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.

Additive or PPA
Use as monomer/macromolecule
FRF applicable
SML (mg/kg)
5 mg/kg
Only to be used as a monomer in the production of polyethylene furanoate.

The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).

Notes on verification
V22 When used in contact with non-alcoholic foods for which Table 2 of Annex III assigns food simulant D1, food simulant C shall be used for verification of compliance instead of food simulant D1.

V23 When a final material/article containing this substance is placed on the market, a well described method suitable for use by a competent authority to determine oligomer migration compliance with the restrictions in column 10 Table 1 shall be part of the supporting document referred to in Art. 16. Reference shall be made if an adequate method is publicly available. If it requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.

Expressed As
As Furan-2,5-dicarboxylic acid