INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION SAFETY EVALUATION OF CERTAIN FOOD ADDITIVES AND CONTAMINANTS WHO FOOD ADDITIVES SERIES: 44 Prepared by the Fifty-third meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) World Health Organization, Geneva, 2000 IPCS - International Programme on Chemical Safety ASSESSMENT OF INTAKE OF SPECIFIC FOOD ADDITIVES EVALUATION OF NATIONAL ASSESSMENTS OF INTAKE OF ANNATTO EXTRACTS (BIXIN) First draft prepared by Philippe Verger French Observatory of Food Consumption, National Agricultural Research Institute, Paris, France Introduction Screening of annatto extracts by the budget method Assessments of intake of annatto extracts Assessments based on data on poundage (disappearance) Assessments based on data from household economic surveys Assessments based on model diets Assessments based on individual dietary records Evaluation of estimates of intake of annatto extracts Conclusions and recommendations Bibliography 1. INTRODUCTION The Committee last examined the toxicity of annatto extracts, which are food additives used to impart a yellow colour to food, at its twenty-sixth meeting (Annex 1, reference 59) and allocated an ADI of 0-0.065 mg/kg bw expressed as bixin. At its present meeting, the Committee assessed the intake of annatto extracts. National authorizations are also generally expressed in terms of the primary chemical colouring agent in the extracts, bixin, which is assumed to be present at a minimum concentration of 0.2% and a maximum of 3.5% of the total annatto extracts, with typical concentrations assumed in the assessments of different countries of 3-3.5%. Annatto extracts are proposed for use in a wide range of solid foods in the draft General Standard for Food Additives (GSFA) that is being developed by the Codex Committee on Food Additives and Contaminants. Information was received from seven countries: Australia, Brazil, Canada, France, the Netherlands, the United Kingdom, and the United States. The assessments were conducted on the basis of a variety of assumptions about the potential concentrations of annatto extracts and for various consumption patterns. The submissions are summarized in Table 1. 2. SCREENING OF ANNATO EXTRACTS BY THE BUDGET METHOD The Codex GSFA proposes that annatto extracts be permitted for use in a wide range of solid foods. Table 2 summarizes the data from the Netherlands, which includes the concentration permitted for use in Europe, the proportion of the solid food supply likely to contain annatto, the maximum levels of annatto permitted by GSFA, and a comparison of these levels to the theoretical maximum level calculated by the budget method for European countries. Table 1. Summary of submissions on annatto extracts Country Budget Poundage FBS/HES/ Model Individual method data sales data diets dietary records Australia × Brazil × × Canada × France × × Netherlands × × United Kingdom × United States × × × FBS, food balance sheet; HES, household economic survey; sales, retail stores The theoretical maximum level of use for annatto in solid foods was less than the maximum permitted level for the country that submitted data (25 mg/kg) and was also less than the GSFA level of 1000 mg/kg. A detailed assessment of the intake of annatto from its use in solid foods is therefore required. 3. ASSESSMENTS OF INTAKE OF ANNATTO EXTRACTS 3.1 Assessments based on data on poundage (disappearance) Estimates of the amount of annatto extracts available per capita based on poundage data are given in Table 3 for five countries and compared with the ADI of 0-0.065 mg/kg bw. The estimated intakes are less than the ADI, except in Brazil, and vary from 0.005 to 0.14 mg/kg bw per day (7.6-215% of the ADI). The poundage method shows a significant increase in the use of this additive in the USA between 1987 and 1996. 3.2 Assessments based on data from household economic surveys France submitted data from household surveys and data on sales, and the estimated intake was based on national maximum levels of use (Table 4). The estimates indicate that the potential intake of annatto extracts by high consumers (0.034 mg/kg bw per day) represents 52% of the ADI. Although it is generally not possible to identify high consumers from household economic surveys, in this submission high consumption of annatto extracts was estimated by dividing the household consumption by the number of members of the household in order to derive the intake of individual consumers. Table 2. Estimate of a theoretical maximum level for annatto extracts by the budget method Country % solid food National GSFA Theoretical containing maximum maximum maximum annato extracts level levela level (mg/kg) (mg/kg) (mg/kg) Netherlands 25 25 1000 10.4 a The draft General Standard for Food Additives (GSFA) proposes a maximum use level of 1000 mg/kg for food category 8.1.1.2, mince of fresh meat, poultry, and game Table 3. Estimates of intake of annatto extracts based on poundage data Country Date Consumers Estimated intake % ADIa (millions) of bixin (mg/kg bw per day) Brazil 1997 44.6 (28% of 0.14 215 population) United Kingdom 1984-86 56 0.0083 12.8 United States 1987 244 Mean, 0.005 7.7 90th percentile, 0.01 15.4 1996 260 Mean, 0.008 12.3 90th percentile, 0.016 24.6 a JECFA ADI, 0-0.065 mg/kg bw b Assumes that all persons are consumers and that the 90th percentile intake is twice the mean intake. 