Posted by
yogibear on 2008-9-19 16:13
CONCLUSIONS
The Scientific Committee of Food (SCF) derived a tolerable daily intake (TDI) of 0.5
mg/kg body weight (b.w.) per day for melamine for food contact materials but no details
were given for its derivation. Recently the U.S. Food and Drug Administration (FDA)
derived a TDI of 0.63 mg/kg b.w. per day which is in line with the TDI derived by the
SCF. For melamine a specific migration limit of 30 mg/kg food was agreed by the SCF
assuming a maximum consumption of 1 kg food containing the substance for a 60 kg
person.
Based on the NOAEL for sodium cyanurate derived from the 2-year study in rats of 154
mg/kg b.w. per day, a TDI of 1.5 mg/kg b.w. per day can be proposed using an
uncertainty factor of 100.
There is a lack of toxicity data for ammeline and ammelide. Because of the structural
similarities to melamine these compounds have been assumed to be of equal potency.
In conclusion, EFSA provisionally recommends to apply a TDI of 0.5 mg/kg b.w. per
day for the total of melamine and its analogues (ammeline, ammelide, cyanuric acid).
Because of a lack of toxicity data in domestic animals, EFSA provisionally recommends
to apply this tolerable intake level as established for humans also to domestic animals.
A source of uncertainty is the combined toxicity of melamine and cyanuric acid and their
possible synergistic effects in relation to the recently observed toxicity linked to the acute
renal failure and death of pet animals (cats and dogs) in the U.S.
This mechanism is
currently under investigation.
Ocurrence data on melamine and its analogues in food and feed from Europe are needed
to
perform a comprehensive risk assessment.
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