FCM and Articles Regulation, Annex I - Authorised Substances

This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

dimethyl carbonate

ecnumber: 210-478-4 casnumber: 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.