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
EVALUATION OF NATIONAL ASSESSMENTS OF INTAKE OF CANTHAXANTHIN
First draft prepared by M. DiNovi
Division of Product Manufacture and Use, Office of Premarket Approval,
Center for Food Safety and Applied Nutrition, United States Food and
Drug Administration, Washington DC, United States
Introduction
Assessments of intake of canthaxanthin
Assessments based on data on poundage (disappearance)
Assessments based on model diets
Assessments based on individual dietary records
Evaluation of estimates of intake of canthaxanthin
Conclusions and recommendations
Bibliography
1. INTRODUCTION
The Committee evaluated the toxicity of canthaxanthin, a food
additive used to colour foods both directly and also indirectly
through its use in animal feeds, at its tenth, eighteenth,
thirty-first, thirty-fifth, and forty-fourth meetings (Annex 1,
references 13, 35, 77, 88, and 116). It established an ADI of 0-25
mg/kg bw at its eighteenth meeting, which it reduced to 0-0.05 mg/kg
bw and made temporary at its thirty-first meeting. This temporary ADI
was not extended by the Committee at its thirty-fifth meeting. At its
forty-fourth meeting, the Committee established an ADI of 0-0.03 mg/kg
bw. The present Committee assessed the intake of canthaxanthin.
Maximum limits have been proposed for its use in a variety of solid
foods and beverages in the draft General Standard for Food Additives
(GSFA) being established by the Codex Committee on Food Additives and
Contaminants.
Four member countries provided information on the intake of
canthaxanthin: Australia, New Zealand, the United Kingdom, and the
United States. Information was also provided by a manufacturer of
canthaxanthin. A joint assessment was submitted by Australia and New
Zealand. The intake assessments were based on 'poundage' data, model
diets, and individual dietary records. A summary of the data
submissions is given in Table 1.
2. ASSESSMENTS OF INTAKE OF CANTHAXANTHIN
2.1 Assessments based on data on poundage (disappearance)
In the United Kingdom, the recorded poundage for canthaxanthin is
0, indicating that there is no direct use of the colour as an
additive. In the United States, disappearance data for 1987 were used
to estimate a per capita poundage of canthaxanthin of 0.0002 mg/kg bw
per day and a 'pseudo-90th percentile' intake of 0.0004 mg/kg bw per
day, representing approximately 1% of the ADI. This estimate is based
on the assumption that the reported poundage represented only 60% of
the amount which actually disappeared and was corrected for presumed
underreporting. An extensive report provided by the producer on the
poundages of canthaxanthin that disappeared in 1995-97 in 75 countries
in which canthaxanthin is used directly and indirectly presents
analyses that take into account the deposition of canthaxanthin in
foods from its indirect use in feed, primarily in eggs, fish, and
poultry. The report also describes imports and exports of
canthaxanthin, where appropriate. In none of the 75 countries does the
per capita intake estimated on this basis approach the ADI. The
highest estimated per capita intakes during 1995-97 were in Portugal
and Norway, representing approximately 7 and 8% of the ADI,
respectively.
Table 1. Summary of submissions on canthaxanthin
Country or company Budget Poundage FBS/HES/ Model Individual
method data sales data diets dietary
records
Australia-New Zealand ×
F. Hoffman-La Roche ×
United Kingdom × ×
United States × × ×
FBS, food balance sheet; HES, household economic survey; sales, retail stores
2.2 Assessments based on model diets
The United States submitted analysis of canthaxanthin intake
based on model diets. For proper interpretation of such analyses, the
assumptions on which they are based must be clearly stated. In this
case, the model diet was constructed to predict the canthaxanthin
intake of an average and a 90th percentile consumer and was completed
by combining food consumption data derived from a 14-day food
frequency survey made during 1982-88 by the Market Research
Corporation of America with average portion sizes from a three-day
national food consumption survey conducted in 1987-88 by the US
Department of Agriculture. The levels of use of canthaxanthin proposed
in the draft GSFA were used for all food categories.
The analysis yielded a mean estimate of intake of canthaxanthin
of 0.27 mg/kg bw per day, representing 900% of the ADI, and an
estimated intake at the 90th percentile of 0.54 mg/kg bw per day,
1800% of the ADI. It should be noted that the conservative assumption
was made in this analysis that all the canthaxanthin used in animal
feed indirectly colours food and is transferred to consumed animal
products.
2.3 Assessments based on individual dietary records
Three countries submitted analyses of canthaxanthin intake based
on individual dietary records (Table 2). The combined Australia-New
Zealand analysis was based on food intake data from a one-day recall
survey of 13 858 individuals and proposed GSFA use levels, as there
are no permitted direct uses for canthaxanthin in Australia. When the
level of use proposed in the GSFA was reported as that concordant with
good manufacturing practice, a level of zero was assumed. Further, it
was assumed that canthaxanthin coloured any food in which it occurred
and that the average weight of a consumer is 67 kg.
