FCM and Articles Regulation, Annex I - Authorised Substances

Also referred to as the Plastics Implementation Measure (PIM), this Regulation provides the Union List of monomers and other substances authorized in the manufacture of food contact plastics.

dimethyl carbonate

EC / List no: 210-478-4 CAS no: 616-38-6
Additive or PPA
Use as monomer/macromolecule
FRF applicable
Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4'-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short-term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.
Notes on verification
V27 When a final material/article containing this substance, produced under conditions not described in (a) column10 Table1 is placed on the market, a method suitable for use by a competent authority to determine if oligomer migration complies with restrictions in (b) column10 Table1 shall be described in the supporting document referred to in Art.16. Reference shall be made if a method is publicly available. If it requires a calibration sample, a sufficient sample shall be supplied on its request.

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