1. Aflatoxins John L. Herrman
WHO Joint Secretary of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)
International Programme on Chemical Safety (IPCS)
World Health Organization, Geneva

2. JECFA Joint FAO/WHO Expert Committee on Food Additives
Advises the Codex Committee on Food Additives and Contaminants and FAO and WHO Member States
Characterizes risk on the basis of evaluation of toxicological, epidemiological and related data and information on intake (risk assessment)

3. Endpoints of assessment for food contaminants (1)
Tolerable intake, expressed on a weekly basis (provisional tolerable weekly intake, PTWI)
“Irreducible level” - that concentration of a substance which cannot be eliminated from a food without involving the discarding of that food altogether, severely compromising the ultimate availability of food supplies

4. Endpoints of assessment for food contaminants (2)
Quantitative risk assessment - relationship between intake of a contaminant and the probability of an adverse response in humans

5. Provisional tolerable weekly intake (PTWI)
Expressed on a weekly basis to emphasize that long-term exposure is important (for contaminants that cumulate in the body)
Provides a “bright line” for the risk manager against which intake can be compared
Adverse effects are seen with many contaminants in the range of exposure for some population groups - difficult to separate risk assessment from risk management

6. Irreducible level
Often referred to as ‘ALARA’ - as low as reasonably achievable
Difficult for risk managers to use because health effects are not quantified
Creates difficulty for the Codex because of widely varying levels of contamination around the world, e.g. aflatoxins

7. Quantitative risk assessment
Determination of the relationship between intake and the probability of an adverse response is difficult with most contaminants because data are lacking
Performed with aflatoxin B1 at the forty-ninth meeting of JECFA in 1997
Although the PTWIs for lead and cadmium were retained by JECFA in 1999 and 2000, risk assessments were performed at these meetings to provide guidance to risk managers on potential risks posed by these heavy metals to at-risk groups

8. Aflatoxin B1
Animal toxicity data were evaluated - causes primary liver cancer in most species studied
Assessment was based on epidemiology studies, which found an association between consumption of food contaminated with aflatoxin B1 and liver cancer

9. Assessment of carcino-genicity of aflatoxin B1
Carcinogenic potency is enhanced in individuals with simultaneous hepatitis B infection
Carcinogenic potency of aflatoxin B1 was estimated in the presence and absence of hepatitis B surface antigen in the serum, which is an indicator of infection with the virus

10. Carcinogenic potency of aflatoxin B1
For persons negative for hepatitis B virus: 0.01 case per year/ people per ng of aflatoxin B1/kg body weight per day (range )
For persons positive for hepatitis B virus: 0.3 case per year/ people per ng of aflatoxin B1/kg body weight per day (range ); 30-fold higher than in the absence of hepatitis B surface antigen in the serum)

11. Population risks (1) Two examples
Level of contamination with aflatoxin B1 is low and proportion of population carrying hepatitis B is small (1% of the population)
Level of contamination with aflatoxin B1 is higher with a higher proportion of the population carrying the hepatitis B virus (25% of the population)

12. Population risks (2)
Estimates were based on food consumption data available at the international level
Estimates of contamination in the first example were based on monitoring data from Europe on aflatoxin B1 levels in groundnuts and maize and the “European” diet
Estimates of contamination in the second example were based on monitoring data from China on aflatoxin B1 levels in groundnuts and maize and the “Far Eastern” diet

13. Hypothetical standards
Population risks were calculated on the basis of two hypothetical standards
10 µg aflatoxin B1/kg groundnuts or maize
20 µg aflatoxin B1/kg groundnuts or maize
If the more stringent standard were used, more product would be removed from the market, and population risks should be lower

14. Low-risk group – potency
Assumes that 1% of the population carries the hepatitis B virus
Potency: 0.01 x 99% x 1% = cancers per year/ people per ng aflatoxin B1/kg body weight per day (range )

15. Low-risk group – intake
Intake of aflatoxins 20 µg/kg standard - 19 ng per person per day 10 µg/kg standard - 18 ng per person per day
Differences are small because the most highly contaminated samples have been removed in both cases

16. Low-risk group – population risks
20 µg/kg standard
(19 ng x 0.013)/60 kg bw = cancers per year per people (range )
10 µg/kg standard
(18 ng x 0.013)/60 kg bw = cancers per year per people (range )
Reducing the hypothetical standard from 20 to 10 µg/kg yields a reduction in estimated population risk by 2 cancers per year per billion people

17. Higher-risk group – potency
Assumes that 25% of the population carries the hepatitis B virus
Potency: 0.01 x 75% x 25% = cancers per year/ people per ng aflatoxin B1/kg body weight per day (range )

18. Higher-risk group – intake
Intake of aflatoxins 20 µg/kg standard ng per person per day 10 µg/kg standard ng per person per day
Differences are relatively small because the most highly contam-inated samples have been removed in both cases

19. Higher-risk group – population risks
20 µg/kg standard
(125 ng x 0.083)/60 kg bw = 0.17 cancers per year per people (range )
10 µg/kg standard
(103 ng x 0.083)/60 kg bw = 0.14 cancers per year per people (range )
Reducing the hypothetical standard from 20 to 10 µg/kg yields a reduction in estimated population risk by 300 cancers per year per billion people

20. Selected conclusions of JECFA
Vaccination against hepatitis B would reduce the potency of aflatoxins to vaccinated populations and thus the risk of liver cancer
Detectable differences in population risks are unlikely to be exhibited in going from a hypothetical standard of 20 to 10 µg/kg in populations with a low prevalence of hepatitis B in which the mean intake of aflatoxins is low

21. Use of potency estimates
Can be used world-wide because toxicity is an inherent property
Should be updated periodically by JECFA and/or other scientific committees to ensure that they are based upon the latest relevant information

22. Risk determination
Population risks at the international level can, at best, be indicative because precise information on intake is lacking
More precise risk estimates must be made at the national or local level, based on contamination levels and food consumption
Must be careful when using surveillance data because they may not provide a clear picture of the total food supply (may be targeting more heavily contaminated commodities)

23. Vulnerable population groups
JECFA identified carriers of hepatitis B virus as a vulnerable group
Carriers of hepatitis C are probably also at increased risk from consumption of products containing aflatoxin, but quantitative estimates could not be made

24. Population risks vs risks of vulnerable groups
JECFA provided sample calculations of population risks
Population risks can be performed at the national level, which would provide an overall estimate of risk in the country
Estimation of risks of vulnerable groups (carriers of hepatitis B) may be more appropriate at the national level, where a potency of 0.3 cancers per year/ population per ng aflatoxin B1/kg body weight per day is assumed

25. Further details
Report of the forty-ninth meeting of JECFA – WHO Technical Report Series No. 884, 1999
Toxicological and intake monograph on aflatoxins – WHO Food Additives Series No.40, 1998
Above documents are available from WHO Marketing and Dissemination (
Information on estimating intake of food contaminants may be obtained at

26. JECFA summary
Information on evaluations performed by JECFA is available in searchable HTML format at
Current through the forty-ninth meeting held in 1997
Updated approximately every two years