Scientific Opinion on Melamine in Food and Feed

The European Food Safety Authority (EFSA) was asked by the European Commission to provide a scientific opinion related to the presence of melamine and the structural analogues (cyanuric acid, ammeline and ammelide) in food and feed. EFSA identified the potential sources of melamine and cyanuric acid in food that were not clearly related to incidences of adulteration, including food contact materials, and estimated the associated dietary exposure. Melamine does not exhibit systemic toxicity, but is able to complex with other substances such as endogenous uric acid or substances related to melamine to form crystals in the urine, which cause kidney damage. From the available toxicological data, a Tolerable Daily Intake (TDI) of 0.2 mg/kg body weight was established for melamine. Due to uncertainties in the exposure estimates, the human data related to adulteration in infant milk formula with melamine in 2008 were not considered to be sufficiently robust, to form the primary basis for the TDI, but provided supporting evidence for the TDI derived from animal studies. The exposure from background levels of melamine and cyanurate that can occur in food and feed from approved sources does not represent a risk to the human consumer or to animals. Exposure in children due to migration from food contact materials would be below or in the region of the TDI. The migration limit for melamine should be reconsidered in the light of the TDI taking into account all sources of exposure. The potential of melamine to form crystals is increased by concomitant exposure to cyanuric acid, and therefore the TDI is not appropriate for protection of consumer health in the presence of such concomitant exposure. This opinion does not consider the potential exposure to melamine and/or cyanurate that can arise from adulteration with these substances.