Safety evaluation of certain food additives - ipcs inchem

264 INTRODUCTION
Figure 1. Procedure for the Safety Evaluation of Flavouring Agents
1. Determine structural class
2. Can the substance be predicted to be metabolized to innocuous products?
A Yes No B
Yes
B3. Do the conditions of use result in an
intake greater than the threshold of
concern for the structural class?
A3. Do the conditions of use result in an
intake greater than the threshold of
concern for the structural class?
No
No
Yes
Data must be available on
the substance or a closely
related substance in order
to perform a safety
evaluation
Yes
B4. Does a NOEL exist for the substance that
provides an adequate margin of safety under
conditions of intended use, or does a NOEL
exist for structurally related substances that
is high enough to accommodate any perceived
difference in toxicity between the substance
and the related substance?
A4. Is the substance or are its
metabolites endogenous?
Substance would not
be expected to be of
safety concern
No
Yes
No
B5. Do the conditions of use result in an
intake greater than 1.5 μg/day?
A5. Does a NOEL exist for the substance
that provides an adequate margin of
safety under conditions of intended use,
or does a NOEL exist for structurally
related substances that is high enough
to accommodate any perceived difference
in toxicity between the substance and the
related substances?
Yes
No
Substance would not
be expected to be of
safety concern
No Yes
Additional data required
Substance would not
be expected to be of
safety concern