Statement of EFSA on risks for public health due to the presences of melamine in infant milk and other milk products in China
The European Food Safety Authority (EFSA) received a request on 19 September 2008 from the European Commission, Health and Consumers Directorate requesting urgent scientific advice on
the risks to human health due to the possible presence of melamine in composite food products imported from China into the European Union (EU). Considering the urgency of this request
for advice EFSA issued a statement following Art. 13 b of the “Decision concerning the establishment and operations of the scientific committee and panels” adopted by the
Management Board of EFSA on 11 September 2007.
In 2008, high levels of melamine in infant milk and other milk products have led to very severe health effects in Chinese children. The import of milk and milk products originating from
China is prohibited into the EU, however composite food products such as biscuits and chocolate, which could be made from contaminated milk powder, may have reached the EU. Therefore,
the European Commission has requested EFSA to provide scientific advice on the risk for human health related to presence of melamine in such composite foods.
The primary target organ for melamine toxicity is the kidney. There is uncertainty with respect to the time scale for the development of kidney damage. Thus, EFSA applied a tolerable
daily intake (TDI) of 0.5 mg/kg body weight (b.w.) in considering possible health effects which might occur with repeated consumption of melamine contaminated products over a relatively
EFSA was asked to consider health effects due to melamine exposure via the consumption of contaminated biscuits and confectionary. Based on available data, EFSA developed a number of
theoretical exposure scenarios for biscuits and chocolate containing milk powder both for adults and children. In the absence of actual data for milk powder, EFSA used the highest value
of melamine (approximately 2,500 mg/kg) reported in Chinese infant formula as a basis for worst case scenarios.
Based on these scenarios, estimated exposure does not raise concerns for the health of adults in Europe should they consume chocolates and biscuits containing contaminated milk powder.
Children with a mean consumption of biscuits, milk toffee and chocolate made with such milk powder would also not exceed the TDI. However, in worst case scenarios with the highest level
of contamination, children with high daily consumption of milk toffee, chocolate or biscuits containing high levels of milk powder would exceed the TDI. Children who consume both such
biscuits and chocolate could potentially exceed the TDI by more than threefold. However, EFSA noted that it is presently unknown whether such high level exposure scenarios may occur in