INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
SAFETY EVALUATION OF CERTAIN
FOOD ADDITIVES
WHO FOOD ADDITIVES SERIES: 42
Prepared by the Fifty-first meeting of the Joint FAO/WHO
Expert Committee on Food Additives (JECFA)
World Health Organization, Geneva, 1999
IPCS - International Programme on Chemical Safety
EVALUATION OF NATIONAL INTAKE ASSESSMENTS OF BUTYLATED HYDROXYTOLUENE
(BHT)
First draft prepared by
Dr Philippe Verger
Observatory of Food Consumption, Paris
1. INTRODUCTION
The Committee assessed the intake of butylated hydroxytoluene
(BHT), for which maximum limits have been proposed in a wide range of
solid foods in the draft General Standard for Food Additives (GSFA)
being developed by the Codex Committee on Food Additives and
Contaminants (CCFAC). An ADI of 0-0.3 mg/kg bw has been allocated to
BHT (Annex 1, reference 116).
BHT is generally used as an antioxidant in products containing
fats or oils. It can be use in conjunction with butylated
hydroxyanisole, tert-butylated hydroquinone, and propyl gallate,
providing a synergistic combination of antioxidants.
Information was provided by 10 countries: Australia, Brazil,
China, Finland, France, Japan, New Zealand, Spain, the United Kingdom,
and the United States. A combined assessment was provided by Australia
and New Zealand (Aus-NZ). The submitted intake assessments were based
on 'poundage', household economic surveys, sales data, model diets, or
individual dietary records. Table 1 summarizes the submissions.
Table 1. Summary of submissions on butylated hydroxytoluene
Country Budget Poundage FBS/HES/ Model Individual dietary
method data sales data diets records
Australia-New Zealand x x x
Brazil x x
China x x x
Finland x
France x x
Japan x
Spain x x x
United Kingdom x x x
United States x x
FBS, food balance sheet; HES, household economic survey; sales, retail stores
2. SCREENING OF BUTYLATED HYDROXYTOLUENE BY THE BUDGET METHOD
National submissions of intakes derived by the budget method
indicate whether BHT is used in solid foods. The Codex GSFA proposes
that BHT be permitted in a wide range of solid foods. Table 2
summarizes data for each country on the permitted patterns of BHT use,
the proportion of the solid food supply likely to contain BHT, the
maximum levels of BHT permitted, and a comparison of the levels with
the theoretical maximum level calculated by the budget method for that
country.
The theoretical maximum level of use for BHT in solid foods was
less than the national maximum permitted level of use in the four
countries that submitted data and was also less than the GSFA level of
1000 mg/kg. Detailed assessments of the intake of BHT from its use in
solid foods are therefore required.
3. ASSESSMENTS OF INTAKE OF BUTYLATED HYDROXYTOLUENE
3.1 Assessments based on data on poundage (disappearance)
Estimates of the amount of BHT available per capita based on
poundage data are given in Table 3 for five countries and compared
with the JECFA ADI of 0-0.3 mg/kg bw for BHT. The estimated intakes
are all lower than the ADI but vary from 0.003 to 0.11 mg/kg bw per
day (1-40% of the ADI) in recent studies. Results obtained by the
poundage method show a large decrease in use of this additive in the
United States between 1987 and 1995.
3.2 Assessments based on data from household economic surveys or
sales
Four countries submitted data based on household surveys or
sales, in which national maximum levels of use were assumed national
in each country. The data are summarized in Table 4. The estimated
intakes are all lower than the ADI, ranging from 0.052 mg/kg bw per
day in Brazil to 0.1 mg/kg bw per day in Spain (17 and 33% of the ADI,
respectively). Although high consumers generally cannot be identified
from household economic surveys or sales data, the submission from
France included estimates of high consumption derived by dividing
household consumption by the number of members and then estimating
high intake for individual consumers.