In the analysis completed in the United Kingdom, 97.5th
percentile food intakes from two surveys--a survey of adults in 1990
and one of children in 1995--were combined with the maximum reported
or theoretically possible concentrations in eggs, poultry, salmon, and
trout. Actual body weights were used in the calculations.
The analysis supplied by the United States was based on food
intakes from a three-day recall survey combined with reported or
allowable levels of use of canthaxanthin in five broad food
categories. Actual body weights were used.
When national measured or regulatory levels of use of
canthaxanthin are combined with mean food intakes, the estimated
intake is equal to or below the ADI, but analyses of estimated intakes
at the 90th, 95th, or 97.5th percentile exceed the ADI. Use of the
draft GSFA maximum use levels results in estimates of intake that
greatly exceed the ADI.
3. EVALUATION OF ESTIMATES OF INTAKE OF CANTHAXANTHIN
The data submitted show that canthaxanthin is rarely used
directly for colouring food anywhere in the world, but is primarily
used to colour the meat of poultry, salmon, and trout and the yolks of
eggs indirectly through animal feeds. Therefore, estimates of intake
that are based on procedures used to determine intake of direct
additives will necessarily result in overestimation of probable
intake.
The submission of the producing company provided a comprehensive
picture of the actual use of and resulting intake of canthaxanthin. In
no country does the estimated per capita intake approach the ADI if
account is taken of the amount of canthaxanthin that is deposited in
animal flesh when it is used in animal feed Additionally, since the
highly conservative national estimates of intake at mean consumption
levels do not exceed the ADI, assurance is provided that long-term
intake of canthaxanthin is unlikely to exceed the ADI. The Committee
concluded that per capita estimates are appropriate, as the foods that
are indirectly coloured by canthaxanthin are primary components of
most diets and would probably be consumed by a large percentage of the
population.
Table 2. Estimates of intake of canthaxanthin based on individual dietary records
Country Date Survey Assumptions Model Intake % ADIa
(mg/kg bw
per day)
Australia- 1985 National nutrition - maximum additive levels (GSFA) Mean intake (all 0.44 1470
New Zealand survey; 24-h - modified GSFA classification respondents) GSFA 0.46 1530
recall; 2- > 70 system Mean intake 2.11 7030
years; sample, - maximum additive level within (consumers) GSFA
13 858 any one group 95th percentile
- reports 95th percentile (consumers) GSFA
consumption
- intakes adjusted for
individual body weight
United 1990, Dietary and 97.5th percentile intake National adult use 0.01 30
Kingdom 1995 nutritional survey levels 0.04 130
of British adults, National use by
National Diet and children aged 1-4
Nutrition Survey,
children
United 1989- 48 states and - national use levels Mean 0.031 100
States 92 Washington DC; - eaters only 90th percentile 0.11 370
3-day recall;
all age groups;
sample, 11 912
GSFA, General Standard for Food Additives
a JECFA ADI, 0-0.3 mg/kg bw
4. CONCLUSIONS AND RECOMMENDATIONS
The Committee noted that estimates of the intake of canthaxanthin
that are based on the assumption that it is used directly in all foods
at the maximum levels proposed in the draft General Standard for Food
Additives greatly exceed the ADI, as the General Standard proposes
much broader use in food than occurs in those countries in which
canthaxanthin is used. Intake based on national data did not exceed
the ADI. The data submitted by the manufacturer indicated that
indirect exposure to canthaxanthin from its use as a feed colourant is
the major source of intake.
The Committee concluded that use of canthaxanthin will not result
in long-term intake that exceeds the ADI.
5. BIBLIOGRAPHY
Baines, J. Estimated intake assessment for canthaxanthin in Australia.
Personal communication. Australia-New Zealand Food Authority,
Canberra, to FAO, January 1999.
Fisher, C.E. Dietary exposure to the four additives referred to JECFA
by CCFAC. London: Ministry for Agriculture, Fisheries and Food, Joint
Food Safety and Standards Group. Submitted to FAO, 22 December 1998.
F. Hoffmann-LaRoche Ltd. Canthaxanthin intake 1995-1997. A poundage
approach for evaluation by JECFA. April 1999. Submitted to WHO by F.
Hoffmann-LaRoche Ltd, Basel, Switzerland.
Rulis, A.M. United State intake data on canthaxanthin. Food and Drug
Administration, Washington DC, submitted to FAO, 10 December 1998.
Verger, P. Estimation of the theoretical maximum intake for certain
food additives in France, Observatory of Food Consumption, Paris.
Personal communication, submitted to FAO, 1 June 1999.