3.3 Assessments based on model diets The USA submitted data based on model diets, details of which are summarized in Table 5. The model diet was constructed to predict the intake of annatto by a long-term consumer by using food consumption data derived from food frequency data for 1982-88 from the Market Research Corporation of America and average portion sizes from the 1987-88 three-day national food consumption survey of the US Department of Agriculture. Maximum additive levels were assumed. The estimates of intake of annatto extracts do not exceed the ADI. 3.4 Assessments based on individual dietary records Intake estimates for annatto extracts based on individual dietary records were submitted by six countries. In each case, the mean and specified percentile estimates were derived for individuals adjusted for body weight, except in the Canadian assessment. The assumptions made and the intake estimates derived are summarized in Table 6. Table 4. Estimates of intake of annatto extracts based on household economic surveys and sales data Country Date Survey Assumptions Estimated % ADIa intake of bixin (mg/kg bw per day) France 1995 Sales Maximum European 0.034 52 data Union levels of use, with adjustment for catering outside the home (1994) a JECFA ADI, 0-0.065 mg/kg bw The estimates based on individual dietary records and national use levels indicate intakes of bixin lower than the ADI for mean consumers in all countries except Australia and Brazil. For Australia, the estimates were based on the asumption that annatto is used only in all the products in each food class for which permission has been granted. For Brazil, the estimate was made for a specific at-risk population which consumes annatto extracts in large amounts after direct addition to foods as a condiment; the results do not correspond to the mean exposure of the total Brazilian population. For high consumers, the reported intakes were below the ADI in the USA and about twice the ADI in Brazil, Canada, France, and the Netherlands. All the countries except Brazil recognized that the results are overestimates because they assume maximum additive concentrations in all food categories in which annatto is authorized for use or might be used. Australia reported intakes that were above the ADI but recognized that very conservative assumptions were made. Moreover, the Australian survey is based on a one-day food intake recall, which would contributes to the overestimate of bixin intake. Table 5. Estimates of intake of annatto extracts based on model diets Country Date Survey Assumptions Model Annatto intake % ADIa (mg/kg bw per day) United 1982-88 14-day menu obtained Long-term consumer Long-term consumer States from MRCA food - maximum additive Mean 0.028 43 frequency data (1982-87) levels (GSFA) 90th percentile 0.73 86 combined with portion - 90th percentile sizes from USDA/NFCS high consumption (1987-88); > 2 years level twice mean consumption - all respondents are consumers - GSFA classification system GSFA, General Standard for Food Additives; MRCA, Market Research Corporation of America; USDA/NFCS, US Department of Agriculture/National Food Consumption Survey a JECFA ADI, 0-0.065 mg/kg bw 4. EVALUATION OF ESTIMATES OF INTAKE OF ANNATTO EXTRACTS Screening of additives by the budget method indicated that annatto extracts require further assessment for use as an additive. Inclusion of national proportions of the food supply that may contain annatto extracts did not change this decision. 5. CONCLUSIONS AND RECOMMENDATIONS The Committee concluded that intake of annatto extracts would exceed the ADI for bixin if all foods contained annatto extracts at the levels proposed in the draft General Standard for Food Additives. Intakes based on national permissions would not exceed the ADI for most populations. Since estimates of intake that result from use of the general assumption that all foods in a category are coloured by the same additive at the maximum level are overestimates, the Committee recognized that the ADI for bixin is unlikely to be exceeded as a result of use of annatto extracts. However, information from Brazil indicated that about 44 million people (28% of the population) consume annatto seeds directly as a condiment and have done so for many years, at a level of