3.3 Assessments based on data from model diets
Five countries submitted data based on model diets, details of
which are summarized in Table 5. The results cannot be compared
directly because different assumptions were made. The model diets used
in Aus-NZ and the United Kingdom were constructed to estimate the BHT
intake of a high consumer, assuming a maximum permitted level of
additive. The United States model diet was constructed to predict the
BHT intake of 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 a three-day
national food consumption survey conducted in 1987-88 by the US
Department of Agriculture. Maximum additive levels were assumed. The
Japanese model diet (based on a total diet survey) included analysed
concentrations of food additives with national food consumption data
to derive an estimate of the actual BHT intake of the average
consumer.
The estimates of BHT intake based on the models of Aus-NZ and the
United Kingdom do not exceed the ADI when additive levels at the
national standards are assumed (0.02 and 0.09 mg/kg bw per day and 10
and 30% of the ADI, respectively), but largely exceed the ADI if GSFA
levels of use are assumed (5.3 and 6.0 mg/kg bw per day, respectively,
corresponding to 1800 and 2000% of the ADI). The last result is
consistent with estimates of BHT intake based on the Chinese and
United States models with the GSFA standard, which are 0.7 mg/kg bw
per day (230% of the ADI) and 0.99 mg/kg bw per day (330% of the ADI)
for average consumers and 4.4 mg/kg bw per day (1600% of the ADI) and
2.0 mg/kg bw per day (660% of the ADI) for high consumers,
respectively. When national standards for BHT are used in the United
States model, the ADI is also exceeded. The Japanese estimate of BHT
intake is much lower than those from other model diets because the
actual concentrations of BHT detected are used, which are much lower
than the maximum permitted levels.
3.3 Assessments based on individual dietary records
Estimates of the intake of BHT based on individual dietary
records were submitted by three countries. In each case, means and
percentiles were derived from individual intake estimates adjusted for
individual body weight (except in the United Kingdom). The assumptions
made in deriving these estimates and the estimates themselves are
summarized in Table 6. The estimates show that the intakes are lower
than the ADI for both mean and high consumers in all countries. The
estimates based on GSFA levels in Aus-NZ are higher than those based
on national levels of use and exceed the ADI for both mean (0.7 mg/kg
bw per day and 240% of the ADI) and high consumers (1.8 mg/kg bw per
day and 580% of the ADI).
Table 7 summarizes the results of intake assessments based on the
levels of use of the GSFA. The results for Aus-NZ, China, and the
United Kingdom are consistent in showing a potential to exceed the
ADI.
3.5 Food groups that are major sources of butylated hydroxytoluene
Assessment of intake based on GSFA levels of BHT, in conjunction
with the data on food consumption supplied by countries, points to
certain foods as major contributors to the overall intake of BHT. The
ADI would be exceeded when 90 g/day of any food containing more than
200 mg/kg BHT, 45 g/day of any food containing more than 400 mg/kg
BHT, or 18 g/day of any food containing more than 1000 mg/kg BHT was
ingested. Some of the GSFA levels are the result of a high permission
for one type of food within a food grouping which drives the permitted
use level for the whole group to an unlikely high level. This is the
case for edible fats and oils (75-200 mg/kg), confectionery (200-750
mg/kg), and frozen fish, fish fillets, and fish products (100-1000
mg/kg).
4. EVALUATION OF ESTIMATES OF INTAKE OF BUTYLATED HYDROXYTOLUENE
Screening of BHT by the budget method indicated that use of BHT
as an additive requires further assessment. Inclusion of national
proportions of the food supply that may contain BHT in the budget
method of screening did not change this decision.
Estimates of the intake of BHT were submitted by 10 countries.
All of the estimates based on model diets or individual consumption
data combined with GSFA levels of use show that the ADI is
consistently exceeded. The mean intake is estimated to be between 0.70
and 0.99 mg/kg bw (230 and 240% of the ADI for China and the United
States), and the intake of high consumers is estimated to be 2.0-6.0
mg/kg bw (690-2000% of the ADI).
