Scientific Opinion on Melamine in Food and Feed

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Article
Acknowledgements

The Panel wishes to thank the members of the Working Group on melamine in food for the preparation of this opinion: David Bell (December 2009), Diane Benford, Laurence Castle, Daniel Doerge, Lutz Edler, Johanna Fink-Gremmels, Helle Katrine Knutsen, Wim Mennes and EFSA’s staff members Davide Arcella, Jean Lou Dorne, Marc Vandenbroeck, and Francesco Vernazza for the support provided to this EFSA scientific output.

Panel on Contaminants in the Food Chain
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2010; 8(4):1573 [145 pp.].
doi
10.2903/j.efsa.2010.1573
Panel members at the time of adoption
CONTAM Panel members: Jan Alexander, Diane Benford, Alan Boobis, Sandra Ceccatelli, Jean-Pierre Cravedi, Alessandro Di Domenico, Daniel Doerge, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Metka Filipič, Johanna Fink-Gremmels, Peter Fürst, Thierry Guerin, Helle Katrine Knutsen, Miroslav Machala, Antonio Mutti, Josef Schlatter and Rolaf van Leeuwen. CEF Panel members: Arturo Anadon, David Bell, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertle, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldra, Rosemary, Waring, Detlef Wölfle.
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2009-00234
EFSA-Q-2009-00235
Adopted
18 March 2010
Published
13 April 2010
Last Updated
16 April 2010. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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.

Keywords
Melamine (CAS No 108-78-1), cyanuric acid (CAS No. 108-80-5), food, feed, occurrence, risk assessment, toxicity, tolerable daily intake (TDI).
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Number of Pages
145