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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FCM No
790
Ref No.
80480
Additive or PPA
yes
Use as monomer/macromolecule
no
FRF applicable
no
SML (mg/kg)
5 mg/kg
Restriction(s)
Average molecular weight not less than 2400 Da.

Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.

Notes on verification
V16 There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) containing more than 0.3 % w/w of the substance when in contact with fatty foods.