Efsa Publishes Opinion on Dimethyl Carbonate Use in FCMs

The European Food Safety Authority has published an opinion on the safety of dimethyl carbonate in "repeated-use" food contact materials.

Responding to a request from Germany’s Federal Office for Consumer Protection and Food Safety to assess a specific use in a polymer intended for FCMs, Efsa said there is no safety concern when the substance is:

used with 1,6-hexanediol in the manufacture of polycarbonate prepolymers. [This prepolymer is used at up to 30% to make a thermoplastic polyurethane with MDI (4,4'-methylenediphenyldiisocyanate) and diols, such as polypropylene glycol and 1,4-butanediol]; and

applied in repeated-use articles intended for contact with foods for which 3% acetic acid and 10% ethanol are specified as simulants and under contact conditions covered by simulation during 30 minutes at 40°C.

The German request referred to use in thermoplastic polyurethane containing 29% of the polycarbonate prepolymer. This polymer is intended for repeated-use articles with short-term contact (≤ 30 minutes) at room temperature for types of food, simulated by 10% ethanol and 3% acetic acid.

Efsa's panel on food contact materials, enzymes, flavourings and processing aids said other uses might result in different migrates, which need to be evaluated by the business operators.

"In such cases, the migration of Dimethyl Carbonate and total polycarbonate oligomers below 1,000 Da is of no safety concern, if each of them does not exceed 0.05mg/kg food," the panel said.

In May, Efsa issued guidance for applicants seeking to authorise substances for use in plastic FCMs. And, in the same month, the European Commission made changes to the Regulation on plastic FCMs and articles.