Safety evaluation of certain food additives - ipcs inchem

HYDROXY- AND ALKOXY-SUBSTITUTED BENZYL DERIVATIVES (addendum) 541
(i.e. 1800 μg/person per day for class I). However, these five flavouring agents, as
well as the other 47 flavouring agents evaluated previously and currently, are all
expected to be metabolized efficiently, and the available metabolic pathways would
not be saturated. Moreover, more than 90% of the potential combined intakes in
both Europe and the USA are accounted for by vanillin (No. 889), for which the
Committee had maintained the ADI of 0–10 mg/kg bw at its fifty-seventh meeting
(Annex 1, reference 154). The Committee noted that the potential combined intakes
do not exceed this ADI. Overall, the evaluation of the data indicated that combined
intake would not raise safety concerns.
1.6 Consideration of secondary components
The three flavouring agents of this group that are derivatives of vanillin
(Nos 1879, 1881 and 1882) have minimum assay values of less than 95%. However,
the major secondary component in each of these is vanillin (No. 889), for which an
ADI of 0–10 mg/kg bw per day has been allocated (Annex 1, reference 14) and
which the Committee concluded was of no safety concern at current estimated
levels of intake as a flavouring agent. Information on the safety of the secondary
component of this compound is summarized in Annex 5 (Summary of the safety
evaluation of secondary components for flavouring agents with minimum assay
values of less than 95%).
1.7 Conclusion
In the previous evaluations of substances in this group, studies of acute
toxicity, short-term studies of toxicity, long-term studies of toxicity and
carcinogenicity, and studies of genotoxicity and reproductive toxicity were available.
None raised safety concerns. The toxicity data available for this evaluation
supported those from the previous evaluations (Annex 1, reference 154).
The Committee concluded that these six flavouring agents, which are
additions to the group of hydroxy- and alkoxy-substituted benzyl derivatives
evaluated previously, would not give rise to safety concerns at the current estimated
levels of intake.
2. RELEVANT BACKGROUND INFORMATION
2.1 Explanation
This monograph summarizes key aspects relevant to the safety evaluation
of six hydroxy- and alkoxy-substituted benzyl derivatives, which are additions to a
group of 46 flavouring agents evaluated previously by the Committee at its fiftyseventh
meeting (Annex 1, reference 154).
1 Combined intake was calculated on a molar basis relative to the formation of a common
metabolite. In this instance, the common metabolite is 4-hydroxy-3-methoxy benzoic acid,
with a relative molecular mass of 168.15.