Intake estimates based on national levels of use are relatively
consistent, ranging from 0 to 0.11 mg/kg bw per day (0-30% of the ADI)
on the basis of poundage, 0.052-0.1 mg/kg bw per day (20-40% of the
ADI) on the basis of household surveys or sales data, 0.02-0.09 mg/kg
bw per day (10-30% of the ADI) on the basis of model diets and
national levels of use (except for the United States), and 0.02-0.1
mg/kg bw per day (0.1-30% of the ADI) on the basis of individual
consumption data.
Two exceptions must be noted. The first is estimates for mean and
high consumption based on a model diet and authorized levels of use in
the United States (0.39 and 0.78 mg/kg bw per day and 130 and 260% of
the ADI, respectively). This result can be explained by the high
levels of BHT authorized in that country. The second is the low
estimate (0.00089 mg/kg bw per day or 0.003% of the ADI) in the study
provided by Japan, which is based on the concentrations of BHT found
in a total diet survey.
5. CONCLUSIONS AND RECOMMENDATIONS
The Committee recognized that the ADI for BHT is unlikely to be
exceeded on the basis of the estimated intakes in the 10 countries for
which data were available but that it might be exceeded when the
proposed maximum limits in the GSFA are assumed.
The Committee recognized that BHT is likely to be used in
conjunction with other antioxidants, such as tert-butylated
hydroquinone and butylated hydroxyanisole, which act synergistically
with BHT. Consequently, the amount of BHT used in practice will be
lower and it will be used in fewer foods than assumed in the
estimates. All of the estimates except that from Japan are based on
the assumption that BHT is the only antioxidant in foods where use is
permitted and that all such foods contain it at maximum permitted
levels. The actual intakes of BHT will depend on the relative
proportions of antioxidants used in foods and on the proportion of
foods in any one category that contains the additive.
Recommendations to the Codex Committee on Food Additives and
Contaminants
The Committee identified certain food groups that could
potentially contribute to a high intake of BHT. The Codex Committee
may wish to review the appropriate levels of BHT in the following food
groups: category 2.1, 'edible oils and fats'; category 9.2, 'fish and
fish products'; and category 5.3, 'chewing gum'.
6. BIBLIOGRAPHY
Australia New Zealand Food Authority (1997) Aus-NZ Food Standards
Code, Canberra.
Baines, J. Data sheets for Australia for TBHQ, BHA, BHT, sulfites, and
benzoates. Personal communication. Australia-New Zealand Food
Authority, Canberra, to J. Paakkanen, FAO, 5 January 1998.
Chen Junshi. Food additive intake from China. Personal communication.
Chinese Academy of Preventive Medicine, Beijing, to J. Paakkanen, FAO,
16 March 1998.
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).
Codex Committee on Food Additives and Contaminants (1998)
Consideration of the Codex General Standard for Food Additives:
Proposed draft revised annex A at step 3. Request for comments and
information. Rome, Food and Agriculture Organization of the United
Nations (document CX/FAC 98/9).
European Commission (1995) European Union Directive 95/2/CE, Brussels.
Fisher, C.E. Dietary exposure in the United Kingdom to the five
additives referred to JECFA by CCFAC. Personal communication. Joint
Food Safety and Standards Group, London, to J. Paakkanen, FAO, 29
April 1998.
Ishii, K. Use levels and intake estimates of certain food additives in
Japan. Personal communication. Japan Food Additives Association,
Tokyo, to J. Paakkanen, FAO, 10 May 1998.
Table 2. Estimation of theoretical maximum level for butylated hydroxytiluene (BHT) by the budget method
Country % food supply National maximum GSFA maximum Theoretical maximum
containing BHT level (mg/kg) levela (mg/kg) level (mg/kg)
Australia-New Zealand 50 70 1000 24
Brazil 25 200 1000 48
China 20 200 1000 60
Spain 5 400 1000 240
GSFA, General Standard for Food Additives
a Maximum use level proposed is 1000 mg/kg for 9.2.1, 'frozen fish, fish fillet and fish products,
including molluscs, crustacea and echinoderms'.
