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.

Additive or PPA
Use as monomer/macromolecule
FRF applicable
SML(T) Group Restriction No
G7 Group Restriction No. 7 corresponds to FCM substance No. 19,20,1081. Group restriction specification is expressed as tertiary amine.
SML(T) Group FCM substances
SML(T) (mg/kg)
1.2 mg/kg
Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III.
Notes on verification
V30 There is a risk that migration limits may be exceeded; migration increases with the thickness of the plastic in which the substance is contained, and with a decreasing polarity of the polymer and a decreasing degree of esterification of the substance itself.
Expressed As
As tertiary amine