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.

FCM No
729
Ref No.
75105
Additive or PPA
yes
Use as monomer/macromolecule
no
FRF applicable
no
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
728,729
SML(T) (mg/kg)
1.8 mg/kg
Restriction(s)
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.
Expressed As
As the sum of the substances

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Group members
This group of substance has the following member substances:
Results list is empty
Name EC / List no. CAS no. Association
Bis(2-methyldecyl) phthalate 288-643-5 85851-83-8 Expert judgement
3-ethylheptyl 6-methyloctyl phthalate 288-639-3 85851-80-5 Expert judgement
Bis(2-propylheptyl) phthalate 258-469-4 53306-54-0 Expert judgement
2,5-dimethylheptyl 4-methyloctyl phthalate 288-635-1 85851-76-9 Expert judgement
4-methyloctyl 6-methyloctyl phthalate 288-637-2 85851-78-1 Expert judgement
Bis(3-ethylheptyl) phthalate 286-806-5 85391-51-1 Expert judgement
Bis(6-methyloctyl) phthalate 286-803-9 85391-49-7 Expert judgement
Isodecyl isononyl phthalate 285-916-0 85168-75-8 Expert judgement
Bis(3,5,5-trimethylhexyl) phthalate 237-954-4 14103-61-8 Expert judgement
Bis(4-methyloctyl) phthalate 286-804-4 85391-50-0 Expert judgement
Bis(8-methylnonyl) phthalate 201-884-2 89-16-7 Expert judgement
Di-''isodecyl'' phthalate 247-977-1 26761-40-0 Expert judgement
Di-''isononyl'' phthalate 249-079-5 28553-12-0 Expert judgement
3-ethylheptyl 2,5-dimethylheptyl phthalate 307-707-6 97692-55-2 Expert judgement
3-ethylheptyl 4-methyloctyl phthalate 288-638-8 85851-79-2 Expert judgement
Diisoundecyl phthalate 306-165-8 96507-86-7 Expert judgement
Isodecyl isoundecyl phthalate 305-701-8 94979-22-3 Expert judgement
Bis(2-ethyloctyl) phthalate 288-640-9 85851-81-6 Expert judgement
Bis(2,5-dimethylheptyl) phthalate 286-802-3 85391-48-6 Expert judgement
Bis(2-methyloctyl) phthalate 274-944-9 70857-56-6 Expert judgement
Bis(2-propyloctyl) phthalate 288-645-6 85851-85-0 Expert judgement
Bis(2-ethylnonyl) phthalate 288-641-4 85851-82-7 Expert judgement
Bis(2-ethylheptyl) phthalate 274-344-7 70152-36-2 Expert judgement
Bis(2-propylhexyl) phthalate 288-644-0 85851-84-9 Expert judgement
2,5-dimethylheptyl 6-methyloctyl phthalate 288-636-7 85851-77-0 Expert judgement
Isononyl isoundecyl phthalate 285-920-2 85168-79-2 Expert judgement