body weight (in Kg) * n=1921

30 A review on risk assessment of selected food additives ( ) 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

31 S.No Name of the food colour INS No ADI (mg/ kg bw) Percentage of ADI at Mean value 1 Erythrosine % % Percentage of ADI at 95 th percentile value 2 Ponceau 4R % % 3 Carmoisine % % 4 Sunset Yellow FCF % % 5 Indigo carmine % % 6 Tartrazine % 7.1 % 7 Brilliant blue FCF % 4.3 % 8 Fast green FCF % 2.15 %

32 FREQUENCY CONSUMPTION OF TABLETOP SWEETENERS AMONG TYPE 2 DIABETIC, OVERWEIGHT AND OBESE INDIVIDUALS 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 82.70% 60.60% 21.20% 14.90% 1.10% 3.00% DAILY OCCASIONALLY RARELY/VERY RARELY TYPE II DIABETIC OVERWEIGHT AND OBESE

33 Quantity And Type Of Sweetener Added In Commonly Available Diet Beverages And Energy Drinks Diet beverages Sweetener used Quantity of sweetener (mg) Brand 1 Aspartame Acesulfame-k 49.5 Brand 2 Aspartame Acesulfame-k 37.5 Brand 3 Aspartame Acesulfame-k 45 Brand 4 Sucralose Acesulfame-k 37.5 Brand 5 Sucralose Net quantity (ml)

34 Commonly Prepared Sugar Free Sweets Sweets Sweetener used Weight of each sweet (g) 1.Sugarfree angeer rolls relish(sucralose) 29.16±3.76 Amount of sweetener in one unit of sweet (mg) 7.29± Sugarfree ragi laddu relish(sucralose) 45.83± ± Sugarfree badusha relish(sucralose) 52.66± ± Sugarfree agmeri kalakanda relish(sucralose) 45± ± Sugarfree kaju barfi relish(sucralose) 40± ± Sugarfree kajukathli relish(sucralose) 9.83± ± Sugarfree gondh laddu relish(sucralose) 50.16± ± Sugarfree mothichurladdu relish(sucralose) 44.83± ± Sugarfree mysore pak relish(sucralose) 35± ± Sugarfree sunnunda relish(sucralose) 42.33± ± Sugarfree kova pure relish(sucralose) 47.66± ± Sugarfree kalakanda relish(sucralose) 45± ±0.50

35 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± Sucralose 23 (69.6) 0.41± Saccharin 0(0) Acesulfame-k 16(48.4) 0.15± Total number of subjects exceeds, because some people were having more than one sweetener through their diet foods

36 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) Aspartame 52(59.7) 0.85± Sucralose 34(39) 0.41± Saccharin 1(1.1) 0.002± Acesulfame-k 2(2.2) 0.035± % ADI Total number of subjects exceed because, people had more than one sweetener through their diet foods

37 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

38 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

39 Thank you for your attention