Safety evaluation of certain food additives

ANNEX 4
ACCEPTABLE DAILY INTAKES, OTHER TOXICOLOGICAL INFORMATION
AND INFORMATION ON SPECIFICATIONS
1.
FOOD ADDITIVES EVALUATED
Food additive
Specifications
a
Acceptable daily intake (ADI) and other
toxicological recommendations
Branching
glycosyltransferase from
Rhodothermus
obamensis expressed in
Bacillus subtilis
N
The Committee allocated an ADI “not
specified” for branching glycosyltransferase
from Rhodothermus obamensis expressed in
Bacillus subtilis used in the specified
applications and in accordance with Good
Manufacturing Practice.
Cassia gum
N, T
The Committee allocated an ADI “not
specified” for cassia gum that complies with the
tentative specifications established at the
current meeting, when used in the applications
specified and in accordance with Good
Manufacturing Practice.
The Committee decided to make the
specifications tentative pending submission of
data on a suitable and validated method for
determination of anthraquinones at a level of
0.5 mg/kg and below, by the end of 2010.
Cyclamic acid and its
salts (dietary exposure
assessment)
Of the four maximum use levels (250, 500, 750
and 1000 mg/kg) that the Committee
considered at the request of the Codex
Committee on Food Additives (CCFA) for
cyclamates in beverages covered by General
Standard for Food Additives (GSFA) Food
Category 14.1.4, only the lowest level of 250
mg/kg was not likely to lead to dietary
exposures exceeding the ADI for high
consumers, including children. Moreover, it
was noted that a maximum use level of 350 mg/
kg also resulted in dietary exposures for high
consumers, including children, that were less
than the ADI.
Cyclotetraglucose and
cyclotetraglucose syrup
R
(cyclotetraglucose
syrup)
The Committee removed the temporary
designation and established an ADI “not
specified” for cyclotetraglucose and
cyclotetraglucose syrup.
The specifications for cyclotetraglucose syrup
were revised, and the tentative designation
was removed.
Ferrous ammonium
phosphate
N
The newly available information on the toxicity
of iron did not indicate a need to revise the
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Food additive
Specifications
a
Acceptable daily intake (ADI) and other
toxicological recommendations
provisional maximum tolerable daily intake
(PMTDI) of 0.8 mg/kg body weight (bw).
Consideration of the toxicity of ammonium and
phosphate did not indicate a need to revise the
Committee’s previous evaluations of these
ions.
The Committee concluded that ferrous
ammonium phosphate is acceptable for use as
a source of iron for dietary fortification,
provided that the total intake of iron does not
exceed the PMTDI.
Products, including ferrous ammonium
phosphate, that are intended to provide a
source of additional iron should not be
consumed by individuals with any type of iron
storage disease, except under medical
supervision.
Glycerol ester of gum
rosin (GEGR)
N, T
The Committee decided to include GEGR in
the ADI for glycerol esters of wood rosin
(GEWR) of 0–25 mg/kg bw, thereby
establishing a group ADI of 0–25 mg/kg bw for
GEWR and GEGR.
The specifications for GEGR were made
tentative pending the submission of infrared
spectra that correspond to the commercially
available products, data on the resin acid
composition obtained with updated
chromatographic techniques and additional
information on methods that enable the
identification of the individual glycerol esters of
rosins and their differentiation. This information
should be submitted by the end of 2010.
Glycerol ester of tall oil
rosin (GETOR)
N, T
The Committee concluded in principle that the
data from GEWR could be used in the
evaluation of GETOR; however, the
Committee did not have adequate information
on the composition of GETOR, considering that
the source material and production processes
are different, which may result in different by-
products.
The Committee decided that it could not
evaluate GETOR without additional
information on its composition in order to clarify
the extent and significance of any differences
relative to other glycerol esters of rosins.
The specifications for GETOR were made
tentative pending the submission of infrared
spectra that correspond to the commercially

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