plastic-material-food-contact
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
| FCM No |
283
|
|
| Ref No. |
74640
|
|
| Additive or PPA |
yes
|
|
| Use as monomer/macromolecule |
no
|
|
| FRF applicable |
no
|
|
| SML(T) Group Restriction No |
G36 Group Restriction No. 36 corresponds to FCM substance No. 157,159,283,1085. Group restriction specification is expressed as DEHP equivalents using the following equation: DBPx5 + DIBPx4 + BBPx0.1 + DEHPx1.
|
|
| SML(T) Group FCM substances |
157,159,283,1085
|
|
| SML(T) (mg/kg) |
0.6 mg/kg
|
|
| Restriction(s) |
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)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.
|
|
| Notes |
eupn3 Diisobutyl phthalate, FCM No 1085, with synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or ‘DIBP’ and CAS number 84-69-5 is not listed as an authorised substance in Table 1. However, it may co-occur with other phthalates as a consequence of its use as an aid to polymerisation and is included in group restrictions with the assignment FCM No 1085
|
|
| Expressed As |
As DEHP equivalents using the equation: DBPx5+DIBPx4+ BBPx0.1+DEHPx1
|