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.

Ref No.
Additive or PPA
Use as monomer/macromolecule
FRF applicable
SML(T) Group Restriction No
G26 Group Restriction No. 26 corresponds to FCM substance No. 728,729. Group restriction specification is expressed as the sum of the substances.
SML(T) Group FCM substances
SML(T) (mg/kg)
9 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 C9-C11 alcohols more than 90 % C10
Expressed As
As the sum of the substances

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