Table 3. Estimates of intake of butylated hydroxytoluene (BHT) based on
poundage data
Country Date Consumers Estimated intake of % ADIa
(millions) BHT (mg/kg bw per day)
China 1992 1200 0.016 5
70% of total population
Finland 1980 4.9 0 0
1994 5.1 0 0
Spain ? 0.07 23
85% of total population
United Kingdom 1984-86 56 0.003 1
United Statesb 1987 240 0.056 (mean) 19
0.11 (90th percentile) 37
1995 260 0.023 (mean) 7
0.046 (90th percentile) 14
a JECFA ADI, 0-0.3 mg/kg bw
b Assuming that 100% of consumers ingest BHT and that the intake for 90th
percentile consumers is twice the mean
Table 4. Estimates of intake of butylated hydroxytoluene (BHT) based on household economic surveys and sales data
Country Date Survey Assumptions Estimated intake % ADIa
of BHT (mg/kg bw
per day)
Brazilb 1992-96 AC Nielsan Brazil; Maximum national use levels for all foods 0.052 17
sales data
1984-94 Datamark Maximum national use levels for all foods 0.08 26
France Sales data Maximum European Union levels of use 0.089 30
Adjustment for catering outside the home
Spain 1993 Household survey All foods in permitted groups contain BHT 0.1 33
a JECFA ADI, 0-0.5 mg/kg bw
b Assumed maximal level in final coconut and chewing gum products even though the use level in coconut is based on 60% fat
content and that in chewing gum is based on 20% gum content, resulting in overestimates of BHT intake
Table 5. Model diets used to estimate intake of butylated hydroxytoluene (BHT)
Country Date Survey Assumptions Model BHT intake % ADIa
(mg/kg bw
per day)
Aus-NZ 1983 National, 24-h recall; Two models: Aus-NZ/GSFA High consumerb/ 0.02 10
adults, 25-64 years; -- maximum levels (Aus-NZ or GSFA) Aus-NZ permissions
sample, 6254 -- 95th percentile high consumption level High consumerb/ 5.3 1800
-- modified GSFA classification system Aus-NZ permissions
China 1992 National household survey, One model Average consumer/ 0.7 230
24-h recall; 30 provinces; -- maximum GSFA levels GSFA permissions
sample, 91 818 High consumer/ 4.9 1600
GSFA permissions
Japan 1994 National nutrition intake One model: Japan Average consumer 0.00085 0.003
survey -- Analysed food additive concentrations levels/measured BHT
(zero values when not detected)
United 1986-87 National; 7-day weighed Three models: UK adult/child, GSFA High consumerb/ 0.09 30
Kingdom record; adults, 16-64 years -- maximum additive levels (EU) UK permissions/adult
-- unit quantity diet (Codex model with High consumerb/ 0.17 60
GSFA levels) UK permissions/child
1992 National; 7-day weighed -- 97.5th percentile high consumption High consumerb/ 6.0 2000
record; children, 1.5-4.5 level (UK adult/child models) GSFA permissions
years -- GSFA classification system
United 1982-88 14-day menu obtained Two models: US and GSFA Long-term consumer/USA 0.39 130
States from MRCA food -- maximum additive levels (US or GSFA) permissions/mean
frequency data (1982-87) -- 90th percentile high consumption level Long-term consumer/USA 0.78 260
combined with portion twice mean consumption permissions/90th
sizes from USDA/NFCS -- all respondents are consumers percentile 0.99330
(1987-88); > 2 years -- GSFA classification system Long-term consumer/GSFA
permissions/mean
Long-term consumer/GSFA 2.0 660
permissions/90th
percentile
Table 5 (continued)
Aus-NZ, Australia-New Zealand; GSFA, General Standard for Food Additives; EU, European Union; MRCA, Market Research Corporation of America;
