plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorized Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation (EU) 2023/1627, OJ L 201, 11 August 2023

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.

RELEVANT LEGISLATION
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furan-2,5-dicarboxylic acid

EC / List no: 221-800-8 CAS no: 3238-40-2
FCM No
1031
Additive or PPA
no
Use as monomer/macromolecule
yes
FRF applicable
no
SML (mg/kg)
5 mg/kg
Restriction(s)
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.