consumption that is approximately 150% of the ADI. Although the results of studies in humans normally take precedence over those in experimental animals, the submitted reports were of only limited value. In order to ensure that all of the relevant data on annatto extrcts have been reviewed, the Committee recommended their re-evaluation in 2001. The Committee also recommended that populations with a high intake of annatto extracts continue to be monitored. Table 6. Estimates of intake of annatto extracts based on individual dietary records Country Date Survey Assumptions Model Intake % ADIa (mg/kg bw per day) Australia 1985 National survey; - maximum additive levels Mean intake 0.14 205 24-h recall; (Australia or GSFA) (population = consumers) adults, > 2 years; - modified GSFA classification Australia sample, 13 858 system - maximum additive level Mean intake 0.87 1246 within any one group (population = consumers) - reports 95th percentile GSFA consumption - intakes adjusted for individual body weight 95th percentile 0.47 672 (consumers) Australia 95th percentile 2.54 3634 (consumers) GSFA Brazil 1998 Local; food All members of household Mean consumption 0.097- 149- frequency considered to be consumers 0.103 158 questionnaires; one-month recall, 202 households, 849 consumers. High consumers of 'Colorifico' Canada 1973 National - maximum additive levels Mean intake of 1.2a 64 - intakes adjusted for all persons 0.042b individual body weight - reports 95th, 97.5th percentile consumption Mean intake in 3.0a 161 - reports by age group worst case 0.105b Table 6. (continued) Country Date Survey Assumptions Model Intake % ADIa (mg/kg bw per day) France 1993-94 National; - maximum additive levels (EU) Mean intake (population) EU 0.027 41 7-day record; - adjusted for catering 90th percentile EU 0.052 80 5-75 years; outside the home sample, 1116 - intakes adjusted for individual body weight 97.5th percentile EU 0.083 127 - reports 90th, 95th percentile consumption - reports by age group Corrected mean intake EU 0.006 9.2 (population) Netherlands 1992 National; 2-day - maximum additive levels (EU) Mean intake (population) EU 0.028 43 record; 5-65 - intakes adjusted for individual 95th percentile EU 0.104 160 years; sample, body weight 6000 - reports 95th, 97.5th 97.5th percentile EU 0.158 243 percentile consumption - reports by age group Maximum 0.669 Corrected mean intake < 100 (population) EU United 1989-92 48 states and Mean intake (total 0.018 28 States Washington DC; population) 29 3-day recall; Mean intake (consumers) 0.019 all age groups; sample, 11 912 90th percentile (total 0.046 70 population) 0.048 74 90th percentile (consumers) GSFA, General Standard for Food Additives; EU, European Community a JECFA ADI, 0-0.07 mg/kg bw; not corrected for bixin b Assuming 3.5% bixin 6. BIBLIOGRAPHY Australia-New Zealand Food Authority (1997) Aus-NZ Food Standards Code, Canberra. Baines, J. Estimated intake assessment for annatto in Australia. Personal communication. Australia-New Zealand Food Authority, Canberra, to FAO, January 1999. Codex Committee on Food Additives and Contaminants (1997) Report of the Twenty-ninth Session of the Codex Committee on Food Additives and Contaminants, Rome, Food and Agriculture Organization of the United Nations (document ALINORM 97/12A, Appendix V). Commission of the European Communities (1979) Reports of the Scientific Committee for Food, Eighth Series, Luxembourg. European Commission (1995) European Union Directive 95/2/CE, Brussels Fisher, C.E. Dietary exposure to the four additives referred to JECFA by CCFAC. London, Ministry of Agriculture, Fisheries and Food, Joint Food Safety and Standards Group, submitted to FAO, 22 December 1998. Rulis, A.M. United State intake data on annatto extract. Food and Drug Administration, Washington DC, submitted to FAO, 10 December 1998. Salminen, J.W. Comments about the list of substances scheduled for evaluation by the JECFA. Health Protection Branch, Ottawa, submitted to FAO, 16 December 1998. TNO Nutrition and Food Research Institute (1999) Assessment of the intake of selected additives with a screening approach, Zeist. Submitted to FAO by the Ministry of Health, Sport and Welfare, The Hague, 21 May 1999. Toledo, C.F. National intake assessment of the intake of bixin in Brazil. Faculty of Food Enginneering, University of Campinas, Campinas. Submitted to FAO, 1999. Verger, P. Estimation of the theoretical maximum intake for certain food additives in France, Observatory of Food Consumption, Paris. Personnal communication, submitted to FAO, 1 June 1999.
See Also: Toxicological Abbreviations Annatto Extracts (WHO Food Additives Series 52) Annatto extracts (FAO Nutrition Meetings Report Series 46a) Annatto extracts (WHO Food Additives Series 6) Annatto extracts (WHO Food Additives Series 17) ANNATTO EXTRACTS (JECFA Evaluation)