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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poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)

EC / List no: - CAS no: 147398-31-0
FCM No
1059
Additive or PPA
no
Use as monomer/macromolecule
yes
FRF applicable
no
SML(T) Group Restriction No
G35 Group Restriction No. 35 corresponds to FCM substance No. 467,744,1059. Group restriction specification is expressed as crotonic acid.
SML(T) Group FCM substances
467,744,1059
SML(T) (mg/kg)
0.05 mg/kg
Restriction(s)
The substance is a macromolecule obtained from microbial fermentation. Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000Da shall not exceed 5.0 mg/kg food.
Notes on verification
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.
Expressed As
As crotonic acid