USDA/NFCS, US Department of Agriculture/National Food Consumption Survey
a JECFA ADI, 0-0.3 mg/kg bw
b Assumed to consume one food with potentially highest BHT intake from two major food groups at the 97.5th percentile (United Kingdom) or
95th percentile (Aus-NZ) and from one food with potentially highest BHT intake from each of the other major food groups at a mean level
for all respondents
Table 6. Estimates of intake of butylated hydroxytoluene (BHT) based on individual records
Country Date Survey Model BHT intake % ADIa
(mg/kg bw
per day)
Aus-NZ 1983 National survey; Mean intake (population = consumers) Aus-NZ 0.02 7
24-h recall; Mean (population = consumers) GSFA 0.7 240
adults, 25-64 years; 95th percentile (consumers) Aus-NZ 0 0
sample, 6254 95th percentile (consumers) GSFA 1.8 580
France 1993-94 National survey; Mean intake (population) EU 0.033 11
7-day record; 90th percentile EU 0.071 24
5-75 years; 95th percentile EU 0.089 30
sample, 1116 Corrected mean intake (population) EU 0.001 00.3
United Kingdom 1986-87 National survey; Mean intake (population = consumers) EU 0.04 13
7-day weighed 97.5th percentile (consumers) EU 0.1 33
record; adults,
16-64 years;
sample, 3000
Aus-NZ, Australia-New Zealand; GSFA, General Standard for Food Additives; EU, European Union
a JECFA ADI, 0-0.3 mg/kg bw
Table 7. Summary of estimates of intake of butylated hydroxytoluene (BHT) based on additive levels permitted within
the General Standard for Food Additives
Country Model Intake of BHT % ADIa
mg/person per day mg/kg bw per day
Australia-New Zealand Individual records, mean intake 51 0.85 240
Individual records, 95th percentile consumers 125 2.1 690
China Model diet, mean intake 41 0.7 230
Model diet, high consumers 290 4.9 1600
United States MRCA, mean intake 59 0.99 330
MRCA, pseudo-90th percentile consumers 120 2.0 660
MRCA, Market Research Corporation of America
a JECFA ADI, 0-0.3 mg/kg bw
Ishiwata, H., Nishijima, M., Fukasawa, Y., Ito, Y. & Yamada, T. (1997)
Evaluation of the contents of BHA, BHT, propylene glycol, and sodium
saccharin in foods and estimation of daily intake based on the results
of official inspection in Japan in fiscal year 1994. J. Food Hyg.
Soc. Jpn, 39, 89-100.
Ministry of Public Health (Spain) (1998) Calculation of certain food
additives in Spain. Submitted to FAO.
National Food Administration (Finland) (1998) Estimated intake of
certain food additives in Finland. Submitted to FAO.
Rulis, A.M. United States intake data on BHA, BHT, TBHQ, sulfites, and
benzoates. Personal communication. Food and Drug Administration,
Washington DC, to J. Paakkanen, FAO, 24 February 1998.
Toledo, M.C.F. Brazilian intake estimates of BHA, BHT, and TBHQ.
Personal communication. University of Campinas, to J. Paakkanen, FAO,
26 February 1998.
United States Department of Agriculture (1996) Nationwide food
consumption survey: 1989-91. Technical Information Service,
Springfield, VA, United States.
Verger, P. Estimation of the theoretical maximum intake of certain
food additives in France. CNERNA, Paris. Submitted to J. Paakkanen,
FAO, 16 March 1998.
See Also:
Toxicological Abbreviations
Butylated hydroxytoluene (BHT) (WHO Food Additives Series 15)
Butylated hydroxytoluene (BHT) (WHO Food Additives Series 18)
Butylated hydroxytoluene (BHT) (WHO Food Additives Series 28)
Butylated Hydroxytoluene (BHT) (IARC Summary & Evaluation, Volume 40, 1986)