Scientific opinion on the re‐evaluation of dimethyl dicarbonate (DMDC, E 242) as a food additive

Abstract

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on dimethyl dicarbonate (DMDC, E 242) when used as a food additive. DMDC is authorised for the treatment of various beverages at a level of up to 250 mg/L. Once in solution, DMDC rapidly and fully hydrolysed (into carbon dioxide and methanol) and/or react with different constituents of beverages; the main identified reaction products are dimethyl carbonate (DMC), methyl ethyl carbonate (MEC) and methyl carbamate (MC). With no residue of DMDC remaining in the treated beverages ready for consumption, the risk resulting from DMDC use as a food additive was assessed by considering the exposure to methanol (a product of its hydrolysis) and to the main identified reaction products (DMC, MEC and MC). Taking into account several considerations (e.g. available toxicity database for the main identified reaction products, that the main identified reaction products belong to Cramer class I and the exposure to them remains below the threshold of toxicological concern (TTC) with one exception for MEC for high-level consumers), the Panel concluded that it was not possible to derive an ADI from the available toxicological database, there is no indication for a safety concern from the use of DMDC (E 242) as a food additive at its currently reported uses and use levels and that a new assessment would be warranted in case of any change in the conditions of use. However, some recommendations were proposed. The use of DMDC for treatment of beverages has been evaluated by the SCF (1992, 1997, 2001) and by JECFA (1991a,b). Both Committees found the treatment of non-alcoholic beverages toxicologically acceptable with a treatment level (as ingoing amount) of 250 mg/L for non-alcoholic beverages and 200 mg/L for wine. No acceptable daily intake (ADI) was allocated. © EuropeanDMDC is a very reactive substance and is used to inactivate microorganisms. In aqueous solution, DMDC rapidly (half-life between 15 and 20 minutes at 20°C) and fully decomposes into carbon dioxide and methanol, after which no antimicrobial effect remains. With no residue of DMDC remaining in the treated beverage ready for consumption, there is no exposure of the consumers to the substance as such. Therefore, the risk resulting from the use or DMDC as a food additive was assessed considering the main identified reaction products in treated beverages (dimethyl carbonate (DMC), methyl ethyl carbonate (MEC) and methyl carbamate (MC)) and the products of hydrolysis of DMDC (methanol and carbon dioxide). Biological and toxicological data were available for MC, MEC and DMC. Detailed analysis of the biological and toxicological data on methanol has been provided by the Panel on its opinion on the re-evaluation of aspartame as a food additive (EFSA ANS Panel, 2013a). Several DMDC-treated beverages have been tested as models for the evaluation of the toxicity of potential reaction products, which may result fr...

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