FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

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.

Ref No.
Additive or PPA
Use as monomer/macromolecule
FRF applicable
SML(T) Group Restriction No
G32 Group Restriction No. 32 corresponds to FCM substance No. 8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815. Group restriction specification is expressed as the sum of the substances.
SML(T) Group FCM substances
SML(T) (mg/kg)
60 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Notes on verification
V7 If testing in food is performed, Annex V 1.4 shall be taken into account.
Group name
phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9
Expressed As
As the sum of the substances