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
phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10
EC / List no: - CAS no: -FCM No |
729
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Ref No. |
75105
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Additive or PPA |
yes
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Use as monomer/macromolecule |
no
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FRF applicable |
no
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SML(T) Group Restriction No |
G32 Group Restriction No. 32 corresponds to FCM substance No. 8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815,1078,1085. Group restriction specification is expressed as the sum of the substances (plasticisers).
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SML(T) Group FCM substances |
8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815,1078,1085
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SML(T) (mg/kg) |
60 mg/kg
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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.
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Notes on verification |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account.
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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
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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(2,5-dimethylheptyl) phthalate | 286-802-3 | 85391-48-6 | Expert judgement |
Isodecyl isoundecyl phthalate | 305-701-8 | 94979-22-3 | Expert judgement |
Di-''isononyl'' phthalate | 249-079-5 | 28553-12-0 | Expert judgement |
3-ethylheptyl 4-methyloctyl phthalate | 288-638-8 | 85851-79-2 | Expert judgement |
3-ethylheptyl 6-methyloctyl phthalate | 288-639-3 | 85851-80-5 | Expert judgement |
Bis(2-ethylnonyl) phthalate | 288-641-4 | 85851-82-7 | Expert judgement |
Bis(2-propylheptyl) phthalate | 258-469-4 | 53306-54-0 | Expert judgement |
Bis(6-methyloctyl) phthalate | 286-803-9 | 85391-49-7 | Expert judgement |
Bis(8-methylnonyl) phthalate | 201-884-2 | 89-16-7 | 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(2-propylhexyl) phthalate | 288-644-0 | 85851-84-9 | Expert judgement |
Diisoundecyl phthalate | 306-165-8 | 96507-86-7 | Expert judgement |
Bis(4-methyloctyl) phthalate | 286-804-4 | 85391-50-0 | Expert judgement |
Di-''isodecyl'' phthalate | 247-977-1 | 26761-40-0 | Expert judgement |
2,5-dimethylheptyl 6-methyloctyl phthalate | 288-636-7 | 85851-77-0 | Expert judgement |
Isodecyl isononyl phthalate | 285-916-0 | 85168-75-8 | Expert judgement |
Bis(2-ethylheptyl) phthalate | 274-344-7 | 70152-36-2 | Expert judgement |
Isononyl isoundecyl phthalate | 285-920-2 | 85168-79-2 | Expert judgement |
Bis(3-ethylheptyl) phthalate | 286-806-5 | 85391-51-1 | Expert judgement |
Bis(2-methyloctyl) phthalate | 274-944-9 | 70857-56-6 | Expert judgement |
Bis(2-methyldecyl) phthalate | 288-643-5 | 85851-83-8 | Expert judgement |
Bis(2-ethyloctyl) phthalate | 288-640-9 | 85851-81-6 | Expert judgement |
Bis(3,5,5-trimethylhexyl) phthalate | 237-954-4 | 14103-61-8 | Expert judgement |
3-ethylheptyl 2,5-dimethylheptyl phthalate | 307-707-6 | 97692-55-2 | Expert judgement |
Bis(2-propyloctyl) phthalate | 288-645-6 | 85851-85-0 | Expert judgement |